National Health (Highly Specialised Drugs Program) Special Arrangement 2021

Contents

1Name#

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement 2021.

(2)This instrument may also be cited as PB 27 of 2021.

3Authority#

This instrument is made under sections 85, 85A, 88, 99 and 100 of the National Health Act 1953.

5Simplified outline of this instrument#

This instrument makes a special arrangement for the supply of pharmaceutical benefits that contain highly specialised drugs for the treatment of chronic conditions.

Restrictions apply to the prescribing and supply of these benefits because of their clinical use and other special features.

The prescribing of these benefits is in most cases limited to practitioners who have undertaken particular training or are affiliated with a specialised hospital unit.

The supply of these benefits is restricted to persons who are receiving treatment by medical practitioners and authorised nurse practitioners.

These benefits will be supplied by approved suppliers (public and private hospitals, community pharmacies and certain medical practitioners).

This instrument also deals with payments for supplies of these pharmaceutical benefits.

Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

6Definitions#

Note 1: A number of expressions used in this instrument are defined in the Act, including the following:

(a) Chief Executive Medicare;

(b) hospital;

Note 2: Under subsection 4(1A) of the Act, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that are defined in that Act include the following:

(a) eligible person;

(b) medical practitioner;

(d) specialist.

In this instrument:

accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS in accordance with this instrument.

accredited prescriber of medication for the treatment of schizophrenia means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of schizophrenia in accordance with this instrument.

Act means the National Health Act 1953.

affiliated: a specialist is affiliated with a hospital if the specialist is:

(a)a staff specialist of the hospital; or

(b)a visiting or consulting specialist of the hospital.

approved ex-manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

approved hospital authority has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.

approved medical practitioner has the same meaning as in Part VII of the Act.

approved pharmacist has the same meaning as in Part VII of the Act.

Approved Pharmacists Commonwealth Price Determination means the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.

Approved Pharmacists Conditions Determination means the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.

approved supplier has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.

authorised nurse practitioner has the same meaning as in Part VII of the Act.

authorised prescriber has the meaning given by section 7.

CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:

(a)abatacept;

(b)adalimumab;

(c)ambrisentan;

(d)anifrolumab;

(e)avatrombopag;

(f)azacitidine;

(g)benralizumab;

(h)bosentan;

(i)burosumab;

(j)difelikefalin;

(k)dupilumab;

(l)eculizumab;

(m)eflornithine;

(n)elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;

(o)eltrombopag;

(p)epoprostenol;

(q)etanercept;

(r)iloprost;

(s)infliximab;

(t)ivacaftor;

(u)lenalidomide;

(v)lumacaftor with ivacaftor;

(w)macitentan;

(x)macitentan with tadalafil;

(y)mepolizumab;

(z)midostaurin;

(aa)nitisinone;

(ab)nusinersen;

(ac)omalizumab;

(ad)onasemnogene abeparvovec;

(ae)pasireotide;

(af)pegcetacoplan;

(ag)pegunigalsidase alfa;

(ah)pegvisomant;

(ai)pomalidomide;

(aj)ravulizumab;

(ak)riociguat;

(al)risdiplam;

(am)romiplostim;

(an)rozanolixizumab;

(ao)selexipag;

(ap)sildenafil;

(aq)tadalafil;

(ar)teduglutide;

(as)tezacaftor with ivacaftor and ivacaftor;

(at)tezepelumab;

(au)tocilizumab;

(av)ustekinumab;

(aw)vanzacaftor with tezacaftor and with deutivacaftor;

(ax)vedolizumab;

(ay)vutrisiran;

(az)zilucoplan.

circumstances code means the letter “C” followed by a number.

community access medication means any of the following:

(a)medication for the treatment of hepatitis B;

(b)medication for the treatment of HIV or AIDS, other than a pharmaceutical benefit that has the drug:

(i)azithromycin; or

(ii)doxorubicin - pegylated liposomal; or

(iii)rifabutin;

(c)medication for the treatment of opioid dependence;

(d)medication for continuing treatment of schizophrenia;

(e)edaravone;

(f)lanreotide;

(g)octreotide, if:

(i)the description of its form includes “Injection (modified release)”; and

(ii)it is for continuing treatment.

CTG registered patient has the same meaning as in the CTG Special Arrangement.

CTG Special Arrangement means the National Health (Closing the Gap—PBS Co-payment Program) Special Arrangement 2026.

CTG supplier has the same meaning as in the CTG Special Arrangement.

dangerous drug has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

dangerous drug fee has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:

(a)is admitted to the hospital (other than through the hospital’s emergency department); and

(b)receives treatment; and

(c)is discharged from the hospital;

in accordance with a pre-existing plan for the person’s treatment.

dispensed price:

(a)for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 29; and

(b)for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital—has the meaning given by section 32.

EFC patient has the meaning given by subsection 8(7).

eligible patient has the meaning given by section 8.

erythropoietin stimulating agent means any of the following:

(a)darbepoetin alfa;

(b)epoetin alfa;

(c)epoetin lambda;

(d)methoxy polyethylene glycol-epoetin beta.

General statement for drugs for the treatment of hepatitis C has the same meaning as in the Listing Instrument.

highly specialised drug means a listed drug mentioned in Schedule 1.

hospital authority has the same meaning as in Part VII of the Act.

HSD hospital authority means a hospital authority for which:

(a)an approval under section 94 of the Act, as modified by section 10 of this instrument, is in force; or

(b)an approval mentioned in section 38 of this instrument is in force.

HSD pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.

listed drug has the same meaning as in Part VII of the Act.

Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024).

medication chart prescription has the same meaning as in the Regulations.

medication for the treatment of hepatitis B means any of the following:

(a)entecavir;

(b)lamivudine;

(c)tenofovir.

medication for the treatment of hepatitis C means medication mentioned in the table in clause 3 of the General statement for drugs for the treatment of hepatitis C.

medication for the treatment of HIV or AIDS means any of the following:

(a)abacavir;

(b)abacavir with lamivudine;

(c)atazanavir with cobicistat;

(d)azithromycin;

(e)bictegravir with emtricitabine with tenofovir alafenamide;

(f)cabotegravir;

(g)cabotegravir and rilpivirine;

(h)darunavir;

(i)darunavir with cobicistat;

(j)darunavir with cobicistat, emtricitabine and tenofovir alafenamide;

(k)dolutegravir;

(l)dolutegravir with abacavir and lamivudine;

(m)dolutegravir with lamivudine;

(n)dolutegravir with rilpivirine;

(o)doxorubicin - pegylated liposomal;

(p)emtricitabine with rilpivirine with tenofovir alafenamide;

(q)emtricitabine with tenofovir alafenamide;

(r)etravirine;

(s)ganciclovir;

(t)lamivudine;

(u)lamivudine with zidovudine;

(v)lopinavir with ritonavir;

(w)maraviroc;

(x)nevirapine;

(y)raltegravir;

(z)rifabutin;

(aa)rilpivirine;

(ab)ritonavir;

(ac)tenofovir;

(ad)tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;

(ae)tenofovir with emtricitabine;

(af)tenofovir with emtricitabine and efavirenz;

(ag)valganciclovir;

(ah)zidovudine.

medication for the treatment of opioid dependence means any of the following:

(a)buprenorphine;

(b)buprenorphine with naloxone;

(c)methadone.

medication for the treatment of schizophrenia means clozapine.

ODT pharmaceutical benefit means an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of opioid dependence.

pack quantity has the same meaning as in Part VII of the Act.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

pharmaceutical item has the same meaning as in Part VII of the Act.

price to pharmacists has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

proportional ex-manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

purposes code means the letter “P” followed by a number.

Regulations means the National Health (Pharmaceutical Benefit) Regulations 2017.

residential care service has the same meaning as in the Regulations.

special arrangement supply has the meaning given by sections 13 and 41.

UNAR drug (short for Unrestricted—No Authority Required drug) means any of the following highly specialised drugs:

(a)rituximab.

7Definition of authorised prescriber#

Specialists affiliated with hospitals

(1)A specialist is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if the specialist is affiliated with the hospital.

Medical practitioners—with the agreement of specialists

(2)A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if all of the following apply:

(a)the benefit is for continuing treatment for the patient;

(b)the patient’s treatment is being managed by a specialist;

(c)it is impractical for the patient to obtain a prescription for the benefit from the specialist;

(d)the specialist has agreed to the prescribing of the benefit for the patient by the medical practitioner.

Medical practitioners—if authorised by Commonwealth and State authorities

(3)A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient if all of the following apply:

(a)the HSD pharmaceutical benefit is for continuing treatment for the patient;

(b)the medical practitioner is authorised (however described) by an authority of the Commonwealth for the purposes of this provision;

(c)the medical practitioner is authorised (however described) by an authority of the State or Territory in which the hospital is located for the purposes of this provision.

Medical practitioners—specified medications

(4)A medical practitioner is an authorised prescriber for the following HSD pharmaceutical benefits:

(a)a benefit that has a drug that is a medication for the treatment of hepatitis C;

(b)a benefit that has the drug edaravone;

(c)a benefit that has the drug lanreotide;

(d)a benefit that has the drug octreotide, if:

(i)the description of its form includes “Injection (modified release)”; and

(ii)it is for continuing treatment;

(e)a benefit that has an erythropoietin stimulating agent;

(f)a benefit that has a drug that is a medication for the treatment of hepatitis B.

Accredited prescribers—HSD pharmaceutical benefits for the treatment of HIV or AIDS, and schizophrenia

(5)The following table has effect.

Authorised prescribers for certain HSD pharmaceutical benefits
Item	Column 1The following person …	Column 2is an *authorised prescriber* for an HSD pharmaceutical benefit that has a drug that is …
1	An accredited prescriber of medication for the treatment of HIV or AIDS	a medication for the treatment of HIV or AIDS.
2	An accredited prescriber of medication for the treatment of schizophrenia	a medication for the treatment of schizophrenia.

Authorised nurse practitioners and medical practitioners—ODT pharmaceutical benefits

(6)Each of the following is an authorised prescriber for an ODT pharmaceutical benefit:

(a)an authorised nurse practitioner;

(b)a medical practitioner.

Authorised nurse practitioners—specified medications

(6A)An authorised nurse practitioner is an authorised prescriber for the following HSD pharmaceutical benefits:

(a)a benefit that has an erythropoietin stimulating agent;

(b)a benefit that has a drug that is a medication for the treatment of hepatitis B;

(c)a benefit that has a drug that is a medication for the treatment of hepatitis C;

(d)a benefit that has the drug ruxolitinib.

(7)To avoid doubt, a person is not an authorised prescriber, within the meaning of this instrument, for an HSD pharmaceutical benefit only because the person is authorised in accordance with section 12 of the Listing Instrument to write a prescription for the supply of the pharmaceutical benefit.

Note: A supply of an HSD pharmaceutical benefit is not a special arrangement supply of the benefit unless the supply was prescribed by an authorised prescriber for the benefit (see section 13 of this instrument).

8Definition of eligible patient#

Persons receiving treatment by medical practitioners at or from public hospitals other than as admitted patients

(1)A person is an eligible patient for an HSD pharmaceutical benefit if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by a medical practitioner at or from a public hospital; and

(c)is receiving that treatment as:

(i)a non-admitted patient of the hospital; or

(ii)a day admitted patient of the hospital; or

(iii)a patient on discharge from the hospital; and

(d)is not an EFC patient (see subsection (7)) for the benefit.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—medication for the treatment of hepatitis C

(2)A person is an eligible patient for an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of hepatitis C if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

(c)is receiving that treatment as:

(i)a non-admitted patient of the hospital; or

(ii)a day admitted patient of the hospital; or

(iii)a patient on discharge from the hospital.

Persons receiving treatment by medical practitioners in public hospitals as admitted patients—HSD pharmaceutical benefits that contain eculizumab for the treatment of atypical haemolytic uraemic syndrome

(3)A person is an eligible patient for an HSD pharmaceutical benefit that has the drug eculizumab for the treatment of atypical haemolytic uraemic syndrome if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by a medical practitioner in a public hospital; and

(c)is receiving that treatment as an admitted patient (other than a day admitted patient) of the hospital.

Persons receiving treatment by medical practitioners in, at or from private hospitals

(4)A person is an eligible patient for an HSD pharmaceutical benefit if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by a medical practitioner in, at or from a private hospital; and

(c)is not an EFC patient (see subsection (7)) for the benefit.

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—medication for the treatment of hepatitis C

(5)A person is an eligible patient for an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of hepatitis C if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Persons receiving HSD pharmaceutical benefits that have drugs that are community access medications

(6)A person is an eligible patient for an HSD pharmaceutical benefit if:

(a)the benefit has a drug that is a community access medication; and

(b)the person is, or is to be treated as, an eligible person.

EFC patient

(7)A person is an EFC patient for an HSD pharmaceutical benefit that has a UNAR drug if the benefit is or will be prescribed to the person:

(a)in accordance with the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024; or

(b)for the purposes of chemotherapy treatment for cancer.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—azithromycin, doxorubicin - pegylated liposomal or rifabutin

(8)A person is an eligible patient for an HSD pharmaceutical benefit that has the drug azithromycin, doxorubicin - pegylated liposomal or rifabutin if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

(c)is receiving that treatment as:

(i)a non-admitted patient of the hospital; or

(ii)a day admitted patient of the hospital; or

(iii)a patient on discharge from the hospital.

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—azithromycin, doxorubicin - pegylated liposomal or rifabutin

(9)A person is an eligible patient for an HSD pharmaceutical benefit that has the drug azithromycin, doxorubicin - pegylated liposomal or rifabutin if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—specified medications

(10)A person is an eligible patient for an HSD pharmaceutical benefit mentioned in paragraph 7(6A)(a) or (d) if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

(c)is receiving that treatment as:

(i)a non-admitted patient of the hospital; or

(ii)a day admitted patient of the hospital; or

(iii)a patient on discharge from the hospital.

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—specified medications

(11)A person is an eligible patient for an HSD pharmaceutical benefit mentioned in paragraph 7(6A)(a) or (d) if the person:

(a)is, or is to be treated as, an eligible person; and

(b)is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Division 2 · Supplies of HSD pharmaceutical benefits from hospitals

9Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals#

(1)In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved hospital authority supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which it is the governing body or proprietor includes a reference to the hospital authority supplying HSD pharmaceutical benefits to patients receiving treatment from the hospital.

(2)This section applies in addition to section 94 of the Act.

Division 3 · HSD hospital authorities

10HSD hospital authorities#

(1)Section 94 of the Act applies as if that section permitted the Minister to approve a hospital authority for the purpose of its supplying HSD pharmaceutical benefits to patients receiving treatment in, at or from the hospital of which it is the governing body or proprietor if the dispensing of those benefits is performed:

(a)other than at the hospital; and

(b)by or under the direct supervision of a medical practitioner or pharmacist.

(2)Subsection (1) applies despite subsection 94(5) of the Act.

11References to approved suppliers and approved hospital authorities#

In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority.

12Numbers allotted to HSD hospital authorities#

For the purposes of Part VII of the Act and regulations or other instruments made for the purposes of that Part, a number allotted to an HSD hospital authority under either of the following provisions is taken to have been allotted by the Minister under subsection 16(4) of the Regulations:

(a)subsection 52(3) of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010);

(b)subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010).

Part 2 · Special arrangement supplies of HSD pharmaceutical benefits

Division 1 · Preliminary

13Definition of special arrangement supply#

Prescriptions written for public hospital patients

(1)A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

(a)the person is an eligible patient for the benefit; and

(b)the benefit is supplied by:

(i)for any benefit—an approved hospital authority for a public hospital; or

(ii)for a benefit that has a CAR drug or UNAR drug—an approved pharmacist; and

(c)the benefit is supplied on the basis of a prescription written:

(i)when the person was receiving medical treatment in, at or from a public hospital; and

(ii)by an authorised prescriber for the benefit; and

(iii)unless the benefit has a UNAR drug—in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Prescriptions written for private hospital patients

(2)A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

(a)the person is an eligible patient for the benefit; and

(b)the benefit is supplied by:

(i)an approved hospital authority for a private hospital; or

(ii)an approved pharmacist; and

(c)the benefit is supplied on the basis of a prescription written:

(i)when the person was receiving medical treatment in, at or from a private hospital; and

(ii)by an authorised prescriber for the benefit; and

(iii)unless the benefit has a UNAR drug—in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Community access arrangements

(3)A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

(a)the benefit has a drug that is a community access medication; and

(b)the person is an eligible patient for the benefit; and

(c)the benefit is supplied by an approved supplier; and

(d)the benefit is supplied on the basis of a prescription written:

(i)by an authorised prescriber for the benefit; and

(ii)in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Division 2 · Prescribing of HSD pharmaceutical benefits

15Prescription circumstances—general (Act s 85(7)(a) and (b))#

(1)For the purposes of paragraph 85(7)(a) of the Act, an HSD pharmaceutical benefit, other than a benefit that has a UNAR drug, is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

(2)For the purposes of paragraph 85(7)(b) of the Act, the circumstances in which a prescription for a special arrangement supply of an HSD pharmaceutical benefit, other than a benefit that has a UNAR drug, may be written are the circumstances mentioned in Schedule 3 to this instrument for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 to this instrument for the benefit.

(3)This section applies in addition to section 13 of the Listing Instrument.

16Prescription circumstances—authority required procedures#

(1)This section applies to a prescription for a special arrangement supply of an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 (if any) in which the prescription is written include:

(a)Compliance with Authority Required procedures; or

(b)Compliance with Written Authority Required procedures.

(2)Section 19 of the Listing Instrument applies to the prescription as if:

(a)a reference to Part 1 of Schedule 4 to that instrument were a reference to Schedule 3 to this instrument; and

(b)a reference to an authorised prescriber were a reference to an authorised prescriber within the meaning of this instrument.

18When medication chart prescriptions not to be written#

Persons receiving treatment in residential care services

(2)Subparagraph 41(1)(a)(i) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit.

19Prescriptions not to direct repeated supplies for visitors to Australia#

(1)An authorised prescriber for an HSD pharmaceutical benefit must not write a prescription directing a repeated supply of an HSD pharmaceutical benefit to a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.

(2)This section applies despite section 85A of the Act.

20Maximum quantity or number of units (Act s 85A(2)(a))#

(1)For the purposes of paragraph 85A(2)(a) of the Act, this section sets out the maximum quantity or number of units of the pharmaceutical item in an HSD pharmaceutical benefit that may, in one prescription for a special arrangement supply of the benefit, be directed by an authorised prescriber to be supplied on any one occasion.

Supply for particular purposes

(2)If:

(a)a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b)the supply of the benefit is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum quantity or number of units is the quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

(3)If:

(a)a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b)a quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit;

the maximum quantity or number of units is that quantity or number of units.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

(4)If:

(a)a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b)the words “See Schedule 2” appear in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit; and

(c)the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum quantity or number of units is the quantity or number of units that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

Application of this section

(5)To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

(6)To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

21Maximum number of repeats (Act s 85A(2)(b))#

(1)For the purposes of paragraph 85A(2)(b) of the Act, this section sets out the maximum number of occasions an authorised prescriber may, in one prescription, direct that a special arrangement supply of an HSD pharmaceutical benefit be repeated.

Supply for particular purposes

(2)If:

(a)a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b)the supply is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum number is the number mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

(3)If:

(a)a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b)a number is mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit;

the maximum number is that number.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

(4)If:

(a)a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b)the words “See Schedule 2” appear in the column headed “Maximum repeats” in Schedule 1 for the benefit; and

(c)the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum number is the number that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

Application of this section

(5)To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

(6)To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

23Records to be kept—prescriptions for HSD pharmaceutical benefits that have eculizumab for the treatment of atypical haemolytic uraemic syndrome#

(1)If an authorised prescriber for an HSD pharmaceutical benefit that has the drug eculizumab for the treatment of atypical haemolytic uraemic syndrome writes a prescription for a special arrangement supply of the benefit, a copy of any clinical records relating to the prescription, including records required to demonstrate that the prescription was written in compliance with the circumstances and purposes determined in relation to the benefit under subsection 85(7) of the Act, must be kept by:

(a)the approved hospital authority for the hospital in, at or from which the eligible patient is receiving treatment; or

(b)if the approved hospital authority is not able to keep the records—the authorised prescriber.

(2)The records must be kept for 2 years after the date the prescription to which the records relate is written.

Division 3 · Supplying HSD pharmaceutical benefits

24Special patient contribution for certain HSD pharmaceutical benefits#

(1)This section applies to a special arrangement supply of an HSD pharmaceutical benefit mentioned in the following table.

Special patient contribution for certain HSD pharmaceutical benefits
Item	Drug	Form	Manner of administration	Brand	Pack quantity	Claimed price ($)
1	Lamivudine	Tablet 100 mg	Oral	Zeffix	28	28.09
2	Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	100	42.70

(2)The special patient contribution for a pack quantity of a listed brand of a pharmaceutical item mentioned in the table is the amount that is the difference between:

(a)the price that would have been the dispensed price for that quantity of the brand of the pharmaceutical item if that dispensed price had been based on the claimed price (within the meaning of Part VII of the Act) mentioned in the table for that quantity; and

(b)the dispensed price for that quantity of the brand of the pharmaceutical item.

(3)This section applies despite subsection 85B(5) of the Act.

25Conditions for approved pharmacists#

Special arrangement supplies of certain HSD pharmaceutical benefits

(1)The Approved Pharmacists Conditions Determination does not apply to the dispensing or supply of an HSD pharmaceutical benefit if:

(a)the manner of administration of the benefit is injection or extracorporeal circulation; and

(b)the benefit does not have a drug that is a community access medication; and

(c)the supply is a special arrangement supply of the benefit.

ODT pharmaceutical benefits—special arrangement supplies through agents

(2)If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph 6(e), subsection 9(1), section 10, paragraphs 14(a) and (b) and section 15 of that Determination were omitted.

ODT pharmaceutical benefits—special arrangement supplies other than through agents

(3)If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit other than a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph (c) of the definition of dispensing step in section 5 of that Determination were omitted.

26Supplies need not be directly to persons#

Supplies of HSD pharmaceutical benefits by HSD hospital authorities

(1)An HSD hospital authority may make a special arrangement supply of an HSD pharmaceutical benefit to a person:

(a)other than directly to the person; or

(b)through an agent.

Supplies of ODT pharmaceutical benefits by approved pharmacists and approved hospital authorities

(2)An approved pharmacist or an approved hospital authority may make a special arrangement supply of an ODT pharmaceutical benefit to a person through a person or organisation:

(a)that has premises in a State or Territory; and

(b)that is authorised (however described) by an authority of the State or Territory for the purposes of supplying medication for the treatment of opioid dependence.

Application of this section

(3)This section applies in addition to section 94 of the Act.

27Repeated supplies of pharmaceutical benefits#

Section 51 of the Regulations does not apply to a special arrangement supply of HSD pharmaceutical benefits.

Part 3 · Payment for special arrangement supplies of HSD pharmaceutical benefits

Division 1 · Supplies by approved hospital authorities for public hospitals

28Rates of payment for approved hospital authorities for public hospitals (Act s 99(4))#

(1)For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a public hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the hospital authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

(2)This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017).

Note: See subsection 99(4) of the Act (read with section 9 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

29Dispensed price for approved hospital authorities for public hospitals#

(1)The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital is as follows:

(a)if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex-manufacturer price or the proportional ex-manufacturer price (as applicable) for each pack quantity;

(b)if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the amount worked out in accordance with subsection (2);

(c)if neither paragraph (a) or (b) applies to the quantity of the benefit supplied—the sum of:

(i)the approved ex-manufacturer price or the proportional ex-manufacturer price (as applicable) for each pack quantity; and

(ii)the amount calculated in accordance with subsection (2) for the remainder of the quantity that is a broken quantity.

Broken quantities

(2)For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out by:

(a)dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

(b)applying that percentage to the approved ex-manufacturer price or proportional ex-manufacturer price (as applicable) for the pack quantity.

Rounding

(3)The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

Division 2 · Supplies by other approved suppliers

30Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners#

(1)This section applies if:

(a)an approved pharmacist or approved medical practitioner has supplied an HSD pharmaceutical benefit; and

(b)the supply is a special arrangement supply of the benefit.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

(2)The approved pharmacist or approved medical practitioner is, subject to section 99AAA of the Act and the conditions determined under section 98C of the Act that are applicable at the time of the supply, entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 87 of the Act in respect of the supply.

Note: Section 87 of the Act limits the amounts that approved pharmacists and approved medical practitioners can charge patients for the supply of pharmaceutical benefits.

(3)This section applies despite subsections 99(2) and (2AA) of the Act.

30A Paragraph 99AAAB(1)(b) of the Act does not apply to certain HSD pharmaceutical benefits #

Paragraph 99AAAB(1)(b) of the Act does not apply to a special arrangement supply of an HSD pharmaceutical benefit if:

(a)the manner of administration of the benefit is injection or extracorporeal circulation; and

(b)the benefit is not a community access medication.

31Rates of payment for approved hospital authorities for private hospitals (Act s 99(4))#

(1)For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a private hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

(2)This section applies despite the National Health (Commonwealth Price - Pharmaceutical benefits supplied by private hospitals) Determination 2020 (PB 99 of 2020).

32Dispensed price for approved suppliers other than approved hospital authorities for public hospitals#

(1)The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital is as follows:

(a)if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of:

(i)the approved ex-manufacturer price or the proportional ex-manufacturer price (as applicable) for each pack quantity; and

(ia)if the approved supplier is an approved pharmacist—the wholesale mark-up for a pack quantity of a ready-prepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved ex-manufacturer price or proportional ex-manufacturer price (as applicable) for that pack quantity; and

(ii)if the benefit is a ready-prepared pharmaceutical benefit—the mark-up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

(iii)the dispensing fee for the benefit in accordance with section 34; and

(iv)if the benefit is a ready-prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee;

(b)if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the sum of:

(i)the amount worked out in accordance with subsection (2); and

(ii)the dispensing fee for the benefit in accordance with section 34; and

(iii)if the benefit is a ready-prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee;

(c)if the quantity of the benefit supplied is more than a multiple of a pack quantity of the benefit—the sum of:

(i)the approved ex-manufacturer price or the proportional ex-manufacturer price (as applicable) for each pack quantity; and

(ii)if the benefit is a ready-prepared pharmaceutical benefit—the mark-up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

(iii)the amount worked out in accordance with subsection (2) for the remainder of the quantity that is a broken quantity; and

(iv)the dispensing fee for the benefit in accordance with section 34; and

(v)if the benefit is a ready-prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee.

Broken quantities

(2)For the purposes of subparagraphs (1)(b)(i) and (c)(iii), the amount for a broken quantity is worked out by:

(a)dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

(b)applying that percentage to the sum of:

(i)the approved ex-manufacturer price or the proportional ex-manufacturer price (as applicable) for the pack quantity; and

(ii)if the benefit is a ready-prepared pharmaceutical benefit—the mark-up mentioned in section 33 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards).

Rounding

(3)The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

33Mark-up for ready-prepared pharmaceutical benefits#

Approved suppliers other than approved pharmacists

(1)Subsection (2) applies if an approved supplier is not an approved pharmacist.

(2)For the purposes of subparagraphs 32(1)(a)(ii), (c)(ii) and (2)(b)(ii), the mark-up for a pack quantity of an HSD pharmaceutical benefit that is a ready-prepared pharmaceutical benefit is:

(a)if the pack quantity of the benefit is equal to the maximum quantity of the benefit mentioned in section 20—the amount mentioned in the following table for the approved ex-manufacturer price (AEMP) or proportional ex-manufacturer price (PEMP) (as applicable) for that quantity; or

(b)if the pack quantity of the benefit is less than the maximum quantity of the benefit mentioned in section 20:

(i)if the mark-up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

(ii)if the mark-up mentioned in the following table for the maximum quantity is a percentage of the AEMP or PEMP (as applicable)—that percentage of the AEMP or PEMP for the pack quantity.

Mark-up for ready-prepared pharmaceutical benefits
Item	If the AEMP or PEMP (as applicable) for the maximum quantity is …	the mark-up for the maximum quantity is …
1	less than $40	10% of the AEMP or PEMP
2	at least $40 but not more than $100	$4
3	more than $100 but not more than $1,000	4% of the AEMP or PEMP
4	more than $1,000	$40

Approved pharmacists

(3)Subsection (4) applies if an approved supplier is an approved pharmacist.

(4)For the purposes of subparagraphs 32(1)(a)(ii), (c)(ii) and (2)(b)(ii), the mark-up for a pack quantity of an HSD pharmaceutical benefit that is a ready-prepared pharmaceutical benefit is:

(a)if the pack quantity of the benefit is equal to the maximum quantity of the benefit mentioned in section 20—the amount mentioned in the following table for the price to pharmacists (PTP) for that quantity; or

(b)if the pack quantity of the benefit is less than the maximum quantity of the benefit mentioned in section 20:

(i)if the mark-up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

(ii)if the mark-up mentioned in the following table for the maximum quantity is a percentage of the price to pharmacists—that percentage of the price to pharmacists for the pack quantity.

Mark-up for ready-prepared pharmaceutical benefits
Item	If the PTP for the maximum quantity is …	the mark-up for the PTP is …
1	less than $40	10% of the PTP
2	at least $40 but not more than $100	$4
3	more than $100 but not more than $1,000	4% of the PTP
4	more than $1,000	$40

Note: See the definition of price to pharmacists in section 6.

34Dispensing fee#

(1)For the purposes of subparagraphs 32(1)(a)(iii), (b)(ii) and (c)(iv):

(a)the dispensing fee for the supply of an HSD pharmaceutical benefit is:

(i)if the benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously-prepared dispensing fee (within the meaning of the Approved Pharmacists Commonwealth Price Determination); or

(ii)if subparagraph (i) does not apply—the ready-prepared dispensing fee (within the meaning of that Determination); and

(b)if the authorised prescriber who prescribed the benefit, instead of directing a repeated supply of the benefit, directed the supply on one occasion of a quantity or number of units of the benefit, not exceeding the total quantity or number of units that could be prescribed if the authorised prescriber directed a repeated supply, the dispensed price for the supply of the benefit includes:

(i)only one dispensing fee; and

(ii)only one dangerous drug fee.

Note: See section 49 of the Regulations for the circumstances in which such a supply may be directed.

(2)For the purpose of subparagraph (1)(a)(i), the drugs and the forms for the drugs are as follows:

(a)mycophenolic acid as a powder for oral suspension containing mycophenolate mofetil 1g per 5 mL, 165mL;

(b)valganciclovir as a powder for oral solution 50mg (as hydrochloride) per mL, 100 mL.

Part 3A · Supply to CTG registered patients by CTG suppliers

34AApplication of this Part#

This Part applies to a special arrangement supply (the relevant supply) of an HSD pharmaceutical benefit under this Special Arrangement if the relevant supply is made:

(a)to an eligible patient who is a CTG registered patient; and

(b)by an approved supplier who is a CTG supplier.

34BApplication of the CTG Special Arrangement—co-payment and payment etc.#

(1)Despite sections 28, 30, 31 and 37 of this Special Arrangement, subsections 10(1), (2), (3) and (10) (co-payment reduction etc.), section 11 (value for safety net purposes) and section 12 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section.

(2)A reference in the CTG Special Arrangement to a special arrangement supply (within the meaning of the CTG Special Arrangement) of a pharmaceutical benefit is taken to be a reference to the relevant supply under this Special Arrangement.

(3)However, the notes to subsections 10(2) and (3) of the CTG Special Arrangement do not apply in relation to the relevant supply under this Special Arrangement.

Note: The notes to subsections 10(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under Part 4 of this Special Arrangement.

Part 4 · Claims for payment for special arrangement supplies of HSD pharmaceutical benefits

35Rules for providing information about supplies—definition of under co-payment data#

The National Health (Supply of Pharmaceutical Benefits—Under Co-payment Data and Claims for Payment) Rules 2022 apply to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier as if the definition of under co-payment data in that instrument were replaced with the following definition:

under co-payment data means information relating to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier where the amount payable by the Commonwealth is nil because the dispensed price for the supply of the benefit does not exceed the amount that the supplier was entitled to charge under section 87 of the Act in respect of the supply.

35AClaim for payment if an eligible patient is a CTG registered patient#

If:

(a)a claim for payment for a special arrangement supply of an HSD pharmaceutical benefit made under the National Health (Supply of Pharmaceutical Benefits—Under Co-payment Data and Claims for Payment) Rules 2022 is made using the manual system referred to in section 99AAA of the Act; and

(b)the claim is made:

(i)by an approved supplier who is a CTG supplier; and

(ii)in relation to a special arrangement supply of an HSD pharmaceutical benefit to an eligible patient who is a CTG registered patient;

the claim must include an indicator that the eligible patient is a CTG registered patient.

Part 5 · Miscellaneous

36Compliance and audit arrangements#

(1)If an approved supplier makes a special arrangement supply of an HSD pharmaceutical benefit, the approved supplier must keep adequate, secure and auditable records of all supplied HSD pharmaceutical benefits for which a claim is made.

(2)The records must be kept in systems that are able to be audited by the Chief Executive Medicare on reasonable notice being given to the approved supplier.

37Value for safety net purposes for supplies#

Supplies by approved hospital authorities

(1)The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved hospital authority is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under subsection 87(5) of the Act for the supply of the benefit less the amount chargeable under that subsection because of subsection 87(2A) of the Act.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

Supplies by approved pharmacists and approved medical practitioners

(2)The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved pharmacist or approved medical practitioner is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under section 87 of the Act for the supply of the benefit less the amount chargeable under subsection 87(2A) of the Act.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

Application of this section

(3)This section applies despite regulation 17A of the Regulations.

Part 6 · Application, saving and transitional provisions

Division 1 · Provisions relating to this instrument as made

38HSD hospital authorities#

Despite the repeal of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010):

(a)an approval that was in force under subsection 52(2) of that instrument immediately before 1 April 2021; and

(b)an approval that was continued in force under section 53 of that instrument as if it were an approval under subsection 52(2) of that instrument, and was in force immediately before 1 April 2021;

continues in force as if it were an approval under section 94 of the Act, as modified by section 10 of this instrument.

Division 2 · Provisions relating to the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023

39Purpose of this Division#

This Division makes provision in relation to certain pre-commencement prescriptions for the purpose of the application of Part VII of the Act, and regulations and other instruments made for the purposes of that Part, to those prescriptions.

40Definitions#

In this Division:

Claims Rules means the National Health (Supply of Pharmaceutical Benefits—Under Co-payment Data and Claims for Payment) Rules 2022.

pre-commencement benefit: see section 50.

pre-commencement prescription: a prescription is a pre-commencement prescription if:

(a)the prescription was written:

(i)before 1 July 2023; and

(ii)by an authorised nurse practitioner or a medical practitioner; and

(iii)for the supply to a person of a drug that is a medication for the treatment of opioid dependence; and

(iv)in the circumstance that the prescription was for the treatment of opiate dependence, including for detoxification (withdrawal) and maintenance of withdrawal; and

(b)immediately before 1 July 2023, a pre-commencement benefit could have been supplied to the person on the basis of the prescription.

41Definition of special arrangement supply#

A supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:

(a)on or after 1 July 2023; and

(b)to a person who is, or is to be treated as, an eligible person; and

(c)by an approved supplier; and

(d)on the basis of a pre-commencement prescription (as affected by this Division, if applicable); and

(e)in accordance with this Division.

42Prescriptions directing supply for dispensing over time#

(1)This section applies if a pre-commencement prescription directed the supply of a specified quantity or number of units (whether expressed as a total or as a dose) to be dispensed over a specified period of time (the directed dispensing period).

Deemed variation of application of determination of maximum number or quantity of units

(2)If the specified quantity or number of units, or the quantity or number of units required for the doses over the directed dispensing period, is more than the maximum quantity or number of units mentioned in Schedule 1 for the pharmaceutical benefit to be supplied on the basis of the prescription:

(a)the application of the determination of the maximum quantity or number of units under paragraph 85A(2)(a) of the Act for the benefit is taken to have been varied under section 30 of the Regulations; and

(b)the prescription is taken to have been authorised in accordance with subsection 30(4) of the Regulations; and

(c)the number P2023OD is taken to have been allotted to, and marked on, the prescription as mentioned in subsection 30(5) of the Regulations.

Deemed modification of prescription—remaining period of up to 28 days

(3)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the period remaining in the directed dispensing period (the remaining period) is not more than 28 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for the remaining period.

Deemed modification of prescription—remaining period of 29 to 55 days

(4)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 28 days but not more than 55 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for 28 days.

Deemed modification of prescription—remaining period of 56 to 83 days

(5)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 55 days but not more than 83 days, the prescription is taken to direct:

(a)the supply on any one occasion of the total quantity or number of units required for 28 days; and

(b)that the supply be repeated once.

Deemed modification of prescription—remaining period of 84 days or more

(6)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is 84 days or more, the prescription is taken to direct:

(a)the supply on any one occasion of the total quantity or number of units required for 28 days; and

(b)that the supply be repeated twice.

43Prescriptions directing supply of buprenorphine for injection#

(1)This section applies if:

(a)a pre-commencement prescription is for the supply of the drug buprenorphine with the manner of administration injection (the medication); and

(b)the prescription directed the supply of a specified quantity or number of units of the medication (the directed quantity) that is more than the quantity of the medication mentioned in subsection (2) (the standard quantity for the medication).

(2)For the purposes of paragraph (1)(b), the standard quantity for the medication is:

(a)if the brand of the medication is Buvidal Weekly—4; or

(b)if the brand of the medication is Buvidal Monthly or Sublocade—1.

Deemed modification of prescription—remaining quantity of not more than standard quantity

(3)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the quantity or number of units of the medication that remains to be supplied (the remaining quantity) is not more than the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the remaining quantity.

Deemed modification of prescription—remaining quantity of more than standard quantity but less than twice standard quantity

(4)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than the standard quantity for the medication but is less than twice the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the standard quantity for the medication.

Deemed modification of prescription—remaining quantity of more than twice standard quantity but less than 3 times standard quantity

(5)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than twice the standard quantity for the medication but is less than 3 times the standard quantity for the medication, the prescription is taken to direct:

(a)the supply on any one occasion of the standard quantity for the medication; and

(b)that the supply be repeated once.

Deemed modification of prescription—remaining quantity of 3 times standard quantity or more

(6)If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is 3 times the standard quantity for the medication or more, the prescription is taken to direct:

(a)the supply on any one occasion of the standard quantity for the medication; and

(b)that the supply be repeated twice.

44Prescriptions directing supply of methadone#

(1)This section applies if a pre-commencement prescription is for the supply of the drug methadone.

(2)On the basis of the prescription, the person for whom the prescription was written is entitled to receive, and an approved supplier may supply to the person, any ODT pharmaceutical benefit that has the drug methadone.

(3)This section applies despite section 89 and paragraph 103(2)(a) of the Act.

45First supply on or after 1 July 2023 deemed to be supply on first presentation#

If the first supply of an ODT pharmaceutical benefit by an approved supplier on the basis of a pre-commencement prescription on or after 1 July 2023 is not a supply of that benefit on first presentation of the prescription, it is taken to be a supply of that benefit on first presentation of the prescription.

46Supply on first presentation of prescription (Regulations s 44)#

Subparagraphs 44(2)(a)(i) and (3)(a)(i) of the Regulations do not apply to a special arrangement supply of an ODT pharmaceutical benefit on the basis of a pre-commencement prescription.

47Repeat authorisations (Regulations s 52)#

(1)Section 52 of the Regulations applies to the supply of an ODT pharmaceutical benefit on the basis of a pre-commencement prescription to which subsection 42(5) or (6) or 43(5) or (6) of this instrument applies as if the benefit were supplied in the circumstances set out in subsection 52(2) of the Regulations.

(2)Subsection 52(3) of the Regulations applies in relation to a pre-commencement prescription as if the prescription had been authorised in accordance with authority required procedures that are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit to be supplied on the basis of the prescription.

48Prescriptions written in electronic form—additional procedures for giving information (Claims Rules s 7) and keeping documents#

Additional procedures for giving information

(1)Section 7 of the Claims Rules applies in relation to a pre-commencement prescription written in electronic form as if a reference in that section to the prescription were a reference to a print-out of the prescription.

Keeping print-outs of prescriptions

(2)If an approved supplier supplies a pharmaceutical benefit on the basis of a pre-commencement prescription written in electronic form, the approved supplier must keep a print-out of the prescription for at least 2 years from the date the pharmaceutical benefit was supplied by the approved supplier.

49Information to be given using Claims Transmission System (Claims Rules Sch 1)#

General

(1)The table in clause 1 of Schedule 1 to the Claims Rules applies to a pre-commencement prescription as follows:

(a)as if, for the purposes of item 2 of the table, the Authority Prescription Number for the prescription were 00000641;

(b)as if, for the purposes of item 8 of the table, the prescription were signed on 1 July 2023;

(c)if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their PBS prescriber number on the prescription—as if, for the purposes of item 28 of the table, that number were written on the prescription;

(d)if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their prescriber ID on the prescription—as if, for the purposes of item 31 of the table, that number were written on the prescription;

(e)if the prescription was written in electronic form—as if, for the purposes of item 32 of the table, the prescription were a paper-based prescription;

(f)as if, for the purposes of item 40 of the table, the authorised nurse practitioner or medical practitioner who wrote the prescription had written on the prescription:

(i)the words “Streamlined Authority Code”; and

(ii)the relevant streamlined authority code included in any circumstances mentioned in an item of the table in Part 1 of Schedule 4 to the Listing Instrument for the writing of a prescription for a pharmaceutical benefit for the treatment of opioid dependence.

Pre-commencement prescriptions written in electronic form

(2)Clause 2 of Schedule 1 to the Claims Rules does not apply to a pre-commencement prescription written in electronic form.

50Pre-commencement benefits#

Each pharmaceutical benefit specified in the following table is a pre-commencement benefit.

Pre-commencement benefits
Item	Listed drug	Form	Manner of administration	Brand
1	Buprenorphine	Injection (modified release) 8 mg in 0.16 mL pre-filled syringe	Injection	Buvidal Weekly
2	Buprenorphine	Injection (modified release) 16 mg in 0.32 mL pre-filled syringe	Injection	Buvidal Weekly
3	Buprenorphine	Injection (modified release) 24 mg in 0.48 mL pre-filled syringe	Injection	Buvidal Weekly
4	Buprenorphine	Injection (modified release) 32 mg in 0.64 mL pre-filled syringe	Injection	Buvidal Weekly
5	Buprenorphine	Injection (modified release) 64 mg in 0.18 mL pre-filled syringe	Injection	Buvidal Monthly
6	Buprenorphine	Injection (modified release) 96 mg in 0.27 mL pre-filled syringe	Injection	Buvidal Monthly
7	Buprenorphine	Injection (modified release) 128 mg in 0.36 mL pre-filled syringe	Injection	Buvidal Monthly
8	Buprenorphine	Injection (modified release) 160 mg in 0.45 mL pre-filled syringe	Injection	Buvidal Monthly
9	Buprenorphine	Injection (modified release) 100 mg in 0.50 mL pre-filled syringe	Injection	Sublocade
10	Buprenorphine	Injection (modified release) 300 mg in 1.50 mL pre-filled syringe	Injection	Sublocade
11	Buprenorphine	Tablet (sublingual) 400 micrograms (as hydrochloride)	Sublingual	Subutex
12	Buprenorphine	Tablet (sublingual) 2 mg (as hydrochloride)	Sublingual	Subutex
13	Buprenorphine	Tablet (sublingual) 8 mg (as hydrochloride)	Sublingual	Subutex
14	Buprenorphine with naloxone	Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)	Sublingual	Suboxone Film 2/0.5
15	Buprenorphine with naloxone	Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)	Sublingual	Suboxone Film 8/2
16	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL	Oral	Biodone Forte
17	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL	Oral	Aspen Methadone Syrup
18	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L	Oral	Biodone Forte
19	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L	Oral	Aspen Methadone Syrup

Note: The drugs mentioned in the table were declared by the Minister under subsection 85(2) of the Act, and the forms, manners of administration and brands mentioned in the table were determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively—see the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) as in force before 1 July 2023.

Division 3 · Provisions relating to the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Increases in Maximum Quantity and Number of Repeats for Complex Authority required (CAR) Medicines) Instrument 2026

51Prescriptions directing increased maximum quantities or numbers of units of HSD pharmaceutical benefits that have a CAR drug#

(1)This section applies to the special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug that is made on or after 1 February 2026 if:

(a)the supply is made on the basis of a prescription that was written before 1 February 2026; and

(b)the prescription directs the supply on any one occasion of a quantity or number of units of the pharmaceutical item in the HSD pharmaceutical benefit that is more than the applicable maximum quantity for the pharmaceutical item; and

(c)before 1 February 2026, the Minister purported under section 30 of the Regulations to:

(i)authorise the variation of the application of the determination of the applicable maximum quantity; and

(ii)allot a number to the prescription.

Note: Former section 22 of this instrument prevented the Minister from authorising, under section 30 of the Regulations, a variation of the application of the determination of the maximum quantity or number of units of a pharmaceutical item in an HSD pharmaceutical benefit that a prescriber could direct to be supplied on any one occasion.

(2)The Minister is taken to have authorised, under subsection 30(2) of the Regulations, the variation of the determination of the applicable maximum quantity in relation to the prescription and the person who wrote the prescription.

(3)The number purportedly allotted to the prescription is taken to have been allotted to the prescription in accordance with subsection 30(3) of the Regulations.

(4)In this section, the applicable maximum quantity, for the pharmaceutical item in the HSD pharmaceutical benefit prescribed for supply, means the quantity or number of units of the pharmaceutical item determined for paragraph 85A(2)(a) of the Act under subsection 20(2), 20(3) or 20(4) of this instrument (whichever is applicable).

52Prescriptions directing increased maximum number of repeats of HSD pharmaceutical benefits that have a CAR drug#

(1)This section applies to the special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug that is made on or after 1 February 2026 if:

(a)the supply is made on the basis of a prescription that was written before 1 February 2026; and

(b)the prescription directs the supply of the HSD pharmaceutical benefit be repeated on a number of occasions that is more than the applicable maximum number of repeats for the pharmaceutical benefit; and

(c)before 1 February 2026, the Minister purported under section 30 of the Regulations to:

(i)authorise the variation of the application of the determination of the applicable maximum number of repeats; and

(ii)allot a number to the prescription.

Note: Former section 22 of this instrument prevented the Minister from authorising, under section 30 of the Regulations, a variation of the application of the determination of the maximum number of occasions on which the supply of an HSD pharmaceutical benefit may, in one prescription, be directed to be repeated.

(2)The Minister is taken to have authorised, under subsection 30(2) of the Regulations, the variation of the determination of the applicable maximum number of repeats in relation to the prescription and the person who wrote the prescription.

(3)The number purportedly allotted to the prescription is taken to have been allotted to the prescription in accordance with subsection 30(3) of the Regulations.

(4)In this section, the applicable maximum number of repeats, for the HSD pharmaceutical benefit prescribed for supply, means the number of occasions an authorised prescriber may, in one prescription, direct the supply of the HSD pharmaceutical be repeated, determined for paragraph 85A(2)(b) of the Act under subsection 21(2), 21(3) or 21(4) of this instrument (whichever is applicable).

Schedule 1 · HSD pharmaceutical benefits and related information

Note: See the definitions of highly specialised drug and HSD pharmaceutical benefit in section 6, and sections 13, 15, 20 and 21.

1Highly specialised drugs and HSD pharmaceutical benefits#

(1)Each listed drug specified in the following table is a highly specialised drug.

(2)Each pharmaceutical benefit specified in the following table is an HSD pharmaceutical benefit.

(3)The following table also specifies circumstances, purposes, maximum quantities and maximum repeats for HSD pharmaceutical benefits.

Note: The drugs mentioned in the table have been declared by the Minister under subsection 85(2) of the Act. The forms, manners of administration and brands mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

HSD pharmaceutical benefits and related information
Listed drug	Form	Manner of administration	Brand	Circumstances	Purposes	Maximum quantity	Maximum repeats
Abacavir	Oral solution 20 mg (as sulfate) per mL, 240 mL	Oral	Ziagen	C13920		8	5
	Tablet 300 mg (as sulfate)	Oral	Ziagen	C4454 C4512		120	5
Abacavir with Lamivudine	Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg	Oral	Abacavir/Lamivudine Viatris	C4527 C4528		60	5
Abatacept	Powder for I.V. infusion 250 mg	Injection	Orencia	C14488 C14507 C14555 C14604 C18169 C18272 C18273 C18274		See Schedule 2	See Schedule 2
Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Humira	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Yuflyma	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
	Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Amgevita	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Hadlima	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Humira	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Hyrimoz	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Yuflyma	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Hadlima	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Humira	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Hyrimoz	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Yuflyma	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Abrilada	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Amgevita	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Hadlima	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Hyrimoz	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Amgevita	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Hadlima	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
			Hyrimoz	C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Alemtuzumab	Solution concentrate for I.V. infusion 12 mg in 1.2 mL	Injection	Lemtrada	C6847 C7714 C9589 C9636	P6847 P9589	3	0
				C6847 C7714 C9589 C9636	P7714 P9636	5	0
Ambrisentan	Tablet 5 mg	Oral	Ambrisentan Viatris	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
			PULMORIS	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
			Volibris	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
	Tablet 10 mg	Oral	Ambrisentan Viatris	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
			Cipla Ambrisentan	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
			PULMORIS	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
			Volibris	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Anakinra	Injection 100 mg in 0.67 mL single use pre-filled syringe	Injection	Kineret	C5450		28	5
Anifrolumab	Solution concentrate for I.V. infusion 300 mg in 2 mL	Injection	Saphnelo	C19096 C19216		See Schedule 2	See Schedule 2
Apomorphine	Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL	Injection	Movapo	C11385 C11445		180	5
	Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL	Injection	Apomine Solution for Infusion	C10830 C10863		90	5
			MOVAPO POD	C10830 C10863		90	5
	Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe	Injection	Movapo PFS	C11385 C11445		180	5
	Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen	Injection	Apomine Intermittent	C10830 C10863		100	5
			Movapo Pen	C10830 C10863		100	5
Atazanavir with cobicistat	Tablet containing 300 mg atazanavir and 150 mg cobicistat	Oral	Evotaz	C4454 C4512		60	5
Avatrombopag	Tablet 20 mg	Oral	Doptelet	C14054 C15340 C15375 C18297		See Schedule 2	See Schedule 2
Azacitidine	Powder for injection 100 mg	Injection	Azacitidine Accord	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
			Azacitidine Dr.Reddy's	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
			Azacitidine Juno	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
			Azacitidine MSN	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
			Azacitidine SXP	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
Azithromycin	Tablet 600 mg (as dihydrate)	Oral	Zithromax	C6356 C9604		16	5
Baclofen	Intrathecal injection 10 mg in 5 mL	Injection	Bacthecal	C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
			Lioresal Intrathecal	C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
			Sintetica Baclofen Intrathecal	C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
	Intrathecal injection 40 mg in 20 mL	Injection	Sintetica Baclofen Intrathecal	C7134 C7148 C7152 C7153 C9525 C9562 C9606 C9638		2	0
Benralizumab	Injection 30 mg in 1 mL single dose pre-filled pen	Injection	Fasenra Pen	C15376 C19082 C19128 C19130		See Schedule 2	See Schedule 2
Bictegravir with emtricitabine with tenofovir alafenamide	Tablet containing bictegravir 50 mg with emtricitabine 200 mg with tenofovir alafenamide 25 mg	Oral	Biktarvy	C4470 C4522		60	5
Bosentan	Tablet 62.5 mg (as monohydrate)	Oral	Bosentan APO	C11229 C12425 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
			BOSENTAN DR.REDDY’S	C11229 C12425 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
			Bosentan RBX	C11229 C12425 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
	Tablet 125 mg (as monohydrate)	Oral	Bosentan APO	C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
			BOSENTAN DR.REDDY’S	C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
			Bosentan GH	C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
			Bosentan RBX	C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
			Bosentan Viatris	C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Buprenorphine	Injection (modified release) 8 mg in 0.16 mL pre-filled syringe	Injection	Buvidal Weekly	C16051		4	5
	Injection (modified release) 16 mg in 0.32 mL pre-filled syringe	Injection	Buvidal Weekly	C16051		4	5
	Injection (modified release) 24 mg in 0.48 mL pre-filled syringe	Injection	Buvidal Weekly	C16051		4	5
	Injection (modified release) 32 mg in 0.64 mL pre-filled syringe	Injection	Buvidal Weekly	C16051		4	5
	Injection (modified release) 64 mg in 0.18 mL pre-filled syringe	Injection	Buvidal Monthly	C16015		1	5
	Injection (modified release) 96 mg in 0.27 mL pre-filled syringe	Injection	Buvidal Monthly	C16015		1	5
	Injection (modified release) 100 mg in 0.5 mL pre-filled syringe	Injection	Sublocade	C16050		1	5
	Injection (modified release) 128 mg in 0.36 mL pre-filled syringe	Injection	Buvidal Monthly	C16015		1	5
	Injection (modified release) 160 mg in 0.45 mL pre-filled syringe	Injection	Buvidal Monthly	C16015		1	5
	Injection (modified release) 300 mg in 1.5 mL pre-filled syringe	Injection	Sublocade	C16050		1	5
	Tablet (sublingual) 400 micrograms (as hydrochloride)	Sublingual	Subutex	C16009		28	5
	Tablet (sublingual) 2 mg (as hydrochloride)	Sublingual	Subutex	C16009		84	5
	Tablet (sublingual) 8 mg (as hydrochloride)	Sublingual	Subutex	C16009		112	5
Buprenorphine with naloxone	Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)	Sublingual	Suboxone Film 2/0.5	C16009		84	5
	Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)	Sublingual	Suboxone Film 8/2	C16009		112	5
Burosumab	Solution for injection 10 mg in 1 mL	Injection	Crysvita	C13377 C18950 C18952 C18953 C18982		See Schedule 2	See Schedule 2
	Solution for injection 20 mg in 1 mL	Injection	Crysvita	C13377 C18950 C18952 C18953 C18982		See Schedule 2	See Schedule 2
	Solution for injection 30 mg in 1 mL	Injection	Crysvita	C13377 C18950 C18952 C18953 C18982		See Schedule 2	See Schedule 2
Cabotegravir	Tablet 30 mg	Oral	Vocabria	C12619		30	0
Cabotegravir and rilpivirine	Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3 mL	Injection	Cabenuva	C12636		1	5
Ciclosporin	Capsule 10 mg	Oral	Neoral 10	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Capsule 25 mg	Oral	APO-Ciclosporin	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			CICLOSPORIN-WGR	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Neoral 25	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Capsule 50 mg	Oral	APO-Ciclosporin	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			CICLOSPORIN-WGR	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Neoral 50	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Capsule 100 mg	Oral	APO-Ciclosporin	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			CICLOSPORIN-WGR	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Neoral 100	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Oral liquid 100 mg per mL, 50 mL	Oral	Neoral	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		4	5
	Solution concentrate for I.V. infusion 50 mg in 1 mL	Injection	Sandimmun	C6628 C9831		10	0
Cinacalcet	Tablet 30 mg (as hydrochloride)	Oral	Cinacalcet Viatris	C10063 C10067 C10073		56	5
			Pharmacor Cinacalcet	C10063 C10067 C10073		56	5
	Tablet 60 mg (as hydrochloride)	Oral	Cinacalcet Viatris	C10063 C10067 C10073		56	5
			Pharmacor Cinacalcet	C10063 C10067 C10073		56	5
	Tablet 90 mg (as hydrochloride)	Oral	Cinacalcet Viatris	C10063 C10067 C10073		56	5
			Pharmacor Cinacalcet	C10063 C10067 C10073		56	5
Clozapine	Oral liquid 50 mg per mL, 100 mL	Oral	Clopine Suspension	C4998 C5015 C9490		1	0
			Versacloz	C4998 C5015 C9490		1	0
	Tablet 25 mg	Oral	Clopine 25	C4998 C5015 C9490		200	0
			Clozaril 25	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
	Tablet 50 mg	Oral	Clopine 50	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
	Tablet 100 mg	Oral	Clopine 100	C4998 C5015 C9490		200	0
			Clozaril 100	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
	Tablet 200 mg	Oral	Clopine 200	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
Darbepoetin alfa	Injection 10 micrograms in 0.4 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 20 micrograms in 0.5 mL pre-filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 20 micrograms in 0.5 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 30 micrograms in 0.3 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 40 micrograms in 0.4 mL pre-filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 40 micrograms in 0.4 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 50 micrograms in 0.5 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 60 micrograms in 0.3 mL pre-filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 60 micrograms in 0.3 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 80 micrograms in 0.4 mL pre-filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 80 micrograms in 0.4 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 100 micrograms in 0.5 mL pre-filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 100 micrograms in 0.5 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 150 micrograms in 0.3 mL pre-filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 150 micrograms in 0.3 mL pre-filled syringe	Injection	Aranesp	C6294 C9688		8	5
Darunavir	Tablet 600 mg	Oral	Darunavir Juno	C5094		120	5
	Tablet 600 mg (as ethanolate)	Oral	Prezista	C5094		120	5
	Tablet 800 mg	Oral	Darunavir Juno	C4313		60	5
	Tablet 800mg (as ethanolate)	Oral	Prezista	C4313		60	5
Darunavir with cobicistat	Tablet containing darunavir 800mg with cobicistat 150 mg	Oral	Prezcobix	C6377 C6413 C6428		60	5
Darunavir with cobicistat, emtricitabine and tenofovir alafenamide	Tablet containing darunavir 800 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg	Oral	Symtuza	C10317 C10324		60	5
Deferasirox	Tablet 90 mg	Oral	DEFERAMED	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERASIROX-TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERAMED	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			DEFERASIROX-TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
	Tablet 180 mg	Oral	DEFERAMED	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERASIROX-TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERAMED	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			DEFERASIROX-TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
	Tablet 360 mg	Oral	DEFERAMED	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERASIROX-TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERAMED	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			DEFERASIROX-TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
	Tablet, dispersible, 125 mg	Oral	Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
				C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
	Tablet, dispersible, 250 mg	Oral	Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
				C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
	Tablet, dispersible, 500 mg	Oral	Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
Deferiprone	Oral solution 100 mg per mL, 250 mL	Oral	Ferriprox	C6403 C6448 C9228 C9286		5	5
	Tablet 500 mg	Oral	Ferriprox	C6403 C6448 C9228 C9286		300	5
	Tablet 1000 mg	Oral	Ferriprox	C6403 C6448 C9590 C9623		300	5
Desferrioxamine	Powder for injection containing desferrioxamine mesilate 500 mg	Injection	DBL Desferrioxamine Mesilate	C6394 C9696		400	5
	Powder for injection containing desferrioxamine mesilate 2 g	Injection	DBL Desferrioxamine Mesilate	C6394 C9696		60	5
Difelikefalin	Solution for I.V. injection 50 micrograms (as acetate) in 1 mL	Injection	Korsuva	C15171 C15211		See Schedule 2	See Schedule 2
Dolutegravir	Tablet 50mg (as sodium)	Oral	Tivicay	C4454 C4512		60	5
Dolutegravir with abacavir and lamivudine	Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg	Oral	Triumeq	C9981 C10116		60	5
Dolutegravir with lamivudine	Tablet containing dolutegravir 50 mg (as sodium) with lamivudine 300 mg	Oral	Dovato	C9987 C11066		60	5
Dolutegravir with rilpivirine	Tablet containing dolutegravir 50 mg (as sodium) with rilpivirine 25 mg (as hydrochloride)	Oral	Juluca	C8214 C8226		60	5
Dornase Alfa	Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL	Inhalation	Pulmozyme	C5634 C5635 C5740 C9591 C9592 C9624		60	5
Doxorubicin - Pegylated Liposomal	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL	Injection	Caelyx	C6234 C6274 C9223 C9287		4	5
			Liposomal Doxorubicin SUN	C6234 C6274 C9223 C9287		4	5
Dupilumab	Injection 200 mg in 1.14 mL single dose pre-filled pen	Injection	Dupixent	C17009 C19091 C19137 C19236		See Schedule 2	See Schedule 2
	Injection 200 mg in 1.14 mL single dose pre-filled syringe	Injection	Dupixent	C17009 C19091 C19136 C19137 C19181 C19213 C19236		See Schedule 2	See Schedule 2
	Injection 300 mg in 2 mL single dose pre-filled pen	Injection	Dupixent	C17009 C19091 C19137 C19236		See Schedule 2	See Schedule 2
	Injection 300 mg in 2 mL single dose pre-filled syringe	Injection	Dupixent	C17009 C19091 C19132 C19133 C19136 C19137 C19236		See Schedule 2	See Schedule 2
Eculizumab	Solution concentrate for I.V. infusion 300 mg in 30 mL	Injection	Soliris	C14750 C14792 C17602 C17626 C17630 C17651 C17673 C17675 C17684 C17693 C17697 C19249 C19258 C19263 C19270 C19273 C19274		See Schedule 2	See Schedule 2
Edaravone	Solution concentrate for I.V. infusion 30 mg in 20 mL	Injection	Radicava	C19252 C19267	P19267	20	2
				C19252 C19267	P19252	28	0
Eflornithine	Tablet 192 mg (as hydrochloride)	Oral	Ifinwil	C16841 C17753		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 28 sachets containing granules elexacaftor 80 mg with tezacaftor 40 mg and with ivacaftor 60 mg and 28 sachets containing granules ivacaftor 59.5 mg	Oral	Trikafta	C17770 C17772		See Schedule 2	See Schedule 2
	Pack containing 28 sachets containing granules elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 sachets containing granules ivacaftor 75 mg	Oral	Trikafta	C17770 C17772		See Schedule 2	See Schedule 2
	Pack containing 56 tablets elexacaftor 50 mg with tezacaftor 25 mg and with ivacaftor 37.5 mg and 28 tablets ivacaftor 75 mg	Oral	Trikafta	C17846 C17971		See Schedule 2	See Schedule 2
	Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg	Oral	Trikafta	C17937 C17970		See Schedule 2	See Schedule 2
Eltrombopag	Tablet 25 mg (as olamine)	Oral	Revolade	C13327 C14127 C14129 C15173 C16455 C18209 C18210		See Schedule 2	See Schedule 2
	Tablet 50 mg (as olamine)	Oral	Revolade	C13327 C14127 C14129 C15173 C16455 C18209 C18210		See Schedule 2	See Schedule 2
Emtricitabine with rilpivirine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg	Oral	Odefsey	C4470 C4522		60	5
Emtricitabine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg	Oral	Descovy	C4454 C4512		60	5
	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg	Oral	Descovy	C4454 C4512		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	ENTAC	C4993 C5036		60	5
			ENTECAVIR APO	C4993 C5036		60	5
			Entecavir GH	C4993 C5036		60	5
			ENTECAVIR RBX	C4993 C5036		60	5
			Entecavir Sandoz	C4993 C5036		60	5
			Entecavir Viatris	C4993 C5036		60	5
			ENTECAVIR-WGR	C4993 C5036		60	5
	Tablet 1 mg (as monohydrate)	Oral	ENTECAVIR APO	C5037 C5044		60	5
			ENTECAVIR RBX	C5037 C5044		60	5
			Entecavir Sandoz	C5037 C5044		60	5
			Entecavir Viatris	C5037 C5044		60	5
			ENTECAVIR-WGR	C5037 C5044		60	5
Epoetin Alfa	Injection 1,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 1000	C6294 C9688		12	5
	Injection 2,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 2000	C6294 C9688		12	5
	Injection 3,000 units in 0.3 mL pre-filled syringe	Injection	Eprex 3000	C6294 C9688		12	5
	Injection 4,000 units in 0.4 mL pre-filled syringe	Injection	Eprex 4000	C6294 C9688		12	5
	Injection 5,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 5000	C6294 C9688		12	5
	Injection 6,000 units in 0.6 mL pre-filled syringe	Injection	Eprex 6000	C6294 C9688		12	5
	Injection 8,000 units in 0.8 mL pre-filled syringe	Injection	Eprex 8000	C6294 C9688		12	5
	Injection 10,000 units in 1 mL pre-filled syringe	Injection	Eprex 10000	C6294 C9688		12	5
	Injection 20,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 20,000	C6294 C9688		12	5
	Injection 40,000 units in 1 mL pre-filled syringe	Injection	Eprex 40,000	C6294 C9688		2	5
Epoetin lambda	Injection 1,000 units in 0.5 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 2,000 units in 1 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 3,000 units in 0.3 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 4,000 units in 0.4 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 5,000 units in 0.5 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 6,000 units in 0.6 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 8,000 units in 0.8 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 10,000 units in 1 mL pre-filled syringe	Injection	Novicrit	C6294 C9688		12	5
Epoprostenol	Powder for I.V. infusion 500 micrograms (as sodium)	Injection	Veletri	C13491 C13506 C13577 C18208 C18401 C18802 C18859		See Schedule 2	See Schedule 2
	Powder for I.V. infusion 1.5 mg (as sodium)	Injection	Veletri	C13491 C13506 C13577 C18208 C18401 C18802 C18859		See Schedule 2	See Schedule 2
Esketamine	Nasal spray device 28 mg in 2 actuations	Nasal	Spravato	C16419 C16422 C16454 C16460 C16470 C16477	P16460	4	5
				C16419 C16422 C16454 C16460 C16470 C16477	P16477	8	0
				C16419 C16422 C16454 C16460 C16470 C16477	P16470	8	5
				C16419 C16422 C16454 C16460 C16470 C16477	P16419	12	5
				C16419 C16422 C16454 C16460 C16470 C16477	P16422	16	0
				C16419 C16422 C16454 C16460 C16470 C16477	P16454	24	0
Etanercept	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Enbrel	C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
			Erelzi	C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
			Nepexto	C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
	Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Enbrel	C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
			Erelzi	C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	Injection	Enbrel	C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
Etravirine	Tablet 200 mg	Oral	Intelence	C5014		120	5
Everolimus	Tablet 0.25 mg	Oral	Certican	C5554 C5795 C9691 C9693		120	5
			Everocan	C5554 C5795 C9691 C9693		120	5
	Tablet 0.5 mg	Oral	Certican	C5554 C5795 C9691 C9693		120	5
			Everocan	C5554 C5795 C9691 C9693		120	5
	Tablet 0.75 mg	Oral	Certican	C5554 C5795 C9691 C9693		240	5
			Everocan	C5554 C5795 C9691 C9693		240	5
	Tablet 1 mg	Oral	Certican	C5554 C5795 C9691 C9693		240	5
			Everocan	C5554 C5795 C9691 C9693		240	5
Filgrastim	Injection 120 micrograms in 0.2 mL single-use pre-filled syringe	Injection	Nivestim	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
	Injection 300 micrograms in 0.5 mL single-use pre-filled syringe	Injection	Nivestim	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
			Zarzio	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
	Injection 480 micrograms in 0.5 mL single-use pre-filled syringe	Injection	Nivestim	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
			Zarzio	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
Foslevodopa with foscarbidopa	Solution for subcutaneous infusion containing foslevodopa 2400 mg with foscarbidopa 120 mg in 10 mL	Injection	Vyalev	C16812 C16853 C16883 C16972	P16812 P16883	28	5
				C16812 C16853 C16883 C16972	P16853 P16972	56	5
Ganciclovir	Powder for I.V. infusion 500 mg (as sodium)	Injection	Cymevene	C5000 C15782 C15784 C15800 C15814		10	1
			GANCICLOVIR SXP	C5000 C15782 C15784 C15800 C15814		10	1
Glecaprevir with pibrentasvir	Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir	Oral	Maviret	C7593 C7615 C10268	P7593	84	1
				C7593 C7615 C10268	P7615	84	2
				C7593 C7615 C10268	P10268	84	3
Iloprost	Solution for inhalation 20 micrograms (as trometamol) in 2 mL	Inhalation	Ventavis	C13491 C13506 C13577 C18294 C18403 C18802 C18859		See Schedule 2	See Schedule 2
Infliximab	Powder for I.V. infusion 100 mg	Injection	Inflectra	C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
			Ixifi	C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
			Remicade	C4524 C8296 C9068 C9111 C9559 C9632 C9754 C11158 C12059 C14504 C14505 C14507 C14548 C14705 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18849 C18866 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19152 C19176		See Schedule 2	See Schedule 2
			Remsima	C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
			Renflexis	C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
Interferon Gamma-1b	Injection 2,000,000 I.U. in 0.5 mL	Injection	Imukin	C6222 C9639		12	11
Ivacaftor	Sachet containing granules 13.4 mg	Oral	Kalydeco	C16928 C16971		See Schedule 2	See Schedule 2
	Sachet containing granules 25 mg	Oral	Kalydeco	C16844 C16845 C16876 C16878		See Schedule 2	See Schedule 2
	Sachet containing granules 50 mg	Oral	Kalydeco	C16844 C16845 C16876 C16878		See Schedule 2	See Schedule 2
	Sachet containing granules 75 mg	Oral	Kalydeco	C16844 C16845 C16876 C16878		See Schedule 2	See Schedule 2
	Tablet 150 mg	Oral	Kalydeco	C16844 C16845 C16876 C16878		See Schedule 2	See Schedule 2
Lamivudine	Oral solution 10 mg per mL, 240 mL	Oral	3TC	C4454 C4512		8	5
	Tablet 100 mg	Oral	Zeffix	C4993 C5036		56	5
			Zetlam	C4993 C5036		56	5
	Tablet 150 mg	Oral	3TC	C4454 C4512		120	5
			Lamivudine Viatris	C4454 C4512		120	5
	Tablet 300 mg	Oral	3TC	C4454 C4512		60	5
			Lamivudine Viatris	C4454 C4512		60	5
Lamivudine with Zidovudine	Tablet 150 mg-300 mg	Oral	Combivir	C4454 C4512		120	5
			Lamivudine/Zidovudine Viatris 150/300	C4454 C4512		120	5
Lanreotide	Injection 60 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac	C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057		2	5
			Somatuline Autogel	C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057		2	5
	Injection 90 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac	C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057		2	5
			Somatuline Autogel	C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057		2	5
	Injection 120 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac	C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057 C17635 C17637 C17638 C17696		2	5
			Somatuline Autogel	C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057 C17635 C17637 C17638 C17696		2	5
Lanthanum	Tablet, chewable, 500 mg (as carbonate hydrate)	Oral	Fosrenol	C5530 C9762		180	5
	Tablet, chewable, 750 mg (as carbonate hydrate)	Oral	Fosrenol	C5530 C9762		180	5
	Tablet, chewable, 1000 mg (as carbonate hydrate)	Oral	Fosrenol	C5530 C9762		180	5
Lenalidomide	Capsule 5 mg	Oral	Lenalide	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
	Capsule 10 mg	Oral	Lenalide	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
	Capsule 15 mg	Oral	Lenalide	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
	Capsule 20 mg	Oral	Lenalide	C13782 C13787 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13787 C13805 C13813 C14362 C17414 C18932 C19062 C19067 C19119		See Schedule 2	See Schedule 2
	Capsule 25 mg	Oral	Lenalide	C13782 C13787 C13805 C13811 C13813 C14362 C17414 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13787 C13805 C13811 C13813 C14362 C17414 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13787 C13805 C13811 C13813 C14362 C17414 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
Levodopa with carbidopa	Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL	Intra-intestinal	Duodopa	C10138 C10161 C10363 C10375	P10138 P10161	28	5
				C10138 C10161 C10363 C10375	P10363 P10375	56	5
Lipegfilgrastim	Injection 6 mg in 0.6 mL single use pre-filled syringe	Injection	Lonquex	C7822 C7843 C9224 C9322		1	11
Lopinavir with ritonavir	Oral liquid 400 mg-100 mg per 5 mL, 60 mL	Oral	Kaletra	C4454 C4512		10	5
	Tablet 200 mg-50 mg	Oral	Kaletra	C4454 C4512		240	5
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 75 mg and ivacaftor 94 mg	Oral	Orkambi	C17763 C17765		See Schedule 2	See Schedule 2
	Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg	Oral	Orkambi	C17763 C17765		See Schedule 2	See Schedule 2
	Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg	Oral	Orkambi	C17763 C17765		See Schedule 2	See Schedule 2
	Tablet containing lumacaftor 100 mg with ivacaftor 125 mg	Oral	Orkambi	C17933 C17967		See Schedule 2	See Schedule 2
	Tablet containing lumacaftor 200 mg with ivacaftor 125 mg	Oral	Orkambi	C17842 C17934		See Schedule 2	See Schedule 2
Macitentan	Tablet 10 mg	Oral	Opsumit	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Macitentan with tadalafil	Tablet containing 10 mg macitentan with 40 mg tadalafil	Oral	Opsynvi	C16433 C16457		See Schedule 2	See Schedule 2
Mannitol	Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers	Inhalation by mouth	Bronchitol	C7362 C7367 C9527 C9593		4	5
Maraviroc	Tablet 150 mg	Oral	Celsentri	C5008		120	5
			Maraviroc Waymade	C5008		120	5
	Tablet 300 mg	Oral	Celsentri	C5008		120	5
			Maraviroc Waymade	C5008		120	5
Maribavir	Tablet 200 mg	Oral	Livtencity	C16735 C16806		112	1
Mepolizumab	Injection 100 mg in 1 mL single dose pre-filled pen	Injection	Nucala	C13865 C15376 C19092 C19128 C19139 C19166 C19184 C19198 C19200		See Schedule 2	See Schedule 2
Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL	Oral	Aspen Methadone Syrup	C16083		840	5
			Biodone Forte	C16083		840	5
	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL	Oral	Aspen Methadone Syrup	C16083		840	5
			Biodone Forte	C16083		840	5
Methoxsalen	Solution for blood fraction 20 microgram per mL, 10 mL	Extracorporeal Circulation	Uvadex	C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P10988 P10989	1	5
				C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P12531 P12567	2	0
				C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P10971 P10985	2	6
				C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P12546 P12579	12	1
Methoxy polyethylene glycol-epoetin beta	Injection 30 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 50 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 75 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 100 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 120 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 200 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 360 micrograms in 0.6 mL pre-filled syringe	Injection	Mircera	C6294 C9688		2	5
Midostaurin	Capsule 25 mg	Oral	Rydapt	C11699 C13001 C19073		See Schedule 2	See Schedule 2
Mycophenolic acid	Capsule containing mycophenolate mofetil 250 mg	Oral	APO-Mycophenolate	C5600 C5653 C9689 C9690		600	5
			Mycophenolate Sandoz	C5600 C5653 C9689 C9690		600	5
			Pharmacor Mycophenolate 250	C5600 C5653 C9689 C9690		600	5
	Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL	Oral	CellCept	C5554 C5795 C9691 C9693		2	5
			Pharmacor Mycophenolate	C5554 C5795 C9691 C9693		2	5
	Tablet containing mycophenolate mofetil 500 mg	Oral	ARX-MYCOPHENOLATE	C5554 C5795 C9691 C9693		300	5
			Ceptolate	C5554 C5795 C9691 C9693		300	5
			Mycophenolate GH	C5554 C5795 C9691 C9693		300	5
			Mycophenolate Sandoz	C5554 C5795 C9691 C9693		300	5
			Pharmacor Mycophenolate 500	C5554 C5795 C9691 C9693		300	5
	Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid	Oral	Mycophenolic Acid ARX	C4084 C4095 C9692 C9809		240	5
			Myfortic	C4084 C4095 C9692 C9809		240	5
	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	Mycophenolic Acid ARX	C4084 C4095 C9692 C9809		240	5
			MYCOTEX	C4084 C4095 C9692 C9809		240	5
			Myfortic	C4084 C4095 C9692 C9809		240	5
Natalizumab	Injection 150 mg in 1 mL single dose pre-filled syringe	Injection	Tysabri	C13625 C13718		2	5
	Solution concentrate for I.V. infusion 300 mg in 15 mL	Injection	Tysabri	C13625 C13718		1	5
Nevirapine	Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL	Oral	Viramune	C4454 C4512		10	5
	Tablet 200 mg	Oral	Nevirapine Viatris	C4454 C4512		120	5
Nitisinone	Capsule 2 mg	Oral	Orfadin	C18958 C19053 C19057		See Schedule 2	See Schedule 2
	Capsule 5 mg	Oral	Orfadin	C18958 C19053 C19057		See Schedule 2	See Schedule 2
	Capsule 10 mg	Oral	Orfadin	C18958 C19053 C19057		See Schedule 2	See Schedule 2
	Capsule 20 mg	Oral	Orfadin	C18958 C19053 C19057		See Schedule 2	See Schedule 2
	Oral suspension 4 mg per mL, 90 mL	Oral	Orfadin	C18959 C19055 C19058		See Schedule 2	See Schedule 2
Nusinersen	Solution for injection 12 mg in 5 mL	Injection	Spinraza	C14433 C14459 C15069 C15112 C18053 C18073 C18076 C18077 C18078 C18094 C18101 C18110		See Schedule 2	See Schedule 2
Obinutuzumab	Solution for I.V. infusion 1000 mg in 40 mL	Injection	Gazyva	C19168 C19169 C19188	P19188	1	0
				C19168 C19169 C19188	P19168 P19169	1	1
Ocrelizumab	Solution concentrate for I.V. infusion 300 mg in 10 mL	Injection	Ocrevus	C7386 C7699 C9523 C9635		2	0
	Solution for subcutaneous injection 920 mg in 23 mL	Injection	Ocrevus SC	C7386 C7699 C9523 C9635		1	0
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Octreotide (SUN)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Sandostatin 0.05	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection 100 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Octreotide (SUN)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Sandostatin 0.1	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection 500 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Octreotide (SUN)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Sandostatin 0.5	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection (modified release) 10 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313		2	5
	Injection (modified release) 20 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313		2	5
	Injection (modified release) 30 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313 C17634 C17635 C17637		2	5
Omalizumab	Injection 75 mg in 0.5 mL single dose pre-filled pen	Injection	Omlyclo	C15376 C19080 C19083 C19135 C19161 C19214		See Schedule 2	See Schedule 2
			Xolair	C15376 C19080 C19083 C19161		See Schedule 2	See Schedule 2
	Injection 75 mg in 0.5 mL single dose pre-filled syringe	Injection	Omlyclo	C15376 C17012 C17085 C17086 C17102 C19080 C19083 C19135 C19141 C19161 C19163 C19214		See Schedule 2	See Schedule 2
			Xolair	C15376 C17012 C17086 C19080 C19083 C19141 C19161 C19163		See Schedule 2	See Schedule 2
	Injection 150 mg in 1 mL single dose pre-filled pen	Injection	Omlyclo	C7046 C15376 C16905 C16906 C16960 C19080 C19083 C19135 C19161 C19214		See Schedule 2	See Schedule 2
			Xolair	C7046 C15376 C16906 C19080 C19083 C19161		See Schedule 2	See Schedule 2
	Injection 150 mg in 1 mL single dose pre-filled syringe	Injection	Omlyclo	C7046 C15376 C16905 C16906 C16960 C17012 C17084 C17096 C19080 C19083 C19135 C19141 C19161 C19163 C19214		See Schedule 2	See Schedule 2
	Injection 300 mg in 2 mL single dose pre-filled pen	Injection	Xolair	C7046 C15376 C16906 C19080 C19083 C19135 C19161		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
	Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C15989 C16045 C18211 C18213		See Schedule 2	See Schedule 2
Pamidronic Acid	Concentrated injection containing pamidronate disodium 60 mg in 10 mL	Injection	Pamisol	C4433 C9234		1	2
	Concentrated injection containing pamidronate disodium 90 mg in 10 mL	Injection	Pamisol	C4433 C5218 C5291 C9234 C9315 C9335		1	11
Pasireotide	Injection (modified release) 20 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	C19069 C19121		See Schedule 2	See Schedule 2
	Injection (modified release) 40 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	C19069 C19121		See Schedule 2	See Schedule 2
	Injection (modified release) 60 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	C19069 C19121		See Schedule 2	See Schedule 2
Pegcetacoplan	Solution for subcutaneous infusion 1,080 mg in 20 mL	Injection	Empaveli	C17598 C17599 C17601 C17622 C17623 C17647 C17683		See Schedule 2	See Schedule 2
Pegfilgrastim	Injection 6 mg in 0.6 mL single use pre-filled syringe	Injection	Pelgraz	C7822 C7843 C9235 C9303		1	11
			Ziextenzo	C7822 C7843 C9235 C9303		1	11
Peginterferon alfa-2a	Injection 135 micrograms in 0.5 mL single use pre-filled syringe	Injection	Pegasys	C17022 C17108		8	5
	Injection 135 micrograms in 0.5 mL single use pre-filled syringe (s19A)	Injection	Pegasys (Ireland)	C17022 C17108		8	5
	Injection 180 micrograms in 0.5 mL single use pre-filled syringe	Injection	Pegasys	C17022 C17108		8	5
	Injection 180 micrograms in 0.5 mL single use pre-filled syringe (s19A)	Injection	Pegasys (Ireland)	C17022 C17108		8	5
Pegunigalsidase alfa	Solution for I.V. injection 20 mg in 10 mL	Injection	ELFABRIO	C18929 C18930 C19015 C19045		See Schedule 2	See Schedule 2
Pegvisomant	Injection set containing powder for injection 10 mg, 30 and diluent, 30	Injection	Somavert	C19069 C19121		See Schedule 2	See Schedule 2
	Injection set containing powder for injection 15 mg, 30 and diluent, 30	Injection	Somavert	C19069 C19121		See Schedule 2	See Schedule 2
	Injection set containing powder for injection 20 mg, 1 and diluent, 1	Injection	Somavert	C19071		See Schedule 2	See Schedule 2
	Injection set containing powder for injection 20 mg, 30 and diluent, 30	Injection	Somavert	C19071 C19122		See Schedule 2	See Schedule 2
Plerixafor	Injection 24 mg in 1.2 mL	Injection	Plerixafor ARX	C4549 C9329		1	1
			PLERIXAFOR EUGIA	C4549 C9329		1	1
Pomalidomide	Capsule 1 mg	Oral	Pomolide	C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
			Pomalidomide Sandoz	C13755 C19229		See Schedule 2	See Schedule 2
	Capsule 2 mg	Oral	Pomolide	C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
			Pomalidomide Sandoz	C13755 C19229		See Schedule 2	See Schedule 2
	Capsule 3 mg	Oral	Pomalidomide Sandoz	C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
			Pomolide	C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
	Capsule 4 mg	Oral	Pomalidomide Sandoz	C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
			Pomolide	C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
Raltegravir	Tablet 400 mg (as potassium)	Oral	Isentress	C4454 C4512		120	5
	Tablet 600 mg (as potassium)	Oral	Isentress HD	C4454 C4512		120	5
Ravulizumab	Solution concentrate for I.V. infusion 300 mg in 3 mL	Injection	Ultomiris	C14748 C16368 C17055 C17605 C17606 C17609 C17610 C17629 C17630 C17631 C18131 C18132 C18133 C18134 C18135 C18137 C18153 C18155 C18237 C18238 C18260 C18262 C18283 C18350 C18423 C19240		See Schedule 2	See Schedule 2
	Solution concentrate for I.V. infusion 1,100 mg in 11 mL	Injection	Ultomiris	C14748 C16368 C17055 C17605 C17606 C17609 C17610 C17629 C17630 C17631 C18131 C18132 C18133 C18134 C18135 C18137 C18153 C18155 C18237 C18238 C18260 C18262 C18283 C18350 C18423 C19240		See Schedule 2	See Schedule 2
Rifabutin	Capsule 150 mg	Oral	Mycobutin	C6350 C6356 C9560 C9622		120	5
Rilpivirine	Tablet 25 mg (as hydrochloride)	Oral	Edurant	C4454 C4512		60	5
Riociguat	Tablet 500 micrograms	Oral	Adempas	C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
	Tablet 1 mg	Oral	Adempas	C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
	Tablet 1.5 mg	Oral	Adempas	C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
	Tablet 2 mg	Oral	Adempas	C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
	Tablet 2.5 mg	Oral	Adempas	C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
Risdiplam	Powder for oral solution 750 micrograms per mL, 80 mL	Oral	Evrysdi	C14392 C14420 C15095 C15986 C18087 C18090 C18118 C18197 C18356 C18357		See Schedule 2	See Schedule 2
	Tablet 5 mg	Oral	Evrysdi	C14420 C18225 C18306 C18307 C18308 C18369 C18479		See Schedule 2	See Schedule 2
Ritonavir	Tablet 100 mg	Oral	Norvir	C4454 C4512		720	5
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Riximyo			6	0
			Ruxience			6	0
			Truxima			6	0
	Solution for I.V. infusion 500 mg in 50 mL	Injection	Riximyo			2	1
			Ruxience			2	1
			Truxima			2	1
Romiplostim	Powder for injection 375 micrograms	Injection	Nplate	C13396 C14099 C14149 C18405		See Schedule 2	See Schedule 2
	Powder for injection 625 micrograms	Injection	Nplate	C13396 C14099 C14149 C18405		See Schedule 2	See Schedule 2
Rozanolixizumab	Solution for subcutaneous infusion 280 mg in 2 mL (140 mg per mL)	Injection	Rystiggo	C18129 C18232 C18319 C18378 C18789		See Schedule 2	See Schedule 2
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	C13907 C13911 C19098 C19147	P13907 P13911	56	0
				C13907 C13911 C19098 C19147	P19098 P19147	56	5
	Tablet 10 mg	Oral	Jakavi	C13907 C13911 C19098 C19147	P13907 P13911	56	0
				C13907 C13911 C19098 C19147	P19098 P19147	56	5
Selexipag	Tablet 200 micrograms	Oral	Uptravi	C11193 C11195 C11261		See Schedule 2	See Schedule 2
	Tablet 400 micrograms	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 600 micrograms	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 800 micrograms	Oral	Uptravi	C11193 C11195 C11261		See Schedule 2	See Schedule 2
	Tablet 1 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 1.2 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 1.4 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 1.6 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
Selinexor	Tablet 20 mg	Oral	Xpovio	C14021 C14023 C14024 C14031 C14039 C14045	P14021 P14045	16	2
				C14021 C14023 C14024 C14031 C14039 C14045	P14023 P14024	20	2
				C14021 C14023 C14024 C14031 C14039 C14045	P14031 P14039	32	2
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	ARX-SEVELAMER	C5530 C9762		360	5
			Sevelamer Lupin	C5530 C9762		360	5
	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel	C5530 C9762		360	5
Sildenafil	Tablet 20 mg (as citrate)	Oral	SILDATIO PHT	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
			Sildenafil PHT APOTEX	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
			SILDENAFIL PHT ARX	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
			Sildenafil Sandoz PHT 20	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Siltuximab	Powder for injection 100 mg	Injection	Sylvant	C12585 C12594		2	4
	Powder for injection 400 mg	Injection	Sylvant	C12585 C12594		2	4
Sirolimus	Oral solution 1 mg per mL, 60 mL	Oral	Rapamune	C5795 C9914		2	5
	Tablet 0.5 mg	Oral	Rapamune	C5795 C9914		200	5
	Tablet 1 mg	Oral	Rapamune	C5795 C9914		200	5
	Tablet 2 mg	Oral	Rapamune	C5795 C9914		200	5
Sofosbuvir with velpatasvir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir	Oral	Epclusa	C5969		28	2
Sofosbuvir with velpatasvir and voxilaprevir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir and 100 mg voxilaprevir	Oral	Vosevi	C10248		28	2
Sucroferric oxyhydroxide	Tablet, chewable, 2.5 g (equivalent to 500 mg iron)	Oral	Velphoro	C5530 C9762		180	5
Tacrolimus	Capsule 0.5 mg	Oral	Pacrolim	C5569 C9697		200	5
			Pharmacor Tacrolimus 0.5	C5569 C9697		200	5
			Prograf	C5569 C9697		200	5
			Tacrograf	C5569 C9697		200	5
			Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 0.5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		60	5
			Tacrolimus XR Sandoz	C5569 C9697		60	5
	Capsule 0.75 mg	Oral	Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 1 mg	Oral	Pacrolim	C5569 C9697		200	5
			Pharmacor Tacrolimus 1	C5569 C9697		200	5
			Prograf	C5569 C9697		200	5
			Tacrograf	C5569 C9697		200	5
			Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 1 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		120	5
			Tacrolimus XR Sandoz	C5569 C9697		120	5
	Capsule 2 mg	Oral	Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 3 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		100	3
			Tacrolimus XR Sandoz	C5569 C9697		100	3
	Capsule 5 mg	Oral	Pharmacor Tacrolimus 5	C5569 C9697		100	5
			Prograf	C5569 C9697		100	5
			Tacrograf	C5569 C9697		100	5
			Tacrolimus Sandoz	C5569 C9697		100	5
	Capsule 5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		60	5
			Tacrolimus XR Sandoz	C5569 C9697		60	5
Tadalafil	Tablet 20 mg	Oral	Adcirca	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
			Tadalca	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
			TADALIS 20	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
			Tadalis 20	C15463 C15495 C15525 C18780 C18824 C18852 C18872 C18884		See Schedule 2	See Schedule 2
Teduglutide	Powder for injection 5 mg with diluent	Injection	Revestive	C11999 C18198 C18986		See Schedule 2	See Schedule 2
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	TENOFOVIR ARX	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			Tenofovir Sandoz	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			TENOFOVIR ARX	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
			Tenofovir Sandoz	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
	Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Viatris	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			Tenofovir Disoproxil Viatris	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
				C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat	Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg	Oral	Genvoya	C4470 C4522		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	CIPLA TENOFOVIR + EMTRICITABINE 300/200	C6985 C6986		60	5
			TENOFOVIR/EMTRICITABINE 300/200 APX	C6985 C6986		60	5
			TENOFOVIR/EMTRICITABINE 300/200 ARX	C6985 C6986		60	5
			Tenofovir/Emtricitabine Sandoz Pharma 300/200	C6985 C6986		60	5
	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Viatris 300/200	C6985 C6986		60	5
	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz 301/200	C6985 C6986		60	5
Tenofovir with emtricitabine and efavirenz	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg (s19A)	Oral	Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablet 600 mg/200 mg/300 mg (Camber, USA)	C4470 C4522		60	5
	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg	Oral	Tenofovir Disoproxil Emtricitabine Efavirenz Viatris 300/200/600	C4470 C4522		60	5
Tezacaftor with ivacaftor and ivacaftor	Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg	Oral	Symdeko	C17844 C17935 C17968 C17969		See Schedule 2	See Schedule 2
Tezepelumab	Solution for injection 210 mg in 1.91 mL single dose pre-filled pen (110 mg per mL)	Injection	Tezspire	C19093 C19094 C19095 C19199		See Schedule 2	See Schedule 2
Thalidomide	Capsule 50 mg	Oral	Thalomid	C5914 C9290		112	0
	Capsule 100 mg	Oral	Thalomid	C5914 C9290		56	0
Tocilizumab	Concentrate for injection 80 mg in 4 mL	Injection	Actemra	C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18945 C18946 C18947		See Schedule 2	See Schedule 2
			Avtozma	C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18933 C18934 C18936 C18938 C18939 C18941 C18945 C18946 C18947 C18978 C18980 C19000 C19024 C19046		See Schedule 2	See Schedule 2
	Concentrate for injection 200 mg in 10 mL	Injection	Actemra	C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18945 C18946 C18947		See Schedule 2	See Schedule 2
			Avtozma	C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18933 C18934 C18936 C18938 C18939 C18941 C18945 C18946 C18947 C18978 C18980 C19000 C19024 C19046		See Schedule 2	See Schedule 2
	Concentrate for injection 400 mg in 20 mL	Injection	Actemra	C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18945 C18946 C18947		See Schedule 2	See Schedule 2
			Avtozma	C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18933 C18934 C18936 C18938 C18939 C18941 C18945 C18946 C18947 C18978 C18980 C19000 C19024 C19046		See Schedule 2	See Schedule 2
Tofersen	Solution for intrathecal injection 100 mg in 15 mL	Injection	Qalsody	C19231 C19237 C19243 C19253 C19261	P19261	1	2
				C19231 C19237 C19243 C19253 C19261	P19237 P19253	1	5
				C19231 C19237 C19243 C19253 C19261	P19231 P19243	1	6
Ublituximab	Solution concentrate for I.V. infusion 150 mg in 6 mL	Injection	Briumvi	C7386 C7699 C9523 C9635	P7386 P9635	3	0
				C7386 C7699 C9523 C9635	P7699 P9523	4	0
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Stelara	C16866 C16939 C16958 C18785 C18825 C18856 C19149 C19171 C19172		See Schedule 2	See Schedule 2
			Steqeyma	C16866 C16939 C16958 C18785 C18825 C18856 C19149 C19171 C19172		See Schedule 2	See Schedule 2
			Wezlana	C16866 C16939 C16958 C18785 C18825 C18856 C19149 C19171 C19172		See Schedule 2	See Schedule 2
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX Valaciclovir	C5975 C9267		500	2
			Valaciclovir RBX	C5975 C9267		500	2
			Valtrex	C5975 C9267		500	2
Valganciclovir	Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL	Oral	Valcyte	C4980 C15782 C15784 C15800 C15814		11	5
	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir Sandoz	C4980 C15782 C15784 C15800 C15814		120	5
			Valganciclovir Viatris	C4980 C15782 C15784 C15800 C15814		120	5
Vanzacaftor with tezacaftor and with deutivacaftor	Tablet containing 4 mg vanzacaftor (as calcium) with 20 mg tezacaftor and with 50 mg deutivacaftor	Oral	Alyftrek	C17769 C17932		See Schedule 2	See Schedule 2
	Tablet containing 10 mg vanzacaftor (as calcium) with 50 mg tezacaftor and with 125 mg deutivacaftor	Oral	Alyftrek	C17769 C17932		See Schedule 2	See Schedule 2
Vedolizumab	Powder for injection 300 mg	Injection	Entyvio	C15844 C15909 C15910 C15923 C15933 C18759 C18760 C18805 C18806 C18807 C18863 C18906 C19112 C19113 C19155 C19210		See Schedule 2	See Schedule 2
Vutrisiran	Injection 25 mg (as sodium) in 0.5 mL pre-filled syringe	Injection	Amvuttra	C16434 C16446		See Schedule 2	See Schedule 2
Zidovudine	Capsule 100 mg	Oral	Retrovir	C4454 C4512		400	5
	Capsule 250 mg	Oral	Retrovir	C4454 C4512		240	5
	Syrup 10 mg per mL, 200 mL	Oral	Retrovir	C4454 C4512		15	5
Zilucoplan	Solution for injection 16.6 mg in 0.416 mL (as tetrasodium) pre-filled syringe	Oral	Zilbrysq	C18128 C18129 C18232 C18319 C18378		See Schedule 2	See Schedule 2
	Solution for injection 23 mg in 0.574 mL (as tetrasodium) pre-filled syringe	Oral	Zilbrysq	C18128 C18129 C18232 C18319 C18378		See Schedule 2	See Schedule 2
	Solution for injection 32.4 mg in 0.810 mL (as tetrasodium) pre-filled syringe	Oral	Zilbrysq	C18128 C18129 C18232 C18319 C18378		See Schedule 2	See Schedule 2
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	DEZTRON	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 C14729 C14735	P14729 P14735	1	0
			Zoledronate-DRLA 4	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 C14729 C14735	P14729 P14735	1	0
			Zoledronic Acid Accord	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 C14729 C14735	P14729 P14735	1	0
			APO Zoledronic Acid	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328		1	11
			DEZTRON	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 C14729 C14735	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11
			Zoledronate-DRLA 4	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 C14729 C14735	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11
			Zoledronic Acid Accord	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 C14729 C14735	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11
			Zometa	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328		1	11

Schedule 2 · Maximum quantities and repeats for certain HSD pharmaceutical benefits

Note: See sections 20 and 21, and the columns headed “Maximum quantity” and “Maximum repeats” in Schedule 1.

1Maximum quantity or number of units and maximum number of repeats#

The following table sets out the maximum quantity or number of units, and the maximum number of repeats, for prescribing HSD pharmaceutical benefits with the listed drugs, and in the circumstances, mentioned in the table.

Maximum quantity or number of units, and maximum number of repeats
Listed drug	Circumstances	Maximum quantity	Maximum repeats
Abatacept	C14488 C18274	1 dose	Sufficient for treatment for 16 weeks
	C14507 C14555 C14604 C18273	1 dose	Sufficient for treatment for 24 weeks
	C18169 C18272	1 dose	4
Adalimumab	C12120 C17717 C17719 C17733	2 doses	3
	C17707 C17713 C17734	2 doses	5
Ambrisentan	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836	Sufficient for treatment for 1 month	5
Anifrolumab	C19096 C19216	1	5
Avatrombopag	C14054 C15340 C15375 C18297	30	5
Azacitidine	C12439 C12983 C13010 C19124	14 units	2
	C12986 C13011 C13012 C13015	14 units	5
Benralizumab	C15376 C19082 C19130	1	Sufficient for 32 weeks of treatment
	C19128	1	Sufficient for 24 weeks of treatment
Bosentan	C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833	Sufficient for treatment for 1 month	5
	C12425	Sufficient for treatment for 1 month	0
Burosumab	C13377 C18950 C18952 C18953 C18982	Sufficient for treatment for 4 weeks	5
Difelikefalin	C15171	Sufficient for treatment for 4 weeks	2
	C15211	Sufficient for treatment for 4 weeks	5
Dupilumab	C17009 C19136	1 pack	Sufficient for 24 weeks of treatment
	C19091 C19132 C19133 C19137 C19181 C19213 C19236	1 pack	Sufficient for 32 weeks of treatment
Eculizumab	C19273	Sufficient for treatment for 4 weeks	0
	C17675	1	0
	C14750 C14792	Sufficient for treatment for 4 weeks	4
	C19249 C19258 C19263 C19270 C19274	Sufficient for treatment for 4 weeks	5
	C17602 C17626 C17651 C17693 C17697	6	5
	C17630 C17673 C17684	8	0
Eflornithine	C16841 C17753	3 packs	2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	C17770 C17772 C17846 C17937 C17970 C17971	1 pack	5
Eltrombopag	C13327 C14127 C14129 C18210	1 pack	5
	C18209	3 packs	3
	C15173 C16455	3 packs	5
Epoprostenol	C13491 C13506 C13577 C18208 C18401 C18802 C18859	Sufficient for treatment for 1 month	5
Etanercept	C12120 C17706 C17724 C17725	Sufficient for treatment for 4 weeks	3
	C17707 C17713	Sufficient for treatment for 4 weeks	5
Iloprost	C13491 C13506 C13577 C18294 C18403 C18802 C18859	Sufficient for treatment for 1 month	5
Infliximab	C8844 C8940 C9188 C9472 C9584 C9602 C14504 C14505 C14507 C14585 C14638 C18343	1 dose of 3 mg per kg of patient weight	2
	C14502 C14544 C14548 C14623 C18165 C18267 C18345	1 dose of 3 mg per kg of patient weight	3
	C8296 C9068 C9754 C12042 C12059 C12074 C18164 C18196 C18355 C18391 C18431 C18437 C18441 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C19107 C19108 C19150 C19152 C19176 C19207	1 dose of 5 mg per kg of patient weight	2
	C9111 C9559 C11158 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18191 C18192 C18194 C18263 C18287 C18340 C18352 C18436 C18439 C18462 C18468 C18469	1 dose of 5 mg per kg of patient weight	3
	C18992 C18993 C18994 C18995	1 dose of 10 mg per kg of patient weight	3
	C19011 C19042	1 dose of 10 mg per kg of patient weight	5
	C4524 C9632	5 vials	1
Ivacaftor	C16844 C16845 C16876 C16878	1 pack	Sufficient for 24 weeks of treatment
	C16928 C16971	1 pack	2
Lenalidomide	C13811 C19079	14 tablets	3
	C13813	21 tablets	1
	C13782 C14362 C17414	21 tablets	2
	C19065 C19066 C19067	21 tablets	3
	C13787 C13805 C18932 C19062 C19119	21 tablets	5
	C13804 C19076	28 tablets	2
Lumacaftor with ivacaftor	C17763 C17765 C17842 C17933 C17934 C17967	1 pack	5
Macitentan	C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836	Sufficient for treatment for 1 month	5
Macitentan with tadalafil	C16433 C16457	1 pack	5
Mepolizumab	C19128	1	Sufficient for 24 weeks of treatment
	C15376 C19139 C19184	1	Sufficient for 32 weeks of treatment
	C13865 C19166 C19198 C19200	1	5
	C19092	1	6
Midostaurin	C11699 C13001 C19073	1 pack	2
Nitisinone	C18958 C18959 C19053 C19055 C19057 C19058	Sufficient for treatment for 4 weeks	5
Nusinersen	C14433 C14459 C15069 C15112	1 dose	0
	C18053 C18073 C18076 C18077 C18078 C18094 C18101 C18110	1 dose	3
Omalizumab	C16906	Sufficient for 4 weeks of treatment	2
	C7046 C16905 C16960 C17084 C17085 C17086 C17096 C17102 C19080 C19135 C19214	Sufficient for 4 weeks of treatment	5
	C17012 C19141 C19163	Sufficient for 4 weeks of treatment	6
	C15376 C19083 C19161	Sufficient for 4 weeks of treatment	7
Onasemnogene abeparvovec	C15989 C16045 C18211 C18213	1 dose	0
Pasireotide	C19069 C19121	2	5
Pegcetacoplan	C17601 C17623 C17683	Sufficient for treatment for 4 weeks	0
	C17598 C17599 C17622 C17647	Sufficient for treatment for 4 weeks	5
Pegunigalsidase alfa	C18929 C18930 C19015 C19045	Sufficient for treatment for 4 weeks	5
Pegvisomant	C19071 C19122	1	5
Pomalidomide	C13757 C13768	1 pack (14 capsules)	2
	C13755 C19229	1 pack (21 capsules)	0
Ravulizumab	C17055 C17605 C17606 C17610 C17630 C18131 C18132 C18133 C18237 C18283 C18350 C19240	1 dose	0
	C18134	1 dose	1
	C14748 C16368 C17609 C17629 C17631 C18135 C18137 C18153 C18155 C18238 C18260 C18262 C18423	1 dose	2
Riociguat	C18200	Sufficient for treatment for 1 month	3
	C13514 C18215	Sufficient for treatment for 1 month	4
	C13502 C15271 C15272	Sufficient for treatment for 1 month	5
Risdiplam	C18087 C18090 C18118 C18357	1	0
	C15095 C15986	1	5
	C14392 C14420 C18197	3	5
	C18356	3	7
	C14420 C18225 C18306 C18307 C18308 C18369 C18479	28	5
Romiplostim	C18405	1 vial	5
	C13396 C14099	Sufficient for treatment for 4 weeks	5
	C14149	1 vial	Sufficient for treatment for 24 weeks
Rozanolixizumab	C18319	18	1
	C18129 C18232 C18378 C18789	18	2
Selexipag	C11193 C11195	60	5
	C11261	140	Sufficient for treatment for 12 weeks
Sildenafil	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876	Sufficient for treatment for 1 month	5
Tadalafil	C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876	Sufficient for treatment for 1 month	5
	C15463 C15495 C15525 C18780 C18824 C18852 C18872 C18884	60 tablets	5
Teduglutide	C18198	1 pack	5
	C11999 C18986	1 pack	11
Tezacaftor with Ivacaftor and Ivacaftor	C17844 C17935 C17968 C17969	1 pack	5
Tezepelumab	C19093	1 pack	5
	C19094 C19095 C19199	1 pack	7
Tocilizumab	C9386 C12120 C14488 C14507 C17712 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18348 C18933 C18934 C18936 C18980 C19000	1 infusion	3
	C14485 C14621 C17707 C17713 C18346 C18938 C18946 C18978 C19024 C19046	1 infusion	5
	C10570 C14085 C14091 C14148	2 infusions	3
	C14093 C14179 C18939 C18941 C18945 C18947	2 infusions	5
Ustekinumab	C16866 C16939 C16958 C18785 C18825 C18856 C19149 C19171 C19172	4 vials (130 mg each)	0
Vanzacaftor with tezacaftor and with deutivacaftor	C17769 C17932	1 pack	5
Vedolizumab	C18760	1	0
	C15844 C15910 C15923 C15933 C18759 C18805 C18806 C18863 C18906 C19112 C19113 C19155 C19210	1	2
	C15909 C18807	1	Sufficient for treatment for 24 weeks
Vutrisiran	C16434 C16446	1	1
Zilucoplan	C18319	28 units	2
	C18128 C18129 C18232 C18378	28 units	5

Schedule 3 · Circumstances and purposes

Listed Drug	Circumstances Code	Purposes Code	Circumstances and Purposes	Authority Requirements—Part of Circumstances
Lamivudine	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
	C4993		Chronic hepatitis B infectionPatient must not have cirrhosis, ANDPatient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; ORPatient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, ANDPatient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.	Compliance with Authority Required procedures - Streamlined Authority Code 4993
	C5036		Chronic hepatitis B infectionPatient must have cirrhosis, ANDPatient must have detectable HBV DNA.Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 5036
Lamivudine with zidovudine	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
Lanreotide	C4575		Functional carcinoid tumourThe condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg every 28 daysDosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose	Compliance with Authority Required procedures - Streamlined Authority Code 4575
	C7025		AcromegalyThe condition must be active; ANDPatient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; ANDThe treatment must be after failure of other therapy including dopamine agonists; ORThe treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; ORThe treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment; ANDThe treatment must not be given concomitantly with PBS-subsidised pegvisomant.In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures - Streamlined Authority Code 7025
	C9260		Functional carcinoid tumourThe condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg every 28 days.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 9260
	C9261		AcromegalyThe condition must be active; ANDPatient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; ANDThe treatment must be after failure of other therapy including dopamine agonists; ORThe treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; ORThe treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment; ANDThe treatment must not be given concomitantly with PBS-subsidised pegvisomant.In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures - Streamlined Authority Code 9261
	C15955		Functional carcinoid tumourContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 15955
	C16024		AcromegalyInitial treatmentMust be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.The condition must be active; ANDPatient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; ANDThe treatment must be after failure of other therapy including dopamine agonists; ORThe treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; ORThe treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment; ANDThe treatment must not be given concomitantly with PBS-subsidised pegvisomant.In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures - Streamlined Authority Code 16024
	C16055		AcromegalyContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe condition must be active; ANDPatient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; ANDThe treatment must be after failure of other therapy including dopamine agonists; ORThe treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; ORThe treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment; ANDThe treatment must not be given concomitantly with PBS-subsidised pegvisomant.In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures - Streamlined Authority Code 16055
	C16057		Functional carcinoid tumourInitial treatmentMust be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.The condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 16057
	C17635		Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease; ANDThe condition must be World Health Organisation (WHO) grade 1 or 2; ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17635
	C17637		Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease; ANDThe condition must be World Health Organisation (WHO) grade 1 or 2; ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17637
	C17638		Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Initial treatmentMust be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.The condition must be unresectable locally advanced disease or metastatic disease; ANDThe condition must be World Health Organisation (WHO) grade 1 or 2; ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17638
	C17696		Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe condition must be unresectable locally advanced disease or metastatic disease; ANDThe condition must be World Health Organisation (WHO) grade 1 or 2; ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17696
Lanthanum	C5530		HyperphosphataemiaInitiation and stabilisationThe condition must not be adequately controlled by calcium; ANDPatient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; ORThe condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; ANDThe treatment must not be used in combination with any other non-calcium phosphate binding agents.Patient must be undergoing dialysis for chronic kidney disease.	Compliance with Authority Required procedures - Streamlined Authority Code 5530
	C9762		HyperphosphataemiaInitiation and stabilisationThe condition must not be adequately controlled by calcium; ANDPatient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; ORThe condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; ANDThe treatment must not be used in combination with any other non-calcium phosphate binding agents.Patient must be undergoing dialysis for chronic kidney disease.	Compliance with Authority Required procedures - Streamlined Authority Code 9762
Lenalidomide	C13782		Relapsed and/or refractory multiple myelomaTriple combination therapy consisting of elotuzumab, lenalidomide and dexamethasonePatient must be undergoing concurrent treatment with elotuzumab obtained through the PBS; ANDPatient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.	Compliance with Authority Required procedures
	C13787		Multiple myelomaContinuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyondPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; ANDThe treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
	C13804		Multiple myelomaContinuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed diseasePatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be as monotherapy.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
	C13805		Multiple myelomaContinuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive diseasePatient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; ANDThe treatment must be as monotherapy; ORThe treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.	Compliance with Authority Required procedures
	C13811		Multiple myelomaContinuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21-day treatment cycles)Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; ANDThe treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ANDThe treatment must not exceed a total of 4 cycles under this restriction.	Compliance with Authority Required procedures
	C13813		Multiple myelomaContinuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28-day treatment cycles)Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; ANDThe treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ANDThe treatment must not exceed a total of 2 cycles under this restriction.	Compliance with Authority Required procedures
	C14362		Relapsed and/or refractory multiple myelomaTriple combination therapy consisting of carfilzomib, lenalidomide and dexamethasonePatient must be undergoing concurrent treatment with carfilzomib obtained through the PBS; ANDPatient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.	Compliance with Authority Required procedures
	C17414		Untreated multiple myelomaTriple combination therapy consisting of daratumumab, lenalidomide and dexamethasonePatient must be undergoing concurrent treatment with daratumumab obtained through the PBS for the treatment of transplant ineligible, newly diagnosed multiple myeloma; ANDPatient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.	Compliance with Authority Required procedures
	C18932		Relapsed or refractory follicular lymphomaThe treatment must be in combination with rituximab and tafasitamab; ORThe treatment must be in combination with tafasitamab.The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.	Compliance with Authority Required procedures
	C19062		Multiple myelomaInitial treatment as monotherapy or dual combination therapy with dexamethasone for progressive diseaseThe condition must be confirmed by a histological diagnosis; ANDThe treatment must be as monotherapy; ORThe treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must have progressive disease after at least one prior therapy; ANDPatient must have undergone or be ineligible for a primary stem cell transplant.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and(2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and(3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and(4) details of the basis of the diagnosis of progressive disease or failure to respond; and(5) nomination of which disease activity parameters will be used to assess response.To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine - the percentage of plasma cells; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient's medical records.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19065		Myelodysplastic syndromeInitial treatmentThe treatment must be limited to a maximum duration of 16 weeks; ANDPatient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS); ANDPatient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; ANDPatient must be red blood cell transfusion dependent.Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias.Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.Classification of a patient as red blood cell transfusion dependent requires that:(i) the patient has been transfused within the last 8 weeks; and(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and(b) details (date, unique identifying number/code or provider number) of the full blood examination report; and(c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and(d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.All the reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19066		Myelodysplastic syndromeContinuing treatmentPatient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome; ANDPatient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS-subsidised therapy with lenalidomide; ANDPatient must not have progressive disease; ANDThe condition must not have progressed to acute myeloid leukaemia.The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.The following evidence of response must be provided at each application:(i) a haemoglobin level taken within the last 4 weeks; and(ii) the date of the last transfusion; and(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;All reports must be documented in the patient's medical records.For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19067		Multiple myelomaInitial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28-day treatment cycleThe condition must be newly diagnosed; ANDThe condition must be confirmed by a histological diagnosis; ANDThe treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ANDPatient must not have been treated with lenalidomide or bortezomib for this condition; ANDThe treatment must not exceed a total of 4 cycles under this restriction.The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and(2) nomination of which disease activity parameters will be used to assess response.To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine - the percentage of plasma cells; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19076		Multiple myelomaInitial treatment with lenalidomide monotherapy in newly diagnosed diseaseThe treatment must be as monotherapy; ANDThe condition must be confirmed by a histological diagnosis; ANDPatient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; ANDPatient must not have progressive disease following autologous stem cell transplant (ASCT).The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and(2) the date the autologous stem cell transplant was performed; and(3) nomination of which disease activity parameters will be used to assess progression.To enable confirmation of eligibility for treatment, the details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f) of at least one of the following must be provided:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine - the percentage of plasma cells; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters will be used to determine progression, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient's medical records.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19079		Multiple myelomaInitial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21-day treatment cycleThe condition must be newly diagnosed; ANDThe condition must be confirmed by a histological diagnosis; ANDThe treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ANDPatient must not have been treated with lenalidomide or bortezomib for this condition; ANDThe treatment must not exceed a total of 4 cycles under this restriction.The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and(2) nomination of which disease activity parameters will be used to assess response.To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine - the percentage of plasma cells; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19119		Multiple myelomaInitial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantationThe condition must be newly diagnosed; ANDThe condition must be confirmed by a histological diagnosis; ANDPatient must be ineligible for a primary stem cell transplantation; ANDThe treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma, and(2) confirmation of ineligibility for prior stem cell transplant; and(3) nomination of which disease activity parameters will be used to assess response.To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine - the percentage of plasma cells; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
Levodopa with carbidopa	C10138	P10138	Advanced Parkinson diseasePatient must have severe disabling motor fluctuations not adequately controlled by oral therapy; ANDThe treatment must be commenced in a hospital-based movement disorder clinic.	Compliance with Authority Required procedures - Streamlined Authority Code 10138
	C10161	P10161	Advanced Parkinson diseasePatient must have severe disabling motor fluctuations not adequately controlled by oral therapy; ANDThe treatment must be commenced in a hospital-based movement disorder clinic.	Compliance with Authority Required procedures - Streamlined Authority Code 10161
	C10363	P10363	Advanced Parkinson diseasePatient must have severe disabling motor fluctuations not adequately controlled by oral therapy; ANDThe treatment must be commenced in a hospital-based movement disorder clinic; ANDPatient must require continuous administration of levodopa without an overnight break; ORPatient must require a total daily dose of more than 2000 mg of levodopa.	Compliance with Authority Required procedures - Streamlined Authority Code 10363
	C10375	P10375	Advanced Parkinson diseasePatient must have severe disabling motor fluctuations not adequately controlled by oral therapy; ANDThe treatment must be commenced in a hospital-based movement disorder clinic; ANDPatient must require continuous administration of levodopa without an overnight break; ORPatient must require a total daily dose of more than 2000 mg of levodopa.	Compliance with Authority Required procedures - Streamlined Authority Code 10375
Lipegfilgrastim	C7822		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7822
	C7843		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7843
	C9224		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 9224
	C9322		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 9322
Lopinavir with ritonavir	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
Lumacaftor with ivacaftor	C17763		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be at least 1 year of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17765		Cystic fibrosisInitial treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be at least 1 year of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17842		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be at least 12 years of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17933		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be aged between 6 and 11 years inclusive.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17934		Cystic fibrosisInitial treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDPatient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be at least 12 years of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17967		Cystic fibrosisInitial treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDPatient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be aged between 6 and 11 years inclusive.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
Macitentan	C11229		Pulmonary arterial hypertension (PAH)Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipagThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); ORThe treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.The authority application for selexipag must be approved prior to the authority application for this agent.For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.PAH (WHO Group 1 pulmonary hypertension) is defined as follows:(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C13497		Pulmonary arterial hypertension (PAH)Initial 3 - changing to this drug in combination therapy (dual or triple therapy)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; ANDPatient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing.	Compliance with Authority Required procedures
	C13575		Pulmonary arterial hypertension (PAH)Continuing treatmentPatient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C18737		Pulmonary arterial hypertension (PAH)Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority applicationThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.	Compliance with Authority Required procedures
	C18741		Pulmonary arterial hypertension (PAH)Initial treatment 2 - Change of treatmentPatient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C18743		Pulmonary arterial hypertension (PAH)Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; ANDPatient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; ORPatient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit.	Compliance with Authority Required procedures
	C18752		Pulmonary arterial hypertension (PAH)Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; this combination therapy is treating a patient with at least WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The test results must not be more than 6 months old at the time of application.	Compliance with Written Authority Required procedures
	C18836		Pulmonary arterial hypertension (PAH)Initial treatment 1 - New patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The test results must not be more than 6 months old at the time of application.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Written Authority Required procedures
Macitentan with tadalafil	C16433		Pulmonary arterial hypertension (PAH)Continuing treatment of combination therapy (triple therapy with selexipag)The treatment must be part of triple combination therapy consisting of: (i) macitentan, (ii) tadalafil, (iii) selexipag.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; ANDPatient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (triple therapy with selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.This treatment is not PBS-subsidised for the use as initial therapyThe authority application for selexipag must be approved prior to the authority application for this agent.	Compliance with Authority Required procedures
	C16457		Pulmonary arterial hypertension (PAH)Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)The treatment must be dual combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil; ORThe treatment must be part of triple combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil, (iii) one prostanoid.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; ANDPatient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (dual or triple therapy, excluding selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.This treatment is not PBS-subsidised for the use as initial therapyFor the purposes of PBS subsidy, a prostanoid is one of: (a) epoprostenol, (b) iloprostAuthority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as 'combination' therapy.	Compliance with Authority Required procedures
Mannitol	C7362		Cystic fibrosisThe treatment must be as monotherapy; ANDPatient must be intolerant or inadequately responsive to dornase alfa.Patient must be 6 years of age or older.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 7362
	C7367		Cystic fibrosisThe treatment must be in combination with dornase alfa; ANDPatient must be inadequately responsive to dornase alfa; ANDPatient must have trialled hypertonic saline for this condition.Patient must be 6 years of age or older.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 7367
	C9527		Cystic fibrosisThe treatment must be as monotherapy; ANDPatient must be intolerant or inadequately responsive to dornase alfa.Patient must be 6 years of age or older.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 9527
	C9593		Cystic fibrosisThe treatment must be in combination with dornase alfa; ANDPatient must be inadequately responsive to dornase alfa; ANDPatient must have trialled hypertonic saline for this condition.Patient must be 6 years of age or older.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 9593
Maraviroc	C5008		HIV infectionPatient must be infected with CCR5-tropic HIV-1, ANDThe treatment must be in addition to optimised background therapy, ANDThe treatment must be in combination with other antiretroviral agents, ANDPatient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.	Compliance with Authority Required procedures - Streamlined Authority Code 5008
Maribavir	C16735		Cytomegalovirus infection and diseasePatient must have received a hematopoietic stem-cell transplant; ORPatient must have received a solid-organ transplant; ANDPatient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; ORPatient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; ANDThe treatment must be used as monotherapy for this condition under this restriction; ANDPatient must not have previously demonstrated resistance to this drug; ANDPatient must not have cytomegalovirus disease that involves the central nervous system; ANDPatient must not have cytomegalovirus retinitis.For the purpose of administering this restriction:(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.	Compliance with Authority Required procedures - Streamlined Authority Code 16735
	C16806		Cytomegalovirus infection and diseasePatient must have received a hematopoietic stem-cell transplant; ORPatient must have received a solid-organ transplant; ANDPatient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; ORPatient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; ANDThe treatment must be used as monotherapy for this condition under this restriction; ANDPatient must not have previously demonstrated resistance to this drug; ANDPatient must not have cytomegalovirus disease that involves the central nervous system; ANDPatient must not have cytomegalovirus retinitis.For the purpose of administering this restriction:(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.	Compliance with Authority Required procedures - Streamlined Authority Code 16806
Mepolizumab	C13865		Chronic rhinosinusitis with nasal polyps (CRSwNP)Continuing treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have both demonstrated and sustained an adequate response to this drug, defined as having at least one of: (i) an improvement in bilateral endoscopic nasal polyp score of at least 1.0 compared to the baseline level provided with the initial authority application, (ii) an improvement in nasal obstruction visual analogue scale (VAS) score of at least 3.0 compared to the baseline level provided with the initial authority application, (iii) an improvement in overall symptom VAS score of at least 2.5 compared to the baseline level provided with the initial authority application.Patient must be at least 18 years of age.	Compliance with Authority Required procedures
	C15376		Uncontrolled severe asthmaBalance of supplyMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; ORPatient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; ORPatient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; ANDThe treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; ORThe treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.	Compliance with Authority Required procedures
	C19092		Uncontrolled chronic obstructive pulmonary disease (COPD)Initial treatment (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have had at least a 12-month break from the most recently approved PBS-subsidised biological medicine for this condition; ANDPatient must have a blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to commencing treatment with this drug in this treatment cycle; ANDPatient must not have achieved adequate control with at least 3 months of an optimised triple inhaler therapy consisting of: (i) long-acting muscarinic antagonist (LAMA); (ii) a long-acting beta-2 agonist (LABA); (iii) an inhaled corticosteroid (ICS), despite formal assessment of and adherence to correct inhaler technique which has been documented in the patient's medical records; ANDPatient must have experienced at least one severe COPD exacerbation, or at least two moderate COPD exacerbations in the 12 months prior to commencing treatment with this drug in this treatment cycle; ANDThe treatment must be in combination with all of: (i) LAMA; (ii) LABA; (iii) ICS in an optimised triple inhaler therapy; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not receive more than 28 weeks of treatment under this restriction.Must be treated by a medical practitioner who is either a: (i) respiratory physician; (ii) general physician experienced in the management of patients with this condition.For the purpose of administering this restriction, COPD exacerbations in the 12 months prior to starting treatment in this treatment cycle are defined as experiencing:(i) at least 1 severe COPD exacerbation which required hospitalisation; and/or(ii) 2 or more moderate COPD exacerbations, of which at least:(a) one required treatment with systemic corticosteroids; and(b) one required treatment with systemic corticosteroids or antibiotics.At least one of the moderate or severe exacerbations must have occurred while the patient was taking all of: (i) LAMA; (ii) LABA; and (iii) ICS in an optimised triple inhaler therapy.The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include the following:(i) the blood eosinophil count and date; and(ii) details of the optimised triple inhaler therapy with the combination of LAMA, LABA and ICS (name of treatment, dosage, date of commencement and duration of therapy); and(iii) details of the number and severity of COPD exacerbation(s) experienced in the 12 months prior to commencing treatment with this drug in this treatment cycle including:(a) number of moderate exacerbations requiring treatment with systemic corticosteroids; and/or(b) number of moderate exacerbations requiring treatment with antibiotics; and(c) number of severe exacerbation(s) which required hospitalisation. The details of the number and the severity of COPD exacerbations are to inform the basis of determining if an adequate response to treatment has been achieved under the continuing treatment restriction. In addition to stating the above details in the authority application, document them in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19128		Uncontrolled severe asthmaContinuing treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be aged 12 years or older.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following information must be provided at the time of application and must be documented in the patient's medical records:(a) if applicable, details of maintenance oral corticosteroid dose; and(b) a completed Asthma Control Questionnaire (ACQ-5) score.	Compliance with Written Authority Required procedures
	C19139		Uncontrolled severe asthmaInitial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; ORPatient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; ORPatient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; ANDPatient must have a duration of asthma of at least 1 year; ANDPatient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; ORPatient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; ANDPatient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and(b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(d) the eosinophil count and date; and(e) Asthma Control Questionnaire (ACQ-5) score.	Compliance with Written Authority Required procedures
	C19166		Uncontrolled chronic obstructive pulmonary disease (COPD)Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supplyPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2026; ANDPatient must have had a blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to commencing non-PBS-subsidised treatment with this drug for this condition; ANDPatient must not have achieved, prior to commencing non-PBS-subsidised treatment with this drug for this condition, adequate control with at least 3 months of optimised triple inhaled therapy consisting of: (i) long-acting muscarinic antagonist (LAMA); (ii) a long-acting beta-2 agonist (LABA); (iii) an inhaled corticosteroid (ICS), despite formal assessment of and adherence to correct inhaler technique which has been documented in the patient's medical records; ANDPatient must have experienced at least one severe COPD exacerbation, or at least two moderate COPD exacerbations in the 12 months prior to commencing non-PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be in combination with all of: (i) LAMA; (ii) LABA; (iii) ICS in an optimised triple inhaler therapy; ANDPatient must have both, achieved and sustained an adequate response to this drug, defined as maintenance (i.e. no change); or a reduction in the number of moderate and/or severe exacerbation(s) compared to the baseline levels provided with this authority application, if they received at least 24 weeks of treatment with this drug for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Must be treated by a medical practitioner who is either a: (i) respiratory physician; (ii) general physician experienced in the management of patients with this condition.For the purpose of administering this restriction, COPD exacerbations in the 12 months prior to commencing non-PBS-subsidised treatment with this drug for this condition, are defined as experiencing:(i) at least 1 severe COPD exacerbation which required hospitalisation; and/or(ii) 2 or more moderate COPD exacerbations, of which at least:(a) one required treatment with systemic corticosteroids; and(b) one required treatment with systemic corticosteroids or antibiotics.At least one of the moderate or severe exacerbations must have occurred while the patient was taking all of: (i) LAMA; (ii) LABA; and (iii) ICS in an optimised triple inhaler therapy.The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include the following:(i) the blood eosinophil count and date; AND(ii) details of therapy with a combination of LAMA, LABA and ICS (name of treatment, dosage, date of commencement, and duration of therapy prior to commencing non-PBS-subsidised treatment with this drug for this condition); AND(iii) the baseline exacerbation history which includes:details of the number and severity of COPD exacerbations experienced in the 12 months immediately prior to commencement of this drug as non-PBS-subsidised therapy for this condition, including:(a) number of moderate exacerbations requiring treatment with systemic corticosteroids; and/or(b) number of moderate exacerbations requiring treatment with antibiotics; and(c) number of severe exacerbations requiring hospitalisation; AND(iv) the assessment of response to treatment where applicable (for patients who have received at least 24 weeks of treatment), which includes:details of the current number and severity of COPD exacerbations, compared with the baseline information supplied in this authority application, including:(a) number of moderate exacerbations requiring treatment with systemic corticosteroids; and/or(b) number of moderate exacerbations requiring treatment with antibiotics; and(c) number of severe exacerbations requiring hospitalisation.The details of the number and the severity of COPD exacerbations are to inform the basis of determining if an adequate response to treatment has been achieved under the continuing treatment restriction.In addition to stating the above details in the authority application, document them in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C19184		Uncontrolled severe asthmaInitial treatment - Initial 2 (Change of treatment)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; ANDPatient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; ANDPatient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; ORPatient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and(b) details (date and duration of treatment) of prior biological medicine treatment; and(c) eosinophil count and date; and(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).	Compliance with Written Authority Required procedures
	C19198		Chronic rhinosinusitis with nasal polyps (CRSwNP)Initial treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.Patient must have a diagnosis of CRSwNP confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan, with the results documented in the patient's medical records; ORPatient must have a diagnosis of CRSwNP from at least two physicians of the above mentioned prescriber types; ANDPatient must have undergone surgery for the removal of nasal polyps; ORPatient must have the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery; ANDPatient must have, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10); ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have had a 12 month break in PBS-subsidised treatment with a biological medicine for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must have failed to achieve adequate control with optimised nasal polyp therapy which has been documented; ANDPatient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months.Patient must be at least 18 years of age.Optimised nasal polyp therapy includes:(a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated(b) if required, nasal irrigation with salineWhere the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient's medical file.The authority application must be made in writing and must include:(a) details of the proposed prescription,(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice),(c) details (date of commencement and duration of therapy) of prior optimised nasal polyp medicine treatment,(d) details (date and treatment) of nasal polyp surgery; or(e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,(f) the eosinophil count and date,(g) two of the following, measured within the past 12 months: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score.	Compliance with Written Authority Required procedures
	C19200		Uncontrolled chronic obstructive pulmonary disease (COPD)Continuing treatmentPatient must have received PBS-subsidised treatment with this biological medicine for this condition; ANDPatient must have both, achieved and sustained an adequate response to this drug, defined as maintenance (i.e. no change); or a reduction in the number of moderate and/or severe exacerbation(s) compared to the baseline levels provided with the initial PBS authority application; ANDThe treatment must be in combination with all of: (i) LAMA; (ii) LABA; (iii) ICS in an optimised triple inhaler therapy; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Must be treated by a medical practitioner who is either a: (i) respiratory physician; (ii) general physician experienced in the management of patients with this condition.The following must be provided in each continuing PBS authority application and be documented in the patient's medical records:details of the current number and severity of exacerbations compared to baseline levels provided in the initial authority application of this treatment cycle including:(i) number of moderate exacerbations requiring treatment with systemic corticosteroids; and/or(ii) number of moderate exacerbations requiring treatment with antibiotics; and(iii) number of severe exacerbation(s) which required hospitalisation.	Compliance with Authority Required procedures
Methadone	C16083		Opioid dependenceThe treatment must be within a framework of medical, social and psychological treatment.The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.	Compliance with Authority Required procedures - Streamlined Authority Code 16083
Methoxsalen	C10971	P10971	Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphomaInitial treatmentPatient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; ORPatient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; ORThe treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; ANDPatient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; ANDPatient must not have previously received PBS-subsidised treatment with this drug for this PBS indication.Must be treated by a haematologist; ORMust be treated by a medical physician working under the supervision of a haematologist.Patient must be aged 18 years or over.	Compliance with Authority Required procedures - Streamlined Authority Code 10971
	C10985	P10985	Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphomaInitial treatmentPatient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; ORPatient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; ORThe treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; ANDPatient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; ANDPatient must not have previously received PBS-subsidised treatment with this drug for this PBS indication.Must be treated by a haematologist; ORMust be treated by a medical physician working under the supervision of a haematologist.Patient must be aged 18 years or over.	Compliance with Authority Required procedures - Streamlined Authority Code 10985
	C10988	P10988	Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphomaContinuing treatmentPatient must have received PBS-subsidised treatment with this drug for this PBS indication; ANDPatient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; ORThe treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; ANDPatient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.Must be treated by a haematologist; ORMust be treated by a medical physician working under the supervision of a haematologist.A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment	Compliance with Authority Required procedures - Streamlined Authority Code 10988
	C10989	P10989	Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphomaContinuing treatmentPatient must have received PBS-subsidised treatment with this drug for this PBS indication; ANDPatient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; ORThe treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; ANDPatient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.Must be treated by a haematologist; ORMust be treated by a medical physician working under the supervision of a haematologist.A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment	Compliance with Authority Required procedures - Streamlined Authority Code 10989
	C12531	P12531	Chronic graft versus host diseaseContinuing treatmentPatient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; ANDPatient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug's 'Initial treatment' PBS-listing for the same treatment episode.Must be treated by a haematologist; ORMust be treated by an oncologist with allogeneic bone marrow transplantation experience; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; ANDPatient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; ANDPatient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see 'Initial treatment' for resuming treatment following relapse.	Compliance with Authority Required procedures - Streamlined Authority Code 12531
	C12546	P12546	Chronic graft versus host diseaseInitial treatment in a treatment episodeThe condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; ORThe condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; ORThe condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed.Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25^thdose) of a treatment episode; ANDMust be treated by a haematologist; ORMust be treated by an oncologist with allogeneic bone marrow transplantation experience; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; ANDPatient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; ANDPatient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12546
	C12567	P12567	Chronic graft versus host diseaseContinuing treatmentPatient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; ANDPatient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug's 'Initial treatment' PBS-listing for the same treatment episode.Must be treated by a haematologist; ORMust be treated by an oncologist with allogeneic bone marrow transplantation experience; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; ANDPatient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; ANDPatient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see 'Initial treatment' for resuming treatment following relapse.	Compliance with Authority Required procedures - Streamlined Authority Code 12567
	C12579	P12579	Chronic graft versus host diseaseInitial treatment in a treatment episodeThe condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; ORThe condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; ORThe condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed.Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25thdose) of a treatment episode; ANDMust be treated by a haematologist; ORMust be treated by an oncologist with allogeneic bone marrow transplantation experience; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; ANDPatient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; ANDPatient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12579
Methoxy polyethylene glycol-epoetin beta	C6294		Anaemia associated with intrinsic renal diseasePatient must require transfusion; ANDPatient must have a haemoglobin level of less than 100 g per L; ANDPatient must have intrinsic renal disease, as assessed by a nephrologist.	Compliance with Authority Required procedures - Streamlined Authority Code 6294
	C9688		Anaemia associated with intrinsic renal diseasePatient must require transfusion; ANDPatient must have a haemoglobin level of less than 100 g per L; ANDPatient must have intrinsic renal disease, as assessed by a nephrologist.	Compliance with Authority Required procedures - Streamlined Authority Code 9688
Midostaurin	C11699		Acute Myeloid LeukaemiaMaintenance therapy - Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; ANDPatient must not be undergoing or have undergone a stem cell transplant.A maximum of 9 cycles will be authorised under this restriction in a lifetime.Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.Progressive disease is defined as the presence of any of the following:Leukaemic cells in the CSF;Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;Extramedullary leukaemia.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.	Compliance with Authority Required procedures
	C13001		Acute Myeloid LeukaemiaInduction / Consolidation therapyPatient must not have received prior chemotherapy as induction therapy for this condition; ORThe treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; ANDThe condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; ANDThe condition must not be acute promyelocytic leukaemia; ANDThe treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.A maximum of 6 cycles will be authorised under this restriction in a lifetime.Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.Progressive disease is defined as the presence of any of the following:Leukaemic cells in the CSF;Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;Extramedullary leukaemia.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.	Compliance with Authority Required procedures
	C19073		Acute Myeloid LeukaemiaMaintenance therapy - Initial treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; ANDPatient must not be undergoing or have undergone a stem cell transplant; ANDThe condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority.A maximum of 3 cycles will be authorised under this restriction in a lifetime.Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.Progressive disease is defined as the presence of any of the following:Leukaemic cells in the CSF;Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;Extramedullary leukaemia.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) confirmation that the patient is not undergoing or has not undergone a stem cell transplant; and(b) confirmation that the patient does not have progressive disease; and(c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and(d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
Mycophenolic Acid	C4084		Prophylaxis of renal allograft rejectionManagementThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required Procedures – Streamlined Authority Code 4084
	C4095		WHO Class III, IV or V lupus nephritisManagementThe condition must be proven by biopsy,Must be treated by a nephrologist or in consultation with a nephrologist.The name of the consulting nephrologist must be included in the patient medical records.	Compliance with Authority Required Procedures – Streamlined Authority Code 4095
	C5554		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 5554
	C5600		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 5600
	C5653		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 5653
	C5795		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 5795
	C9689		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection; ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 9689
	C9690		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy )Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 9690
	C9691		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection; ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 9691
	C9692		Prophylaxis of renal allograft rejectionManagementThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 9692
	C9693		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 9693
	C9809		WHO Class III, IV or V lupus nephritisManagementThe condition must be proven by biopsy.Must be treated by a nephrologist or in consultation with a nephrologist.The name of the consulting nephrologist must be included in the patient medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 9809
Natalizumab	C13625		Clinically definite relapsing-remitting multiple sclerosisMust be treated by a neurologist.The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must be ambulatory (without assistance or support); ANDPatient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; ANDThe condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; ORPatient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 13625
	C13718		Clinically definite relapsing-remitting multiple sclerosisMust be treated by a neurologist.The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must be ambulatory (without assistance or support); ANDPatient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; ANDThe condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; ORPatient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 13718
Nevirapine	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
Nitisinone	C18958		Hereditary tyrosinaemia type 1 (HT-1)Continuing treatmentPatient must have received prior PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; ANDThe treatment must be in combination with dietary restriction of tyrosine and phenylalanine.Must be treated by a physician with expertise in the management of HT-1; ANDMust be treated in a centre with expertise in genetic metabolic disorders.At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.A separate authority prescription form must be completed for each strength requested.Liver function tests (LFT), Full blood count (FBC) and Alpha-fetoprotein (AFP) results confirming eligibility for continuing treatment must be documented in the patient's medical records.Prescribers must state the patient's body weight with every authority application, and document it in the patient's medical records.	Compliance with Authority Required procedures
	C18959		Hereditary tyrosinaemia type 1 (HT-1)Continuing treatmentPatient must have received prior PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; ANDThe treatment must be in combination with dietary restriction of tyrosine and phenylalanine.Must be treated by a physician with expertise in the management of HT-1; ANDMust be treated in a centre with expertise in genetic metabolic disorders.Patient must be less than 18 years of age.At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.A separate authority prescription form must be completed for each strength requested.Liver function tests (LFT), Full blood count (FBC) and Alpha-fetoprotein (AFP) results confirming eligibility for continuing treatment must be documented in the patient's medical records.Prescribers must state the patient's body weight with every authority application, and document it in the patient's medical records.	Compliance with Authority Required procedures
	C19053		Hereditary tyrosinaemia type 1 (HT-1)Initial treatmentPatient must have a confirmed diagnosis of HT-1 based on the presence of succinylacetone in either: (i) urine, (ii) blood; ANDThe treatment must be in combination with dietary restriction of tyrosine and phenylalanine; ANDPatient must not be suffering from any other severe or life-threatening medical condition, including complications or sequelae of HT-1, that might compromise the effectiveness of treatment with this drug or where the long-term prognosis is unlikely to be altered by treatment with this drug.Must be treated by a physician with expertise in the management of HT-1; ANDMust be treated in a centre with expertise in genetic metabolic disorders.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.A separate authority prescription form must be completed for each strength requested.Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results must be conducted no more than 12 months prior to the date of authority application and documented in the patient's medical records.Prescribers must state the patient's body weight with every authority application, and document it in the patient's medical records.	Compliance with Authority Required procedures
	C19055		Hereditary tyrosinaemia type 1 (HT-1)Initial treatmentPatient must have a confirmed diagnosis of HT-1 based on the presence of succinylacetone in either: (i) urine, (ii) blood; ANDThe treatment must be in combination with dietary restriction of tyrosine and phenylalanine; ANDPatient must not be suffering from any other severe or life-threatening medical condition, including complications or sequelae of HT-1, that might compromise the effectiveness of treatment with this drug or where the long-term prognosis is unlikely to be altered by treatment with this drug.Must be treated by a physician with expertise in the management of HT-1; ANDMust be treated in a centre with expertise in genetic metabolic disorders.Patient must be less than 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.A separate authority prescription form must be completed for each strength requested.Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results must be conducted no more than 12 months prior to the date of authority application and documented in the patient's medical records.Prescribers must state the patient's body weight with every authority application, and document it in the patient's medical records.	Compliance with Authority Required procedures
	C19057		Hereditary tyrosinaemia type 1 (HT-1)Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)Patient must have previously received treatment with this drug for this condition under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 August 2026; ANDPatient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; ANDThe treatment must be in combination with dietary restriction of tyrosine and phenylalanine.Must be treated by a physician with expertise in the management of HT-1; ANDMust be treated in a centre with expertise in genetic metabolic disorders.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.A separate authority prescription form must be completed for each strength requested.Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results at baseline, must be documented in the patient's medical records.Prescribers must state the patient's body weight with every authority application, and document it in the patient's medical records.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
	C19058		Hereditary tyrosinaemia type 1 (HT-1)Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)Patient must have previously received treatment with this drug for this condition under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 August 2026; ANDPatient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; ANDThe treatment must be in combination with dietary restriction of tyrosine and phenylalanine.Must be treated by a physician with expertise in the management of HT-1; ANDMust be treated in a centre with expertise in genetic metabolic disorders.Patient must be less than 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.A separate authority prescription form must be completed for each strength requested.Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results at baseline, must be documented in the patient's medical records.Prescribers must state the patient's body weight with every authority application, and document it in the patient's medical records.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
Nusinersen	C14433		Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhoodThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDPatient must be undergoing continuation of existing PBS-subsidised treatment with this drug; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.	Compliance with Authority Required procedures
	C14459		Spinal muscular atrophy (SMA)Continuing/maintenance treatment in an adult where treatment was initiated in adulthoodThe treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; ORThe treatment must be occurring within the first 104 weeks from the first administered dose; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing continuation of existing PBS-subsidised treatment with this drug; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.Undertake re-assessments for a clinically meaningful response at least every six months. Document these re-assessments in the patient's medical records.In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient's motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) or 6-minute walk test (6MWT), and the patient's quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA-HI) or SMA Functional Rating Scale (SMAFRS).	Compliance with Authority Required procedures
	C15069		Spinal muscular atrophy (SMA)Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA (1 or 2 copies of the SMN2 gene) listingMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDPatient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Patient must have been 18 years of age or younger at the time of initial treatment with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.	Compliance with Authority Required procedures
	C15112		Spinal muscular atrophy (SMA)Continuing/maintenance treatment of a patient commenced on this drug under the pre-symptomatic SMA (3 copies of the SMN2 gene) listingMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDPatient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Patient must have been 18 years of age or younger at the time of initial treatment with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.	Compliance with Authority Required procedures
	C18053		Spinal muscular atrophy (SMA)Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with one of: (i) Type 1 SMA, or, (ii) pre-symptomatic SMAPatient must have experienced a regression in a developmental state listed below (see 'Definition') despite treatment with gene therapy - confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non-compliance to best-supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team - state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDPatient must be undergoing treatment under this Treatment phase listing once only - for continuing treatment beyond this authority application, refer to the drug's relevant 'Continuing treatment' listing for the patient's SMA type.Patient must have a prior authority approval for any drug PBS-listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy; ORPatient must have a prior authority approval for any drug PBS-listed for pre-symptomatic SMA, with at least one approval having been for gene therapy.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.Confirm that a previous PBS authority application has been approved for one of the following:(i) Symptomatic Type 1 SMA; or(ii) Pre-symptomatic SMA treated with nusinersen.Definition:Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.0. Absence of developmental states (1 to 9) listed below:1. Rolls from side to side on back;2. Child holds head erect for at least 3 seconds unsupported;3. Sitting, but with assistance;4. Sitting without assistance:(a) Child sits up straight with the head erect for at least 10 seconds;(b) Child does not use arms or hands to balance body or support position.5. Hands and knees crawling:(a) Child alternately moves forward or backwards on hands and knees;(b) The stomach does not touch the supporting surface;(c) There are continuous and consecutive movements at least 3 in a row.6. Standing with assistance:(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;(b)The body does not touch the stable object, and the legs support most of the body weight;(c) Child thus stands with assistance for at least 10 seconds.7. Standing alone:(a) Child stands in upright position on both feet (not on the toes) with the back straight;(b) The leg supports 100% of the child's weight;(c) There is no contact with a person or object;(d) Child stands alone for at least 10 seconds.8. Walking with assistance:(a) Child is in an upright position with the back straight;(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;(c) One leg moves forward while the other supports part of the body weight;(d) Child takes at least 5 steps in this manner.9. Walking alone:(a) Child takes at least 5 steps independently in upright position with the back straight;(b) One leg moves forward while the other supports most of the body weight;(c) There is no contact with a person or object.Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 - 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient's current overall developmental state (i.e. a number that is lower than stated in (i).Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS-subsidy of this benefit is not available.	Compliance with Written Authority Required procedures
	C18073		Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)Initial treatment - Loading dosesMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; ANDThe treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; ANDPatient must not have received PBS-subsidised gene therapy.Patient must be 18 years of age or under.Defined signs and symptoms of type I SMA are:i) Onset before 6 months of age; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Hypotonia; orv) Absence of deep tendon reflexes; orvi) Failure to gain weight appropriate for age; orvii) Any active chronic neurogenic changes; orviii) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type II SMA are:i) Onset between 6 and 18 months; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Weakness in trunk righting/derotation; orv) Hypotonia; orvi) Absence of deep tendon reflexes; orvii) Failure to gain weight appropriate for age; orviii) Any active chronic neurogenic changes; orix) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type IIIa SMA are:i) Onset between 18 months and 3 years of age; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Hypotonia; orv) Absence of deep tendon reflexes; orvi) Failure to gain weight appropriate for age; orvii) Any active chronic neurogenic changes; orviii) A compound muscle action potential below normative values for an age-matched child.Application for authorisation of initial treatment must be in writing and must include:(a) details of the proposed prescription; and(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:(i) specification of SMA type (I, II or IIIa); and(ii) sign(s) and symptom(s) that the patient has experienced; and(iii) patient's age at the onset of sign(s) and symptom(s).	Compliance with Written Authority Required procedures
	C18076		Pre-symptomatic spinal muscular atrophy (SMA)Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene - Loading dosesMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDThe condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; ANDPatient must not have received PBS-subsidised gene therapy.Patient must be aged under 36 months prior to commencing treatment.Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:(a) details of the proposed prescription; and(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:(i) confirmation of genetic diagnosis of SMA; and(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)	Compliance with Written Authority Required procedures
	C18077		Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)Initial PBS-subsidised treatment in a childThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Patient must be of an age that is prior to their 19thbirthday at the time of this authority application; ANDPatient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rdbirthday, but before their 19thbirthday (SMA type IIIB/IIIC).Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDPatient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); ORPatient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,(ii) Proximal weakness,(iii) Hypotonia,(iv) Absence of deep tendon reflexes,(v) Any active denervation or chronic neurogenic changes found on electromyography,(vi) A compound muscle action potential below normative values for an age-matched child.In this authority application, confirm:(1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,(2) which of the above (i to vi) (at least 1) were present after their 3rdbirthday, but before their 19thbirthday,(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.	Compliance with Written Authority Required procedures
	C18078		Spinal muscular atrophy (SMA)Changing the prescribed therapyPatient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient's 19thbirthday; ANDMust be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.Patient must not have received PBS-subsidised gene therapy; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.The prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy.	Compliance with Authority Required procedures
	C18094		Spinal muscular atrophy (SMA)Initial PBS-subsidised treatment in an adult who did not initiate PBS subsidy during childhoodThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; ANDPatient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19thbirthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised).Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); ORPatient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,(ii) Proximal weakness,(iii) Hypotonia,(iv) Absence of deep tendon reflexes,(v) Failure to gain weight appropriate for age,(vi) Any active denervation or chronic neurogenic changes found on electromyography,(vii) A compound muscle action potential below normative values for an age-matched child.In this authority application, confirm:(1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,(2) which of the above (i to vii) (at least 1) were present during childhood,(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.	Compliance with Written Authority Required procedures
	C18101		Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)Changing the prescribed therapyPatient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient's 19thbirthday for SMA type IIIB/IIIC; ANDMust be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.Patient must not have received PBS-subsidised gene therapy; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.The prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy.	Compliance with Authority Required procedures
	C18110		Pre-symptomatic spinal muscular atrophy (SMA)Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 1 or 2 copies of the SMN2 gene - Loading dosesMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDThe condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; ANDPatient must not have received PBS-subsidised gene therapy.Patient must be aged under 36 months prior to commencing treatment.Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:(a) details of the proposed prescription; and(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:(i) confirmation of genetic diagnosis of SMA; and(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)	Compliance with Written Authority Required procedures
Obinutuzumab	C19168	P19168	Lupus nephritisInitial treatmentPatient must have a confirmed diagnosis of active class III or IV lupus nephritis with or without class V disease, confirmed by renal biopsy; ANDPatient must not have severe renal impairment, demonstrated by an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2; ANDPatient must have/have had a urinary protein-to-creatinine ratio (UPCR) of at least 113 mg/mmol (equivalent to 1g/g) prior to initiation of treatment with this drug; ANDThe treatment must be administered with mycophenolate and corticosteroids unless contraindicated/intolerant necessitating treatment withdrawal; ANDThe treatment must not be used in combination with anifrolumab.Must be treated by a specialist physician experienced in the management of this condition.The baseline values of the eGFR and UCPR must be documented in the patient's medical records, as it will inform the basis for determining if worsening of the condition has occurred.	Compliance with Authority Required procedures
	C19169	P19169	Lupus nephritisFirst continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; ANDPatient must not have sustained clinically significant, worsening from baseline values of either: (i) urinary protein-to-creatinine ratio (UPCR); and/or (ii) estimated glomerular filtration rate (eGFR), as determined by the treating physician; ANDThe treatment must be administered with mycophenolate and corticosteroids unless contraindicated/intolerant necessitating treatment withdrawal; ANDThe treatment must not be used in combination with anifrolumab.Must be treated by a specialist physician experienced in the management of this condition.The current values for UPCR and eGFR, used to determine the patient's response to treatment, must be documented in the patient's medical records.	Compliance with Authority Required procedures
	C19188	P19188	Lupus nephritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; ANDPatient must not have demonstrated evidence of clinically significant worsening of the condition, confirmed by either: (i) an increase in urinary protein-to-creatinine ratio (UPCR); or (ii) a reduction in estimated glomerular filtration rate (eGFR) from baseline values, due to persisting active class III or IV lupus nephritis, based on 2 measurements taken 3 months apart; ANDThe treatment must be administered with mycophenolate and corticosteroids unless contraindicated/intolerant necessitating treatment withdrawal; ANDThe treatment must not be used in combination with anifrolumab.Must be treated by a specialist physician experienced in the management of this condition.The values for UPCR and eGFR, taken 3 months apart, used to determine the patient's response to treatment, must be documented in the patient's medical records.	Compliance with Authority Required procedures
Ocrelizumab	C7386		Multiple sclerosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not show continuing progression of disability while on treatment with this drug; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have demonstrated compliance with, and an ability to tolerate this therapy.Must be treated by a neurologist.	Compliance with Authority Required procedures - Streamlined Authority Code 7386
	C7699		Multiple sclerosisInitial treatmentThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; ORThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; ANDPatient must be ambulatory (without assistance or support).Must be treated by a neurologist.Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 7699
	C9523		Multiple sclerosisInitial treatmentThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; ORThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; ANDPatient must be ambulatory (without assistance or support).Must be treated by a neurologist.Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 9523
	C9635		Multiple sclerosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not show continuing progression of disability while on treatment with this drug; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have demonstrated compliance with, and an ability to tolerate this therapy.Must be treated by a neurologist.	Compliance with Authority Required procedures - Streamlined Authority Code 9635
Octreotide	C5901		Functional carcinoid tumourPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 5901
	C5906		Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 5906
	C6369		Vasoactive intestinal peptide secreting tumour (VIPoma)The condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 6369
	C6390		Functional carcinoid tumourThe condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 6390
	C8161		AcromegalyThe condition must be controlled with octreotide immediate release injections; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment; ANDThe treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures - Streamlined Authority Code 8161
	C8165		AcromegalyThe condition must be active; ANDPatient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; ANDThe treatment must be after failure of other therapy including dopamine agonists; ORThe treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; ORThe treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; ANDThe treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures - Streamlined Authority Code 8165
	C8197		AcromegalyPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe condition must be controlled with octreotide immediate release injections; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment; ANDThe treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures - Streamlined Authority Code 8197
	C8198		Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have achieved symptom control on octreotide immediate release injections; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 8198
	C8208		Functional carcinoid tumourPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have achieved symptom control on octreotide immediate release injections; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 8208
	C9232		Vasoactive intestinal peptide secreting tumour (VIPoma)The condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 9232
	C9233		AcromegalyThe condition must be active; ANDPatient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; ANDThe treatment must be after failure of other therapy including dopamine agonists; ORThe treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; ORThe treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 times daily; ANDThe treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures - Streamlined Authority Code 9233
	C9262		AcromegalyThe condition must be controlled with octreotide immediate release injections; ANDThe treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); ANDThe treatment must cease if IGF1 is not lower after 3 months of treatment; ANDThe treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures - Streamlined Authority Code 9262
	C9288		Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have achieved symptom control on octreotide immediate release injections; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 9288
	C9289		Functional carcinoid tumourThe condition must be causing intractable symptoms; ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 9289
	C9313		Functional carcinoid tumourPatient must have achieved symptom control on octreotide immediate release injections; ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 9313
	C17634		Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe condition must be unresectable locally advanced disease or metastatic disease; ANDThe condition must be World Health Organisation (WHO) grade 1 or 2; ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17634
	C17635		Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease; ANDThe condition must be World Health Organisation (WHO) grade 1 or 2; ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17635
	C17637		Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease; ANDThe condition must be World Health Organisation (WHO) grade 1 or 2; ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17637
Omalizumab	C7046		Severe chronic spontaneous urticariaContinuing treatmentMust be treated by a clinical immunologist; ORMust be treated by an allergist; ORMust be treated by a dermatologist; ORMust be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks per authorised course of treatment under this restriction.	Compliance with Authority Required procedures
	C15376		Uncontrolled severe asthmaBalance of supplyMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; ORPatient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; ORPatient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; ANDThe treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; ORThe treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.	Compliance with Authority Required procedures
	C16905		Severe chronic spontaneous urticariaContinuing treatmentMust be treated by a clinical immunologist; ORMust be treated by an allergist; ORMust be treated by a dermatologist; ORMust be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks per authorised course of treatment under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 16905
	C16906		Severe chronic spontaneous urticariaInitial treatmentMust be treated by a clinical immunologist; ORMust be treated by an allergist; ORMust be treated by a dermatologist; ORMust be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); ANDPatient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; ANDPatient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; ANDPatient must not receive more than 12 weeks of treatment under this restriction.A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:1) a H2 receptor antagonist (150 mg twice per day); or2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or3) doxepin (up to 25 mg three times a day)If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.The authority application must be made in writing and must include:(a) details of the proposed prescription; and(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application - Supporting Information Form which must include:(i) demonstration of failure to achieve an adequate response to standard therapy; and(ii) drug names and doses of standard therapies that the patient has failed; and(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.	Compliance with Written Authority Required procedures
	C16960		Severe chronic spontaneous urticariaContinuing treatmentMust be treated by a clinical immunologist; ORMust be treated by an allergist; ORMust be treated by a dermatologist; ORMust be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks per authorised course of treatment under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 16960
	C17012		Uncontrolled severe allergic asthmaInitial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment - Balance of Supply in a patient aged 6 to 12 yearsMust be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy) restriction to complete 28 weeks of treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 2 (Change of treatment) restriction to complete 28 weeks of treatment; ORPatient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; ANDThe treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial 1 and Initial 2 restriction; ORThe treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing restriction.	Compliance with Authority Required procedures
	C17084		Uncontrolled severe allergic asthmaContinuing treatmentPatient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.The following information must be provided at the time of application and must be documented in the patient's medical records:(a) If applicable, the baseline and maintenance oral corticosteroid dose; and(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures - Streamlined Authority Code 17084
	C17085		Uncontrolled severe allergic asthmaContinuing treatmentPatient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.The following information must be provided at the time of application and must be documented in the patient's medical records:(a) If applicable, the baseline and maintenance oral corticosteroid dose; and(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures - Streamlined Authority Code 17085
	C17086		Uncontrolled severe allergic asthmaContinuing treatmentPatient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.The following information must be provided at the time of application and must be documented in the patient's medical records:(a) If applicable, the baseline and maintenance oral corticosteroid dose; and(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures
	C17096		Uncontrolled severe allergic asthmaContinuing treatmentPatient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.The following information must be provided at the time of application and must be documented in the patient's medical records:(a) If applicable, the baseline and maintenance oral corticosteroid dose; and(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures - Streamlined Authority Code 17096
	C17102		Uncontrolled severe allergic asthmaContinuing treatmentPatient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.The following information must be provided at the time of application and must be documented in the patient's medical records:(a) If applicable, the baseline and maintenance oral corticosteroid dose; and(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures - Streamlined Authority Code 17102
	C19080		Uncontrolled severe asthmaContinuing treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be aged 12 years or older.An adequate response to omalizumab treatment is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this drug.Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy.The following information must be provided at the time of application and must be documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5) score; and(b) If applicable, maintenance oral corticosteroid dose; and(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures
	C19083		Uncontrolled severe asthmaInitial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; ORPatient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; ORPatient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; ANDPatient must have a duration of asthma of at least 1 year; ANDPatient must have past or current evidence of atopy that is no more than 1 year old at the time of application that is documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; ANDPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; ANDPatient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for severe asthma within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines for severe asthma within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) details of prior optimised asthma drug therapy (dosage, date of commencement, duration of therapy); and(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(d) the IgE result and date; and(e) Asthma Control Questionnaire (ACQ-5) score.	Compliance with Written Authority Required procedures
	C19135		Uncontrolled severe asthmaContinuing treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be aged 12 years or older.An adequate response to omalizumab treatment is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient's medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.The following information must be documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5) score; and(b) If applicable, maintenance oral corticosteroid dose; and(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures - Streamlined Authority Code 19135
	C19141		Uncontrolled severe allergic asthmaInitial treatment - Initial 2 (Change of treatment)Patient must have received prior PBS-subsidised treatment with a biological medicine in this treatment cycle for either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have had a total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be aged 6 to less than 12 years.The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.Patient must be under the care of the same physician for at least 6 months.An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma or severe allergic asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made no more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.An Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 24 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment at around 24 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date of the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) the IgE result and date; and(b) Asthma Control Questionnaire (ACQ-5) score; or(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.(d) the details of prior biological medicine treatment including the details of date and duration of treatment; and(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).	Compliance with Written Authority Required procedures
	C19161		Uncontrolled severe asthmaInitial treatment - Initial 2 (Change of treatment)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; ANDPatient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; ANDPatient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; ANDPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and(b) details (date and duration of treatment) of prior biological medicine treatment; and(c) the IgE results and date; and(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).	Compliance with Written Authority Required procedures
	C19163		Uncontrolled severe allergic asthmaInitial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)Patient must not have received PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ORPatient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; ANDPatient must have a duration of asthma of at least 1 year; ANDPatient must have past or current evidence of atopy, documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; ANDPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; ANDPatient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be aged 6 to less than 12 years.The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.Patient must be under the care of the same physician for at least 6 months.Optimised asthma therapy includes:(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;AND(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),AND(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(c) the IgE result and date; and(d) Asthma Control Questionnaire (ACQ-5) score; or(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.	Compliance with Written Authority Required procedures
	C19214		Uncontrolled severe asthmaContinuing treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be aged 12 years or older.An adequate response to omalizumab treatment is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient's medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.The following information must be documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5) score; and(b) If applicable, maintenance oral corticosteroid dose; and(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.	Compliance with Authority Required procedures - Streamlined Authority Code 19214
Onasemnogene abeparvovec	C15989		Spinal muscular atrophy (SMA)Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)The treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes.Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; ANDMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; ANDPatient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased.Patient must be no older than 9 months of age; ANDPatient must have pre-symptomatic SMA with 3 copies of the SMN2 gene.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.Confirm that a previous PBS authority application has been approved for pre-symptomatic SMA with 3 copies of SMN2 gene.State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit.	Compliance with Written Authority Required procedures
	C16045		Spinal muscular atrophy (SMA)Use in a patient untreated with disease modifying therapies for this conditionThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDThe condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; ANDThe treatment must be given concomitantly with best supportive care for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; ANDPatient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.Patient must be no older than 9 months of age.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.	Compliance with Written Authority Required procedures
	C18211		Spinal muscular atrophy (SMA)Use in a patient untreated with disease modifying therapies for this conditionThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must have experienced at least two of the defined signs/symptoms of Type 1 SMA specified below; ORThe condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; ANDThe treatment must be given concomitantly with best supportive care for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; ANDPatient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.Patient must be no older than 9 months of age; ANDPatient must have symptomatic Type 1 SMA; ORPatient must have pre-symptomatic SMA.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribing Instructions:In the relevant PBS Authority Application form, specify the following:(i) the SMA type being treated: symptomatic Type 1 SMA, or, pre-symptomatic SMA;(ii) for Type 1 SMA, the signs/symptoms that the patient has experienced, together with the patient's age at the onset of these signs/symptoms.State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.If the condition is pre-symptomatic SMA, confirm that there is genetic test finding that substantiates the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.Defined signs and symptoms of type I SMA are:i) Onset before 6 months of age; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Hypotonia; orv) Absence of deep tendon reflexes; orvi) Failure to gain weight appropriate for age; orvii) Any active chronic neurogenic changes; orviii) A compound muscle action potential below normative values for an age-matched child.	Compliance with Written Authority Required procedures
	C18213		Spinal muscular atrophy (SMA)Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)The treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes.Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; ANDMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; ANDPatient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased.Patient must be no older than 9 months of age; ANDPatient must have symptomatic Type 1 SMA; ORPatient must have pre-symptomatic SMA with 1-2 copies of SMN2 gene.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.Confirm that a previous PBS authority application has been approved for one of the following:(i) Symptomatic Type 1 SMA; or(ii) Pre-symptomatic SMA with 1-2 copies of SMN2 gene.State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit.	Compliance with Written Authority Required procedures
Pamidronic Acid	C4433		Hypercalcaemia of malignancyPatient must have a malignancy refractory to anti-neoplastic therapy	Compliance with Authority Required procedures – Streamlined Authority Code 4433
	C5218		Multiple Myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 5218
	C5291		Bone metastasesThe condition must be due to breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 5291
	C9234		Hypercalcaemia of malignancyPatient must have a malignancy refractory to anti-neoplastic therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 9234
	C9315		Bone metastasesThe condition must be due to breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 9315
	C9335		Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 9335
Pasireotide	C19069		AcromegalyContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be given concomitantly with PBS-subsidised pegvisomant.Patient must be at least 18 years of age.In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.Biochemical evidence of remission is defined as:1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.	Compliance with Authority Required procedures
	C19121		AcromegalyInitial treatmentPatient must not have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have a mean growth hormone (GH) level greater than 1 microgram per litre or 3 mlU/L; ORPatient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN); ANDThe treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; ANDThe treatment must not be given concomitantly with PBS-subsidised pegvisomant.Patient must be at least 18 years of age.If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR2) IGF-1 level is greater than the age- and sex-adjusted ULN.In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.Biochemical evidence of remission is defined as:1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)The authority application must be made in writing and must include:a) details of the proposed prescription; andb) a completed Acromegaly PBS Authority Application - Supporting Information Form; andc) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; the date and result of GH or IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; andd) a recent result of GH or IGF-1 levels must be provided.	Compliance with Written Authority Required procedures
Pegcetacoplan	C17598		Paroxysmal nocturnal haemoglobinuria (PNH)Subsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First continuing treatment', 'Return' criteria, or 'Grandfather' treatment restrictions; ANDPatient must have experienced clinical improvement as a result of treatment with this drug; ORPatient must have experienced a stabilisation of the condition as a result of treatment with this drug; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.	Compliance with Written Authority Required procedures
	C17599		Paroxysmal nocturnal haemoglobinuria (PNH)Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 1 (Complement 5 (C5) inhibitor inexperienced patients)Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; ANDPatient must not have received any treatment for this condition prior to commencing non-PBS-subsidised treatment with this drug; ANDPatient must have had a diagnosis of PNH established by flow cytometry prior to commencing non-PBS-subsidised treatment with this drug; ANDPatient must have had PNH granulocyte clone size equal to or greater than 10% prior to commencing non-PBS-subsidised treatment with this drug; ANDPatient must have had a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing non-PBS-subsidised treatment with this drug; ANDPatient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing non-PBS-subsidised treatment with this drug; ORPatient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing non-PBS-subsidised treatment with this drug; ORPatient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; ORPatient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; ORPatient must have had debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; ORPatient must have had a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m², where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; ORPatient must have had recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.	Compliance with Written Authority Required procedures
	C17601		Paroxysmal nocturnal haemoglobinuria (PNH)Initial treatment - Initial 1 (new untreated patient)Patient must not have received prior treatment with any of the PBS-subsidised therapies listed for this condition; ANDPatient must have a diagnosis of PNH established by flow cytometry; ANDPatient must have PNH granulocyte clone size equal to or greater than 10%; ANDPatient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; ANDPatient must have experienced a thrombotic/embolic event which required anticoagulant therapy; ORPatient must have been transfused with at least 4 units of red blood cells in the last 12 months; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; ORPatient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; ORPatient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m², where causes other than PNH have been excluded; ORPatient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)	Compliance with Written Authority Required procedures
	C17622		Paroxysmal nocturnal haemoglobinuria (PNH)Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 2 (Complement 5 (C5) inhibitor experienced patients)Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; ANDPatient must have had PNH granulocyte clone size equal to or greater than 10% within the last 3 months prior to commencing non-PBS-subsidised treatment with this drug; ANDPatient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating non-PBS-subsidised treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; ANDThe treatment must have been in combination with one C5 inhibitor for a period of 4 weeks during initiation of therapy; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.	Compliance with Written Authority Required procedures
	C17623		Paroxysmal nocturnal haemoglobinuria (PNH)Initial treatment - Initial 2 (switching from a Complement 5 (C5) inhibitor)Patient must not have received prior treatment with this drug for this condition; ANDPatient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; ANDPatient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; ANDThe treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)	Compliance with Written Authority Required procedures
	C17647		Paroxysmal nocturnal haemoglobinuria (PNH)First continuing treatmentPatient must have received PBS-subsidised treatment with this drug for this condition under 'Initial 1' (new untreated patient) or 'Initial 2' (switching from a Complement 5 (C5) inhibitor); ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)	Compliance with Written Authority Required procedures
	C17683		Paroxysmal nocturnal haemoglobinuria (PNH)Return from PBS-subsidised eculizumab post pregnancy or from one of the PBS-subsidised therapies for this condition, for reasons other than post pregnancyPatient must have received prior PBS-subsidised treatment with this drug for this condition; ANDPatient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)' criteria; ORPatient must have received prior PBS-subsidised treatment with at least one drug listed for this condition and must be returning to pegcetacoplan treatment for reasons other than post pregnancy; ANDPatient must have experienced clinical improvement as a result of treatment with this drug; ORPatient must have experienced a stabilisation of the condition as a result of treatment with this drug; ANDThe treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long-term continuing PBS-subsidised treatment with pegcetacoplan is planned, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria of pegcetacoplan.	Compliance with Written Authority Required procedures
Pegfilgrastim	C7822		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7822
	C7843		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7843
	C9235		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 9235
	C9303		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 9303
Peginterferon alfa-2a	C17022		Chronic hepatitis C infectionMust be treated in an accredited treatment centre.Patient must be at least 18 years of age; ANDPatient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age.Patient must have compensated liver disease; ANDPatient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; ANDPatient must have a contraindication to ribavirin; ANDThe treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; ANDThe treatment must be limited to a maximum duration of 48 weeks.Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17022
	C17108		Chronic hepatitis C infectionMust be treated in an accredited treatment centre.Patient must be at least 18 years of age; ANDPatient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age.Patient must have compensated liver disease; ANDPatient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; ANDPatient must have a contraindication to ribavirin; ANDThe treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; ANDThe treatment must be limited to a maximum duration of 48 weeks.Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17108
Pegunigalsidase alfa	C18929		Fabry diseaseGrandfather arrangement (transition from LSDP-funded Fabry disease therapy)Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 August 2026; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a physician with expertise in the management of Fabry disease.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).	Compliance with Written Authority Required procedures
	C18930		Fabry diseaseContinuing treatmentPatient must have received prior PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a physician with expertise in the management of Fabry disease.At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).	Compliance with Authority Required procedures
	C19015		Fabry diseaseInitial treatmentPatient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity; ANDPatient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; ORPatient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; ORPatient must have Fabry-related cardiac disease confirmed by at least one of the following: (i) left ventricular hypertrophy, as evidenced by cardiac magnetic resonance imaging (MRI) or echocardiogram data, in the absence of hypertension, (ii) significant life-threatening arrhythmia or conduction defect, (iii) late gadolinium enhancement or a low T1 on cardiac MRI; ORPatient must have Fabry-related either: (i) ischaemic disease, (ii) cerebrovascular disease as shown on objective testing with no other cause or risk factors identified; ORPatient must have Fabry-related uncontrolled chronic pain despite the use of recommended doses of appropriate analgesia and antiseizure medications for peripheral neuropathy; ORPatient must have significant Fabry-related gastrointestinal symptoms despite the use of the recommended doses of appropriate pharmacological therapies; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a physician with expertise in the management of Fabry disease.If hypertension is present in patients relying their eligibility on Fabry-related cardiac disease, the prescriber must treat it optimally for at least 6 months prior to submitting the first PBS authority application.Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C19045		Fabry diseaseSwitching from PBS-subsidised migalastatPatient must have received prior treatment with PBS-subsidised migalastat for this condition; ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; ANDThe treatment must be the sole PBS-subsidised therapy for this condition; ANDPatient must not have failed to demonstrate clinical improvement or stabilisation of this condition with previous PBS-subsidised treatment with this drug.Must be treated by a physician with expertise in the management of Fabry disease.Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).	Compliance with Authority Required procedures
Pegvisomant	C19071		AcromegalyInitial treatmentPatient must not have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN); ANDThe treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; ANDThe treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue.Somatostatin analogues include octreotide, lanreotide and pasireotideFailure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR2) IGF-1 level is greater than the age- and sex-adjusted ULN.If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF-1 levels measured every 4 to 6 weeks in order to maintain the serum IGF-1 level within the age-adjusted normal range based on the dosage recommendations in the TGA-approved Product Information.The authority application must be made in writing and must include:a) details of the proposed prescription(s); andb) a completed Acromegaly Pegvisomant initial PBS Authority Application - Supporting Information Form; andc) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy, the date and result of IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; andd) a recent result of the IGF-1 level and the date of assessment ; ande) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotideNo increase in the maximum quantity or number of units may be authorised for the loading dose.	Compliance with Written Authority Required procedures
	C19122		AcromegalyContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue; ANDThe treatment must cease if IGF-1 is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose.Somatostatin analogues include octreotide, lanreotide and pasireotideIn a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of IGF-1 level taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of application.	Compliance with Authority Required procedures
Plerixafor	C4549		Mobilisation of haematopoietic stem cellsThe treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); ANDPatient must have lymphoma; ORPatient must have multiple myeloma; ANDPatient must require autologous stem cell transplantation; ANDPatient must have failed previous stem cell collection; ORPatient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; ORPatient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.Evidence that the patient meets the PBS restriction criteria must be recorded in the patient’s medical records	Compliance with Authority Required procedures - Streamlined Authority Code 4549
	C9329		Mobilisation of haematopoietic stem cellsThe treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); ANDPatient must have lymphoma; ORPatient must have multiple myeloma; ANDPatient must require autologous stem cell transplantation; ANDPatient must have failed previous stem cell collection; ORPatient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; ORPatient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.Evidence that the patient meets the PBS restriction criteria must be recorded in the patient’s medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 9329
Pomalidomide	C13755		Multiple myelomaContinuing treatment - dual therapy in combination with dexamethasonePatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; ANDThe treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).	Compliance with Authority Required procedures
	C13757		Multiple myelomaInitial treatment with triple therapy (this drug, bortezomib and dexamethasone)The condition must be confirmed by a histological diagnosis; ANDThe treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ANDPatient must have progressive disease after at least one prior therapy that is either: (i) lenalidomide monotherapy, (ii) contains lenalidomide; ANDPatient must have undergone or be ineligible for a stem cell transplant.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
	C13768		Multiple myelomaContinuing treatment with triple therapy (this drug, bortezomib and dexamethasone)Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
	C19229		Multiple myelomaInitial treatment - dual therapy in combination with dexamethasoneThe treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must have undergone or be ineligible for a primary stem cell transplant; ANDPatient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; ANDPatient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information.Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(1) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with lenalidomide, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide according to the relevant TGA-approved Product Information; and(2) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with bortezomib, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to bortezomib according to the relevant TGA-approved Product Information.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
Raltegravir	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
Ravulizumab	C14748		Atypical haemolytic uraemic syndrome (aHUS)Balance of Supply - maintenance dosesPatient must have received PBS-subsidised loading dose of ravulizumab for this condition for this current treatment phase; ANDPatient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; ANDPatient must have received insufficient therapy to complete the maximum allowable treatment under their specified treatment phase; ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the relevant treatment phase.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion and must have been submitted to Services Australia within 13 days of commencement of ravulizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.	Compliance with Written Authority Required procedures
	C16368		Neuromyelitis optica spectrum disorder (NMOSD)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have an Expanded Disability Status Scale (EDSS) score of no higher than 7; ANDPatient must not have experienced a relapse while receiving treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a neurologist; ORMust be treated by a medical practitioner who has consulted a neurologist, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures
	C17055		Neuromyelitis optica spectrum disorder (NMOSD)Initial treatment - loading dosePatient must have a confirmed diagnosis of NMOSD with aquaporin-4 immunoglobulin G auto-antibody (AQP4-IgG); ANDPatient must have an Expanded Disability Status Scale (EDSS) score of no higher than 7; ANDPatient must have experienced at least one relapse in the last 12 months while receiving treatment with rituximab; ORPatient must have a documented intolerance to rituximab of a severity necessitating permanent treatment withdrawal; ORPatient must have a documented contraindication to rituximab therapy; ANDPatient must not receive more than 2 weeks of treatment under this restriction.Must be treated by a neurologist; ORMust be treated by a medical practitioner who has consulted a neurologist, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for a single loading dose for induction therapy, according to the specified dosage in the approved Product Information (PI). Refer to the approved PI for patient weight ranges for the 100 mg/mL doses (consisting of 300 mg in 3 mL and 1.1 g in 11 mL vials).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.The authority application must be in writing and must include all of the following:(1) details of the proposed authority prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:(i) the patient's Expanded Disability Status Scale (EDSS) score; and(ii) details of prior rituximab treatment (dosage, date of commencement and duration of therapy), or details of contraindications or developed intolerances necessitating treatment withdrawal.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Written Authority Required procedures
	C17605		Paroxysmal nocturnal haemoglobinuria (PNH)Initial treatment - Initial 1 (new patient) induction dosePatient must not have received prior treatment with this drug for this condition; ANDPatient must have a diagnosis of PNH established by flow cytometry; ANDPatient must have a PNH granulocyte clone size equal to or greater than 10%; ANDPatient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; ANDPatient must have experienced a thrombotic/embolic event which required anticoagulant therapy; ORPatient must have been transfused with at least 4 units of red blood cells in the last 12 months; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; ORPatient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; ORPatient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m², where causes other than PNH have been excluded; ORPatient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product InformationAt the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5	Compliance with Written Authority Required procedures
	C17606		Paroxysmal nocturnal haemoglobinuria (PNH)Return from PBS-subsidised eculizumab - induction dosePatient must have received prior PBS-subsidised treatment with this drug for this condition; ANDPatient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)' criteria; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product InformationPatient may qualify under this treatment phase more than once for the purposes of family planning. Where long-term continuing PBS-subsidised treatment with this drug is planned, a 'Returning' patient may proceed under the 'Subsequent Continuing Treatment' criteria.	Compliance with Written Authority Required procedures
	C17609		Paroxysmal nocturnal haemoglobinuria (PNH)Subsequent Continuing TreatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Return' criteria; ANDPatient must have experienced clinical improvement as a result of treatment with this drug; ORPatient must have experienced a stabilisation of the condition as a result of treatment with this drug; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.	Compliance with Written Authority Required procedures
	C17610		Paroxysmal nocturnal haemoglobinuria (PNH)Initial treatment - Initial 2 (switch from LSDP eculizumab) induction dosePatient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); ANDPatient must have a diagnosis of PNH established by flow cytometry prior to LSDP-funded treatment with eculizumab; ANDPatient must have a PNH granulocyte clone size equal to or greater than 10% prior to LSDP-funded treatment with eculizumab; ANDPatient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to LSDP-funded treatment with eculizumab; ANDPatient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to LSDP-funded treatment with eculizumab; ORPatient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to LSDP-funded treatment with eculizumab; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to LSDP-funded treatment with eculizumab; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to LSDP-funded treatment with eculizumab; ORPatient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; ORPatient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m², where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; ORPatient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product InformationAt the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5	Compliance with Written Authority Required procedures
	C17629		Paroxysmal nocturnal haemoglobinuria (PNH)First Continuing TreatmentPatient must have received PBS-subsidised treatment with this drug for this condition under the 'Initial' or 'Grandfather' treatment restriction; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)	Compliance with Written Authority Required procedures
	C17630		Paroxysmal nocturnal haemoglobinuria (PNH)Switching from PBS-subsidised pegcetacoplan or iptacopan - induction dosesPatient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; ANDPatient must have developed resistance or intolerance to either: (i) pegcetacoplan, (ii) iptacopan; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).For continuing PBS-subsidised treatment with this drug, a 'Returning' patient must proceed under the'Subsequent Continuing Treatment' criteria.	Compliance with Written Authority Required procedures
	C17631		Paroxysmal nocturnal haemoglobinuria (PNH)Grandfather (transition from non-PBS-subsidised treatment)Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2022; ANDPatient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with ravulizumab; ANDPatient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with ravulizumab; ANDPatient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with ravulizumab; ANDPatient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; ANDPatient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with ravulizumab; ORPatient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with ravulizumab; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with ravulizumab; ORPatient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with ravulizumab; ORPatient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; ORPatient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m², where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; ORPatient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist; ORMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x10⁹/L)(iii) White Cell Count (x10⁹/L)(iv) Reticulocytes (x10⁹/L)(v) Neutrophils (x10⁹/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5	Compliance with Written Authority Required procedures
	C18131		Bridging therapy for generalised myasthenia gravis (gMG)Loading dosePatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication ('bridging therapy for gMG').Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System or in writing and must include:(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.	Compliance with Authority Required procedures
	C18132		Acute severe generalised myasthenia gravis (gMG)Loading dosePatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must be commencing treatment with an NS-IST within 2 weeks; ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication ('acute severe gMG'); ANDPatient must not have accessed a prior PBS-subsidised gMG biological agent; ORPatient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18133		Treatment refractory generalised myasthenia gravis (gMG)Continuing treatment - Treatment refractory gMG patients (Loading dose)Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; ANDPatient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; ANDPatient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18134		Acute severe generalised myasthenia gravis (gMG)Non-loading/maintenance dosesPatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must be commencing treatment with an NS-IST within 2 weeks; ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication ('acute severe gMG'); ANDPatient must not have accessed a prior PBS-subsidised gMG biological agent; ORPatient must have received a loading dose of this drug for this indication; ORPatient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18135		Bridging therapy for generalised myasthenia gravis (gMG)Non-loading/maintenance dosesPatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System or in writing and must include:(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.	Compliance with Authority Required procedures
	C18137		Treatment refractory generalised myasthenia gravis (gMG)Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatmentPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 March 2026; ANDPatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; ANDPatient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; ANDPatient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; ANDThe treatment must provide no more than 6 months of therapy under this restriction.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System, or in writing and must include:(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.	Compliance with Authority Required procedures
	C18153		Atypical haemolytic uraemic syndrome (aHUS)Continuing recommencement of treatmentPatient must have received PBS-subsidised ravulizumab under the 'Recommencement of treatment' restriction for this condition; ORPatient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Recommencement treatment' restriction for this condition; ORPatient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Continuing recommencement treatment' restriction for this condition; ANDPatient must have demonstrated ongoing treatment response to 'Recommencement of treatment' with a C5 inhibitor for this condition; ANDPatient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; ANDPatient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.A treatment response is defined as:(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and(2) One of the following:a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; orb) an eGFR within +/- 25% from baseline; orc) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR > 25% from baseline.PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.A treatment failure is defined as a patient who is:(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).The authority application must be in writing and must include all of the following:(1) Details of the proposed prescription(s);(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);(3) A measurement of body weight at the time of application;(4) Results of genetic testing, if not previously submitted;(5) A family history of aHUS, if applicable;(6) A history of multiple episodes of aHUS before recommencing ravulizumab treatment, if applicable;(7) A history of kidney transplant if applicable (especially if required due to aHUS);(8) An inclusion of the individual consequences of recurrent disease, if applicable;(9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;(10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;(11) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.	Compliance with Authority Required procedures
	C18155		Atypical haemolytic uraemic syndrome (aHUS)Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangementsPatient must have previously received non-PBS-subsidised therapy with this drug for this condition; ANDPatient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS supply of a C5 inhibitor treatment was commenced, the patient: (i) had active and progressing thrombotic microangiopathy (TMA) caused by aHUS; (ii) had ADAMTS-13 activity of greater than or equal to 10% on a blood sample not confounded by any plasma exchange or infusion; (iii) had a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days of commencing C5 inhibitor treatment; (iv) had clinical features of active organ damage or impairment; ANDPatient must have demonstrated ongoing treatment response with ravulizumab for this condition if received at least 26 weeks of initial non-PBS-subsidised therapy; ANDPatient must not have experienced treatment failure with ravulizumab for this condition if they have received at least 26 weeks of initial non-PBS-subsidised therapy.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.Evidence of active and progressing TMA is defined by the following:(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:(i) presence of schistocytes on blood film;(ii) low or absent haptoglobin;(iii) lactate dehydrogenase (LDH) above normal range; or(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:(a) kidney impairment as demonstrated by one or more of the following:(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;(iv) a renal biopsy consistent with aHUS;(b) onset of TMA-related neurological impairment;(c) onset of TMA-related cardiac impairment;(d) onset of TMA-related gastrointestinal impairment;(e) onset of TMA-related pulmonary impairment.Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.The authority application must be in writing and must include all of the following:(1) Details of the proposed prescription(s);(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);(3) A detailed cover letter from the prescriber;(4) A measurement of body weight at the time of application;(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay;(6) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days of initiating treatment with non-PBS-subsidised C5 inhibitor treatment;(7) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of commencement of non-PBS-subsidised C5 inhibitor treatment;(8) For patients who have received at least 26 weeks of ravulizumab treatment, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.	Compliance with Authority Required procedures
	C18237		Treatment refractory generalised myasthenia gravis (gMG)Initial treatment - Treatment refractory gMG patients (Loading dose)Patient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); ORPatient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System, or in writing and must include:(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18238		Treatment refractory generalised myasthenia gravis (gMG)Continuing treatment - Treatment refractory gMG patientsPatient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; ANDPatient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; ANDPatient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDThe treatment must provide no more than 6 months of therapy per continuing authority application.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18260		Atypical haemolytic uraemic syndrome (aHUS)Continuing treatmentPatient must have received PBS-subsidised ravulizumab under the initial treatment phase for this condition; ORPatient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; ORPatient must have received PBS-subsidised ravulizumab under the grandfather restriction for this condition; ANDPatient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; ANDPatient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; ANDPatient must not receive more than 72 weeks of ravulizumab treatment in total under this restriction; ORPatient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; ANDPatient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.A treatment response is defined as:(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and(2) One of the following:a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; orb) an eGFR within +/- 25% from baseline; orc) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR > 25% from baseline.PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.A treatment failure is defined as a patient who is:(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).The authority application must be in writing and must include all of the following:(1) Details of the proposed prescription(s);(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);(3) A measurement of body weight at the time of application;(4) Results of genetic testing, if not previously submitted;(5) A family history of aHUS, if applicable;(6) A history of kidney transplant if applicable (especially if required due to aHUS);(7) An inclusion of the individual consequences of recurrent disease, if applicable;(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;(10) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.	Compliance with Authority Required procedures
	C18262		Atypical haemolytic uraemic syndrome (aHUS)Extended continuing treatmentPatient must have received PBS-subsidised ravulizumab under the continuing treatment phase for this condition; ORPatient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; ORPatient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the extended continuing treatment phase for this condition; ANDPatient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; ANDPatient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; ANDPatient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; ORPatient must have severe TMA-related neurological impairment; ORPatient must have severe TMA-related gastrointestinal impairment; ORPatient must have severe TMA-related pulmonary impairment on current objective measurement; ORPatient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); ORPatient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with ravulizumab; ANDPatient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.A treatment response is defined as:(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and(2) One of the following:a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; orb) an eGFR within +/- 25% from baseline; orc) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR > 25% from baseline.PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.A treatment failure is defined as a patient who is:(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).The authority application must be in writing and must include all of the following:(1) Details of the proposed prescription(s);(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);(3) A measurement of body weight at the time of application;(4) Results of genetic testing, if not previously submitted;(5) A family history of aHUS, if applicable;(6) A history of multiple episodes of aHUS before commencing ravulizumab treatment, if applicable;(7) A history of kidney transplant, if applicable (especially if required due to aHUS);(8) An inclusion of the individual consequences of recurrent disease;(9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;(10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.	Compliance with Authority Required procedures
	C18283		Atypical haemolytic uraemic syndrome (aHUS)Recommencement of treatmentPatient must have demonstrated treatment response to previous treatment with a PBS-subsidised C5 inhibitor for this condition; ANDPatient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; ANDPatient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.A treatment response is defined as:(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and(2) One of the following:a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; orb) an eGFR within +/- 25% from baseline; orc) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR > 25% from baseline.PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.A treatment failure is defined as a patient who is:(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).The authority application must be in writing and must include all of the following:(1) Details of the proposed prescription(s);(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);(3) A measurement of body weight at the time of application;(4) Results of genetic testing, if not previously submitted;(5) A family history of aHUS if applicable;(6) A history of multiple episodes of aHUS following the treatment break, if applicable;(7) A history of kidney transplant if applicable (especially if required due to aHUS);(8) An inclusion of the individual consequences of recurrent disease;(9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;(10) Evidence that the patient has had a treatment response to their previous treatment with a C5 inhibitor;(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.Two authority prescription forms will be required to cover for the 26 weeks of recommencement therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.	Compliance with Written Authority Required procedures
	C18350		Atypical haemolytic uraemic syndrome (aHUS)Switch from PBS-subsidised eculizumab (all phases) - loading dosePatient must have previously received PBS-subsidised eculizumab under the 'Initial treatment' restriction for this condition; ORPatient must have previously received PBS-subsidised eculizumab under the 'Continuing treatment' restriction for this condition; ORPatient must have previously received PBS-subsidised eculizumab under the 'Extended continuing treatment' restriction for this condition; ORPatient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; ORPatient must have previously received PBS-subsidised eculizumab under the 'Continuing recommencement of treatment' restriction for this condition; ANDPatient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; ANDPatient must not receive more than 2 weeks of treatment under this restriction.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.The application must indicate the most recent treatment phase that the patient is switching from.For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.The authority application must be in writing and must include all of the following:(1) Details of the proposed prescription(s);(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);(3) A measurement of body weight at the time of application;(4) Results of genetic testing, if not previously submitted.	Compliance with Authority Required procedures
	C18423		Treatment refractory generalised myasthenia gravis (gMG)Initial treatment - Treatment refractory gMG patients (Non-loading/maintenance doses)Patient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); ORPatient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; ANDThe treatment must provide no more than 6 months of therapy per initial authority application.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.The authority application must be via the Online PBS Authorities System, or in writing and must include:(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C19240		Atypical haemolytic uraemic syndrome (aHUS)Initial treatment - Initial (new patient) loading dosePatient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; ANDPatient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; ANDPatient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; ANDPatient must have clinical features of active organ damage or impairment; ANDPatient must not receive more than 2 weeks of treatment under this restriction.Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; ANDPatient must be undergoing treatment with one C5 inhibitor therapy only at any given time.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.Evidence of active and progressing TMA is defined by the following:(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:(i) presence of schistocytes on blood film;(ii) low or absent haptoglobin;(iii) lactate dehydrogenase (LDH) above normal range; or(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:(a) kidney impairment as demonstrated by one or more of the following:(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;(iv) a renal biopsy consistent with aHUS;(b) onset of TMA-related neurological impairment;(c) onset of TMA-related cardiac impairment;(d) onset of TMA-related gastrointestinal impairment;(e) onset of TMA-related pulmonary impairment.Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.The authority application must be in writing and must include all of the following:(1) Details of the proposed prescription(s);(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);(3) A detailed cover letter from the prescriber;(4) A measurement of body weight at the time of application;(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion (if available); the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay. The ADAMTS-13 result must be submitted to Services Australia within 13 days of commencement of ravulizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised C5 inhibitor treatment, under Initial balance of supply;(6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 13 days of commencement of ravulizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised C5 inhibitor treatment, under Initial balance of supply;(7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;(8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;(9) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.Two authority prescription forms will be required to cover for the 26 weeks of initial therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.	Compliance with Written Authority Required procedures
Rifabutin	C6350		Mycobacterium avium complex infectionPatient must be human immunodeficiency virus (HIV) positive.	Compliance with Authority Required procedures - Streamlined Authority Code 6350
	C6356		Mycobacterium avium complex infectionThe treatment must be for prophylaxis; ANDPatient must be human immunodeficiency virus (HIV) positive; ANDPatient must have CD4 cell counts of less than 75 per cubic millimetre.	Compliance with Authority Required procedures - Streamlined Authority Code 6356
	C9560		Mycobacterium avium complex infectionPatient must be human immunodeficiency virus (HIV) positive.	Compliance with Authority Required procedures - Streamlined Authority Code 9560
	C9622		Mycobacterium avium complex infectionThe treatment must be for prophylaxis; ANDPatient must be human immunodeficiency virus (HIV) positive; ANDPatient must have CD4 cell counts of less than 75 per cubic millimetre.	Compliance with Authority Required procedures - Streamlined Authority Code 9622
Rilpivirine	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
Riociguat	C13502		Pulmonary arterial hypertension (PAH)Continuing treatmentPatient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C13514		Pulmonary arterial hypertension (PAH)Initial 2 (change)Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; ANDPatient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.	Compliance with Authority Required procedures
	C15271		Chronic thromboembolic pulmonary hypertension (CTEPH)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must demonstrate stable or responding disease; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated in a centre with expertise in the management of CTEPH.Patient must be at least 18 years of age.Response to this drug is defined as follows:For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease.For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease.For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease.Test requirements to establish response to treatment for continuation of treatment are as follows:The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:(1) RHC plus ECHO composite assessments plus 6MWT;(2) RHC plus ECHO composite assessments;(3) RHC composite assessment plus 6MWT;(4) ECHO composite assessment plus 6MWT;(5) RHC composite assessment only;(6) ECHO composite assessment only.The results of the same tests as conducted at baseline should be documented in the patient's medical record with each continuing treatment application (i.e., every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be documented in the patient's medical records.The test results conducted for continuing treatment must be no more than 2 months old at the time of application.The assessment of the patient's response to the continuing 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.The maximum quantity per prescription must be based on the dosage recommendations in the TGA-approved Product Information and be limited to provide sufficient supply for 1 month of treatment.A maximum of 5 repeats will be authorised.Patients who fail to demonstrate disease stability or improvement to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.	Compliance with Authority Required procedures
	C15272		Chronic thromboembolic pulmonary hypertension (CTEPH)Balance of supplyPatient must have received insufficient therapy with this drug under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; ORPatient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; ANDThe treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated in a centre with expertise in the management of CTEPH.Patient must be at least 18 years of age.	Compliance with Authority Required procedures
	C18200		Chronic thromboembolic pulmonary hypertension (CTEPH)Initial treatmentPatient must have WHO Functional Class II, III or IV CTEPH; ANDThe condition must be inoperable by pulmonary endarterectomy; ORThe condition must be recurrent or persistent following pulmonary endarterectomy; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated in a centre with expertise in the management of CTEPH.Patient must be at least 18 years of age.CTEPH that is inoperable by pulmonary endarterectomy is defined as follows:(a) Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dynseccm-5measured at least 90 days after start of full anticoagulation; and(b) A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation.CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows:RHC demonstrating a PVR of greater than 300 dynseccm-5measured at least 180 days following pulmonary endarterectomy.Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be documented in the patient's medical records.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) the results from the 3 tests below, to establish baseline measurements, where available:(i) RHC composite assessment, and(ii) ECHO composite assessment, and(iii) 6 Minute Walk Test (6MWT); and(b) confirmation of evidence of inoperable CTEPH including the pulmonary vascular resistance (PVR) value, a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or(c) confirmation of evidence of recurrent or persistent CTEPH including the PVR value and the date that pulmonary endarterectomy was performed; or(d) confirmation of an echocardiogram demonstrating right ventricular dysfunction.Where it is not possible to perform all 3 tests above on clinical grounds, the expected test combination, in descending order of preference is:(1) RHC plus ECHO composite assessments;(2) RHC composite assessment plus 6MWT;(3) RHC composite assessment only.In circumstance where a RHC cannot be performed on clinical grounds, the expected test combinations, in descending order of preference is:(1) ECHO composite assessment plus 6MWT;(2) ECHO composite assessment only.Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be documented in the patient's medical records.The test results provided must not be more than 2 months old at the time of application.Prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.Approvals for subsequent authority prescription will be limited to 1 month of treatment, The quantity approved must be based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 3 repeats.The assessment of the patient's response to the initial 20-week course of treatment should be made following the preceding 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated.Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.	Compliance with Written Authority Required procedures
	C18215		Pulmonary arterial hypertension (PAH)Initial 1 (new patients)Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDPatient must have been assessed by a physician with expertise in the management of PAH; ANDPatient must have WHO Functional Class III PAH or WHO Functional Class IV PAH; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The test results must not be more than 6 months old at the time of application.Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.	Compliance with Written Authority Required procedures
Risdiplam	C14392		Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhoodPatient must be undergoing continuation of existing PBS-subsidised treatment with this drug; ORPatient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient's 19^th birthday for SMA type IIIB/IIIC; ANDMust be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Authority Required procedures
	C14420		Spinal muscular atrophy (SMA)Continuing/maintenance treatment in an adult where treatment was initiated in adulthoodPatient must be undergoing continuation of existing PBS-subsidised treatment with this drug; ORPatient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient's 19^th birthday; ANDMust be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; ORThe treatment must be occurring within the first 104 weeks from the first administered dose; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.Undertake re-assessments for a clinically meaningful response at least every six months. Document these re-assessments in the patient's medical records.In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient's motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) or 6-minute walk test (6MWT), and the patient's quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA-HI) or SMA Functional Rating Scale (SMAFRS).	Compliance with Authority Required procedures
	C15095		Spinal muscular atrophy (SMA)Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)Patient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; ANDThe treatment must be given concomitantly with best supportive care for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; ANDPatient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.Patient must have been 18 years of age or younger at the time of initial treatment with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Authority Required procedures
	C15986		Pre-symptomatic spinal muscular atrophy (SMA)Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 geneMust be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Patient must have been 18 years of age or younger at the time of initial treatment with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Authority Required procedures
	C18087		Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)Initial treatmentThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic.Patient must not have received PBS-subsidised gene therapy.Patient must be 18 years of age or under.Defined signs and symptoms of type I SMA are:i) Onset before 6 months of age; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Hypotonia; orv) Absence of deep tendon reflexes; orvi) Failure to gain weight appropriate for age; orvii) Any active chronic neurogenic changes; orviii) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type II SMA are:i) Onset between 6 and 18 months; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Weakness in trunk righting/derotation; orv) Hypotonia; orvi) Absence of deep tendon reflexes; orvii) Failure to gain weight appropriate for age; orviii) Any active chronic neurogenic changes; orix) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type IIIa SMA are:i) Onset between 18 months and 3 years of age; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Hypotonia; orv) Absence of deep tendon reflexes; orvi) Failure to gain weight appropriate for age; orvii) Any active chronic neurogenic changes; orviii) A compound muscle action potential below normative values for an age-matched child.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.Application for authorisation of initial treatment must be in writing and must include:(a) details of the proposed prescription; and(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:(i) specification of SMA type (I, II or IIIa); and(ii) sign(s) and symptom(s) that the patient has experienced; and(iii) patient's age at the onset of sign(s) and symptom(s).The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Written Authority Required procedures
	C18090		Pre-symptomatic spinal muscular atrophy (SMA)Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 geneMust be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDThe condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDPatient must not have received PBS-subsidised gene therapy.Patient must be aged under 36 months prior to commencing treatment.Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:(a) details of the proposed prescription; and(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:(i) confirmation of genetic diagnosis of SMA; and(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Written Authority Required procedures
	C18118		Pre-symptomatic spinal muscular atrophy (SMA)Initial treatment with this drug of pre-symptomatic spinal muscular atrophy (SMA)Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDThe condition must have genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; ANDThe condition must be pre-symptomatic; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDPatient must not have received PBS-subsidised gene therapy.Patient must be aged under 36 months prior to commencing treatment.Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:(a) details of the proposed prescription; and(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:(i) confirmation of genetic diagnosis of SMA; and(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Written Authority Required procedures
	C18197		Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)Initial PBS-subsidised treatment with this drug in a childPatient must be of an age that is prior to their 19thbirthday at the time of this authority application; ANDPatient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rdbirthday, but before their 19thbirthday (SMA type IIIB/IIIC).Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; ORPatient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,(ii) Proximal weakness,(iii) Hypotonia,(iv) Absence of deep tendon reflexes,(v) Any active denervation or chronic neurogenic changes found on electromyography,(vi) A compound muscle action potential below normative values for an age-matched child.In this authority application, confirm:(1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,(2) which of the above (i to vi) (at least 1) were present after their 3rdbirthday, but before their 19thbirthday,(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Written Authority Required procedures
	C18225		Spinal muscular atrophy (SMA)Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhoodPatient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; ANDPatient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19thbirthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised).Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; ORPatient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,(ii) Proximal weakness,(iii) Hypotonia,(iv) Absence of deep tendon reflexes,(v) Failure to gain weight appropriate for age,(vi) Any active denervation or chronic neurogenic changes found on electromyography,(vii) A compound muscle action potential below normative values for an age-matched child.In this authority application, confirm:(1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,(2) which of the above (i to vii) (at least 1) were present during childhood,(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.	Compliance with Written Authority Required procedures
	C18306		Spinal muscular atrophy (SMA)Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)Patient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; ANDThe treatment must be given concomitantly with best supportive care for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; ANDPatient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.Patient must have been 18 years of age or younger at the time of initial treatment with this drug; ANDPatient must be 2 years of age or older, and weigh 20 kg or more.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.	Compliance with Authority Required procedures
	C18307		Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)Initial treatmentThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; ANDPatient must not have received PBS-subsidised gene therapy.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic.Patient must be between 2 and 18 years of age and weigh 20 kg or more.Defined signs and symptoms of type I SMA are:i) Onset before 6 months of age; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Hypotonia; orv) Absence of deep tendon reflexes; orvi) Failure to gain weight appropriate for age; orvii) Any active chronic neurogenic changes; orviii) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type II SMA are:i) Onset between 6 and 18 months; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Weakness in trunk righting/derotation; orv) Hypotonia; orvi) Absence of deep tendon reflexes; orvii) Failure to gain weight appropriate for age; orviii) Any active chronic neurogenic changes; orix) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type IIIa SMA are:i) Onset between 18 months and 3 years of age; andii) Failure to meet or regression in ability to perform age-appropriate motor milestones; oriii) Proximal weakness; oriv) Hypotonia; orv) Absence of deep tendon reflexes; orvi) Failure to gain weight appropriate for age; orvii) Any active chronic neurogenic changes; orviii) A compound muscle action potential below normative values for an age-matched child.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.Application for authorisation of initial treatment must be in writing and must include:(a) details of the proposed prescription; and(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:(i) specification of SMA type (I, II or IIIa); and(ii) sign(s) and symptom(s) that the patient has experienced; and(iii) patient's age at the onset of sign(s) and symptom(s).	Compliance with Written Authority Required procedures
	C18308		Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)Initial PBS-subsidised treatment with this drug in a childPatient must be of an age that is prior to their 19thbirthday at the time of this authority application; ANDPatient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rdbirthday, but before their 19thbirthday (SMA type IIIB/IIIC); ANDPatient must be 2 years of age or older, and weigh 20 kg or more.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; ORPatient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,(ii) Proximal weakness,(iii) Hypotonia,(iv) Absence of deep tendon reflexes,(v) Any active denervation or chronic neurogenic changes found on electromyography,(vi) A compound muscle action potential below normative values for an age-matched child.In this authority application, confirm:(1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,(2) which of the above (i to vi) (at least 1) were present after their 3rdbirthday, but before their 19thbirthday,(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.	Compliance with Written Authority Required procedures
	C18356		Spinal muscular atrophy (SMA)Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhoodPatient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; ANDPatient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19thbirthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised).Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; ORPatient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; ANDPatient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,(ii) Proximal weakness,(iii) Hypotonia,(iv) Absence of deep tendon reflexes,(v) Failure to gain weight appropriate for age,(vi) Any active denervation or chronic neurogenic changes found on electromyography,(vii) A compound muscle action potential below normative values for an age-matched child.In this authority application, confirm:(1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,(2) which of the above (i to vii) (at least 1) were present during childhood,(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.	Compliance with Written Authority Required procedures
	C18357		Spinal muscular atrophy (SMA)Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with Type 1 SMAPatient must have experienced a regression in a developmental state listed below (see 'Definition') despite treatment with gene therapy - confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non-compliance to best-supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team - state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; ANDPatient must be undergoing treatment under this Treatment phase listing once only - for continuing treatment beyond this authority application, refer to the drug's relevant 'Continuing treatment' listing for the patient's SMA type.Patient must have a prior authority approval for any drug PBS-listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.Confirm that a previous PBS authority application has been approved for symptomatic Type 1 SMA.Definition:Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.0. Absence of developmental states (1 to 9) listed below:1. Rolls from side to side on back;2. Child holds head erect for at least 3 seconds unsupported;3. Sitting, but with assistance;4. Sitting without assistance:(a) Child sits up straight with the head erect for at least 10 seconds;(b) Child does not use arms or hands to balance body or support position.5. Hands and knees crawling:(a) Child alternately moves forward or backwards on hands and knees;(b) The stomach does not touch the supporting surface;(c) There are continuous and consecutive movements at least 3 in a row.6. Standing with assistance:(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;(b)The body does not touch the stable object, and the legs support most of the body weight;(c) Child thus stands with assistance for at least 10 seconds.7. Standing alone:(a) Child stands in upright position on both feet (not on the toes) with the back straight;(b) The leg supports 100% of the child's weight;(c) There is no contact with a person or object;(d) Child stands alone for at least 10 seconds.8. Walking with assistance:(a) Child is in an upright position with the back straight;(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;(c) One leg moves forward while the other supports part of the body weight;(d) Child takes at least 5 steps in this manner.9. Walking alone:(a) Child takes at least 5 steps independently in upright position with the back straight;(b) One leg moves forward while the other supports most of the body weight;(c) There is no contact with a person or object.Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 - 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient's current overall developmental state (i.e. a number that is lower than stated in (i).Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS-subsidy of this benefit is not available.The approved Product Information recommended dosing is as follows:(i) 16 days to less than 2 months of age: 0.15 mg/kg(ii) 2 months to less than 2 years of age: 0.20 mg/kg(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg(iv) 2 years of age and older weighing 20 kg or more: 5 mgIn this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:1 unit where (i) applies;2 units where (ii) applies;3 units where (iii) applies;3 units where (iv) applies.	Compliance with Written Authority Required procedures
	C18369		Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhoodThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; ORPatient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient's 19thbirthday for SMA type IIIB/IIIC; ANDMust be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.Patient must be 2 years of age or older, and weigh 20 kg or more.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.	Compliance with Authority Required procedures
	C18479		Pre-symptomatic spinal muscular atrophy (SMA)Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 genePatient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; ANDThe treatment must be given concomitantly with best supportive care for this condition; ANDThe treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; ORMust be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; ANDPatient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.Patient must have been 18 years of age or younger at the time of initial treatment with this drug; ANDPatient must be 2 years of age or older, and weigh 20 kg or more.Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.	Compliance with Authority Required procedures
Ritonavir	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
Romiplostim	C13396		Severe thrombocytopeniaSecond or Subsequent Continuing treatmentThe condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; ANDPatient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; ANDThe treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.Authority approval will not be given for doses higher than 10 micrograms/kg/week	Compliance with Authority Required procedures
	C14099		Severe thrombocytopeniaFirst Continuing treatment or Re-initiation of interrupted continuing treatmentThe condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); ANDPatient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have changed treatment from either eltrombopag or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; ORPatient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; ANDThe treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.Authority approval will not be given for doses higher than 10 micrograms/kg/weekThe platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records.	Compliance with Authority Required procedures
	C14149		Severe thrombocytopeniaBalance of supply or change of therapyThe condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); ANDThe treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; ANDPatient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; ORPatient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; ORPatient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; ORPatient must be changing therapy from eltrombopag or avatrombopag to this drug for this condition; ANDThe treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.Patients receiving treatment with eltrombopag or avatrombopag may change to romiplostim under this restriction.	Compliance with Authority Required procedures
	C18405		Severe thrombocytopeniaInitial treatment - New patientThe condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); ANDPatient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; ANDPatient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; ANDThe treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;(a) a platelet count of less than or equal to 20,000 million per L; OR(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.Authority approval will not be given for doses higher than 10 micrograms/kg/weekThe authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) details of a platelet count supporting the diagnosis of ITP.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
Rozanolixizumab	C18129		Treatment refractory generalised myasthenia gravis (gMG)Continuing treatment - Treatment refractory gMG patientsPatient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; ANDPatient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; ANDPatient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDThe treatment must provide no more than 6 months of therapy per continuing authority application.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18232		Bridging therapy for generalised myasthenia gravis (gMG)Patient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System or in writing and must include:(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.	Compliance with Authority Required procedures
	C18319		Acute severe generalised myasthenia gravis (gMG)Patient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must be commencing treatment with an NS-IST within 2 weeks; ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication ('acute severe gMG'); ANDPatient must not have accessed a prior PBS-subsidised gMG biological agent; ORPatient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18378		Treatment refractory generalised myasthenia gravis (gMG)Initial treatment - Treatment refractory gMG patientsPatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); ORPatient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; ANDThe treatment must provide no more than 6 months of therapy per initial authority application.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).The authority application must be via the Online PBS Authorities System, or in writing and must include:(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18789		Treatment refractory generalised myasthenia gravis (gMG)Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patientsPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 July 2026; ANDPatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; ANDPatient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; ANDPatient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; ANDThe treatment must provide no more than 6 months of therapy under this restriction.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System, or in writing and must include:(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.	Compliance with Authority Required procedures
Ruxolitinib	C13907	P13907	Grade II to IV acute graft versus host disease (aGVHD)Initial treatmentPatient must have received prior systemic steroid treatment for this condition; ANDPatient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment.Must be treated by a haematologist; ORMust be treated by an oncologist with allogeneic bone marrow transplantation experience; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).Steroid-refractory disease is defined as:(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.Details of prior steroid use should be documented in the patient's medical records.A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.The assessment of response must be documented in the patient's medical records.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13907
	C13911	P13911	Grade II to IV acute graft versus host disease (aGVHD)Initial treatmentPatient must have received prior systemic steroid treatment for this condition; ANDPatient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment.Must be treated by a haematologist; ORMust be treated by an oncologist with allogeneic bone marrow transplantation experience; ORMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).Steroid-refractory disease is defined as:(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.Details of prior steroid use should be documented in the patient's medical records.A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.The assessment of response must be documented in the patient's medical records.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13911
	C19098	P19098	Grade II to IV acute graft versus host disease (aGVHD)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist medical practitioner.Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.The assessment of response must be documented in the patient's medical records.Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 19098
	C19147	P19147	Grade II to IV acute graft versus host disease (aGVHD)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist medical practitioner.Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.The assessment of response must be documented in the patient's medical records.Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 19147
Selexipag	C11193		Pulmonary arterial hypertension (PAH)Continuing treatmentPatient must have received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition; ANDThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); ORThe treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); ANDThe treatment must not be as monotherapy.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:(i) Hospitalisation due to worsening PAH;(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.	Compliance with Authority Required procedures
	C11195		Pulmonary arterial hypertension (PAH)Initial treatment following dose titrationPatient must have WHO Functional Class III PAH at treatment initiation with this drug; ORPatient must have WHO Functional Class IV PAH at treatment initiation with this drug; ANDThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); ORThe treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); ANDPatient must have completed the dose titration phase; ANDThe treatment must not be as monotherapy.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.PAH (WHO Group 1 pulmonary hypertension) is defined as follows:(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.	Compliance with Authority Required procedures
	C11261		Pulmonary arterial hypertension (PAH)Initial treatment - dose titrationPatient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; ANDPatient must have WHO Functional Class III PAH at treatment initiation with this drug; ORPatient must have WHO Functional Class IV PAH at treatment initiation with this drug; ANDThe treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; ANDThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); ORThe treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); ANDThe treatment must not be as monotherapy.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.PAH (WHO Group 1 pulmonary hypertension) is defined as follows:(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.	Compliance with Authority Required procedures
Selinexor	C14021	P14021	Relapsed and/or refractory multiple myelomaInitial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per weekThe condition must be confirmed by a histological diagnosis; ANDPatient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ORPatient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must have progressive disease after at least one prior therapy; ANDPatient must not have previously received this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy	Compliance with Authority Required procedures
	C14023	P14023	Relapsed and/or refractory multiple myelomaContinuing treatment - Dose requirement of 100 mg per weekPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ORPatient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
	C14024	P14024	Relapsed and/or refractory multiple myelomaInitial treatment - Dose requirement of 100 mg per weekThe condition must be confirmed by a histological diagnosis; ANDPatient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ORPatient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must have progressive disease after at least one prior therapy; ANDPatient must not have previously received this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy	Compliance with Authority Required procedures
	C14031	P14031	Relapsed and/or refractory multiple myelomaContinuing treatment - Dose requirement of 160 mg per weekPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
	C14039	P14039	Relapsed and/or refractory multiple myelomaInitial treatment - Dose requirement of 160 mg per weekThe condition must be confirmed by a histological diagnosis; ANDPatient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must have progressive disease after at least one prior therapy; ANDPatient must not have previously received this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy	Compliance with Authority Required procedures
	C14045	P14045	Relapsed and/or refractory multiple myelomaContinuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per weekPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; ORPatient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
Sevelamer	C5530		HyperphosphataemiaInitiation and stabilisationThe condition must not be adequately controlled by calcium; ANDPatient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; ORThe condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; ANDThe treatment must not be used in combination with any other non-calcium phosphate binding agents.Patient must be undergoing dialysis for chronic kidney disease.	Compliance with Authority Required procedures - Streamlined Authority Code 5530
	C9762		HyperphosphataemiaInitiation and stabilisationThe condition must not be adequately controlled by calcium; ANDPatient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; ORThe condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; ANDThe treatment must not be used in combination with any other non-calcium phosphate binding agents.Patient must be undergoing dialysis for chronic kidney disease.	Compliance with Authority Required procedures - Streamlined Authority Code 9762
Sildenafil	C11229		Pulmonary arterial hypertension (PAH)Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipagThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); ORThe treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.The authority application for selexipag must be approved prior to the authority application for this agent.For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.PAH (WHO Group 1 pulmonary hypertension) is defined as follows:(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C13569		Pulmonary arterial hypertension (PAH)Initial 3 - changing to this drug in combination therapy (dual or triple therapy)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; ANDMust be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.	Compliance with Authority Required procedures
	C13572		Pulmonary arterial hypertension (PAH)Continuing treatmentPatient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C18748		Pulmonary arterial hypertension (PAH)Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; this combination therapy is treating a patient with at least class WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.	Compliance with Written Authority Required procedures
	C18749		Pulmonary arterial hypertension (PAH)Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; ORPatient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit; ANDMust be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.	Compliance with Authority Required procedures
	C18782		Pulmonary arterial hypertension (PAH)Initial treatment 1 - New patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The test results must not be more than 6 months old at the time of application.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Written Authority Required procedures
	C18854		Pulmonary arterial hypertension (PAH)Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority applicationThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.	Compliance with Authority Required procedures
	C18876		Pulmonary arterial hypertension (PAH)Initial treatment 2 - Change of treatmentPatient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
Siltuximab	C12585		Idiopathic multicentric Castleman disease (iMCD)Initial treatmentPatient must have a diagnosis of iMCD consistent with the latest international, evidence-based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient's medical records; ANDThe condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus-8 infection, (ii) an Epstein-Barr virus-lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder.Must be treated by a haematologist; ORMust be treated by a medical physician working under the supervision of a haematologist; ANDPatient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; ORPatient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.	Compliance with Authority Required procedures
	C12594		Idiopathic multicentric Castleman disease (iMCD)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Must be treated by a haematologist; ORMust be treated by a medical physician working under the supervision of a haematologist.Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.	Compliance with Authority Required procedures
Sirolimus	C5795		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 5795
	C9914		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection; ANDThe treatment must be under the supervision and direction of a transplant unit.	Compliance with Authority Required procedures - Streamlined Authority Code 9914
Sofosbuvir with velpatasvir	C5969		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.	Compliance with Authority Required procedures
Sofosbuvir with velpatasvir and voxilaprevir	C10248		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.The application must include details of the prior treatment regimen containing an NS5A inhibitor.	Compliance with Authority Required procedures
Sucroferric oxyhydroxide	C5530		HyperphosphataemiaInitiation and stabilisationThe condition must not be adequately controlled by calcium; ANDPatient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; ORThe condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; ANDThe treatment must not be used in combination with any other non-calcium phosphate binding agents.Patient must be undergoing dialysis for chronic kidney disease.	Compliance with Authority Required procedures - Streamlined Authority Code 5530
	C9762		HyperphosphataemiaInitiation and stabilisationThe condition must not be adequately controlled by calcium; ANDPatient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; ORThe condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; ANDThe treatment must not be used in combination with any other non-calcium phosphate binding agents.Patient must be undergoing dialysis for chronic kidney disease.	Compliance with Authority Required procedures - Streamlined Authority Code 9762
Tacrolimus	C5569		Management of rejection in patients following organ or tissue transplantationThe treatment must be under the supervision and direction of a transplant unit, ANDThe treatment must include initiation, stabilisation, and review of therapy as required.	Compliance with Authority Required procedures - Streamlined Authority Code 5569
	C9697		Management of rejection in patients following organ or tissue transplantationThe treatment must be under the supervision and direction of a transplant unit; ANDThe treatment must include initiation, stabilisation, and review of therapy as required.	Compliance with Authority Required procedures - Streamlined Authority Code 9697
Tadalafil	C11229		Pulmonary arterial hypertension (PAH)Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipagThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); ORThe treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.The authority application for selexipag must be approved prior to the authority application for this agent.For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.PAH (WHO Group 1 pulmonary hypertension) is defined as follows:(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C13569		Pulmonary arterial hypertension (PAH)Initial 3 - changing to this drug in combination therapy (dual or triple therapy)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; ANDMust be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.	Compliance with Authority Required procedures
	C13572		Pulmonary arterial hypertension (PAH)Continuing treatmentPatient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C15463		Pulmonary arterial hypertension (PAH)Initial 3 - changing to this drug in combination therapy (dual or triple therapy)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; ANDMust be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Authority Required procedures
	C15495		Pulmonary arterial hypertension (PAH)Continuing treatmentPatient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Authority Required procedures
	C15525		Pulmonary arterial hypertension (PAH)Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipagThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); ORThe treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.The authority application for selexipag must be approved prior to the authority application for this agent.For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.PAH (WHO Group 1 pulmonary hypertension) is defined as follows:(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Authority Required procedures
	C18748		Pulmonary arterial hypertension (PAH)Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; this combination therapy is treating a patient with at least class WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.	Compliance with Written Authority Required procedures
	C18749		Pulmonary arterial hypertension (PAH)Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; ORPatient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit; ANDMust be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.	Compliance with Authority Required procedures
	C18780		Pulmonary arterial hypertension (PAH)Initial treatment 2 - Change of treatmentPatient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Authority Required procedures
	C18782		Pulmonary arterial hypertension (PAH)Initial treatment 1 - New patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The test results must not be more than 6 months old at the time of application.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Written Authority Required procedures
	C18824		Pulmonary arterial hypertension (PAH)Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; this combination therapy is treating a patient with at least class WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Written Authority Required procedures
	C18852		Pulmonary arterial hypertension (PAH)Initial treatment 1 - New patientPatient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:- RHC composite assessment; and- ECHO composite assessment; and- 6 Minute Walk Test (6MWT)Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:- RHC plus ECHO composite assessments;- RHC composite assessment plus 6MWT;- RHC composite assessment only.In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:- ECHO composite assessment plus 6MWT;- ECHO composite assessment only.(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:(i) for why fewer than 3 tests are able to be performed on clinical grounds;(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.The test results must not be more than 6 months old at the time of application.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Written Authority Required procedures
	C18854		Pulmonary arterial hypertension (PAH)Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority applicationThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.	Compliance with Authority Required procedures
	C18872		Pulmonary arterial hypertension (PAH)Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority applicationThe treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Authority Required procedures
	C18876		Pulmonary arterial hypertension (PAH)Initial treatment 2 - Change of treatmentPatient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; ANDThe treatment must be the sole PBS-subsidised PAH agent for this condition.Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.A maximum of 5 repeats may be requested.	Compliance with Authority Required procedures
	C18884		Pulmonary arterial hypertension (PAH)Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; ORThe treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid.Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; ORPatient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit; ANDMust be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.	Compliance with Authority Required procedures
Teduglutide	C11999		Type III Short bowel syndrome with intestinal failureInitial treatment - balance of supplyMust be treated by a gastroenterologist; ORMust be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; ANDPatient must have received insufficient therapy with this drug under the initial treatment restriction to complete the maximum duration of 12 months of initial treatment; ANDThe treatment must provide no more than the balance of up to 12 months of treatment.	Compliance with Authority Required procedures
	C18198		Type III Short bowel syndrome with intestinal failureContinuing treatmentMust be treated by a gastroenterologist; ORMust be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; ANDPatient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline; ORPatient must have, as a patient yet to turn 18 years of age, a reduction in the mean weekly parenteral support volume of at least 20% (mL per kg of body weight) relative to baseline; ORThe treatment must be resuming after a break in therapy, but before the break in therapy occurred, a reduction in parenteral support relative to baseline had been occurring to an extent as stated as above.Refer to the measurement(s) stated in the Initial treatment authority application for the baseline dependence on parenteral support. Determine the current mean use per week of parental support in days (for a patient of any age) and/or the mean volume per week in mL per kg (for a patient yet to turn 18 years of age). State these values in this authority application.The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.The current mean weekly parenteral support volume is calculated as the mean mL per kg of body weight of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.From 1 September 2021Where the mean weekly volume of parenteral support in terms of mL per kg of body weight for 4 consecutive weeks has not been stated in an Initial treatment authority application for a patient yet to turn 18 years of age, provide in this authority application both:(i) a known or estimated retrospective baseline value that would have applied to the patient immediately before commencing treatment with this drug, and(ii) the current value (observed over a 4 week timeframe)Provide these values for a child only where mean weekly volume is to be used as an alternative response assessment to mean days of parenteral support per week. Otherwise, continue to use mean days per week.Where treatment is resuming after a break in treatment with this drug, state parenteral support days/volume values as occurring prior to the break instead of current values.A patient who has turned 18 years of age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean number of days of parenteral support.Patients who do not meet the clinical criteria with respect to demonstrating the minimum reduction in parenteral support must permanently discontinue PBS subsidy.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C18986		Type III Short bowel syndrome with intestinal failureInitial treatmentMust be treated by a gastroenterologist; ORMust be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.Patient must have short bowel syndrome with intestinal failure following major surgery; ANDPatient must have a history of dependence on parenteral support for at least 12 months; ANDPatient must have received a stable parenteral support regimen for at least 3 days per week in the 4 weeks prior to commencing this drug; ANDPatient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; ANDThe treatment must not exceed 12 months under this restriction; ANDPatient must not have previously received PBS-subsidised treatment with this drug for this condition.Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either:(i) for a patient of any age, the mean number of days of parenteral support per week,(ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg.Determine the mean over any given 4 week period prior to commencing this drug. For a patient yet to turn 18 years of age, both (i) and (ii) may be supplied, but provide at least (i).Assessment of treatment response/non-response in the 'Continuing treatment' authority application will be compared against the baseline value(s) submitted in this application.A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
Tenofovir	C6980	P6980	Chronic hepatitis B infectionPatient must have cirrhosis; ANDPatient must be nucleoside analogue naive; ANDPatient must have detectable HBV DNA; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 6980
	C6982	P6982	HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6982
	C6983	P6983	Chronic hepatitis B infectionPatient must have cirrhosis; ANDPatient must have failed antihepadnaviral therapy; ANDPatient must have detectable HBV DNA.Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 6983
	C6984	P6984	Chronic hepatitis B infectionPatient must not have cirrhosis; ANDPatient must have failed antihepadnaviral therapy; ANDPatient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; ORPatient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.	Compliance with Authority Required procedures - Streamlined Authority Code 6984
	C6992	P6992	Chronic hepatitis B infectionPatient must not have cirrhosis; ANDPatient must be nucleoside analogue naive; ANDPatient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; ORPatient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; ANDPatient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 6992
	C6998	P6998	HIV infectionInitialPatient must be antiretroviral treatment naive; ANDThe treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6998
	C10362	P10362	Chronic hepatitis B infectionPatient must be in the third trimester of pregnancy; ANDPatient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.	Compliance with Authority Requiredprocedures - Streamlined Authority Code 10362
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat	C4470		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection.	Compliance with Authority Required procedures - Streamlined Authority Code 4470
	C4522		HIV infectionInitialPatient must be antiretroviral treatment naive.	Compliance with Authority Required procedures - Streamlined Authority Code 4522
Tenofovir with emtricitabine	C6985		HIV infectionInitialPatient must be antiretroviral treatment naive; ANDThe treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6985
	C6986		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6986
Tenofovir with emtricitabine and efavirenz	C4470		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection	Compliance with Authority Required procedures - Streamlined Authority Code 4470
	C4522		HIV infectionInitialPatient must be antiretroviral treatment naïve	Compliance with Authority Required procedures - Streamlined Authority Code 4522
Tezacaftor with ivacaftor and ivacaftor	C17844		Cystic fibrosis - one residual function (RF) mutationInitial treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDPatient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.Patient must be at least 12 years of age.For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and(3) details of the pathology report substantiating the patient having at least one RF mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient ; and(4) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17935		Cystic fibrosis - one residual function (RF) mutationContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be at least 12 years of age.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17968		Cystic fibrosis - homozygous for the F508del mutationInitial treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDPatient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.Patient must be at least 12 years of age.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C17969		Cystic fibrosis - homozygous for the F508del mutationContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be at least 12 years of age.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be in writing and must include:(1) details of the proposed prescription; and(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
Tezepelumab	C19093		Uncontrolled severe asthmaContinuing treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be aged 12 years or older.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.The assessment should, where possible, be completed by the same physician who initiated treatment with this drug and should be conducted within 4 weeks of the last dose of biological medicine.Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following information must be provided at the time of application and must be documented in the patient's medical records:(a) if applicable, details of maintenance oral corticosteroid dose; and(b) a completed Asthma Control Questionnaire (ACQ-5) score.	Compliance with Written Authority Required procedures
	C19094		Uncontrolled severe asthmaInitial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; ORPatient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; ORPatient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; ANDPatient must have a duration of asthma of at least 1 year; ANDPatient must have blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to initiating treatment with this drug; ORPatient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the 12 months prior to initiating treatment with this drug; ORPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the 12 months prior to initiating treatment with this drug that has past or current evidence of atopy, documented by either: (i) skin prick testing; or (ii) an in vitro measure of specific IgE; ANDPatient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the month prior to initiating this drug, AND(b) while receiving optimised asthma therapy in the 12 months prior to initiating this drug, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(d) Asthma Control Questionnaire (ACQ-5) score; and(e) if applicable, the eosinophil count and date; and(f) if applicable, the IgE result and date.	Compliance with Written Authority Required procedures
	C19095		Uncontrolled severe asthmaGrandfathering arrangements - Transitioning from non-PBS to PBS-subsidised supplyMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received non-PBS-subsidised treatment with this biological medicine for this PBS indication prior to 1 July 2026; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; ORPatient must have had a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records prior to initiation of non-PBS-subsidised treatment with this drug for this condition; ANDPatient must have had a duration of asthma of at least 1 year prior to initiating non-PBS-subsidised treatment with this drug for this condition; ANDPatient must have had blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; ORPatient must have had blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; ORPatient must have had total serum human immunoglobulin E of at least 30 IU/mL, measured in the 12 months prior to initiation of non-PBS subsidised treatment with this drug for this condition that had past or current evidence of atopy, documented by either: (i) skin prick testing; or (ii) an in vitro measure of specific IgE no more than 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; ANDPatient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating non-PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated or sustained an adequate response to treatment with this drug if the patient has received at least 28 weeks of treatment with this drug for this condition; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the month prior to starting treatment with this drug, AND(b) while receiving optimised asthma therapy in the 12 months prior to starting treatment with this drug, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.The following must be provided at the time of application and documented in the patient's medical records:(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(d) Asthma Control Questionnaire (ACQ-5) score; and(e) if applicable, the eosinophil count and date; and(f) if applicable, the IgE result and date.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A patient may qualify for PBS-subsidised treatment under this restriction once only.	Compliance with Written Authority Required procedures
	C19199		Uncontrolled severe asthmaInitial treatment - Initial 2 (Change of treatment)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; ANDPatient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; ANDPatient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing biological medicine treatment for severe asthma; ORPatient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing biological medicine treatment for severe asthma; ORPatient must have each of: i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating treatment with a biological medicine for severe asthma, ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating treatment with a biological medicine for severe asthma; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and(c) if applicable, the eosinophil count and date; and(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and(e) if applicable, the IgE result and date; and(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).	Compliance with Written Authority Required procedures
Thalidomide	C5914		Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 5914
	C9290		Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 9290
Tocilizumab	C9386		Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supplyMust be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
	C10570		Systemic juvenile idiopathic arthritisBalance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; ANDThe treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment.Must be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.	Compliance with Authority Required procedures
	C12120		Severe active juvenile idiopathic arthritisInitial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supplyMust be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
	C14085		Systemic juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months)Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have had a break in treatment of 12 months or more from this drug for this condition; ANDPatient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); ORPatient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must be under 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.The following reports must be documented in the patient's medical records where appropriate:(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
	C14091		Systemic juvenile idiopathic arthritisInitial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be under 18 years of age.Must be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.An adequate response to treatment is defined as:(a) in a patient with polyarticular course disease:(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).(b) in a patient with refractory systemic symptoms:(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.The assessment of response to treatment must be documented in the patient's medical records.At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.The following reports must be documented in the patient's medical records where appropriate:(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
	C14093		Systemic juvenile idiopathic arthritisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.An adequate response to treatment is defined as:(a) in a patient with polyarticular course disease:(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).(b) in a patient with refractory systemic symptoms:(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 14093
	C14148		Systemic juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; ORPatient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; ORPatient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be under 18 years of age.Must be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:(a) an active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to prior treatment must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:(a) an active joint count of at least 2 active joints; and(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).The assessment of response to prior treatment must be documented in the patient's medical records.The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and(b) the details of prior treatment including dose and duration of treatment.The following reports must be documented in the patient's medical records where appropriate:(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.	Compliance with Authority Required procedures
	C14179		Systemic juvenile idiopathic arthritisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.An adequate response to treatment is defined as:(a) in a patient with polyarticular course disease:(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).(b) in a patient with refractory systemic symptoms:(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 14179
	C14485		Severe active rheumatoid arthritisSubsequent continuing treatmentMust be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; ORPatient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 14485
	C14488		Severe active rheumatoid arthritisInitial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supplyMust be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
	C14507		Severe active rheumatoid arthritisFirst continuing treatment - balance of supplyMust be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; ANDThe treatment must provide no more than the balance of up to 24 weeks treatment.	Compliance with Authority Required procedures
	C14621		Severe active rheumatoid arthritisSubsequent continuing treatmentMust be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; ORPatient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 14621
	C17707		Severe active juvenile idiopathic arthritisContinuing treatmentMust be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 17707
	C17712		Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; ORPatient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be under 18 years of age.Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:(a) an active joint count of at least 10 active (swollen and tender) joints; or(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or(c) active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or(e) development/worsening of erosive disease due to active arthritis.The assessment of response to prior treatment must be documented in the patient's medical records.The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) details of prior treatment including dose and duration of treatment.At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
	C17713		Severe active juvenile idiopathic arthritisContinuing treatmentMust be treated by a rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 17713
	C17714		Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)Must be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; ANDPatient must not receive more than 16 weeks of treatment under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures
	C17729		Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)Must be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; ANDThe condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) the date of the last continuing prescription.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
	C18172		Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.Up to a maximum of 3 repeats will be authorised.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.	Compliance with Written Authority Required procedures
	C18174		Severe active rheumatoid arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be aged 18 years or older.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
	C18177		Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be aged 18 years or older.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
	C18180		Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; ORPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be aged 18 years or older.If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) an active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
	C18275		Severe active rheumatoid arthritisInitial treatment - Initial 1 (new patient)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; ORPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) a total active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.Up to a maximum of 3 repeats will be authorised.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
	C18276		Severe active rheumatoid arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; ORThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L; ANDThe condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.Up to a maximum of 3 repeats will be authorised.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
	C18280		Severe active juvenile idiopathic arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilzumab after resolution of the critical shortage of tocilizumab)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be aged 18 years or older.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
	C18282		Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; ORPatient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; ORThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L; ANDThe condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be aged 18 years or older.Active joints are defined as:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count must be no more than 4 weeks old at the time of this application.At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
	C18346		Severe active rheumatoid arthritisFirst continuing treatmentMust be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.Up to a maximum of 5 repeats will be authorised.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
	C18348		Severe active juvenile idiopathic arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Must be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be under 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
	C18933		Severe active rheumatoid arthritisInitial treatment - Initial 1 (new patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; ORPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) a total active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to prior treatment must be documented in the patient's medical records.The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the active joint count, ESR and/or CRP result and date of results;(b) details of prior treatment, including dose and date/duration of treatment.(c) If applicable, details of any contraindications/intolerances.(d) If applicable, the maximum tolerated dose of methotrexate.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
	C18934		Severe active rheumatoid arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; ORThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L; ANDThe condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the active joint count, ESR and/or CRP result and date of result;(b) the most recent biological agent and the date of the last continuing prescription.(c) If applicable, the new baseline scores.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
	C18936		Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records.An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.	Compliance with Authority Required procedures
	C18938		Severe active rheumatoid arthritisFirst continuing treatment - balance of supplyPatient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; ANDThe treatment must provide no more than the balance of up to 24 weeks treatment.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.	Compliance with Authority Required procedures - Streamlined Authority Code 18938
	C18939		Severe active juvenile idiopathic arthritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.	Compliance with Authority Required procedures - Streamlined Authority Code 18939
	C18941		Severe active juvenile idiopathic arthritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.	Compliance with Authority Required procedures - Streamlined Authority Code 18941
	C18945		Severe active juvenile idiopathic arthritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.	Compliance with Written Authority Required procedures
	C18946		Severe active juvenile idiopathic arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
	C18947		Severe active juvenile idiopathic arthritisBalance of supply - Continuing treatmentPatient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.	Compliance with Authority Required procedures
	C18978		Severe active rheumatoid arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the prescribing.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 18978
	C18980		Severe active rheumatoid arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
	C19000		Severe active juvenile idiopathic arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must be under 18 years of age.If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures
	C19024		Severe active rheumatoid arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; ANDPatient must have demonstrated an adequate response to treatment with this drug; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the prescribing.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 19024
	C19046		Severe active rheumatoid arthritisFirst continuing treatment - balance of supplyPatient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; ANDThe treatment must provide no more than the balance of up to 24 weeks treatment.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.	Compliance with Authority Required procedures - Streamlined Authority Code 19046
Tofersen	C19231	P19231	Amyotrophic lateral sclerosisInitial treatmentPatient must have/have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing treatment with this drug; ANDThe condition must have been diagnosed by a neurologist; ANDThe condition must have a confirmed pathogenic (class 5) or likely pathogenic (class 4) superoxide dismutase 1 (SOD1) gene variant; ANDPatient must not have undergone a tracheostomy; ANDPatient must not have experienced respiratory failure; ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition; ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.The following must be documented in the patient's medical records:a) date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant; andb) baseline score of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) at treatment initiation.	Compliance with Authority Required procedures
	C19237	P19237	Amyotrophic lateral sclerosisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the first continuing treatment, the extended first continuing treatment or the grandfather treatment restriction; ANDPatient must have demonstrated an adequate response to treatment defined as any improvement or stabilisation in the ALSFRS-R score (i.e. no more than a 20% decline from the baseline ALSFRS-R score), if they have received treatment under the first continuing or extended first continuing restriction; ORPatient must have demonstrated a clinical benefit from treatment, based on clinician judgment, within 12 months of treatment initiation, if they have received treatment under the grandfather listing; ANDPatient must not have undergone a tracheostomy; ANDPatient must not have experienced respiratory failure; ANDPatient must not be receiving palliative (end of life) care; ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition; ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.	Compliance with Authority Required procedures
	C19243	P19243	Amyotrophic lateral sclerosisFirst continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; ANDPatient must not have undergone a tracheostomy; ANDPatient must not have experienced respiratory failure; ANDPatient must not be receiving palliative (end of life) care; ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition; ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.Assessment of response must be conducted after 6 months of the first continuing treatment (i.e. at 12 months from treatment initiation).If a response to treatment cannot be demonstrated at this assessment, prescribers may apply for up to a maximum of three months (i.e. 2 repeats) of additional continuing treatment under the extended first continuing treatment phase to verify non-response.Reassessment of response must be conducted after the additional three months of therapy to determine the patient's eligibility for further treatment.If this reassessment is not undertaken, the patient will not be eligible for ongoing treatment.All the assessments of response must be documented in the patient's medical records.Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R.	Compliance with Authority Required procedures
	C19253	P19253	Amyotrophic lateral sclerosisGrandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatmentPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2026; ANDPatient must have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing non-PBS-subsidised treatment with this drug; ANDThe condition must have been diagnosed by a neurologist; ANDThe condition must have a confirmed pathogenic (class 5) or likely pathogenic (class 4) superoxide dismutase 1 (SOD1) gene variant; ANDPatient must not have undergone a tracheostomy; ANDPatient must not have experienced respiratory failure; ANDPatient must not be receiving palliative (end of life) care; ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition; ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.The date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant must be documented in the patient's medical records.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.	Compliance with Authority Required procedures
	C19261	P19261	Amyotrophic lateral sclerosisExtended first continuing treatment (additional 3 doses)Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; ANDPatient must not have demonstrated an adequate response to treatment with this drug for this condition; ANDPatient must not have undergone a tracheostomy; ANDPatient must not have experienced respiratory failure; ANDPatient must not be receiving palliative (end of life) care; ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition; ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.Reassessment of response must be conducted after the additional three months of therapy to determine the patient's eligibility for further treatment.If this reassessment is not undertaken, the patient will not be eligible for ongoing treatment.All the assessments of response must be documented in the patient's medical records.Patient may qualify for this treatment phase once only.Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R.	Compliance with Authority Required procedures
Ublituximab	C7386	P7386	Multiple sclerosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not show continuing progression of disability while on treatment with this drug; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have demonstrated compliance with, and an ability to tolerate this therapy.Must be treated by a neurologist.	Compliance with Authority Required procedures - Streamlined Authority Code 7386
	C7699	P7699	Multiple sclerosisInitial treatmentThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; ORThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; ANDPatient must be ambulatory (without assistance or support).Must be treated by a neurologist.Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 7699
	C9523	P9523	Multiple sclerosisInitial treatmentThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; ORThe condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; ANDPatient must be ambulatory (without assistance or support).Must be treated by a neurologist.Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 9523
	C9635	P9635	Multiple sclerosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not show continuing progression of disability while on treatment with this drug; ANDThe treatment must be the sole PBS-subsidised disease modifying therapy for this condition; ANDPatient must have demonstrated compliance with, and an ability to tolerate this therapy.Must be treated by a neurologist.	Compliance with Authority Required procedures - Streamlined Authority Code 9635
Ustekinumab	C16866		Moderate to severe ulcerative colitisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)Must be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; ANDPatient must have a Mayo clinic score greater than or equal to 6; ORPatient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); ANDThe treatment must not exceed a single dose to be administered at week 0 under this restriction.Patient must be at least 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A maximum of 16 weeks of treatment with this drug will be approved under this criterion.Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.Details of the accepted toxicities including severity can be found on the Services Australia website.	Compliance with Written Authority Required procedures
	C16939		Moderate to severe ulcerative colitisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)Must be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; ANDThe treatment must not exceed a single dose to be administered at week 0 under this restriction.Patient must be at least 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.A maximum of 16 weeks of treatment with this drug will be approved under this criterion.Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.Details of the accepted toxicities including severity can be found on the Services Australia website.	Compliance with Written Authority Required procedures
	C16958		Moderate to severe ulcerative colitisInitial treatment - Initial 1 (new patient)Must be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; ANDPatient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; ORPatient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; ORPatient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; ANDPatient must have a Mayo clinic score greater than or equal to 6; ORPatient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); ANDThe treatment must not exceed a single dose to be administered at week 0 under this restriction.Patient must be at least 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy).All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.A maximum of 16 weeks of treatment with this drug will be approved under this criterion.Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.	Compliance with Written Authority Required procedures
	C18785		Severe Crohn diseaseInitial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; ANDPatient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; ANDPatient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; ORPatient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; ORPatient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) the date of the most recent clinical assessment.Evidence of flared disease must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or(ii) faeces: higher than normal lactoferrin or calprotectin level; or(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
	C18825		Severe Crohn diseaseInitial 1 (new patient)Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; ANDPatient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; ANDPatient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; ORPatient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; ANDPatient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; ORPatient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; ORPatient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and(c) if applicable, details of intestinal inflammation marker/s; and(d) if applicable, the CDAI score and the date of assessment; and(e) the date of the most recent clinical assessment.Evidence of not achieving an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or(ii) faeces: higher than normal lactoferrin or calprotectin level; or(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
	C18856		Severe Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, the CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) if applicable, the date of the most recent clinical assessment; and(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:(a) the baseline CDAI score and the date of assessment; and/or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
	C19149		Complex refractory Fistulising Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial restriction (Initial 1 or Initial 2); ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
	C19171		Complex refractory Fistulising Crohn diseaseInitial 1 (new patient or recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; ANDPatient must have an externally draining enterocutaneous or rectovaginal fistula; ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].The number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition must be provided by the prescriber at the time of application and documented in the patient's medical records.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures
	C19172		Complex refractory Fistulising Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) current number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition; and(b) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The application must also provide details of the baseline scores of the prior eligibility requirements, including the number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures
Valaciclovir	C5975		Cytomegalovirus infection and diseaseProphylaxisPatient must have undergone a renal transplant; ANDPatient must be at risk of cytomegalovirus disease.	Compliance with Authority Required procedures - Streamlined Authority Code 5975
	C9267		Cytomegalovirus infection and diseaseProphylaxisPatient must have undergone a renal transplant; ANDPatient must be at risk of cytomegalovirus disease.	Compliance with Authority Required procedures - Streamlined Authority Code 9267
Valganciclovir	C4980		Cytomegalovirus retinitisPatient must have HIV infection.	Compliance with Authority Required procedures - Streamlined Authority Code 4980
	C15782		Cytomegalovirus infection and diseasePatient must be a solid organ transplant recipient at risk of cytomegalovirus disease.	Compliance with Authority Required procedures - Streamlined Authority Code 15782
	C15784		Cytomegalovirus infection and diseasePatient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.	Compliance with Authority Required procedures - Streamlined Authority Code 15784
	C15800		Cytomegalovirus infection and diseasePatient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.	Compliance with Authority Required procedures - Streamlined Authority Code 15800
	C15814		Cytomegalovirus infection and diseasePatient must be a solid organ transplant recipient at risk of cytomegalovirus disease.	Compliance with Authority Required procedures - Streamlined Authority Code 15814
Vanzacaftor with tezacaftor and with deutivacaftor	C17769		Cystic fibrosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must be at least 6 years of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C17932		Cystic fibrosisInitial treatmentPatient must have at least one mutation in the CFTR gene that is considered responsive to vanzacaftor/tezacaftor/deutivacaftor potentiation based on clinical and/or in vitro assay data; ANDThe treatment must be given concomitantly with standard therapy for this condition; ANDPatient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must be at least 6 years of age.For the purposes of this restriction, the list of mutations considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the pathology report substantiating the specific mutation considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
Vedolizumab	C15844		Moderate to severe ulcerative colitisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)Must be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; ANDPatient must have a Mayo clinic score greater than or equal to 6; ORPatient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).Patient must be at least 18 years of age.Application for authorisation must be made in writing and must include:(a) details of the proposed prescription; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.Details of the accepted toxicities including severity can be found on the Services Australia website.
	C15909		Moderate to severe ulcerative colitisBalance of supplyMust be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); ORPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); ORPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); ORPatient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; ANDThe treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; ORThe treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.
	C15910		Moderate to severe ulcerative colitisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)Must be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.Patient must be at least 18 years of age.Application for authorisation must be made in writing and must include:(a) details of the proposed prescription; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.Up to a maximum of 2 repeats will be authorised.Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
	C15923		Moderate to severe ulcerative colitisContinuing treatmentMust be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; ORPatient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab subcutaneous form continuing restriction; ANDPatient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug.Patient must be at least 18 years of age.Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.Up to a maximum of 2 repeats will be authorised.An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
	C15933		Moderate to severe ulcerative colitisInitial treatment - Initial 1 (new patient)Must be treated by a gastroenterologist (code 87); ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; ANDPatient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; ORPatient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; ORPatient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; ANDPatient must have a Mayo clinic score greater than or equal to 6; ORPatient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).Patient must be at least 18 years of age.Application for authorisation of initial treatment must be in writing and must include:(a) details of the proposed prescription; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.Details of the accepted toxicities including severity can be found on the Services Australia website.
	C18759		Severe Crohn diseaseContinuing treatmentPatient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; ORPatient must have demonstrated an adequate response to treatment with this drug (in any form).Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.A maximum quantity and number of repeats of this drug consisting of one vial of 300 mg per dose, with up to 2 repeats will be authorised.If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.	Compliance with Authority Required procedures
	C18760		Severe Crohn diseaseInitial 4 (additional dose at week 10)Patient must have received prior PBS-subsidised treatment with this drug for this condition in this treatment cycle; ANDPatient must have received 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3; ANDPatient must not have achieved an adequate response to this drug after a total of 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.A maximum quantity and number of repeats to provide for an additional dose of this drug consisting of one vial of 300 mg, with one dose to be administered at week 10, will be authorised.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.Patient must be assessed as having an inadequate response to the drug after completing an initial infusion regimen at 0, 2, and 6 weeks and prior to 10 weeks.	Compliance with Authority Required procedures
	C18805		Severe Crohn diseaseInitial 1 (new patient)Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; ANDPatient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; ANDPatient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; ORPatient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; ANDPatient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; ORPatient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; ORPatient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and(c) if applicable, details of intestinal inflammation marker/s; and(d) if applicable, the CDAI score and the date of assessment; and(e) the date of the most recent clinical assessment.Evidence of not achieving an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or(ii) faeces: higher than normal lactoferrin or calprotectin level; or(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
	C18806		Severe Crohn diseaseTransitioning from non-PBS-subsidised therapy that was commenced as a paediatric patientPatient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); ANDPatient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; ANDPatient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) if applicable, the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.A maximum quantity and number of repeats of this drug consisting of one vial of 300 mg per dose, with up to 2 repeats will be authorised.If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend beyond 24 weeks.A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
	C18807		Severe Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment); ANDThe treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; ORThe treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
	C18863		Severe Crohn diseaseInitial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; ANDPatient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; ANDPatient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; ORPatient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; ORPatient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) the date of the most recent clinical assessment.Evidence of flared disease must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or(ii) faeces: higher than normal lactoferrin or calprotectin level; or(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
	C18906		Severe Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, the CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) if applicable, the date of the most recent clinical assessment; and(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:(a) the baseline CDAI score and the date of assessment; and/or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
	C19112		Moderate to severe chronic pouchitisInitial 2 (Recommencement of treatment after a break in targeted therapy)Patient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; ANDThe treatment must be initiated in combination with standard of care antibiotic; ANDPatient must not receive more than 14 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) details of the most recent targeted therapy for this condition [date of commencement and duration of therapy].The prescriber must have excluded secondary causes of pouchitis, for example:(a) Ischaemia;(b) Crohn's disease (CD) or CD of the pouch;(c) Irritable pouch syndrome;(d) Predominant cuffitis;(e) Pouch stricture or pouch fistula;(f) Active infection;(g) NSAIDs;(h) Coeliac disease.	Compliance with Authority Required procedures
	C19113		Moderate to severe chronic pouchitisBalance of SupplyPatient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 14 weeks of treatment; ORPatient must have received insufficient therapy with this drug under the Initial 2 (recommencement of treatment after a break in targeted therapy) to complete 14 weeks of treatment; ANDThe treatment must provide no more than the balance of up to 14 weeks treatment available under the above treatment phases.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
	C19155		Moderate to severe chronic pouchitisContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; ANDPatient must have demonstrated or sustained a partial or complete response, as determined by the treating clinician, to the most recent PBS-subsidised course of treatment with this drug for this condition; ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
	C19210		Moderate to severe chronic pouchitisInitial 1 (new patient)Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis (UC) at least one year previously; ANDPatient must not have previously received PBS-subsidised treatment with this drug for this condition; ANDThe condition must be confirmed based on the patient's symptoms, treatment history and baseline endoscopic examination of the pouch (pouchoscopy); ANDPatient must have a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5; ANDPatient must have a minimum endoscopic mPDAI sub-score of at least 2; ANDPatient must have had at least 3 recurrent episodes of pouchitis within the previous year each of which was treated with at least: (i) 2 weeks of antibiotic, (ii) other prescription therapy; ORThe condition must have required maintenance antibiotic therapy taken continuously for at least 4 weeks before commencing treatment with this drug; ANDThe treatment must be initiated in combination with standard of care antibiotic; ANDPatient must not receive more than 14 weeks of treatment under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) baseline Modified Pouchitis Disease Activity Index (mPDAI) score and endoscopic mPDAI subscore and the date of assessment; and(b) details of prior drug therapy for this condition [dosage, date of commencement and duration of therapy].The prescriber must have excluded secondary causes of pouchitis, for example:(a) Ischaemia;(b) Crohn's disease (CD) or CD of the pouch;(c) Irritable pouch syndrome;(d) Predominant cuffitis;(e) Pouch stricture or pouch fistula;(f) Active infection;(g) NSAIDs;(h) Coeliac disease.	Compliance with Authority Required procedures
Vutrisiran	C16434		Hereditary transthyretin amyloidosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must continue to demonstrate clinical benefit; ANDPatient must not have previously undergone a liver transplant; ANDPatient must not be permanently bedridden; ORPatient must not be receiving end-of-life care.Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; ANDPatient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
	C16446		Hereditary transthyretin amyloidosisInitial treatmentPatient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; ANDThe condition must be hereditary transthyretin amyloidosis confirmed by genetic testing; ANDPatient must have a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB; ORPatient must have a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2; ANDPatient must not have previously undergone a liver transplant; ANDPatient must not exhibit heart failure symptoms (defined as New York Heart Association NYHA class III or IV).Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; ANDPatient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).Patient must have either: (i) stage 1 polyneuropathy, (ii) stage 2 polyneuropathy; ANDPatient must be at least 18 years of age.PND scores in the context of this PBS restriction are:Stage 0 - No symptoms;Stage I - Sensory disturbances but preserved walking capability;Stage II - Impaired walking capacity but able to walk without stick or crutches;Stage IIIA - Walking with help of one stick or crutch;Stage IIIB - Walking with help of two sticks or crutches;Stage IV - Confined to wheelchair or bedridden.FAP stage in the context of this PBS restriction are:Stage 0 - No symptoms;Stage 1 - Unimpaired ambulation;Stage 2 - Assistance with ambulation required;Stage 3 - Wheelchair-bound or bedridden.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
Zidovudine	C4454		HIV infectionContinuingPatient must have previously received PBS-subsidised therapy for HIV infection; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512		HIV infectionInitialPatient must be antiretroviral treatment naïve; ANDThe treatment must be in combination with other antiretroviral agents	Compliance with Authority Required procedures - Streamlined Authority Code 4512
Zilucoplan	C18128		Treatment refractory generalised myasthenia gravis (gMG)Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patientsPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 April 2026; ANDPatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; ANDPatient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; ANDPatient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; ANDThe treatment must provide no more than 6 months of therapy under this restriction.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System, or in writing and must include:(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.	Compliance with Authority Required procedures
	C18129		Treatment refractory generalised myasthenia gravis (gMG)Continuing treatment - Treatment refractory gMG patientsPatient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; ANDPatient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; ANDPatient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDThe treatment must provide no more than 6 months of therapy per continuing authority application.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18232		Bridging therapy for generalised myasthenia gravis (gMG)Patient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System or in writing and must include:(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.	Compliance with Authority Required procedures
	C18319		Acute severe generalised myasthenia gravis (gMG)Patient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must be commencing treatment with an NS-IST within 2 weeks; ORPatient must have had a thymectomy; ANDPatient must be receiving concomitant treatment with an oral corticosteroid; ANDPatient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication ('acute severe gMG'); ANDPatient must not have accessed a prior PBS-subsidised gMG biological agent; ORPatient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
	C18378		Treatment refractory generalised myasthenia gravis (gMG)Initial treatment - Treatment refractory gMG patientsPatient must have a diagnosis of MGFA Disease Class II to IV; ANDPatient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; ANDPatient must not be experiencing a myasthenic crisis; ANDPatient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); ORPatient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; ANDPatient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; ANDPatient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); ORPatient must have had a thymectomy; ANDPatient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; ANDThe treatment must provide no more than 6 months of therapy per initial authority application.Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; ORMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).The authority application must be via the Online PBS Authorities System, or in writing and must include:(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).If the application is submitted through HPOS form upload or mail, it must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Authority Required procedures
Zoledronic acid	C5605	P5605	Bone metastasesThe condition must be due to breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 5605
	C5703	P5703	Bone metastasesThe condition must be due to castration-resistant prostate cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 5703
	C5704	P5704	Hypercalcaemia of malignancyPatient must have a malignancy refractory to anti-neoplastic therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 5704
	C5735	P5735	Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 5735
	C9268	P9268	Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 9268
	C9304	P9304	Bone metastasesThe condition must be due to castration-resistant prostate cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 9304
	C9317	P9317	Hypercalcaemia of malignancyPatient must have a malignancy refractory to anti-neoplastic therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 9317
	C9328	P9328	Bone metastasesThe condition must be due to breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 9328
	C14729	P14729	Adjuvant management of breast cancerPatient must be post-menopausal.Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.	Compliance with Authority Required procedures - Streamlined Authority Code 14729
	C14735	P14735	Adjuvant management of breast cancerPatient must be post-menopausal.Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.	Compliance with Authority Required procedures - Streamlined Authority Code 14735

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