law://au/li/2026/f2026l01147@2026-11-13| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 September 2026 | 1 September 2026 |
| Lamivudine Alphapharm | C4454 C4512 | 60 | 5 |
| 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 |
| C19092 | 1 | 6 |
| C17012 | Sufficient for up to 28 weeks of treatment | 0 | |
| C15376 | Sufficient for up to 32 weeks of treatment | 0 |
| Anifrolumab | C19096 | Systemic lupus erythematosusContinuing or recommencement of treatment (within 12 months of a treatment break)Patient must have previously been issued with an authority prescription for this drug for this condition; ANDPatient must be responding to treatment if they have received less than 12 months of treatment with this drug for this condition; ORPatient must have attained a Lupus Low Disease Activity State (LLDAS) and maintained this state while on treatment; ANDThe treatment must not be used in combination with obinutuzumab.Must be treated by a specialist physician experienced in the management of this condition.Lupus Low Disease Activity State (LLDAS) is defined as:(a) Total SLEDAI-2K of not greater than 4, with no major activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever); and(b) No new features of lupus disease activity compared with the previous assessment, and(c) Physician Global Assessment (PGA) of not greater than 1, and(d) Current prednisolone (or equivalent) dose of not greater than 7.5 mg daily, and(e) Well tolerated standard maintenance doses of anti-malarial and immunosuppressive drugs are allowed.Where retreatment with anifrolumab after a break in PBS-subsidised treatment with anifrolumab is being sought, the date of cessation of the previous treatment course with anifrolumab must be included in the application. Recommencement of treatment with anifrolumab for severe SLE is within 12 months from the date that treatment was ceased. | Compliance with Authority Required procedures | |
| C19216 | Systemic lupus erythematosusInitial treatmentPatient must have a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019; ANDPatient must have persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points; ANDPatient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; ANDPatient must be currently receiving immunosuppressant medication, with treatment received for at least 12 weeks, with either: (i) minimum dose of methotrexate 20 mg per week, (ii) azathioprine 100 mg per day, (iii) mycophenolate 1,000 mg per day unless contraindicated/intolerant necessitating treatment withdrawal; ANDPatient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; ANDPatient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus; ANDThe treatment must not be used in combination with obinutuzumab.Must be treated by a specialist physician experienced in the management of this condition.If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day.Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, 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 prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above.If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application.The authority application must be made in writing via HPOS form upload or mail and must include:(a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE;(b) details (date and score) of the completed SLEDAI-2K score sheet;(c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use);(d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose).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 |
| C19124 | Chronic Myelomonocytic LeukaemiaInitial treatmentThe condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; ANDThe condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.The first 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 chronic myelomonocytic leukaemia; and(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology AuthorityAll 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 following reports must be documented in the patient's medical records:(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and(b) full blood examination reportNo more than 3 cycles will be authorised under this restriction in a patient's lifetime. | Compliance with Written Authority Required procedures |
| C19082 | 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 4 repeats to provide for an initial course sufficient for up to 32 weeks of therapy, based on a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter (refer to the TGA-approved Product Information).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 | ||
| 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 | ||
| C19130 | 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.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter.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 |
| C19091 | Uncontrolled severe asthmaInitial treatment - Initial 2 (Change of treatment)Patient 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; ORPatient must have had a blood eosinophil count of at least 150 cells per microlitre no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ORPatient must have had a fractional exhaled nitric oxide of at least 20 ppb 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 32 weeks of treatment under this restriction; ANDPatient must be under the care of the same physician for at least 6 months; ANDPatient 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 not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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) 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 aged 6 to less than 12 years.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 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 at around 28 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. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted 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 submitted, 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 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 dupilumab sufficient for up to 32 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 must be provided at the time of application and documented in the patient's medical records:(a) the IgE, blood eosinophil or fractional exhaled nitric oxide 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 | ||
| C19132 | Uncontrolled severe asthmaInitial treatment 1 - (New patient; 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 been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; ANDPatient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; ORPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (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:(i) 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;AND(ii) treatment with oral corticosteroids as outlined in the clinical criteria.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.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.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.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 | ||
| C19133 | 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 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; 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 PBS-subsidised 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 PBS-subsidised treatment with a biological medicine for severe asthma; ANDPatient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; 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 at around 28 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. 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 biological medicine.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.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 | ||
| C19136 | 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 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.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.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 | ||
| C19137 | Uncontrolled severe 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 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 in the last 12 months; ORPatient must have blood eosinophil count of at least 150 cells per microlitre in the last 12 months; ORPatient must have a fractional exhaled nitric oxide of at least 20 ppb 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; ANDPatient must be under the care of the same physician for at least 6 months; 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) 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 aged 6 to less than 12 years.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 initial IgE assessment, blood eosinophil count or fractional exhaled nitric oxide measurement must be no more than 12 months old at the time of 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 28 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 submitted within 4 weeks of the last dose of biological medicine, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, 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 dupilumab of up to 32 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, blood eosinophil or the fractional exhaled nitric oxide 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 | ||
| C19181 | Uncontrolled severe asthmaInitial treatment 1 - (New patient; 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; ORPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (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 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.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.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.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 | ||
| C19213 | 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; ORPatient must have had a 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, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; 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 at around 28 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. 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 biological medicine.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.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 |
| C19107 | 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 3 doses to be administered at weeks 0, 2 and 6 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 maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, 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.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 | ||
| C19108 | Complex refractory Fistulising Crohn diseaseInitial 2 (change or recommencement of treatment after a break in 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 3 doses to be administered at weeks 0, 2 and 6 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 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.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 1 treatment restriction.A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per 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. | Compliance with Authority Required procedures | ||
| C19150 | Complex refractory Fistulising 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 demonstrated an adequate response to 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].An adequate response is defined as:(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.If a patient does not 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 quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.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 - Streamlined Authority Code 19150 | ||
| C19152 | Complex refractory Fistulising 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 demonstrated an adequate response to 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].An adequate response is defined as:(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.The current 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.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 to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered every 8 weeks 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 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 | ||
| C19176 | Complex refractory Fistulising 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, or Continuing treatment); ANDThe treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1 or 2 treatment; ORThe treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing 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 | ||
| C19207 | Complex refractory Fistulising 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 demonstrated an adequate response to 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].An adequate response is defined as:(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.If a patient does not 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 quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.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 - Streamlined Authority Code 19207 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.