National Health (Listing of Pharmaceutical Benefits) Amendment (September Update) Instrument 2026

Contents

1. Name #

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment (September Update) Instrument 2026.

(2)This Instrument may also be cited as PB 99 of 2026.

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement Information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 September 2026	1 September 2026

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3. Authority #

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

4. Schedules #

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

[1] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[2] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[3] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[4] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[5] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C12148 C12228 C12240

(b) insert in numerical order in the column headed “Circumstances”: C19157 C19158

(d) insert in numerical order in the column headed “Purposes”: P19157 P19158

[6] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[7] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[8] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[9] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[10] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[11] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[12] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[13] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[14] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[15] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[16] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[17] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C12148 C12228 C12240

(b) insert in numerical order in the column headed “Circumstances”: C19157 C19158

(d) insert in numerical order in the column headed “Purposes”: P19157 P19158

[18] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[19] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[20] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[21] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[22] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[23] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[24] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[25] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Abrilada; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[26] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Abrilada; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[27] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Abrilada; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[28] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[29] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[30] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[31] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[32] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[33] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[34] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[35] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[36] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[37] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[38] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[39] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[40] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[41] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[42] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[43] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[44] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11524

(b) omit from the column headed “Circumstances”: C12148 C12228 C12240

(d) omit from the column headed “Purposes”: P11524

(e) omit from the column headed “Purposes”: P12148 P12228 P12240

(f) insert in numerical order in the column headed “Purposes”: P19157 P19158 P19174

[45] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12098 C12101 C12147

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115 C19149

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115 P19149

[46] Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Brand: Humira; Maximum Quantity: 3; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12152 C12229

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115

[47] Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 3; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12152 C12229

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115

[48] Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 3; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12152 C12229

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115

[49] Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 3; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12152 C12229

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115

[50] Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 3; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12152 C12229

(b) insert in numerical order in the column headed “Circumstances”: C19106 C19115

(d) insert in numerical order in the column headed “Purposes”: P19106 P19115

[51] Schedule 1, Part 1, entries for Amoxicillin in the form Capsule 250 mg (as trihydrate)

omit:

Amoxicillin

Capsule 250 mg (as trihydrate)

Oral

Amoxil

MP NP MW PDP

Amoxicillin

Capsule 250 mg (as trihydrate)

Oral

Amoxil

MP NP

P10404

40CN10404

0CN10404

[52] Schedule 1, Part 1, after entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Brand: Cilamox; Maximum Quantity: 40; Number of Repeats: 0]

insert:

Amoxicillin

Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

Oral

AMOXICILLIN MEDSURGE

PDP

Amoxicillin

Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

Oral

AMOXICILLIN MEDSURGE

MP MW NP

[53] Schedule 1, Part 1, after entry for Amoxicillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Brand: APO-Amoxycillin; Maximum Quantity: 1; Number of Repeats: 1]

insert:

Amoxicillin

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Oral

AMOXICILLIN MEDSURGE

PDP

Amoxicillin

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Oral

AMOXICILLIN MEDSURGE

MP MW NP

[54] Schedule 1, Part 1, entries for Aripiprazole in the form Tablet 20 mg

omit:

Aripiprazole

Tablet 20 mg

Oral

ARIPIPRAZOLE-WGR

MP NP

C4246

[55] Schedule 1, Part 1, entries for Asciminib

substitute:

Asciminib

Tablet 20 mg

Oral

Scemblix

MP NP

C19201

Asciminib

Tablet 20 mg

Oral

Scemblix

C13950

Asciminib

Tablet 40 mg

Oral

Scemblix

MP NP

C19201

P19201

Asciminib

Tablet 40 mg

Oral

Scemblix

C13950

P13950

Asciminib

Tablet 40 mg

Oral

Scemblix

MP NP

C19202 C19218

P19202 P19218

300

[56] Schedule 1, Part 1, entry for Azithromycin in the form Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL

omit from the column headed “Circumstances”: C5637

[57] Schedule 1, Part 1, entries for Azithromycin in the form Tablet 500 mg (as dihydrate)

substitute:

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

APO-Azithromycin

MP MW NP

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

Azithromycin Sandoz

MP MW NP

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

Azithromycin Viatris

MP MW NP

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

AZITHROMYCIN-WGR

MP MW NP

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

ZITHRO

MP MW NP

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

Zithromax

MP MW NP

[58] Schedule 1, Part 1, entry for Benzathine benzylpenicillin in the form Powder for injection 1,200,000 units with diluent 4 mL (S19A)

omit from the column headed “Pack Quantity”: 10 substitute: 1

[59] Schedule 1, Part 1, after entry for Benzathine benzylpenicillin in the form Powder for injection 1,200,000 units with diluent 4 mL (S19A)

insert:

Benzathine benzylpenicillin

Powder for injection 1,200,000 units with diluent 4 mL (Spain) (s19A)

Injection

Benzetacil (Spain)

MP MW NP PDP

[60] Schedule 1, Part 1, entries for Bortezomib in the form Powder for injection 3.5 mg

omit:

Bortezomib

Powder for injection 3.5 mg

Injection

Bortezomib Baxter

C11099 C13745

See Note 3

D(100)

[61] Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Brand: B-Patch; Maximum Quantity: 2; Number of Repeats: 0]

omit from the column headed “Variations”: V11753 substitute: V10748 V10752 V10755

[62] Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Brand: B-Patch; Maximum Quantity: 4; Number of Repeats: 0]

omit from the column headed “Variations”: V10748 V10752 V10755 substitute: V11753

[63] Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Brand: Bupredermal; Maximum Quantity: 2; Number of Repeats: 0]

omit from the column headed “Variations”: V11753 substitute: V10748 V10752 V10755

[64] Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Brand: Bupredermal; Maximum Quantity: 4; Number of Repeats: 0]

omit from the column headed “Variations”: V10748 V10752 V10755 substitute: V11753

[65] Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Brand: Buprenorphine Sandoz; Maximum Quantity: 2; Number of Repeats: 0]

omit from the column headed “Variations”: V11753 substitute: V10748 V10752 V10755

[66] Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Brand: Buprenorphine Sandoz; Maximum Quantity: 4; Number of Repeats: 0]

omit from the column headed “Variations”: V10748 V10752 V10755 substitute: V11753

[67] Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Brand: Norspan; Maximum Quantity: 2; Number of Repeats: 0]

omit from the column headed “Variations”: V11753 substitute: V10748 V10752 V10755

[68] Schedule 1, Part 1, after entry for Cyclophosphamide in the form Powder for injection 2 g (NorthStar, USA) (s19A)

insert:

Cyclophosphamide

Powder for injection 2 g (Sagent, USA) (s19A)

Injection

Cyclophosphamide (Sagent, USA)

See Note 3

PB(100)

[69] Schedule 1, Part 1, after entry for Dapsone in the form Tablet 25 mg

insert:

Dapsone

Tablet 25 mg (s19A)

Oral

Dapsone Tablets, USP 25 mg (Rising Pharmaceuticals, USA)

MP NP

100

[70] Schedule 1, Part 1, entries for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

omit:

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Cardizem CD

MP NP

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Cardizem CD

MP NP

P14238

[71] Schedule 1, Part 1, after entry for Disopyramide in the form Capsule 100 mg

insert:

Disopyramide

Capsule 100 mg (Japan) (s19A)

Oral

Rythmodan (Japan)

MP NP

C15956

100

[72] Schedule 1, Part 1, entry for Dupilumab in the form Injection 200 mg in 1.14 mL single dose pre-filled pen [Maximum Quantity: See Note 3]

(a) omit from the column headed “Circumstances”: C17016 C17072

(b) insert in numerical order in the column headed “Circumstances”: C19091 C19137

[73] Schedule 1, Part 1, entry for Dupilumab in the form Injection 200 mg in 1.14 mL single dose pre-filled syringe [Maximum Quantity: See Note 3]

(a) omit from the column headed “Circumstances”: C15886

(b) omit from the column headed “Circumstances”: C17016 C17072

(d) insert in numerical order in the column headed “Circumstances”: C19091 C19136 C19137 C19181 C19213

[74] Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled pen [Maximum Quantity: See Note 3]

(a) omit from the column headed “Circumstances”: C17016 C17072

(b) insert in numerical order in the column headed “Circumstances”: C19091 C19137

[75] Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled syringe [Maximum Quantity: See Note 3]

(a) omit from the column headed “Circumstances”: C17016 C17072

(b) omit from the column headed “Circumstances”: C18269 C18464 C18858

[76] Schedule 1, Part 1, entry for Durvalumab in the form Solution concentrate for I.V. infusion 120 mg in 2.4 mL

insert in numerical order in the column headed “Circumstances”: C19159 C19222

[77] Schedule 1, Part 1, entry for Durvalumab in the form Solution concentrate for I.V. infusion 500 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C19159 C19222

[78] Schedule 1, Part 1, after entry for Dutasteride with tamsulosin in the form Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms [Brand: DUTASTERIDE/TAMSULOSIN-WGR; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Dutasteride with tamsulosin

Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms

Oral

DUTASTERIDE-TAMSULOSIN ZPL

MP NP

C6189

P6189

Dutasteride with tamsulosin

Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms

Oral

DUTASTERIDE-TAMSULOSIN ZPL

MP NP

C15004

P15004

[79] Schedule 1, Part 1, entry for Enfortumab vedotin in the form Powder for I.V. infusion 20 mg

omit from the column headed “Circumstances”: C14416 substitute: C19059 C19060 C19195

[80] Schedule 1, Part 1, entry for Enfortumab vedotin in the form Powder for I.V. infusion 30 mg

omit from the column headed “Circumstances”: C14416 substitute: C19059 C19060 C19195

[81] Schedule 1, Part 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe [Brand: Enoxaject Safety-Lockt; Maximum Quantity: 20; Number of Repeats: 3]

omit from the column headed “Brand”: Enoxaject Safety-Lockt substitute: Enoxaject Safety-Lock

[82] Schedule 1, Part 1, entry for Enzalutamide [Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C17877

(b) insert in numerical order in the column headed “Circumstances”: C19061

(d) insert in numerical order in the column headed “Purposes”: P19061

[83] Schedule 1, Part 1, after entry for Estradiol in the form Transdermal patches 390 micrograms, 8

insert:

Estradiol

Transdermal patches 390 micrograms, 8 (s19A)

Transdermal

Dermestril 25 (Italy)

MP NP

[84] Schedule 1, Part 1, after entry for Estradiol in the form Transdermal patches 780 micrograms, 8

insert:

Estradiol

Transdermal patches 780 micrograms, 8 (s19A)

Transdermal

Dermestril 50 (Italy)

MP NP

[85] Schedule 1, Part 1, after entry for Gliclazide in the form Tablet 60 mg (modified release) [Brand: ARDIX GLICLAZIDE 60mg MR; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Gliclazide

Tablet 60 mg (modified release)

Oral

ARX-Gliclazide MR

MP NP

Gliclazide

Tablet 60 mg (modified release)

Oral

ARX-Gliclazide MR

MP NP

P14238

120

[86] Schedule 1, Part 1, entries for Glimepiride in the form Tablet 3 mg

omit:

Glimepiride

Tablet 3 mg

Oral

GLIMEPIRIDE-WGR

MP NP

Glimepiride

Tablet 3 mg

Oral

GLIMEPIRIDE-WGR

MP NP

P14238

[87] Schedule 1, Part 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Inflectra]

omit from the column headed “Variations”: V18992 V18994 V18995 V19011 V19042 substitute: V14667 V14718 V18196 V18263 V18340 V18774 V18775 V18819 V18849 V18866 V18868 V18992 V18994 V18995 V19011 V19042 V19107 V19108 V19150 V19152 V19207

[88] Schedule 1, Part 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Ixifi]

[89] Schedule 1, Part 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Remicade]

omit from the column headed “Variations”: V18992 V18994 V18995 V19011 V19042 substitute: V18196 V18263 V18340 V18774 V18775 V18849 V18866 V18992 V18994 V18995 V19011 V19042 V19107 V19108 V19152

[90] Schedule 1, Part 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Remsima]

[91] Schedule 1, Part 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Renflexis]

[92] Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C13094

(b) insert in numerical order in the column headed “Circumstances”: C19178

(d) insert in numerical order in the column headed “Purposes”: P19178

[93] Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C13039

(b) insert in numerical order in the column headed “Circumstances”: C19209

(d) insert in numerical order in the column headed “Purposes”: P19209

[94] Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C17533

(b) insert in numerical order in the column headed “Circumstances”: C19110

(d) insert in numerical order in the column headed “Purposes”: P19110

[95] Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C13094

(b) insert in numerical order in the column headed “Circumstances”: C19178

(d) insert in numerical order in the column headed “Purposes”: P19178

[96] Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C13039

(b) insert in numerical order in the column headed “Circumstances”: C19209

(d) insert in numerical order in the column headed “Purposes”: P19209

[97] Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C17533

(b) insert in numerical order in the column headed “Circumstances”: C19110

(d) insert in numerical order in the column headed “Purposes”: P19110

[98] Schedule 1, Part 1, after entry for Itraconazole in the form Capsule 100 mg [Brand: ITRANOX]

insert:

Itraconazole

Capsule 100 mg

Oral

Itrazo

MP NP

C15978 C16035 C16073 C16099 C16101 C16102 C16119

[99] Schedule 1, Part 1, entries for Lamivudine in the form Tablet 300 mg

omit:

Lamivudine

Tablet 300 mg

Oral

Lamivudine Alphapharm

MP NP

C4454 C4512

D(100)

[100] Schedule 1, Part 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 500 mg in 20 mL vial

omit from the column headed “Purposes”: P6276

[101] Schedule 1, Part 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial [Brand: DBL Methotrexate]

omit from the column headed “Purposes”: P6276

[102] Schedule 1, Part 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial [Brand: Methotrexate Accord]

omit from the column headed “Purposes”: P6276

[103] Schedule 1, Part 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 5000 mg in 50 mL vial

omit from the column headed “Purposes”: P6276

[104] Schedule 1, Part 1, entries for Momelotinib

substitute:

Momelotinib

Tablet 100 mg (as dihydrochloride monohydrate)

Oral

Omjjara

MP NP

C18241 C18324

Momelotinib

Tablet 100 mg (as dihydrochloride monohydrate)

Oral

Omjjara

C16363 C16390

Momelotinib

Tablet 150 mg (as dihydrochloride monohydrate)

Oral

Omjjara

MP NP

C18241 C18324

Momelotinib

Tablet 150 mg (as dihydrochloride monohydrate)

Oral

Omjjara

C16363 C16390

Momelotinib

Tablet 200 mg (as dihydrochloride monohydrate)

Oral

Omjjara

MP NP

C18241 C18324

Momelotinib

Tablet 200 mg (as dihydrochloride monohydrate)

Oral

Omjjara

C16363 C16390

[105] Schedule 1, Part 1, after entry for Nebivolol in the form Tablet 5 mg (as hydrochloride) [Brand: Nebivolol Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Nebivolol

Tablet 5 mg (as hydrochloride)

Oral

Nebivolol Viatris

MP NP

C5324

P5324

Nebivolol

Tablet 5 mg (as hydrochloride)

Oral

Nebivolol Viatris

MP NP

C14251

P14251

[106] Schedule 1, Part 1, entry for Nicotine in the form Transdermal patch 114 mg

omit from the column headed “Responsible Person”: GJ substitute: RZ

[107] Schedule 1, Part 1, after entry for Obinutuzumab

insert:

Obinutuzumab

Solution for I.V. infusion 1000 mg in 40 mL

Injection

Gazyva

C19188

P19188

D(100)

Obinutuzumab

Solution for I.V. infusion 1000 mg in 40 mL

Injection

Gazyva

C19168 C19169

P19168 P19169

D(100)

[108] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 20 mg (orally disintegrating)

omit:

Olanzapine

Tablet 20 mg (orally disintegrating)

Oral

OLANZAPINE ODT-WGR

MP NP

C4246 C5869

[109] Schedule 1, Part 1, after entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg [Brand: Olmesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg

Oral

Olmesartan HCT Viatris

MP NP

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg

Oral

Olmesartan HCT Viatris

MP NP

P14238

[110] Schedule 1, Part 1, after entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg [Brand: Olmesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg

Oral

Olmesartan HCT Viatris

MP NP

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg

Oral

Olmesartan HCT Viatris

MP NP

P14238

[111] Schedule 1, Part 1, after entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg [Brand: Olmesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

Oral

Olmesartan HCT Viatris

MP NP

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

Oral

Olmesartan HCT Viatris

MP NP

P14238

[112] Schedule 1, Part 1, entries for Oxaliplatin

omit:

Oxaliplatin

Solution concentrate for I.V. infusion 200 mg in 40 mL

Injection

Oxaliplatin SUN

See Note 3

D(100)

[113] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg [Brand: ARX-Oxycodone/Naloxone 5/2.5; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg

Oral

OXYCODONE NALOXONE ADVZ XR 5/2.5

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg

Oral

OXYCODONE NALOXONE ADVZ XR 5/2.5

MP NP

C11753

P11753

V11753

[114] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg [Brand: ARX-Oxycodone/Naloxone 10/5; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg

Oral

OXYCODONE NALOXONE ADVZ XR 10/5

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg

Oral

OXYCODONE NALOXONE ADVZ XR 10/5

MP NP

C11753

P11753

V11753

[115] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg [Brand: ARX-Oxycodone/Naloxone 20/10; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg

Oral

OXYCODONE NALOXONE ADVZ XR 20/10

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg

Oral

OXYCODONE NALOXONE ADVZ XR 20/10

MP NP

C11753

P11753

V11753

[116] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg [Brand: ARX-Oxycodone/Naloxone 30/15; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg

Oral

OXYCODONE NALOXONE ADVZ XR 30/15

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg

Oral

OXYCODONE NALOXONE ADVZ XR 30/15

MP NP

C11753

P11753

V11753

[117] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg [Brand: ARX-Oxycodone/Naloxone 40/20; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg

Oral

OXYCODONE NALOXONE ADVZ XR 40/20

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg

Oral

OXYCODONE NALOXONE ADVZ XR 40/20

MP NP

C11753

P11753

V11753

[118] Schedule 1, Part 1, entries for Paraffin

omit:

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Poly Visc

MP NP AO

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Poly Visc

MP NP AO

P14238

[119] Schedule 1, Part 1, entry for Pegvisomant in the form Injection set containing powder for injection 15 mg, 30 and diluent, 30

omit from the column headed “Variations”: V9041 substitute: V19071

[120] Schedule 1, Part 1, entry for Pegvisomant in the form Injection set containing powder for injection 10 mg, 30 and diluent, 30

omit from the column headed “Variations”: V9041 substitute: V19071

[121] Schedule 1, Part 1, entry for Pegvisomant in the form Injection set containing powder for injection 20 mg, 1 and diluent, 1

omit from the column headed “Variations”: V9041 substitute: V19071

[122] Schedule 1, Part 1, entry for Pegvisomant in the form Injection set containing powder for injection 20 mg, 30 and diluent, 30

omit from the column headed “Variations”: V9041 substitute: V19071

[123] Schedule 1, Part 1, entry for Pembrolizumab

(a) omit from the column headed “Circumstances”: C10701 C10705 C13432 C13437 C13726 C13727 C13728 C13730 C13731 C13732 C13736 C13739 C13741 C13949 C14027 C14044 C14324

(b) omit from the column headed “Circumstances”: C16933 C16950 C17901

(d) omit from the column headed “Circumstances”: C18372 C18373

(e) omit from the column headed “Circumstances”: C18452 C18453

(f) insert in numerical order in the column headed “Circumstances”: C19192

[124] Schedule 1, Part 1, entries for Pioglitazone in the form Tablet 30 mg (as hydrochloride)

omit:

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actos

MP NP

C15321

P15321

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actos

MP NP

C15290

P15290

[125] Schedule 1, Part 1, entries for Ruxolitinib

substitute:

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C13907 C13911

P13907 P13911

C(100)

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

MP NP

C13906 C19100 C19103 C19104 C19146 C19191

P13906 P19100 P19103 P19104 P19146 P19191

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

MP NP

C19098 C19147

P19098 P19147

C(100)

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

MP NP

C18241 C18324

P18241 P18324

112

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C16364 C16365

P16364 P16365

112

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

C13907 C13911

P13907 P13911

C(100)

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

MP NP

C13906 C18241 C18324 C19100 C19103 C19104 C19146 C19191

P13906 P18241 P18324 P19100 P19103 P19104 P19146 P19191

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

MP NP

C19098 C19147

P19098 P19147

C(100)

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

C16364 C16365

P16364 P16365

Ruxolitinib

Tablet 15 mg

Oral

Jakavi

MP NP

C18241 C18324 C19100 C19103 C19104 C19146

Ruxolitinib

Tablet 15 mg

Oral

Jakavi

C16364 C16365

Ruxolitinib

Tablet 20 mg

Oral

Jakavi

MP NP

C18241 C18324 C19100 C19103 C19104 C19146

Ruxolitinib

Tablet 20 mg

Oral

Jakavi

C16364 C16365

[126] Schedule 1, Part 1, entries for Sitagliptin in the form Tablet 25 mg [Brand: Januvia]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[127] Schedule 1, Part 1, entries for Sitagliptin in the form Tablet 50 mg [Brand: Januvia]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[128] Schedule 1, Part 1, entries for Sitagliptin in the form Tablet 100 mg [Brand: Januvia]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[129] Schedule 1, Part 1, entries for Sitagliptin with metformin in the form Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride [Brand: Janumet XR]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[130] Schedule 1, Part 1, entries for Sitagliptin with metformin in the form Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride [Brand: Janumet XR]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[131] Schedule 1, Part 1, entries for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride [Brand: Janumet]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[132] Schedule 1, Part 1, entries for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride [Brand: Janumet]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[133] Schedule 1, Part 1, entries for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride [Brand: Janumet]

omit from the column headed “Responsible Person” (all instances): XW substitute (all instances): MK

[134] Schedule 1, Part 1, after entry for Telmisartan with amlodipine in the form Tablet 40 mg-5 mg (as besilate) [Brand: Telmisartan/Amlodipine Viatris; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan with amlodipine

Tablet 40 mg-5 mg (as besilate)

Oral

Twilem 40/5

MP NP

Telmisartan with amlodipine

Tablet 40 mg-5 mg (as besilate)

Oral

Twilem 40/5

MP NP

P14238

[135] Schedule 1, Part 1, after entry for Telmisartan with amlodipine in the form Tablet 40 mg-10 mg (as besilate) [Brand: Telmisartan/Amlodipine Viatris; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan with amlodipine

Tablet 40 mg-10 mg (as besilate)

Oral

Twilem 40/10

MP NP

Telmisartan with amlodipine

Tablet 40 mg-10 mg (as besilate)

Oral

Twilem 40/10

MP NP

P14238

[136] Schedule 1, Part 1, after entry for Telmisartan with amlodipine in the form Tablet 80 mg-5 mg (as besilate) [Brand: Telmisartan/Amlodipine Viatris; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan with amlodipine

Tablet 80 mg-5 mg (as besilate)

Oral

Twilem 80/5

MP NP

Telmisartan with amlodipine

Tablet 80 mg-5 mg (as besilate)

Oral

Twilem 80/5

MP NP

P14238

[137] Schedule 1, Part 1, after entry for Telmisartan with amlodipine in the form Tablet 80 mg-10 mg (as besilate) [Brand: Telmisartan/Amlodipine Viatris; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan with amlodipine

Tablet 80 mg-10 mg (as besilate)

Oral

Twilem 80/10

MP NP

Telmisartan with amlodipine

Tablet 80 mg-10 mg (as besilate)

Oral

Twilem 80/10

MP NP

P14238

[138] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Brand: Stelara; Maximum Quantity: 2; Number of Repeats: 0]

insert in the column headed “Variations”: V18826 V18885

[139] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 0]

omit from the column headed “Responsible Person”: AN substitute: TN

[140] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 1]

omit from the column headed “Responsible Person”: AN substitute: TN

[141] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 2]

omit from the column headed “Responsible Person”: AN substitute: TN

[142] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Brand: Wezlana; Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Responsible Person”: AN substitute: TN

(b) insert in the column headed “Variations”: V18826 V18885

[143] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Brand: Wezlana; Maximum Quantity: 2; Number of Repeats: 2]

omit from the column headed “Responsible Person”: AN substitute: TN

[144] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL single use pre-filled syringe [Brand: Steqeyma; Maximum Quantity: 2; Number of Repeats: 0]

insert in the column headed “Variations”: V18885

[145] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 0]

omit from the column headed “Responsible Person”: AN substitute: TN

[146] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 1]

omit from the column headed “Responsible Person”: AN substitute: TN

[147] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 2]

omit from the column headed “Responsible Person”: AN substitute: TN

[148] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Responsible Person”: AN substitute: TN

(b) insert in the column headed “Variations”: V18885

[149] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 2; Number of Repeats: 2]

omit from the column headed “Responsible Person”: AN substitute: TN

[150] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Stelara; Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C14801

(b) omit from the column headed “Circumstances”: C16829

(d) insert in numerical order in the column headed “Circumstances”: C19149 C19171 C19172

(e) omit from the column headed “Purposes”: P14801

(f) omit from the column headed “Purposes”: P16829

(g) omit from the column headed “Purposes”: P16944

(h) insert in numerical order in the column headed “Purposes”: P19149 P19171 P19172

[151] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Stelara; Maximum Quantity: 1; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C16919 C16943

(b) insert in numerical order in the column headed “Circumstances”: C19193

(d) insert in numerical order in the column headed “Purposes”: P19193

(e) insert in the column headed “Variations”: V19193

[152] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Steqeyma; Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C14801

(b) omit from the column headed “Circumstances”: C16829

(d) insert in numerical order in the column headed “Circumstances”: C19149 C19171 C19172

(e) omit from the column headed “Purposes”: P14801

(f) omit from the column headed “Purposes”: P16829

(g) omit from the column headed “Purposes”: P16944

(h) insert in numerical order in the column headed “Purposes”: P19149 P19171 P19172

(i) insert in the column headed “Variations”: V18885

[153] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Steqeyma; Maximum Quantity: 1; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C16919

(b) omit from the column headed “Circumstances”: C16943

(d) omit from the column headed “Purposes”: P16919

(e) omit from the column headed “Purposes”: P16943

(f) insert in numerical order in the column headed “Purposes”: P19193

(g) insert in the column headed “Variations”: V19193

[154] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Steqeyma; Maximum Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C16909

(b) insert in numerical order in the column headed “Circumstances”: C19174

(d) insert in numerical order in the column headed “Purposes”: P19174

[155] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Responsible Person”: AN substitute: TN

(b) omit from the column headed “Circumstances”: C14801

(d) omit from the column headed “Circumstances”: C16944

(e) insert in numerical order in the column headed “Circumstances”: C19149 C19171 C19172

(f) omit from the column headed “Purposes”: P14801

(g) omit from the column headed “Purposes”: P16829

(h) omit from the column headed “Purposes”: P16944

(i) insert in numerical order in the column headed “Purposes”: P19149 P19171 P19172

(j) insert in the column headed “Variations”: V18885

[156] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 1]

(a) omit from the column headed “Responsible Person”: AN substitute: TN

(b) omit from the column headed “Circumstances”: C16919

(d) insert in numerical order in the column headed “Circumstances”: C19193

(e) omit from the column headed “Purposes”: P16919

(f) omit from the column headed “Purposes”: P16943

(g) insert in numerical order in the column headed “Purposes”: P19193

(h) insert in the column headed “Variations”: V19193

[157] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Brand: Wezlana; Maximum Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Responsible Person”: AN substitute: TN

(b) omit from the column headed “Circumstances”: C16909

(d) omit from the column headed “Purposes”: P16909

(e) insert in numerical order in the column headed “Purposes”: P19174

[158] Schedule 1, Part 1, entry for Ustekinumab in the form Solution for I.V. infusion 130 mg in 26 mL [Brand: Wezlana]

omit from the column headed “Responsible Person”: AN substitute: TN

[159] Schedule 1, Part 1, after entry for Vancomycin in the form Capsule 125 mg (125,000 I.U.) (as hydrochloride) [Brand: Vancomycin BNM 125mg]

insert:

Vancomycin

Capsule 125 mg (125,000 I.U.) (as hydrochloride)

Oral

VANCOR

MP NP

C5636 C5660

[160] Schedule 1, Part 1, after entry for Vancomycin in the form Capsule 250 mg (250,000 I.U.) (as hydrochloride) [Brand: Vancomycin BNM 250mg]

insert:

Vancomycin

Capsule 250 mg (250,000 I.U.) (as hydrochloride)

Oral

VANCOR

MP NP

C5636 C5660

[161] Schedule 1, Part 2, after entry for Miconazole

insert:

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Poly Visc

[162] Schedule 3, after entry for Responsible Person Code KP

insert:

PHERO PHARMA PTY LTD

96 673 730 231

[163] Schedule 4, Part 1, omit entry for Circumstances Code “C5637”

[164] Schedule 4, Part 1, omit entry for Circumstances Code “C5718”

[165] Schedule 4, Part 1, omit entry for Circumstances Code “C5772”

[166] Schedule 4, Part 1, omit entry for Circumstances Code “C10701”

[167] Schedule 4, Part 1, omit entry for Circumstances Code “C10705”

[168] Schedule 4, Part 1, omit entry for Circumstances Code “C11524”

[169] Schedule 4, Part 1, omit entry for Circumstances Code “C12098”

[170] Schedule 4, Part 1, omit entry for Circumstances Code “C12101”

[171] Schedule 4, Part 1, omit entry for Circumstances Code “C12147”

[172] Schedule 4, Part 1, omit entry for Circumstances Code “C12148”

[173] Schedule 4, Part 1, omit entry for Circumstances Code “C12152”

[174] Schedule 4, Part 1, omit entry for Circumstances Code “C12228”

[175] Schedule 4, Part 1, omit entry for Circumstances Code “C12229”

[176] Schedule 4, Part 1, omit entry for Circumstances Code “C12240”

[177] Schedule 4, Part 1, omit entry for Circumstances Code “C13039”

[178] Schedule 4, Part 1, omit entry for Circumstances Code “C13094”

[179] Schedule 4, Part 1, omit entry for Circumstances Code “C13432”

[180] Schedule 4, Part 1, omit entry for Circumstances Code “C13437”

[181] Schedule 4, Part 1, omit entry for Circumstances Code “C13726”

[182] Schedule 4, Part 1, omit entry for Circumstances Code “C13727”

[183] Schedule 4, Part 1, omit entry for Circumstances Code “C13728”

[184] Schedule 4, Part 1, omit entry for Circumstances Code “C13730”

[185] Schedule 4, Part 1, omit entry for Circumstances Code “C13731”

[186] Schedule 4, Part 1, omit entry for Circumstances Code “C13732”

[187] Schedule 4, Part 1, omit entry for Circumstances Code “C13736”

[188] Schedule 4, Part 1, omit entry for Circumstances Code “C13739”

[189] Schedule 4, Part 1, omit entry for Circumstances Code “C13741”

[190] Schedule 4, Part 1, omit entry for Circumstances Code “C13867”

[191] Schedule 4, Part 1, omit entry for Circumstances Code “C13876”

[192] Schedule 4, Part 1, omit entry for Circumstances Code “C13892”

[193] Schedule 4, Part 1, omit entry for Circumstances Code “C13923”

[194] Schedule 4, Part 1, omit entry for Circumstances Code “C13949”

[195] Schedule 4, Part 1, omit entry for Circumstances Code “C14027”

[196] Schedule 4, Part 1, omit entry for Circumstances Code “C14044”

[197] Schedule 4, Part 1, omit entry for Circumstances Code “C14324”

[198] Schedule 4, Part 1, omit entry for Circumstances Code “C14416”

[199] Schedule 4, Part 1, omit entry for Circumstances Code “C14801”

[200] Schedule 4, Part 1, omit entry for Circumstances Code “C15886”

[201] Schedule 4, Part 1, omit entry for Circumstances Code “C16829”

[202] Schedule 4, Part 1, omit entry for Circumstances Code “C16909”

[203] Schedule 4, Part 1, omit entry for Circumstances Code “C16919”

[204] Schedule 4, Part 1, omit entry for Circumstances Code “C16933”

[205] Schedule 4, Part 1, omit entry for Circumstances Code “C16943”

[206] Schedule 4, Part 1, omit entry for Circumstances Code “C16944”

[207] Schedule 4, Part 1, omit entry for Circumstances Code “C16950”

[208] Schedule 4, Part 1, omit entry for Circumstances Code “C17016”

[209] Schedule 4, Part 1, omit entry for Circumstances Code “C17019”

[210] Schedule 4, Part 1, omit entry for Circumstances Code “C17052”

[211] Schedule 4, Part 1, omit entry for Circumstances Code “C17053”

[212] Schedule 4, Part 1, omit entry for Circumstances Code “C17054”

[213] Schedule 4, Part 1, omit entry for Circumstances Code “C17072”

[214] Schedule 4, Part 1, omit entry for Circumstances Code “C17533”

[215] Schedule 4, Part 1, entry for Circumstances Code “C17877”

omit from the column headed “Listed Drug”: Enzalutamide

[216] Schedule 4, Part 1, omit entry for Circumstances Code “C17901”

[217] Schedule 4, Part 1, omit entry for Circumstances Code “C18269”

[218] Schedule 4, Part 1, omit entry for Circumstances Code “C18310”

[219] Schedule 4, Part 1, omit entry for Circumstances Code “C18372”

[220] Schedule 4, Part 1, omit entry for Circumstances Code “C18373”

[221] Schedule 4, Part 1, omit entry for Circumstances Code “C18386”

[222] Schedule 4, Part 1, omit entry for Circumstances Code “C18452”

[223] Schedule 4, Part 1, omit entry for Circumstances Code “C18453”

[224] Schedule 4, Part 1, omit entry for Circumstances Code “C18458”

[225] Schedule 4, Part 1, omit entry for Circumstances Code “C18464”

[226] Schedule 4, Part 1, entry for Circumstances Code “C18826”

substitute:

C18826

P18826

CN18826

Ustekinumab

Severe Crohn diseaseContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient, 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].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by applying through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.

Compliance with Authority Required procedures

[227] Schedule 4, Part 1, omit entry for Circumstances Code “C18858”

[228] Schedule 4, Part 1, entry for Circumstances Code “C18885”

substitute:

C18885

P18885

CN18885

Ustekinumab

Severe Crohn diseaseTransitioning from non-PBS-subsidised therapy that was commenced as a paediatric patientPatient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program), ANDPatient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition, ANDPatient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease. ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.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 may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

[229] Schedule 4, Part 1, omit entry for Circumstances Code “C18889”

[230] Schedule 4, Part 1, after entry for Circumstances Code “C19052”

insert:

C19059	P19059	CN19059	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerThe condition must have progressed on/following both: (i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; ORThe condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation, ANDPatient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug, ANDPatient must not have previously received PBS-subsidised treatment with this drug for this indication in any prior line of treatment, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing treatment with this drug for the first time. ORPatient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.	Compliance with Authority Required procedures - Streamlined Authority Code 19059
C19060	P19060	CN19060	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerGrandfather arrangement - Transitioning from non-PBS to PBS-subsided treatmentPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2026, ANDPatient must have/have had a WHO performance status score of no greater than 2 prior to initiation of non-PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Patient must be undergoing combination therapy consisting of no more than 24 months of: (i) enfortumab vedotin, (ii) pembrolizumab. ORPatient must be undergoing monotherapy with this drug after exceeding a lifetime total of 24 cumulative months of combination therapy consisting of: (i) enfortumab vedotin, (ii) pembrolizumab, from the first administered dose. ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to pembrolizumab, requiring temporary/permanent discontinuation; document the details in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 19060
C19061	P19061	CN19061	Enzalutamide	Hormone sensitive carcinoma of the prostateThe treatment must be for metastatic disease initiated within 6 months of treatment initiation with androgen deprivation therapy unless contraindicated to androgen deprivation therapy; ORThe treatment must be for non-metastatic disease where a baseline PSA doubling time (PSADT) of 9 months or less was observed, and the patient has undergone: (i) radical prostatectomy, (ii) radiation therapy, (iii) neither of the above as both therapies were contraindicated, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (i.e. subsidy cannot occur across different treatment settings); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation, ANDPatient must be undergoing concurrent androgen deprivation therapy unless contraindicated.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.The following applies to patients who are being treated for non-metastatic disease:(a) patients should cease treatment after 36 weeks if PSA is less than 0.2 ng/mL unless continued treatment is clinically indicated and the patient remains free of metastases;(b) patients who ceased treatment after meeting the suspension criteria (PSA less than 0.2 ng/mL after 36 weeks) should resume treatment if PSA levels increase to greater than or equal to 2.0 ng/mL for patients who had undergone radical prostatectomy, or greater than or equal to 5.0 ng/mL for those without prior prostatectomy, provided there is no evidence of metastatic disease.	Compliance with Authority Required procedures
C19091	P19091	CN19091	Dupilumab	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
C19098	P19098	CN19098	Ruxolitinib	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
C19100	P19100	CN19100	Ruxolitinib	Polycythemia veraBalance of Initial treatment - up to 48 weeksPatient must have received this drug as their most recent course of PBS-subsidised treatment for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a medical practitioner.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C19103	P19103	CN19103	Ruxolitinib	Polycythemia veraInitial treatmentPatient must be resistant to hydroxycarbamide (hydroxyurea); ORPatient must have an intolerance to hydroxycarbamide (hydroxyurea) of a severity necessitating permanent treatment withdrawal; ORPatient must have developed a clinically important adverse event/contraindication to hydroxycarbamide (hydroxyurea) as defined in the TGA-approved Product Information necessitating permanent treatment withdrawal, ANDPatient must not have previously received PBS-subsidised treatment with this drug for this condition.Patient must be at least 18 years of age.Must be treated by a medical practitioner.Hydroxycarbamide (hydroxyurea) resistance is defined as a minimum of 12 consecutive weeks treatment at a dose of at least 1.5 grams/day or at the maximum tolerated that still results in one of the following:(i) the need to reduce haematocrit levels to below 45% through phlebotomy; OR(ii) a platelet count greater than 400 x 109/L and a white blood cell count greater than 10 x 109/LIf applicable, details of prior systemic treatment with hydroxycarbamide (hydroxyurea) that caused either (i) an intolerance, (ii) an adverse event as listed in the TGA-approved Product Information, or (iii) a contraindication as listed in the TGA-approved Product Information necessitating permanent treatment withdrawal should 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
C19104	P19104	CN19104	Ruxolitinib	Polycythemia veraSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have achieved and maintained a response to treatment with this drug for this condition.Patient must be at least 18 years of age.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C19106	P19106	CN19106	Adalimumab	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, ANDPatient must not receive more than 16 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].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.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.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
C19110	P19110	CN19110	Infliximab	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.Patient must be at least 18 years of age.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.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 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.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.	Compliance with Authority Required procedures - Streamlined Authority Code 19110
C19115	P19115	CN19115	Adalimumab	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, ANDPatient must not receive more than 16 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 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.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.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.	Compliance with Authority Required procedures
C19132	P19132	CN19132	Dupilumab	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	P19133	CN19133	Dupilumab	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	P19136	CN19136	Dupilumab	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	P19137	CN19137	Dupilumab	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
C19146	P19146	CN19146	Ruxolitinib	Polycythemia veraFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised treatment for this condition, ANDPatient must have achieved and maintained a response to treatment with this drug for this condition.Patient must be at least 18 years of age.Must be treated by a medical practitioner.A response to treatment is defined as:(i) Maintaining a haematocrit level of less than 45% without relying on phlebotomy and which was measured at least 12 weeks after the most recent phlebotomy procedure (if performed to reduce red blood cell levels); OR(ii) Ability to demonstrate or maintain a normal platelet count of less than or equal to 400 x 109/L; OR(iii) The absence of palpable splenomegaly.The following must be documented in the patient's medical records:(a) details (dates, unique identifying number/code, or provider number) of the pathology report confirming the patient has achieved and maintained a response within 48 weeks of treatment initiation; OR(b) confirmation that the patient does not have palpable splenomegaly.	Compliance with Authority Required procedures
C19147	P19147	CN19147	Ruxolitinib	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
C19149	P19149	CN19149	AdalimumabUstekinumab	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
C19157	P19157	CN19157	Adalimumab	Complex refractory Fistulising Crohn diseaseContinuing treatmentPatient must have received this drug 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].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.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.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.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.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
C19158	P19158	CN19158	Adalimumab	Complex refractory Fistulising Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under the Continuing treatment restriction, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above 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].	Compliance with Authority Required procedures
C19159	P19159	CN19159	Durvalumab	Resected gastric and gastroesophageal junction adenocarcinomaAdjuvant treatmentPatient must have previously received PBS-subsidised neoadjuvant treatment with this drug for this condition; ORPatient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) treated with combined therapy with durvalumab and FLOT as neoadjuvant treatment for this condition, ANDThe treatment must be for the purposes of adjuvant use following surgical resection, ANDThe treatment must be/have been initiated in combination with adjuvant FLOT for up to 2 cycles unless intolerant to FLOT requiring permanent discontinuation, ANDThe treatment must be sole PBS-subsidised systemic anti-cancer therapy from cycles 3-12 of adjuvant treatment, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) maximum of 12 cycles of adjuvant treatment for this condition from the first administered dose following surgery, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.Where 'FLOT' is referenced in this restriction, it refers to the combination therapy of fluorouracil (5-FU) in combination with leucovorin (folinic acid), oxaliplatin and docetaxel.	Compliance with Authority Required procedures
C19168	P19168	CN19168	Obinutuzumab	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	CN19169	Obinutuzumab	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
C19171	P19171	CN19171	Ustekinumab	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	P19172	CN19172	Ustekinumab	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
C19174	P19174	CN19174	AdalimumabUstekinumab	Complex refractory Fistulising Crohn diseaseContinuing treatmentPatient must have received this drug 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.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.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.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 19174
C19178	P19178	CN19178	Infliximab	Complex refractory Fistulising Crohn diseaseBalance of supplyPatient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive), ANDThe treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment.Patient must be at least 18 years of age.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
C19181	P19181	CN19181	Dupilumab	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
C19188	P19188	CN19188	Obinutuzumab	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
C19191	P19191	CN19191	Ruxolitinib	Moderate to severe chronic graft versus host disease (cGVHD)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must have responding disease at 24 weeks compared with baseline, demonstrated by either a: (i) partial response, (ii) complete response, ANDThe treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors.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 defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.(b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.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 19191
C19192	P19192	CN19192	Pembrolizumab	Immunotherapy sensitive advanced or metastatic cancerPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions. ORPatient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 19192
C19193	P19193	CN19193	Ustekinumab	Complex refractory Fistulising Crohn diseaseContinuing treatmentPatient must have received this drug 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].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.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.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 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
C19195	P19195	CN19195	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerPatient must not have received prior systemic therapy for this condition at the initiation of treatment with this drug, with the exception of neoadjuvant/adjuvant chemotherapy, ANDPatient must have/have had a WHO performance status score of no greater than 2 at treatment initiation with this drug.Patient must be undergoing combination therapy consisting of no more than 24 months of: (i) enfortumab vedotin, (ii) pembrolizumab; ORPatient must be undergoing monotherapy with this drug after exceeding a lifetime total of 24 cumulative months of combination therapy consisting of: (i) enfortumab vedotin, (ii) pembrolizumab, from the first administered dose; ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to pembrolizumab, requiring temporary/permanent discontinuation; document the details in the patient's medical records, ANDPatient must be undergoing treatment with this drug for the first time. ORPatient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.	Compliance with Authority Required procedures - Streamlined Authority Code 19195
C19201	P19201	CN19201	Asciminib	Chronic Myeloid Leukaemia (CML)Continuing treatment for patients without T315I mutationThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; ORPatient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 19201
C19202	P19202	CN19202	Asciminib	Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients with T315I mutationThe condition must not be in the blast phase, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report, ANDThe condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; ORThe condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR), ANDPatient must have failed an adequate trial of at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have experienced intolerance, not failure to respond, to at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority.Must be treated by a medical practitioner.Failure of an adequate trial of a tyrosine kinase inhibitor is defined as:1. Lack of response defined as either:(i) failure to achieve a haematological response after a minimum of 3 months therapy; OR(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; OR(iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor for any phase of chronic myeloid leukaemia; OR5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during TKI therapy in patients with accelerated phase chronic myeloid leukaemia.Accelerated phase is defined by the presence of 1 or more of the following:1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; OR2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; OR3. Peripheral basophils greater than or equal to 20%; OR4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; OR5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).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:(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; OR(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; AND(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; AND(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.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).Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapyUp to a maximum of 18 months of treatment may be authorised under this initial restriction.	Compliance with Written Authority Required procedures
C19209	P19209	CN19209	Infliximab	Complex refractory Fistulising Crohn diseaseInitial treatmentPatient must have received treatment with the PBS-subsidised IV formulation of this drug for this condition; ORPatient must have received an approved PBS authority prescription for treatment with the IV formulation of this drug for this condition; ORPatient must not have received treatment with the IV formulation of this drug, but has met the restrictions criteria as specified in the Initial 1 or 2 for the IV formulation for this condition.Patient must be at least 18 years of age.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 for patients who have not received the IV formulation as loading dose(s), but has met the restrictions criteria as specified in the Initial 1 or 2 for the IV formulation:(i) reason for loading doses being omitted; AND(ii) if applicable, baseline number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition; AND(iii) if applicable, 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(iv) if applicable, details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.	Compliance with Authority Required procedures
C19213	P19213	CN19213	Dupilumab	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
C19218	P19218	CN19218	Asciminib	Chronic Myeloid Leukaemia (CML)Continuing Treatment for patients with T315I mutationPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; ORPatient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.The continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; OR(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].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).Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy	Compliance with Written Authority Required procedures
C19222	P19222	CN19222	Durvalumab	Resectable gastric and gastroesophageal junction adenocarcinomaNeoadjuvant treatmentPatient must be initiating treatment with this drug for this condition; ORPatient must be transitioning from existing non-PBS to PBS-subsidised supply of this drug, ANDThe condition must be Stage II or higher, ANDThe condition must be resectable, ANDThe treatment must be for the purpose of neoadjuvant use in a patient preparing for surgery, ANDPatient must have a WHO performance status no greater than 1, ANDThe treatment must be initiated in combination with neoadjuvant FLOT, ANDThe condition must have been untreated with systemic therapy.Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 2 cycles of neoadjuvant treatment from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression/recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.Where 'FLOT' is referenced in this restriction, it refers to the combination therapy of fluorouracil (5-FU) in combination with leucovorin (folinic acid), oxaliplatin and docetaxel.	Compliance with Authority Required procedures

[231] Schedule 4, Part 2, omit entry for Variation Code “V9041”

[232] Schedule 4, Part 2, after entry for Variation Code “V13998”

insert:

V14667	Infliximab	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.
V14718	Infliximab	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.

[233] Schedule 4, Part 2, after entry for Variation Code “V17616”

insert:

V18196	Infliximab	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.
V18263	Infliximab	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.
V18340	Infliximab	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.

[234] Schedule 4, Part 2, after entry for Variation Code “V18377”

insert:

V18774	Infliximab	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.
V18775	Infliximab	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.
V18819	Infliximab	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.
V18826	Ustekinumab	A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.

[235] Schedule 4, Part 2, after entry for Variation Code “V18840”

insert:

V18849	Infliximab	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.
V18866	Infliximab	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.
V18868	Infliximab	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.
V18885	Ustekinumab	A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.

[236] Schedule 4, Part 2, after entry for Variation Code “V19045”

insert:

V19071	Pegvisomant	No increase in the maximum quantity or number of units may be authorised for the loading dose.
V19107	Infliximab	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.
V19108	Infliximab	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.
V19150	Infliximab	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.
V19152	Infliximab	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.
V19193	Ustekinumab	A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.
V19207	Infliximab	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.

[237] Schedule 5, entry for Amoxicillin [GRP-815]

omit from the column headed “Brand”: Amoxil

[238] Schedule 5, entry for Amoxicillin [GRP-817]

insert as the first entry in the column headed “Brand”: AMOXICILLIN MEDSURGE

[239] Schedule 5, entry for Amoxicillin [GRP-818]

insert as the first entry in the column headed “Brand”: AMOXICILLIN MEDSURGE

[240] Schedule 5, entry for Aripiprazole [GRP-20657]

omit from the column headed “Brand”: ARIPIPRAZOLE-WGR

[241] Schedule 5, after entry for Benzathine benzylpenicillin in the form Powder for injection 1,200,000 units with diluent 4 mL (S19A)

insert:

Benzathine benzylpenicillin

GRP-28195

Powder for injection 1,200,000 units with diluent 4 mL (Spain) (s19A)

Injection

Benzetacil (Spain)

[242] Schedule 5, after entry for Dapsone

insert:

Dapsone	GRP-31100	Tablet 25 mg	Oral	Link Medical Products Pty Ltd
Dapsone	GRP-31100	Tablet 25 mg (s19A)	Oral	Dapsone Tablets, USP 25 mg (Rising Pharmaceuticals, USA)

[243] Schedule 5, entry for Diltiazem [GRP-739]

omit from the column headed “Brand”: Cardizem CD

[244] Schedule 5, after entry for Disopyramide in the form Capsule 100 mg

insert:

Disopyramide

GRP-27352

Capsule 100 mg (Japan) (s19A)

Oral

Rythmodan (Japan)

[245] Schedule 5, entry for Dutasteride with tamsulosin

insert in the column headed “Brand” after entry for the brand “DUTASTERIDE/TAMSULOSIN-WGR”: DUTASTERIDE-TAMSULOSIN ZPL

[246] Schedule 5, after entry for Estradiol

insert:

Estradiol	GRP-31220	Transdermal patches 390 micrograms, 8	Transdermal	Estradot 25
Estradiol	GRP-31220	Transdermal patches 390 micrograms, 8 (s19A)	Transdermal	Dermestril 25 (Italy)
Estradiol	GRP-31221	Transdermal patches 780 micrograms, 8	Transdermal	Estradot 50
Estradiol	GRP-31221	Transdermal patches 780 micrograms, 8 (s19A)	Transdermal	Dermestril 50 (Italy)

[247] Schedule 5, entry for Gliclazide [GRP-15200]

insert in the column headed “Brand” after entry for the brand “ARDIX GLICLAZIDE 60mg MR”: ARX-Gliclazide MR

[248] Schedule 5, entry for Glimepiride [GRP-1267]

omit from the column headed “Brand”: GLIMEPIRIDE-WGR

[249] Schedule 5, entry for Itraconazole

insert in the column headed “Brand” after entry for the brand “ITRANOX”: Itrazo

[250] Schedule 5, entry for Lamivudine [GRP-1139]

omit from the column headed “Brand”: Lamivudine Alphapharm

[251] Schedule 5, entry for Nebivolol [GRP-22484]

insert in the column headed “Brand” after entry for the brand “Nebivolol Sandoz”: Nebivolol Viatris

[252] Schedule 5, entry for Olanzapine in the form Tablet 20 mg (orally disintegrating)

omit from the column headed “Brand”: OLANZAPINE ODT-WGR

[253] Schedule 5, entry for Olmesartan with hydrochlorothiazide [GRP-21129]

insert in the column headed “Brand” after entry for the brand “Olmesartan/HCT Sandoz”: Olmesartan HCT Viatris

[254] Schedule 5, entry for Olmesartan with hydrochlorothiazide [GRP-21131]

insert in the column headed “Brand” after entry for the brand “Olmesartan/HCT Sandoz”: Olmesartan HCT Viatris

[255] Schedule 5, entry for Olmesartan with hydrochlorothiazide [GRP-21133]

insert in the column headed “Brand” after entry for the brand “Olmesartan/HCT Sandoz”: Olmesartan HCT Viatris

[256] Schedule 5, entry for Oxycodone with naloxone [GRP-29601]

insert in the column headed “Brand” after entry for the brand “ARX-Oxycodone/Naloxone 10/5”: OXYCODONE NALOXONE ADVZ XR 10/5

[257] Schedule 5, entry for Oxycodone with naloxone [GRP-29607]

insert in the column headed “Brand” after entry for the brand “ARX-Oxycodone/Naloxone 20/10”: OXYCODONE NALOXONE ADVZ XR 20/10

[258] Schedule 5, entry for Oxycodone with naloxone [GRP-29609]

insert in the column headed “Brand” after entry for the brand “ARX-Oxycodone/Naloxone 30/15”: OXYCODONE NALOXONE ADVZ XR 30/15

[259] Schedule 5, entry for Oxycodone with naloxone [GRP-29611]

insert in the column headed “Brand” after entry for the brand “ARX-Oxycodone/Naloxone 40/20”: OXYCODONE NALOXONE ADVZ XR 40/20

[260] Schedule 5, entry for Oxycodone with naloxone [GRP-29613]

insert in the column headed “Brand” after entry for the brand “ARX-Oxycodone/Naloxone 5/2.5”: OXYCODONE NALOXONE ADVZ XR 5/2.5

[261] Schedule 5, entry for Pioglitazone [GRP-692]

omit from the column headed “Brand”: Actos

[262] Schedule 5, entry for Telmisartan with amlodipine [GRP-14671]

insert in the column headed “Brand” after entry for the brand “Telmisartan/Amlodipine Viatris”: Twilem 40/5

[263] Schedule 5, entry for Telmisartan with amlodipine [GRP-14673]

insert in the column headed “Brand” after entry for the brand “Telmisartan/Amlodipine Viatris”: Twilem 40/10

[264] Schedule 5, entry for Telmisartan with amlodipine [GRP-14675]

insert in the column headed “Brand” after entry for the brand “Telmisartan/Amlodipine Viatris”: Twilem 80/5

[265] Schedule 5, entry for Telmisartan with amlodipine [GRP-14677]

insert in the column headed “Brand” after entry for the brand “Telmisartan/Amlodipine Viatris”: Twilem 80/10

[266] Schedule 5, entry for Vancomycin [GRP-26872]

insert in the column headed “Brand” after entry for the brand “Vancomycin BNM 125mg”: VANCOR

[267] Schedule 5, entry for Vancomycin [GRP-26875]

insert in the column headed “Brand” after entry for the brand “Vancomycin BNM 250mg”: VANCOR

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.

National Health (Listing of Pharmaceutical Benefits) Amendment (September Update) Instrument 2026

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Key facts

History · 1 version

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