National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 11)

Bookmark

this version | go to latest

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 11)

- F2022L01408
No longer in force

PB 99 of 2022 Other as made

This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.

Administered by: Health and Aged Care

Registered

31 Oct 2022

Tabling History	Date
Tabled HR	07-Nov-2022
Tabled Senate	21-Nov-2022

Date of repeal

08 Mar 2023

Repealed by

Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

Commonwealth Coat of Arms of Australia

PB 99 of 2022

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 11)

National Health Act 1953

I , NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 28 October 2022

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments 2

National Health (Listing of Pharmaceutical Benefits) Instrument 2012
(PB 71 of 2012). 2

1 Name

(1) This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 11).

(2) This Instrument may also be cited as PB 99 of 2022.

2 Commencement

(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 November 2022	1 November 2022

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.

Schedule 1—Amendments

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

[1] Schedule 1, Part 1, entry for Abacavir with lamivudine

substitute:

Abacavir with lamivudine

Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

Oral

ABACAVIR/LAMIVUDINE 600/300 SUN

MP NP

C4527 C4528

D(100)

Abacavir/Lamivudine Mylan

MP NP

C4527 C4528

D(100)

Kivexa

MP NP

C4527 C4528

D(100)

[2] Schedule 1, Part 1, entry for Abemaciclib in each of the forms: Tablet 50 mg; Tablet 100 mg; and Tablet 150 mg

omit from the column headed “Circumstances”: C13053

[3] Schedule 1, Part 1, entry for Aflibercept

substitute:

Aflibercept

Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe

Injection

Eylea

C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424

P13336 P13337 P13384 P13387 P13390 P13392 P13406 P13424

C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424

P13388 P13402

Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)

Injection

Eylea

C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424

P13336 P13337 P13384 P13387 P13390 P13392 P13406 P13424

C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424

P13388 P13402

[4] Schedule 1, Part 1, entry for Amoxicillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

(a) omit:

Alphamox 125

PDP

(b) omit:

Alphamox 125

MP NP

[5] Schedule 1, Part 1, entry for Amoxicillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

(a) omit:

Alphamox 250

PDP

(b) omit:

Alphamox 250

MP NP

[6] Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 840 mg in 14 mL

(a) omit from the column headed “Circumstances”: C10312

(b) omit from the column headed “Circumstances”: C10915

(c) insert in numerical order in the column headed “Circumstances”: C13446 C13451

[7] Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL

(a) omit from the column headed “Circumstances”: C10182

(b) omit from the column headed “Circumstances”: C10276

(c) omit from the column headed “Circumstances”: C10915

(d) insert in numerical order in the column headed “Circumstances”: C13442 C13443 C13448

[8] Schedule 1, Part 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Bevaciptin

See Note 3

D(100)

[9] Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Bortezomib Baxter

C11099

See Note 3

D(100)

[10] Schedule 1, Part 1, entry for Brolucizumab

omit from the column headed “Circumstances”: C12268 C12335 substitute: C13413 C13426

[11] Schedule 1, Part 1, entry for Budesonide with formoterol in each of the forms: Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses; and Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

omit from the column headed “Responsible Person” for the brand “DuoResp Spiromax” (all instances): AF substitute: EV

[12] Schedule 1, Part 1, after entry for Bupropion

insert:

Burosumab

Solution for injection 10 mg in 1 mL

Injection

Crysvita

See Note 3

D(100)

Solution for injection 20 mg in 1 mL

Injection

Crysvita

See Note 3

D(100)

Solution for injection 30 mg in 1 mL

Injection

Crysvita

See Note 3

D(100)

[13] Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg

omit:

Candesartan GH

MP NP

[14] Schedule 1, Part 1, after entry for Celecoxib in the form Capsule 200 mg

insert:

Cemiplimab

Solution concentrate for I.V. infusion 350 mg in 7 mL

Injection

Libtayo

C13322 C13372 C13373 C13411 C13419

See Note 3

D(100)

[15] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P9367 P9468 P9469 P9549

[16] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

[17] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P9367 P9468 P9469 P9549

[18] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

[19] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P9367 P9468 P9469 P9549

[20] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

[21] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P9367 P9468 P9469 P9549

[22] Schedule 1, Part 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dasatinib SUN

C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

[23] Schedule 1, Part 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10713 C10822 C10861 C10904 C10933 C10978

(b) insert in numerical order in the column headed “Circumstances”: C13336 C13341 C13387 C13423 C13428 C13429

[24] Schedule 1, Part 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C10713 C10822 C10861 C10904 C10933 C10978

(b) insert in numerical order in the column headed “Circumstances”: C13336 C13341 C13387 C13423 C13428 C13429

(c) omit from the column headed “Purposes”: P10713 P10822 P10861 P10904 P10933 P10978 substitute: P13336 P13341 P13387 P13423 P13428 P13429

[25] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 125 mg

omit:

Ezovir

MP NP

C5937

[26] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 20; Number of Repeats: 1]

omit:

Ezovir

MP NP

C5937 C5951 C5971

P5937

[27] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 21; Number of Repeats: 0]

(a) omit from the column headed “Circumstances” for the brand “Ezovir”: C5937

(b) omit:

Famciclovir generichealth 250

MP NP

C5951 C5971

P5951

[28] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances” for the brand “Ezovir”: C5937

(b) omit:

Famciclovir generichealth 250

MP NP

C5951 C5971

P5971

[29] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 500 mg

omit:

Famciclovir generichealth 500

MP NP

C5947 C5948 C5949 C5954

[30] Schedule 1, Part 1, entry for Flucloxacillin in the form Powder for injection 1 g (as sodium monohydrate)

substitute:

	Powder for injection 1 g (as sodium monohydrate)	Injection		Flucil	AS	PDP			5	0	5
						MP NP			5	1	5

[31] Schedule 1, Part 1, entry for Imatinib in each of the forms: Tablet 100 mg (as mesilate); and Tablet 400 mg (as mesilate)

omit from the column headed “Responsible Person” for the brand “Imatinib-Teva” (all instances): SZ substitute: TB

[32] Schedule 1, Part 1, entry for Lacosamide in the form Tablet 50 mg [Maximum Quantity: 14; Number of Repeats: 1]

insert in numerical order in the column headed “Circumstances” for the brand “Lacosamide ARX”: C12092

[33] Schedule 1, Part 1, entry for Lacosamide in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a) insert in numerical order in the column headed “Circumstances” for the brand “Lacosamide ARX”: C12092

(b) insert in numerical order in the column headed “Purposes” for the brand “Lacosamide ARX”: P12092

[34] Schedule 1, Part 1, entry for Lacosamide in the form Tablet 100 mg [Maximum Quantity: 56; Number of Repeats: 5]

insert in numerical order in the column headed “Circumstances” for the brand “Lacosamide ARX”: C12092

[35] Schedule 1, Part 1, entry for Lacosamide in the form Tablet 150 mg [Maximum Quantity: 56; Number of Repeats: 5]

insert in numerical order in the column headed “Circumstances” for the brand “Lacosamide ARX”: C12092

[36] Schedule 1, Part 1, entry for Lacosamide in the form Tablet 200 mg

insert in numerical order in the column headed “Circumstances” for the brand “Lacosamide ARX”: C12092

[37] Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

omit:

METEX XR 1000

MP NP

[38] Schedule 1, Part 1, entry for Molnupiravir

(a) omit from the column headed “Circumstances”: C13224

(b) insert in numerical order in the column headed “Circumstances”: C13410

[39] Schedule 1, Part 1, entry for Nintedanib

substitute:

Nintedanib

Capsule 100 mg

Oral

Ofev

C13378 C13380 C13381 C13401 C13412 C13420

Capsule 150 mg

Oral

Ofev

C13378 C13380 C13381 C13401 C13412 C13420

[40] Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir

(a) omit from the column headed “Circumstances”: C13224

(b) insert in numerical order in the column headed “Circumstances”: C13410

[41] Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a) omit from the column headed “Circumstances”: C11392 C11434

(b) insert in numerical order in the column headed “Circumstances”: C13433 C13445

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

(a) omit from the column headed “Circumstances”: C10681 C10682

(b) omit from the column headed “Circumstances”: C10693

(c) omit from the column headed “Circumstances”: C10704

(d) insert in numerical order in the column headed “Circumstances”: C13431 C13432 C13436 C13437

[43] Schedule 1, Part 1, entry for Phenelzine

substitute:

Phenelzine

Tablet 15 mg (as sulfate)

Oral

Nardil

C6236

100

Tablet 15 mg (as sulfate) s19A

Oral

Nardil (Canada)

C6236

120

[44] Schedule 1, Part 1, entry for Pirfenidone

substitute:

Pirfenidone

Capsule 267 mg

Oral

Esbriet

C13378 C13380 C13381

270

Tablet 267 mg

Oral

Esbriet

C13378 C13380 C13381

270

Tablet 801mg

Oral

Esbriet

C13380

[45] Schedule 1, Part 1, entry for Piroxicam

substitute:

Piroxicam

Capsule 10 mg

Oral

APO-Piroxicam

PDP

C6214

Feldene

PDP

C6214

APO-Piroxicam

MP NP

C6214

Feldene

MP NP

C6214

Capsule 20 mg

Oral

APO-Piroxicam

PDP

C6214

MP NP

C6214

Dispersible tablet 10 mg

Oral

Mobilis D-10

PDP

C6214

MP NP

C6214

Dispersible tablet 20 mg

Oral

Feldene-D

PDP

C6214

MP NP

C6214

[46] Schedule 1, Part 1, entry for Pomalidomide

substitute:

Pomalidomide

Capsule 3 mg

Oral

Pomalidomide Sandoz

See Note 3

D(100)

See Note 3

D(100)

Pomalyst

See Note 3

D(100)

See Note 3

D(100)

Pomolide

See Note 3

D(100)

See Note 3

D(100)

Capsule 4 mg

Oral

Pomalidomide Sandoz

See Note 3

D(100)

See Note 3

D(100)

Pomalyst

See Note 3

D(100)

See Note 3

D(100)

Pomolide

See Note 3

D(100)

See Note 3

D(100)

[47] Schedule 1, Part 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms; and Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

omit:

Pramipexole XR GP

MP NP

C5131

[48] Schedule 1, Part 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg; Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg; Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg; Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg; and Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

omit:

Pramipexole XR GP

MP NP

C5131

[49] Schedule 1, Part 1, after entry for Pyridostigmine in the form Tablet containing pyridostigmine bromide 180 mg (modified release)

insert:

Tablet containing pyridostigmine bromide 180 mg (modified release) s19A

Oral

Pyridostigmine Bromide Extended-Release Tablets (Rising)

100

[50] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: SZ substitute: TB

[51] Schedule 1, Part 1, entry for Quetiapine in each of the forms: Tablet (modified release) 150 mg (as fumarate); and Tablet (modified release) 200 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: SZ substitute: TB

[52] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: SZ substitute: TB

[53] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: SZ substitute: TB

[54] Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum
Quantity: 30; Number of Repeats: 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Noumed Rabeprazole	VO	MP	C8774 C8775 C8776 C8780 C11310	P8774 P8775	30	1	30
						NP	C8774 C8775 C8776 C8780	P8774 P8775	30	1	30

[55] Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum
Quantity: 30; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Noumed Rabeprazole	VO	MP	C8774 C8775 C8776 C8780 C11310	P8776 P8780	30	5	30
						NP	C8774 C8775 C8776 C8780	P8776 P8780	30	5	30

[56] Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum
Quantity: 60; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Noumed Rabeprazole

C8774 C8775 C8776 C8780 C11310

P11310

[57] Schedule 1, Part 1, entry for Ranibizumab

substitute:

Ranibizumab

Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe

Injection

Lucentis

C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427

P13336 P13337 P13340 P13384 P13387 P13390 P13392 P13406 P13422 P13427

C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427

P13388 P13402

Solution for intravitreal injection 2.3 mg in 0.23 mL

Injection

Lucentis

C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427

P13336 P13337 P13340 P13384 P13387 P13390 P13392 P13406 P13422 P13427

C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427

P13388 P13402

[58] Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg

(a) omit:

Rulide

MP NP PDP

(b) omit:

Rulide

MP NP

P10404

10
CN10404

0
CN10404

[59] Schedule 1, Part 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30

omit:

Asmol 2.5 uni-dose

MP NP

C6815 C6825

[60] Schedule 1, Part 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

omit:

Asmol 5 uni-dose

MP NP

C6815 C6825

[61] Schedule 1, Part 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride; and Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Sitagliptin/Metformin Sandoz	SZ	MP	C6333 C6334 C6344 C6443 C7507 C7530		56	5	56
						NP	C6333 C6334 C6344 C6443 C7530		56	5	56

[62] Schedule 1, Part 1, entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Sitagliptin/Metformin Sandoz	SZ	MP	C6333 C6334 C6344 C6443 C7507 C7530		56	5	56
						NP	C6333 C6334 C6344 C6443 C7530		56	5	56

[63] Schedule 1, Part 1, entry for Somatropin

substitute:

Somatropin

Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12738 C12758 C12760 C12765 C12768 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12791 C12793 C12798 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364

See Note 3

D(100)

Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

See Note 3

D(100)

Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

Humatrope

C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12734 C12738 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364

See Note 3

D(100)

Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

Humatrope

See Note 3

D(100)

Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

Humatrope

See Note 3

D(100)

Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)

Injection

Genotropin GoQuick

C11102 C11104 C12588 C12601 C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12738 C12758 C12760 C12765 C12768 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12791 C12793 C12798 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364

See Note 3

D(100)

Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

Injection

Genotropin GoQuick

See Note 3

D(100)

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Omnitrope Surepal 5

C12713 C12721 C12749 C12752 C12755 C12789 C12790 C12805 C12806 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12876 C12877 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12928 C13288 C13309 C13350 C13352 C13355 C13356 C13359 C13367 C13368 C13393 C13417 C13418

See Note 3

D(100)

Scitropin A

See Note 3

D(100)

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

Injection

Norditropin FlexPro

C11102 C11104 C12588 C12601 C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12738 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12798 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364

See Note 3

D(100)

Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)

Injection

Saizen

C12703 C12704 C12711 C12712 C12721 C12722 C12723 C12725 C12726 C12731 C12738 C12749 C12752 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12803 C12806 C12831 C12832 C12834 C12858 C12860 C12861 C12866 C12884 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364

See Note 3

D(100)

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Omnitrope Surepal 10

See Note 3

D(100)

SciTropin A

See Note 3

D(100)

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

Injection

Norditropin FlexPro

C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12738 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12798 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364

See Note 3

D(100)

Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

Injection

NutropinAq

See Note 3

D(100)

Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Saizen

See Note 3

D(100)

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Omnitrope Surepal 15

See Note 3

D(100)

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

Injection

Norditropin FlexPro

See Note 3

D(100)

Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)

Injection

Saizen

See Note 3

D(100)

[64] Schedule 1, Part 1, entry for Tacrolimus in the form Capsule 5 mg

(a) omit:

Pacrolim

(b) omit:

Pacrolim

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

C(100)

[65] Schedule 1, Part 1, after entry for Tenofovir with emtricitabine and efavirenz

insert:

Tepotinib

Tablet 225 mg

Oral

Tepmetko

C13434 C13435 C13441

[66] Schedule 1, Part 1, entry for Tiotropium in the form Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

omit from the column headed “Responsible Person”: AF substitute: TB

[67] Schedule 1, Part 1, entry for Triglycerides, medium chain

omit:

Oral liquid 225 mL, 15 (betaquik)

Oral

Betaquik

MP NP

C6147 C6191

[68] Schedule 1, Part 1, entry for Triglycerides - medium chain, formula

omit:

Oral liquid 500 mL, 8 (Nutrini Peptisorb)

Oral

Nutrini Peptisorb

MP NP

C4660

[69] Schedule 1, Part 1, entry for Triptorelin in the form Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles

omit from the column headed “Circumstances”: C12397

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

omit from the column headed “Circumstances”: C12293

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

(a) omit from the column headed “Circumstances”: C12293

(b) omit from the column headed “Purposes”: P12293

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

omit from the column headed “Circumstances”: C12293

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

omit from the column headed “Circumstances”: C12293

[74] Schedule 1, Part 1, entry for Vancomycin

substitute:

Vancomycin

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

Oral

Vancocin

C5636 C5660

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

Oral

Vancocin

C5636 C5660

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

Vancomycin Alphapharm

C5716 C5717 C5769

P5717

PDP

C5801

Vancomycin Viatris

C5716 C5717 C5769

P5717

PDP

C5801

Vancomycin Alphapharm

C5716 C5717 C5769

P5716 P5769

Vancomycin Viatris

C5716 C5717 C5769

P5716 P5769

Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

Injection

Vancomycin Alphapharm

C5716 C5717 C5769

P5717

PDP

C5801

Vancomycin Viatris

C5716 C5717 C5769

P5717

PDP

C5801

Vancomycin Alphapharm

C5716 C5717 C5769

P5716 P5769

Vancomycin Viatris

C5716 C5717 C5769

P5716 P5769

[75] Schedule 1, Part 2, omit entry for Clopidogrel

[76] Schedule 1, Part 2, after entry for Pancreatic extract

insert:

Phenelzine

Tablet 15 mg (as sulfate) (USP)

Oral

Phenelzine sulfate USP (Generic Health)

C6236

100

[77] Schedule 1, Part 2, after entry for Tipranavir

insert:

Triglycerides, medium chain

Oral liquid 225 mL, 15 (betaquik)

Oral

Betaquik

MP NP

C6147 C6191

[78] Schedule 3, after details relevant for Responsible Person code JZ

insert:

KYOWA KIRIN AUSTRALIA PTY LTD

47 631 934 453

[79] Schedule 4, Part 1, entry for Abemaciclib

omit:

C13053

Locally advanced or metastatic breast cancer
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received treatment with this drug for this PBS indication prior to 1 November 2021; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS supply was initiated; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated; AND
The treatment must be in combination with one of: (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant, where the patient has never been treated with endocrine therapy for advanced/metastatic disease at the time non-PBS supply was initiated; OR
The treatment must be in combination with fulvestrant only, where at the time non-PBS supply was initiated, the patient had recurrent/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

[80] Schedule 4, Part 1, entry for Aflibercept

substitute:

Aflibercept	C13336	P13336	Central retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13336
	C13337	P13337	Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to pathologic myopia (PM); AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
	C13384	P13384	Branch retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
	C13387	P13387	Branch retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13387
	C13388	P13388	Diabetic macular oedema (DMO) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
	C13390	P13390	Central retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
	C13392	P13392	Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to pathologic myopia (PM); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.	Compliance with Authority Required procedures - Streamlined Authority Code 13392
	C13402	P13402	Diabetic macular oedema (DMO) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13402
	C13406	P13406	Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to age-related macular degeneration (AMD); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.	Compliance with Authority Required procedures - Streamlined Authority Code 13406
	C13424	P13424	Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to age-related macular degeneration (AMD); AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures

[81] Schedule 4, Part 1, entry for Atezolizumab

(a) omit:

C10182

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.

Compliance with Authority Required procedures - Streamlined Authority Code 10182

(b) omit:

C10276

Locally advanced or metastatic non-small cell lung cancer
Initial treatment - 3 weekly treatment regimen
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10276

(c) omit:

C10312

Locally advanced or metastatic non-small cell lung cancer
Initial treatment - 4 weekly treatment regimen
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10312

(d) omit:

C10915

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Transitioning from non-PBS-subsidised to PBS-subsidised supply - Grandfather treatment - 3 weekly treatment regimen (1,200 mg) or 4 weekly treatment regimen (1,680 mg where bevacizumab is discontinued)
Patient must have commenced non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 November 2020; AND
Patient must have met all the PBS eligibility criteria applying to a non-grandfather patient under the Initial treatment restriction for this PBS indication prior to having commenced non-PBS-subsidised treatment with this drug, which are: (i) WHO status score no greater than 1, (ii) Child Pugh class A chronic liver disease, (iii) the patient was unsuitable for transarterial chemoembolization, (iv) the condition was untreated with systemic therapy, unless an intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal had occurred; AND
Patient must not have developed disease progression while being treated with this drug for this condition.
Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.

Compliance with Authority Required procedures - Streamlined Authority Code 10915

(e) insert in numerical order after existing text:

C13442	Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,200 mg administered once every 3 weeks Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR Patient must be continuing existing PBS-subsidised treatment with this drug; OR Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated. Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug. The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy 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) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.	Compliance with Authority Required procedures - Streamlined Authority Code 13442
C13443	Locally advanced or metastatic non-small cell lung cancer Initial treatment - 3 weekly treatment regimen Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy; OR The condition must have progressed after treatment with tepotinib.	Compliance with Authority Required procedures - Streamlined Authority Code 13443
C13446	Locally advanced or metastatic non-small cell lung cancer Initial treatment - 4 weekly treatment regimen Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy; OR The condition must have progressed after treatment with tepotinib.	Compliance with Authority Required procedures - Streamlined Authority Code 13446
C13448	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment 1 Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy. The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with tepotinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.	Compliance with Authority Required procedures - Streamlined Authority Code 13448
C13451	Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR Patient must be continuing existing PBS-subsidised treatment with this drug; OR Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated. Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug. The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy 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) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.	Compliance with Authority Required procedures - Streamlined Authority Code 13451

[82] Schedule 4, Part 1, entry for Brolucizumab

substitute:

Brolucizumab	C13413			Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to age-related macular degeneration (AMD); AND Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with: 1. Aflibercept and/or 2. Ranibizumab; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
	C13426			Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to age-related macular degeneration (AMD); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.	Compliance with Authority Required procedures

[83] Schedule 4, Part 1, after entry for Celecoxib

insert:

Cemiplimab	C13322	Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received non-PBS-subsidised therapy with this drug for this condition prior to 1 November 2022; AND The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.	Compliance with Authority Required procedures
	C13372	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 3 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; AND Patient must not have received prior treatment with a programmed cell death 1 (PD-1) inhibitor or a programmed cell death ligand 1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must express programmed cell death ligand 1 (PD-L1) with a tumour proportion score (TPS) of at least 50% in the tumour sample. The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed a total of 7 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 13372
	C13373	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.	Compliance with Authority Required procedures - Streamlined Authority Code 13373
	C13411	Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Continuing treatment Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.	Compliance with Authority Required procedures
	C13419	Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Initial treatment covering the first 3 treatment cycles The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy; AND Patient must have had a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures

[84] Schedule 4, Part 1, omit entry for Clopidogrel

[85] Schedule 4, Part 1, entry for Dexamethasone

(a) omit:

C10713	P10713	Central retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures
C10822	P10822	Branch retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing. A written application must include: a) a completed authority prescription form; b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and c) a copy of the optical coherence tomography or fluorescein angiogram report.	Compliance with Written Authority Required procedures
C10861	P10861	Branch retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures
C10904	P10904	Central retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing. A written application must include: a) a completed authority prescription form; b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and c) a copy of the optical coherence tomography or fluorescein angiogram report.	Compliance with Written Authority Required procedures
C10933	P10933	Diabetic macular oedema (DMO) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have had a cataract removed in the treated eye; OR Patient must be scheduled for cataract surgery in the treated eye; AND Patient must have previously been issued with an authority prescription for this drug for the same eye; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures
C10978	P10978	Diabetic macular oedema (DMO) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND Patient must have had a cataract removed in the treated eye; OR Patient must be scheduled for cataract surgery in the treated eye; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR Patient must be unsuitable for treatment with VEGF inhibitors; OR Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing. A written application must include: a) a completed authority prescription form; b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report.	Compliance with Written Authority Required procedures

(b) insert in numerical order after existing text:

C13336	P13336	Central retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13336
C13341	P13341	Diabetic macular oedema (DMO) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND Patient must have had a cataract removed in the treated eye; OR Patient must be scheduled for cataract surgery in the treated eye; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR Patient must be unsuitable for treatment with VEGF inhibitors; OR Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C13387	P13387	Branch retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13387
C13423	P13423	Central retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C13428	P13428	Diabetic macular oedema (DMO) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have had a cataract removed in the treated eye; OR Patient must be scheduled for cataract surgery in the treated eye; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13428
C13429	P13429	Branch retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures

[86] Schedule 4, Part 1, entry for Molnupiravir

(a) omit:

C13224

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.
For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions:
1. The patient is in residential aged care,
2. The patient has disability with multiple comorbidities and/or frailty,
3. Neurological conditions, including stroke and dementia and demyelinating conditions,
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,
5. Heart failure, coronary artery disease, cardiomyopathies,
6. Obesity (BMI greater than 30 kg/m²),
7. Diabetes type I or II, requiring medication for glycaemic control,
8. Renal impairment (eGFR less than 60mL/min),
9. Cirrhosis, or
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 13224

(b) insert in numerical order after existing text:

C13410

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.
For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:
1. The patient is in residential aged care
2. The patient has disability with multiple comorbidities and/or frailty
3. Neurological conditions, including stroke and dementia and demyelinating conditions
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease
5. Heart failure, coronary artery disease, cardiomyopathies
6. Obesity (BMI greater than 30 kg/m²)
7. Diabetes type I or II, requiring medication for glycaemic control
8. Renal impairment (eGFR less than 60mL/min)
9. Cirrhosis
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 13410

[87] Schedule 4, Part 1, entry for Nintedanib

substitute:

Nintedanib	C13378	Idiopathic pulmonary fibrosis Initial treatment 1 - new patient The condition must be diagnosed through a multidisciplinary team; AND Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND Patient must not have had an acute respiratory infection at the time of FVC measurement; AND Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by a medical practitioner who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement. A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis. Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records. Authority applications must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice)	Compliance with Written Authority Required procedures
	C13380	Idiopathic pulmonary fibrosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by a medical practitioner who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.	Compliance with Authority Required procedures
	C13381	Idiopathic pulmonary fibrosis Initial treatment 2 - change or recommencement of treatment Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by a medical practitioner who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.	Compliance with Authority Required procedures
	C13401	Progressive fibrosing Interstitial lung disease Initial treatment The condition must be diagnosed through a multidisciplinary team; AND The condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication; AND The condition must display, through HRCT, an affected area of no less than 10%

Federal Register of Legislation - Australian Government

Primary content

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 11)