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

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.

1. 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Note:          This table relates only to the provisions of this instrument as originally made.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.

1. 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	a	ABACAVIR/LAMIVUDINE 600/300 SUN	RA	MP NP	C4527 C4528	60	5	30	D(100)
a	Abacavir/Lamivudine Mylan	AF	MP NP	C4527 C4528	60	5	30	D(100)
a	Kivexa	VI	MP NP	C4527 C4528	60	5	30	D(100)

1. 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

1. 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	BN	MP	C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424	P13336 P13337 P13384 P13387 P13390 P13392 P13406 P13424	1	2	1
MP	C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424	P13388 P13402	1	5	1
Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)	Injection	Eylea	BN	MP	C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424	P13336 P13337 P13384 P13387 P13390 P13392 P13406 P13424	1	2	1
MP	C13336 C13337 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13424	P13388 P13402	1	5	1

1. 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:

a Alphamox 125 AF PDP 1 0 1

(b)omit:

a Alphamox 125 AF MP NP 1 1 1

1. 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:

a Alphamox 250 AF PDP 1 0 1

(b)omit:

a Alphamox 250 AF MP NP 1 1 1

1. 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

1. 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

1. 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 LR MP See Note 3 See Note 3 1 D(100)

1. 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 BX MP C11099 See Note 3 See Note 3 1 D(100)

1. Schedule 1, Part 1, entry for Brolucizumab

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

1. 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

1. Schedule 1, Part 1, after entry for Bupropion

insert:

Burosumab	Solution for injection 10 mg in 1 mL	Injection	Crysvita	KO	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	D(100)
Solution for injection 20 mg in 1 mL	Injection	Crysvita	KO	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	D(100)
Solution for injection 30 mg in 1 mL	Injection	Crysvita	KO	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	D(100)

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

omit:

a Candesartan GH GQ MP NP 30 5 30

1. 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 SW MP C13322 C13372 C13373 C13411 C13419 See Note 3 See Note 3 1 D(100)

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P9367 P9468 P9469 P9549 60 2 60

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P12522 P12524 P12530 P12561 P12565 P12570 60 5 60

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P9367 P9468 P9469 P9549 60 2 60

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P12522 P12524 P12530 P12561 P12565 P12570 60 5 60

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P9367 P9468 P9469 P9549 60 2 60

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P12522 P12524 P12530 P12561 P12565 P12570 60 5 60

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P9367 P9468 P9469 P9549 30 2 30

1. 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”:

a Dasatinib SUN RA MP C9367 C9468 C9469 C9549 C12522 C12524 C12530 C12561 C12565 C12570 P12522 P12524 P12530 P12561 P12565 P12570 30 5 30

1. 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

1. 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

1. Schedule 1, Part 1, entry for Famciclovir in the form Tablet 125 mg

omit:

a Ezovir AF MP NP C5937 40 1 40

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

omit:

a Ezovir AF MP NP C5937 C5951 C5971 P5937 20 1 20

1. 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:

a Famciclovir generichealth 250 GQ MP NP C5951 C5971 P5951 21 0 21

1. 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:

a Famciclovir generichealth 250 GQ MP NP C5951 C5971 P5971 56 5 56

1. Schedule 1, Part 1, entry for Famciclovir in the form Tablet 500 mg

omit:

a Famciclovir generichealth 500 GQ MP NP C5947 C5948 C5949 C5954 56 5 56

1. 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

1. 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

1. 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

1. 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

1. 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

1. 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

1. 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

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

omit:

a METEX XR 1000 RW MP NP 60 5 60

1. 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

1. Schedule 1, Part 1, entry for Nintedanib

substitute:

Nintedanib	Capsule 100 mg	Oral	Ofev	BY	MP	C13378 C13380 C13381 C13401 C13412 C13420	60	5	60
Capsule 150 mg	Oral	Ofev	BY	MP	C13378 C13380 C13381 C13401 C13412 C13420	60	5	60

1. 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

1. 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

1. 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

1. Schedule 1, Part 1, entry for Phenelzine

substitute:

Phenelzine	Tablet 15 mg (as sulfate)	Oral	Nardil	LM	MP	C6236	100	1	100
Tablet 15 mg (as sulfate) s19A	Oral	Nardil (Canada)	DZ	MP	C6236	120	1	60

1. Schedule 1, Part 1, entry for Pirfenidone

substitute:

Pirfenidone	Capsule 267 mg	Oral	Esbriet	RO	MP	C13378 C13380 C13381	270	5	270
Tablet 267 mg	Oral	Esbriet	RO	MP	C13378 C13380 C13381	270	5	90
Tablet 801mg	Oral	Esbriet	RO	MP	C13380	90	5	90

1. Schedule 1, Part 1, entry for Piroxicam

substitute:

Piroxicam	Capsule 10 mg	Oral	a	APO-Piroxicam	TX	PDP	C6214	50	0	50
a	Feldene	PF	PDP	C6214	50	0	50
a	APO-Piroxicam	TX	MP NP	C6214	50	3	50
a	Feldene	PF	MP NP	C6214	50	3	50
Capsule 20 mg	Oral	APO-Piroxicam	TX	PDP	C6214	25	0	25
MP NP	C6214	25	3	25
Dispersible tablet 10 mg	Oral	Mobilis D-10	AF	PDP	C6214	50	0	50
MP NP	C6214	50	3	50
Dispersible tablet 20 mg	Oral	Feldene-D	PF	PDP	C6214	25	0	25
MP NP	C6214	25	3	25

1. Schedule 1, Part 1, entry for Pomalidomide

substitute:

Pomalidomide

Capsule 3 mg

Oral

a

Pomalidomide Sandoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

14

D(100)

MP

See Note 3

See Note 3

See Note 3

See Note 3

21

D(100)

a

Pomalyst

CJ

MP

See Note 3

See Note 3

See Note 3

See Note 3

14

D(100)

MP

See Note 3

See Note 3

See Note 3

See Note 3

21

D(100)

a

Pomolide

JU

MP

See Note 3

See Note 3

See Note 3

See Note 3

14

D(100)

MP

See Note 3

See Note 3

See Note 3

See Note 3

21

D(100)

Capsule 4 mg

Oral

a

Pomalidomide Sandoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

14

D(100)

MP

See Note 3

See Note 3

See Note 3

See Note 3

21

D(100)

a

Pomalyst

CJ

MP

See Note 3

See Note 3

See Note 3

See Note 3

14

D(100)

MP

See Note 3

See Note 3

See Note 3

See Note 3

21

D(100)

a

Pomolide

JU

MP

See Note 3

See Note 3

See Note 3

See Note 3

14

D(100)

MP

See Note 3

See Note 3

See Note 3

See Note 3

21

D(100)

1. 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:

a Pramipexole XR GP AF MP NP C5131 30 5 30

1. 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:

a Pramipexole XR GP AF MP NP C5131 30 5 30

1. 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) DZ MP 100 5 30

1. 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

1. 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

1. 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

1. 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

1. 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

1. 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

1. 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”:

a Noumed Rabeprazole VO MP C8774 C8775 C8776 C8780 C11310 P11310 60 5 30

1. 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	NV	MP	C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427	P13336 P13337 P13340 P13384 P13387 P13390 P13392 P13406 P13422 P13427	1	2	1
MP	C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427	P13388 P13402	1	5	1
Solution for intravitreal injection 2.3 mg in 0.23 mL	Injection	Lucentis	NV	MP	C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427	P13336 P13337 P13340 P13384 P13387 P13390 P13392 P13406 P13422 P13427	1	2	1
MP	C13336 C13337 C13340 C13384 C13387 C13388 C13390 C13392 C13402 C13406 C13422 C13427	P13388 P13402	1	5	1

1. Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg

(a)omit:

a Rulide SW MP NP PDP 5 0 5

(b)omit:

a Rulide SW MP NP P10404 10
CN10404 0
CN10404 5

1. 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 AF MP NP C6815 C6825 2 5 1

1. 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 AF MP NP C6815 C6825 2 5 1

1. 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

1. 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

1. 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	PF	MP	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	See Note 3	7	D(100)
Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	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	See Note 3	7	D(100)
Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)	Injection	Humatrope	LY	MP	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	See Note 3	1	D(100)
Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)	Injection	Humatrope	LY	MP	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	See Note 3	1	D(100)
Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)	Injection	Humatrope	LY	MP	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	See Note 3	1	D(100)
Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)	Injection	Genotropin GoQuick	PF	MP	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	See Note 3	1	D(100)
Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)	Injection	Genotropin GoQuick	PF	MP	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	See Note 3	1	D(100)
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Omnitrope Surepal 5	SZ	MP	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	See Note 3	1	D(100)
Scitropin A	SA	MP	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	See Note 3	1	D(100)
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen	Injection	Norditropin FlexPro	NO	MP	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	See Note 3	1	D(100)
Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)	Injection	Saizen	SG	MP	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	See Note 3	1	D(100)
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Omnitrope Surepal 10	SZ	MP	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	See Note 3	1	D(100)
SciTropin A	SA	MP	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	See Note 3	1	D(100)
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen	Injection	Norditropin FlexPro	NO	MP	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	See Note 3	1	D(100)
Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)	Injection	NutropinAq	IS	MP	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	See Note 3	1	D(100)
Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Saizen	SG	MP	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	See Note 3	1	D(100)
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Omnitrope Surepal 15	SZ	MP	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	See Note 3	1	D(100)
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen	Injection	Norditropin FlexPro	NO	MP	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	See Note 3	1	D(100)
Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)	Injection	Saizen	SG	MP	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	See Note 3	1	D(100)

1. Schedule 1, Part 1, entry for Tacrolimus in the form Capsule 5 mg

(a)omit:

a Pacrolim AF MP 50 3 50

(b)omit:

a Pacrolim AF MP P5569 P9697 100
CN5569 CN9697 5
CN5569 CN9697 50 C(100)

1. Schedule 1, Part 1, after entry for Tenofovir with emtricitabine and efavirenz

insert:

Tepotinib Tablet 225 mg Oral Tepmetko SG MP C13434 C13435 C13441 60 5 60

1. 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

1. Schedule 1, Part 1, entry for Triglycerides, medium chain

omit:

Oral liquid 225 mL, 15 (betaquik) Oral Betaquik VF MP NP C6147 C6191 2 5 1

1. Schedule 1, Part 1, entry for Triglycerides - medium chain, formula

omit:

Oral liquid 500 mL, 8 (Nutrini Peptisorb) Oral Nutrini Peptisorb SB MP NP C4660 8 5 1

1. 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

1. 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

1. 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

1. 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

1. 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

1. Schedule 1, Part 1, entry for Vancomycin

substitute:

Vancomycin	Capsule 125 mg (125,000 I.U.) (as hydrochloride)	Oral	Vancocin	AS	MP	C5636 C5660	40	0	20
Capsule 250 mg (250,000 I.U.) (as hydrochloride)	Oral	Vancocin	AS	MP	C5636 C5660	40	0	20
Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	a	Vancomycin Alphapharm	AF	MP	C5716 C5717 C5769	P5717	2	0	1
PDP	C5801	2	0	1
a	Vancomycin Viatris	AL	MP	C5716 C5717 C5769	P5717	2	0	1
PDP	C5801	2	0	1
a	Vancomycin Alphapharm	AF	MP	C5716 C5717 C5769	P5716 P5769	5	0	1
a	Vancomycin Viatris	AL	MP	C5716 C5717 C5769	P5716 P5769	5	0	1
Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	a	Vancomycin Alphapharm	AF	MP	C5716 C5717 C5769	P5717	1	0	1
PDP	C5801	1	0	1
a	Vancomycin Viatris	AL	MP	C5716 C5717 C5769	P5717	1	0	1
PDP	C5801	1	0	1
a	Vancomycin Alphapharm	AF	MP	C5716 C5717 C5769	P5716 P5769	3	0	1
a	Vancomycin Viatris	AL	MP	C5716 C5717 C5769	P5716 P5769	3	0	1

1. Schedule 1, Part 2, omit entry for Clopidogrel

1. Schedule 1, Part 2, after entry for Pancreatic extract

insert:

Phenelzine Tablet 15 mg (as sulfate) (USP) Oral Phenelzine sulfate USP (Generic Health) GQ MP C6236 100 1 60

1. Schedule 1, Part 2, after entry for Tipranavir

insert:

Triglycerides, medium chain Oral liquid 225 mL, 15 (betaquik) Oral Betaquik VF MP NP C6147 C6191 2 5 1

1. Schedule 3, after details relevant for Responsible Person code JZ

insert:

KO KYOWA KIRIN AUSTRALIA PTY LTD 47 631 934 453

1. 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

1. 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

1. 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

1. 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

1. 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

1. Schedule 4, Part 1, omit entry for Clopidogrel

1. 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

1. Schedule 4, Part 1, entry for Molnupiravir

C13368	Short stature associated with biochemical growth hormone deficiency Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months; AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C13393	Short stature associated with biochemical growth hormone deficiency Continuing treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 4. A bone age result performed within the last 12 months; AND 5. The final adult height (in cm) of the patient's mother and father (where available); AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C13417	Short stature associated with biochemical growth hormone deficiency Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 6. A bone age result performed within the last 12 months; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C13418	Short stature associated with biochemical growth hormone deficiency Recommencement of treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND Patient must have had a lapse in treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. Recent growth data (height and weight, not older than three months); AND 6. A bone age result performed within the last 12 months; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, after entry for Tenofovir with emtricitabine and efavirenz

insert:

Tepotinib	C13434	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of MET exon 14 skipping alterations in tumour material.	Compliance with Authority Required procedures - Streamlined Authority Code 13434
C13435	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2022; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have evidence of MET exon 14 skipping alterations in tumour material.	Compliance with Authority Required procedures - Streamlined Authority Code 13435
C13441	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13441

1. Schedule 4, Part 1, entry for Triptorelin

omit:

C12397 Central precocious puberty
Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
Must be treated by a paediatric endocrinologist; OR
Must be treated by an endocrinologist specialising in paediatrics; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.
Patient must be each of: (i) currently receiving this drug for the PBS-indication, (ii) commenced on non-PBS-subsidised supply prior to 1 November 2021.
Patient must have met each of: (i) experienced signs/symptoms of central precocious puberty prior to their 9^thbirthday, (ii) initiated treatment with this drug prior to their 12^thbirthday, if female; OR
Patient must have met each of: (i) experienced signs/symptoms of central precocious puberty prior to their 10^thbirthday, (ii) initiated treatment with this drug prior to their 13^thbirthday, if male.

1. Schedule 4, Part 1, entry for Ustekinumab

omit:

C12293 P12293 Severe chronic plaque psoriasis
Transitioning from non-PBS to PBS-subsidised supply (Face, hand, foot) - 'Grandfather' arrangements
Must be treated by a dermatologist.
Patient must be receiving treatment with this biological medicine at the time of this application, with initiation of this biological medicine having commenced prior to 1 October 2021; AND
The treatment must be in a patient who prior to initiating treatment with non-PBS-subsidised treatment with this biological medicine, was each of: (i) treatment-naive to this biological medicine, (ii) had psoriatic lesions present on the face/hand/foot for at least 6 months from the time of initial diagnosis; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have, prior to having initiated non-PBS-subsidised treatment with this biological medicine, failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks.
Patient must be under 18 years of age.
Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.
Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; 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 indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:
(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or
(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy
State in this authority application, each of:
(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;
(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;
(iv) the dates that response assessments were determined
State in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:
(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);
(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. Compliance with Written Authority Required procedures

1. Schedule 5, omit entry for Abacavir with lamivudine

1. Schedule 5, after entry for Phenelzine in the form Tablet 15 mg (as sulfate) (USP)

insert:

Pyridostigmine	GRP-26713	Tablet containing pyridostigmine bromide 180 mg (modified release)	Oral	Mestinon Timespan
Tablet containing pyridostigmine bromide 180 mg (modified release) s19A	Oral	Pyridostigmine Bromide Extended-Release Tablets (Rising)

1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21361]

omit from the column headed “Brand”: Asmol 5 uni-dose

1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21535]

omit from the column headed “Brand”: Asmol 2.5 uni-dose