National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 3) (Cth)

PB 21 of 2023

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023
(No. 3)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary, 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               30 March              2023

NIKOLAI TSYGANOV

Assistant Secretary

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 2023 (No. 3).

(2)This Instrument may also be cited as PB 21 of 2023.

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 April 2023	1 April 2023

Note:          This table relates only to the provisions of this instrument as originally made.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 in the form Oral solution 20 mg (as sulfate) per mL, 240 mL

omit from the column headed “Circumstances”: C4454 C4512            substitute: C13920

1. Schedule 1, Part 1, omit entry for Ampicillin

1. Schedule 1, Part 1, entry for Anastrozole 

omit:

a Anastrol TB MP NP C5464 30 5 30

1. Schedule 1, Part 1, omit entry for Apraclonidine

1. Schedule 1, Part 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride); Capsule 25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)

omit:

a Strattera LY MP C7876 C7890 56 5 28

1. Schedule 1, Part 1, entry for Atomoxetine in each of the forms: Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)

omit:

a Strattera LY MP C7876 C7890 28 5 28

1. Schedule 1, Part 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses [Maximum Quantity: 1; Number of Repeats:5]

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

a Rilast TURBUHALER 200/6 ZA MP NP C7970 1 5 1

1. Schedule 1, Part 1, entry for Calcitonin salmon

omit from the column headed “Circumstances”: C6865 C6872            substitute: C13886 C13913

1. Schedule 1, Part 1, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)

omit:

EPOPROSTENOL SUN RA MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

1. Schedule 1, Part 1, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium) 

omit:

EPOPROSTENOL SUN RA MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

1. Schedule 1, Part 1, entry for Estradiol in the form Pessary (modified release) 10 micrograms (as hemihydrate)

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

a Estro-Pess AS MP NP 18 2 18

(b)insert in the column headed “Schedule Equivalent” for the brand “Vagifem Low”: a 

1. Schedule 1, Part 1, entry for Etanercept

omit:

Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P8638 P8760 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707	1	3	1
MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	1	5	1

1. Schedule 1, Part 1, entry for Ethosuximide

substitute:

Ethosuximide	Capsule 250 mg	Oral	Zarontin	IX	MP NP	200	2	100
Oral solution 250 mg per 5 mL, 200 mL	Oral	Zarontin	IX	MP NP	1	5	1

1. Schedule 1, Part 1, entry for Fingolimod in the form Capsule 500 micrograms (as hydrochloride)

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

a AKM Fingolimod RW MP C10162 C10172 28 5 28

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

a Fingolimod SUN RA MP C10162 C10172 28 5 28

1. Schedule 1, Part 1, entry for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

insert in numerical order in the column headed “Circumstances” (all instances): C13917

1. Schedule 1, Part 1, entry for Follitropin beta

substitute:

Follitropin beta	Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge	Injection	a	Puregon 300 IU/0.36 mL	OQ	MP	C5027	2	0	1	C(100)
a	Recagon	OV	MP	C5027	2	0	1	C(100)
a	Puregon 300 IU/0.36 mL	OQ	MP	C6257 C6321	3	5	1
a	Recagon	OV	MP	C6257 C6321	3	5	1
Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge	Injection	a	Puregon 600 IU/0.72 mL	OQ	MP	C6257 C6321	2	5	1
a	Recagon	OV	MP	C6257 C6321	2	5	1
a	Puregon 600 IU/0.72 mL	OQ	MP	C5027	4	0	1	C(100)
a	Recagon	OV	MP	C5027	4	0	1	C(100)
Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge	Injection	a	Puregon 900 IU/1.08 mL	OQ	MP	C6257 C6321	2	5	1
a	Recagon	OV	MP	C6257 C6321	2	5	1
a	Puregon 900 IU/1.08 mL	OQ	MP	C5027	5	0	1	C(100)
a	Recagon	OV	MP	C5027	5	0	1	C(100)

1. Schedule 1, Part 1, entry for Ganirelix

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

a Ganirelix Theramex TT MP C5046 10 0 5 D(100)

1. Schedule 1, Part 1, entry for Hydromorphone 

omit:

Tablet (modified release) containing hydromorphone hydrochloride 4 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 8 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 16 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 32 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 64 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14

1. Schedule 1, Part 1, entry for Icatibant 

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

a Icatibant Lupin GQ MP C7273 C7274 1 1 1

1. Schedule 1, Part 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

omit:

a Natrilix SE MP NP 90 1 90

1. Schedule 1, Part 1, entry for Insulin aspart

(a)omit:

Injection (human analogue) (fast acting) 100 units per mL, 10 mL vial Injection Fiasp NO MP NP 5 2 1

(b)omit:

Injections (human analogue) (fast acting), pre-filled pen, 100 units per mL, 3 mL, 5 Injection Fiasp FlexTouch NO MP NP 5 1 1

1. Schedule 1, Part 1, omit entry for Interferon beta-1a

1. Schedule 1, Part 1, entry for Itraconazole in the form Capsule 100 mg

omit:

a Sporanox JC MP NP C5988 C6005 C6016 C6022 C6035 C6037 C6057 60 5 60

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 “Lacosam”: 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 “Lacosam”: C12092

(b)insert in numerical order in the column headed “Purposes” for the brand “Lacosam”: 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 “Lacosam”: 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 “Lacosam”: 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 “Lacosam”: C12092

1. Schedule 1, Part 1, entry for Mesalazine in the form Tablet 1.2 g (prolonged release)

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

a MESALZ RA MP NP C9444 120 5 120

1. Schedule 1, Part 1, entry for Methyldopa

insert in numerical order in the column headed “Circumstances”: C13887

1. Schedule 1, Part 1, entry for Methylphenidate in each of the forms: Capsule containing methylphenidate hydrochloride 10 mg (modified release); Capsule containing methylphenidate hydrochloride 20 mg (modified release); Capsule containing methylphenidate hydrochloride 30 mg (modified release); Capsule containing methylphenidate hydrochloride 40 mg (modified release); and Capsule containing methylphenidate hydrochloride 60 mg (modified release) 

(a)insert in the column headed “Schedule Equivalent” for the brand “Ritalin LA”: a 

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

a Rubifen LA AE MP NP C10719 30 5 30

1. Schedule 1, Part 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

substitute:

Injection containing morphine sulfate pentahydrate 10 mg in 1 mL	Injection	MORPHINE SULFATE 10 mg/1 mL MEDSURGE	DZ	MP NP	C10762 C10764 C10765 C11697	P10762 P10764 P10765	5	0	5
MW	C10762 C10764 C10765	5	0	5
PDP	C10839	5	0	5
MP NP	C10762 C10764 C10765 C11697	P11697	10	1	5

1. Schedule 1, Part 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 15 mg in 1 mL

substitute:

Injection containing morphine sulfate pentahydrate 15 mg in 1 mL	Injection	MORPHINE SULFATE 15 mg/1 mL MEDSURGE	DZ	MP NP	C10762 C10764 C10765 C11697	P10762 P10764 P10765	5	0	5
MW	C10762 C10764 C10765	5	0	5
PDP	C10839	5	0	5
MP NP	C10762 C10764 C10765 C11697	P11697	10	1	5

1. Schedule 1, Part 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 30 mg in 1 mL

substitute:

Injection containing morphine sulfate pentahydrate 30 mg in 1 mL	Injection	MORPHINE SULFATE 30 mg/1 mL MEDSURGE	DZ	MP NP	C10762 C10764 C10765 C11697	P10762 P10764 P10765	5	0	5
PDP	C10839	5	0	5
MP NP	C10762 C10764 C10765 C11697	P11697	10	1	5

1. Schedule 1, Part 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride)

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

a Nebivolol Lupin GQ MP NP C5324 56 5 28

1. Schedule 1, Part 1, entry for Nebivolol in each of the forms: Tablet 5 mg (as hydrochloride); and Tablet 10 mg (as hydrochloride)               

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

a Nebivolol Lupin GQ MP NP C5324 28 5 28

1. Schedule 1, Part 1, entry for Nicotine 

omit:

Gum 2 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	432	1	216
Gum 4 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	216	2	216
Lozenge 2 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	216	2	216
Lozenge 4 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	216	2	216

1. Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir 

insert in numerical order in the column headed “Circumstances”: C13893

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”: C13280       

(b)insert in numerical order in the column headed “Circumstances”: C13888 C13900

1. Schedule 1, Part 1, entry for Oxybutynin 

omit:

Tablet containing oxybutynin chloride 5 mg (s19A)	Oral	Oxybutynin Chloride (Novitium)	QY	MP NP	C6241	100	5	100
Tablet containing oxybutynin hydrochloride 5 mg (s19A)	Oral	Oxybutynin hydrochloride tablets (Niche Generics Limited)	OJ	MP NP	C6241	100	5	84

1. Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg

substitute:

Tablet containing oxycodone hydrochloride 5 mg	Oral	a	ENDONE	AF	MP NP	C10764 C10766 C10771 C10772	P10766	10	0	10
PDP	C10766 C10768	P10766	10	0	10
a	Oxycodone Viatris	MQ	MP NP	C10764 C10766 C10771 C10772	P10766	10	0	10
PDP	C10766 C10768	P10766	10	0	10
a	ENDONE	AF	MP NP	C10764 C10766 C10771 C10772	P10764 P10771 P10772	20	0	20
PDP	C10766 C10768	P10768	20	0	20
a	Mayne Pharma Oxycodone IR	YN	MP NP	C10764 C10771 C10772	20	0	20
PDP	C10768	20	0	20
a	Oxycodone Mylan	AL	MP NP	C10764 C10771 C10772	20	0	20
PDP	C10768	20	0	20
a	Oxycodone Viatris	MQ	MP NP	C10764 C10766 C10771 C10772	P10764 P10771 P10772	20	0	20
PDP	C10766 C10768	P10768	20	0	20
a	Oxyndone	TX	MP NP	C10764 C10771 C10772	20	0	20
PDP	C10768	20	0	20

1. Schedule 1, Part 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg

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

a Pregabalin Lupin HQ MP NP C4172 56 5 56

1. Schedule 1, Part 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

omit:

a Quetiapine-DRLA RZ MP NP C7893 C7916 C7927 60 0 60

1. Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

omit:

a Quetiapine-DRLA RZ MP NP C4246 C5611 C5639 90 5 90

1. Schedule 1, Part 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

omit:

a Quetiapine-DRLA RZ MP NP C4246 C5611 C5639 60 5 60

1. Schedule 1, Part 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

omit:

a Quetiapine-DRLA RZ MP NP C4246 C5611 C5639 60 5 60

1. Schedule 1, Part 1, entry for Rasagiline 

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

a Rasagiline Lupin HQ MP NP C5339 30 5 30

1. Schedule 1, Part 1, entry for Ruxolitinib

substitute:

Ruxolitinib	Tablet 5 mg	Oral	Jakavi	NV	MP	C13876 C13877 C13891 C13892 C13907 C13911	P13907 P13911	56	0	56	C(100)
MP	C13127 C13128 C13130 C13173 C13866 C13867 C13906	P13866 P13867 P13906	56	5	56
MP	C13876 C13877 C13891 C13892 C13907 C13911	P13876 P13877 P13891 P13892	56	5	56	C(100)
MP	C13127 C13128 C13130 C13173 C13866 C13867 C13906	P13127 P13173	112	0	56
MP	C13127 C13128 C13130 C13173 C13866 C13867 C13906	P13128 P13130	112	5	56
Tablet 10 mg	Oral	Jakavi	NV	MP	C13127 C13128 C13130 C13173 C13866 C13867 C13906	P13127 P13173	56	0	56
MP	C13876 C13877 C13891 C13892 C13907 C13911	P13907 P13911	56	0	56	C(100)
MP	C13127 C13128 C13130 C13173 C13866 C13867 C13906	P13128 P13130 P13866 P13867 P13906	56	5	56
MP	C13876 C13877 C13891 C13892 C13907 C13911	P13876 P13877 P13891 P13892	56	5	56	C(100)
Tablet 15 mg	Oral	Jakavi	NV	MP	C13127 C13128 C13130 C13173	P13127 P13173	56	0	56
MP	C13127 C13128 C13130 C13173	P13128 P13130	56	5	56
Tablet 20 mg	Oral	Jakavi	NV	MP	C13127 C13128 C13130 C13173	P13127 P13173	56	0	56
MP	C13127 C13128 C13130 C13173	P13128 P13130	56	5	56

1. Schedule 1, Part 1, entry for Sapropterin

substitute:

Sapropterin	Powder for oral solution 500 mg (as dihydrochloride)	Oral	Kuvan	IO	MP	C10355 C10391 C13868 C13880 C13885 C13912	P10391 P13868 P13885	30	0	30
MP	C10355 C10391 C13868 C13880 C13885 C13912	P10355 P13880 P13912	30	5	30
NP	C10355 C13880 C13912	30	5	30
Tablet (soluble) containing sapropterin dihydrochloride 100 mg	Oral	Kuvan	IO	MP	C10076 C10390 C11836 C11960 C13868 C13880 C13885 C13912	P13868 P13885	30	0	30
MP	C10076 C10390 C11836 C11960 C13868 C13880 C13885 C13912	P11836 P11960	30	5	30
NP	C10390 C11836 C11960 C13880 C13912	P11836 P11960	30	5	30
MP	C10076 C10390 C11836 C11960 C13868 C13880 C13885 C13912	P10076	180	0	30
MP	C10076 C10390 C11836 C11960 C13868 C13880 C13885 C13912	P10390 P13880 P13912	180	5	30
NP	C10390 C11836 C11960 C13880 C13912	P10390 P13880 P13912	180	5	30

1. Schedule 1, Part 1, entry for Testosterone

omit:

Transdermal patches 24.3 mg, 30 Transdermal Androderm TB MP C6324 C6910 C6919 C6933 C6934 1 5 1

1. Schedule 1, Part 1, entry for Tocilizumab 

(a)omit:

Concentrate for injection 80 mg in 4 mL s19A	Injection	RoActemra	DZ	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	4	PB(100)

(b)omit:

Concentrate for injection 200 mg in 10 mL s19A	Injection	RoActemra	DZ	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	4	PB(100)

(c)omit:

Concentrate for injection 400 mg in 20 mL s19A	Injection	RoActemra	DZ	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	4	PB(100)

1. Schedule 1, Part 1, entry for Trimethoprim with sulfamethoxazole

substitute:

Trimethoprim with sulfamethoxazole	Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL	Oral	Septrin	RW	PDP	1	0	1
MP NP	1	1	1
Tablet 160 mg-800 mg	Oral	a	Bactrim DS	XO	PDP	10	0	10
a	Resprim Forte	AF	PDP	10	0	10
a	Septrin Forte	RW	PDP	10	0	10
a	Bactrim DS	XO	MP NP	10	1	10
a	Resprim Forte	AF	MP NP	10	1	10
a	Septrin Forte	RW	MP NP	10	1	10
a	Bactrim DS	XO	MP	P6201	30 CN6201	2 CN6201	10
a	Resprim Forte	AF	MP	P6201	30 CN6201	2 CN6201	10
a	Septrin Forte	RW	MP	P6201	30 CN6201	2 CN6201	10

1. Schedule 1, Part 1, entry for Varenicline

substitute:

Varenicline	Tablet 1 mg (as tartrate)	Oral	Champix	PF	MP NP	C6885 C7483	P6885	56	2	56
VARENAPIX	TX	MP NP	C6885 C7483	P6885	56	2	56
Champix	PF	MP NP	C6885 C7483	P7483	112	0	56
VARENAPIX	TX	MP NP	C6885 C7483	P7483	112	0	56
Tablet 1 mg (as tartrate) (s19A)	Oral	APO-Varenicline (Canada)	XT	MP NP	C6885 C7483	P6885	56	2	56
MP NP	C6885 C7483	P7483	112	0	56
Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack	Oral	Champix	PF	MP NP	C6871	1	0	1

1. Schedule 1, Part 2, entry for Ampicillin

insert as first entry:

Powder for injection 500 mg (as sodium)	Injection	Austrapen	AL	PDP	5	0	5
MP NP	5	1	5

1. Schedule 1, Part 2, omit entry for Cromoglycic acid

1. Schedule 1, Part 2, entry for Etanercept

omit:

Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C12354 C12359 C12366 C12389	1	5	1

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

1. Schedule 1, Part 2, after entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe

insert:

Hydromorphone	Tablet (modified release) containing hydromorphone hydrochloride 4 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 8 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 16 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 32 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14
Tablet (modified release) containing hydromorphone hydrochloride 64 mg	Oral	Jurnista	JC	MP NP	C10752 C10753 C10754 C11696	P10752 P10753 P10754	14	0	14
MP NP	C10752 C10753 C10754 C11696	P11696	28	0	14

1. Schedule 1, Part 2, after entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe

insert:

Insulin aspart	Injection (human analogue) (fast acting) 100 units per mL, 10 mL vial	Injection	Fiasp	NO	MP NP	5	2	1
Injections (human analogue) (fast acting), pre-filled pen, 100 units per mL, 3 mL, 5	Injection	Fiasp FlexTouch	NO	MP NP	5	1	1

1. Schedule 1, Part 2, omit entry for Interferon beta-1a

1. Schedule 1, Part 2, after entry for Losartan in the form Tablet containing losartan potassium 50 mg

insert:

Nicotine	Gum 2 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	432	1	216
Gum 4 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	216	2	216
Lozenge 2 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	216	2	216
Lozenge 4 mg	Buccal	Nicotinell	ON	MP NP	C5140 C6848	216	2	216

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

1. Schedule 3, details relevant to Responsible Person code GJ

omit from the column headed “Responsible Person”: GlaxoSmithKline Consumer Healthcare Australia Pty Ltd          substitute: HALEON AUSTRALIA PTY LTD

1. Schedule 3, after details relevant to Responsible Person code YT

insert:

ZA AstraZeneca Pty Ltd 54 009 682 311

1. Schedule 4, Part 1, entry for Abacavir

insert in numerical order after existing text:

C13920 Human immunodeficiency virus (HIV) infection
Patient must be less than 13.00 years of age.
Patient must be unable to take a solid dose form of this drug; AND
The treatment must be in combination with other antiretroviral agents. Compliance with Authority Required procedures

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

1. Schedule 4, Part 1, entry for Calcitonin salmon

substitute:

Calcitonin salmon	C13886	Hypercalcaemia The treatment must be initiated in a hospital; AND The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease.	Compliance with Authority Required procedures
C13913	Symptomatic Paget disease of bone The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, after entry for Fluticasone furoate with vilanterol

insert:

Fluticasone propionate C13917 Asthma
Patient must be less than 6.00 years of age.
Must be treated by a respiratory physician; OR
Must be treated by a paediatrician; OR
Must be treated by a health practitioner who is continuing treatment that was initiated by one of the specialists above. Compliance with Authority Required procedures

1. Schedule 4, Part 1, omit entry for Interferon beta-1a

1. Schedule 4, Part 1, after entry for Methoxy polyethylene glycol-epoetin beta

insert:

Methyldopa C13887 Hypertension
Patient must be pregnant. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Nirmatrelvir and ritonavir

insert in numerical order after existing text:

C13893 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be at least 60 years old, but not older than 70 years; AND
Patient must be at high risk of requiring hospitalisation for COVID-19 infection.
For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:
1. The patient is in residential aged care
2. The patient has disability with multiple comorbidities and/or frailty
3. Neurological conditions, including stroke and dementia and demyelinating conditions
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease
5. Heart failure, coronary artery disease, cardiomyopathies
6. Obesity (BMI greater than 30 kg/m²)
7. Diabetes type I or II, requiring medication for glycaemic control
8. Renal impairment (eGFR less than 60mL/min)
9. Cirrhosis
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above
11. Past COVID-19 infection episode resulting in hospitalisation.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. Compliance with Authority Required procedures - Streamlined Authority Code 13893

1. Schedule 4, Part 1, entry for Nivolumab

(a)omit:

C13280 Advanced or metastatic gastro-oesophageal cancers
The condition must be a gastro-oesophageal cancer type as specified in the drug's 'Indications' section of the approved Australian Product Information; AND
The treatment must be prescribed in accordance with the drug's 'Indications' section of the approved Australian Production Information with respect to each of: (i) concomitant drugs/therapies, (ii) line of therapy (i.e. prior treatments, if any); AND
Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.
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 - Streamlined Authority Code 13280

(b)insert in numerical order after existing text:

C13888	Advanced or metastatic gastro-oesophageal cancers The condition must be a gastro-oesophageal cancer type as specified in the drug's 'Indications' section of the approved Australian Product Information; AND The treatment must be prescribed in accordance with the drug's 'Indications' section of the approved Australian Production Information with respect to each of: (i) concomitant drugs/therapies, (ii) line of therapy (i.e. prior treatments, if any); AND Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND Patient must be untreated with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer. 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 - Streamlined Authority Code 13888
C13900	Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer The condition must have histological evidence confirming a diagnosis of a least one of: (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records; AND The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy; AND The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either: (i) at least ypT1, (ii) at least ypN1; document this evidence in the patient's medical records; AND Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must be undergoing treatment with a dosing regimen as set out in the drug's approved Australian Product Information; AND Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first: (i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Ruxolitinib

insert in numerical order after existing text:

C13866	P13866	Moderate to severe chronic graft versus host disease (cGVHD) Grandfather treatment (transition from non-PBS-subsidised treatment) Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2023; AND Patient must have received systemic steroid treatment prior to initiation of this drug for this condition; AND Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND Patient must have responding disease at 24 weeks compared with baseline, demonstrated by either a: (i) partial response, (ii) complete response. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation. Steroid-refractory disease is defined as: (a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 week (or equivalent); or (b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent). Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent). Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13866
C13867	P13867	Moderate to severe chronic graft versus host disease (cGVHD) Continuing treatment Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease at 24 weeks compared with baseline, demonstrated by either a: (i) partial response, (ii) complete response; AND The treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13867
C13876	P13876	Grade II to IV acute graft versus host disease (aGVHD) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13876
C13877	P13877	Grade II to IV acute graft versus host disease (aGVHD) Grandfather treatment (transition from non-PBS-subsidised treatment) Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2023; AND Patient must have received systemic steroid treatment prior to initiation of this drug for this condition; AND Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Steroid-refractory disease is defined as: (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria: (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13877
C13891	P13891	Grade II to IV acute graft versus host disease (aGVHD) Grandfather treatment (transition from non-PBS-subsidised treatment) Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2023; AND Patient must have received systemic steroid treatment prior to initiation of this drug for this condition; AND Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Steroid-refractory disease is defined as: (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria: (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13891
C13892	P13892	Grade II to IV acute graft versus host disease (aGVHD) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13892
C13906	P13906	Moderate to severe chronic graft versus host disease (cGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND The treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation. The severity of cGVHD is defined by the National Institutes of Health (NIH) criteria (Jagasia et al., 2015): (a) Moderate cGVHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1 (b) Severe cGVHD: at least 1 organ with a score of 3, or lung score of 2 or 3 Steroid-refractory disease is defined as: (a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 week (or equivalent); or (b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent). Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent). Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 24 weeks after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13906
C13907	P13907	Grade II to IV acute graft versus host disease (aGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Steroid-refractory disease is defined as: (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria: (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13907
C13911	P13911	Grade II to IV acute graft versus host disease (aGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Steroid-refractory disease is defined as: (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria: (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 13911

1. Schedule 4, Part 1, entry for Sapropterin

(a)omit:

C8898	P8898	Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Initial treatment - responsiveness testing Must be treated by a metabolic physician. Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; OR Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age; OR The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month. Patient must be under 18 years of age. Dietary phenylalanine intake must be maintained at a constant level. Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing.	Compliance with Authority Required procedures
C8926	P8926	Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) First continuing treatment Must be treated by a metabolic physician; OR Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician. Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing. Patient must have been under 18 years of age at the time treatment with this drug was initiated for this condition. Blood phenylalanine levels must be based on measurements taken during stable periods of the condition. Dietary phenylalanine intake must be maintained at a constant level.	Compliance with Authority Required procedures

(b)omit:

C10364 P10364 Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Subsequent continuing
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications.
Patient must have been under 18 years of age at the time treatment with this drug was initiated for this condition. Compliance with Authority Required procedures

(c)omit:

C11989 P11989 Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Initial treatment - responsiveness testing
The treatment must be for the purpose of ascertaining the patient's response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase: 'Pre-conception through to when pregnancy first becomes known'; OR
The treatment must be for the purpose of ascertaining the patient's response to treatment over a period of 7 days in an existing, unplanned pregnancy; AND
Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels.
Must be treated by a metabolic physician; AND
Patient must be undergoing treatment with this drug for the first time; AND
Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND
Patient must not be undergoing simultaneous treatment with this drug under another PBS-listing (apply under either listing type, but not both simultaneously). Compliance with Authority Required procedures

(d)insert in numerical order after existing text:

C13868	P13868	Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Initial treatment - responsiveness testing The treatment must be for the purpose of ascertaining the patient's response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase: First continuing treatment, Indication: Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU); AND Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels. Must be treated by a metabolic physician; AND Patient must be undergoing treatment with this drug for the first time; AND Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND Patient must not be undergoing simultaneous treatment with this drug under another PBS-listing (apply under either listing type, but not both simultaneously). Patient must be one of: (i) planning conception, (ii) pregnant.	Compliance with Authority Required procedures
C13880	P13880	Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) First continuing treatment Must be treated by a metabolic physician; OR Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician. Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing. Blood phenylalanine levels must be based on measurements taken during stable periods of the condition. Dietary phenylalanine intake must be maintained at a constant level.	Compliance with Authority Required procedures
C13885	P13885	Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Initial treatment - responsiveness testing Must be treated by a metabolic physician. Patient must be untreated with this drug; OR Patient must have completed prior responsiveness testing on only 1 occasion - this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; OR Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age; OR The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month. Dietary phenylalanine intake must be maintained at a constant level. Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing.	Compliance with Authority Required procedures
C13912	P13912	Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Subsequent continuing Must be treated by a metabolic physician; OR Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications.	Compliance with Authority Required procedures

1. Schedule 5, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium) [GRP-16914]

omit from the column headed “Brand”: EPOPROSTENOL SUN

1. Schedule 5, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium) [GRP-16976]     

omit from the column headed “Brand”: EPOPROSTENOL SUN

1. Schedule 5, entry for Etanercept [GRP-26053]          

omit:

Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4 Injection Enbrel

1. Schedule 5, entry for Etanercept [GRP-26058]           

omit:

Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4 Injection Enbrel

1. Schedule 5, omit entry for Ethosuximide

1. Schedule 5, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

omit from the column headed “Brand”: DBL Morphine Sulphate Pentahydrate

1. Schedule 5, omit entry for Oxybutynin

1. Schedule 5, omit entry for Tocilizumab

1. Schedule 5, entry for Varenicline in the form Tablet 1 mg (as tartrate)                                         

insert in alphabetical order in the column headed “Brand”: VARENAPIX