Commencement information
1. The whole of this instrument	1 March 2023	1 March 2023

Schedule 1—Amendments

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

[1] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen

substitute:

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

See Note 3

C(100)

Yuflyma

See Note 3

C(100)

Humira

C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P11713

Yuflyma

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P11713

Humira

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

Yuflyma

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

Humira

P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694

Yuflyma

P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694

Humira

P11107 P12155 P12212 P13556 P13607 P13612 P13683

Yuflyma

P11107 P12155 P12212 P13556 P13607 P13612 P13683

Humira

P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

Yuflyma

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

C11526 C12116

C(100)

Humira

P12273

Yuflyma

P12273

Humira

P12272 P12315

Yuflyma

P11529 P12272 P12315

Humira

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609

Yuflyma

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609

[2] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe

substitute:

Injection 40 mg in 0.4 mL pre-filled syringe

Injection

Humira

See Note 3

C(100)

Yuflyma

See Note 3

C(100)

Humira

C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P11713

Yuflyma

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P11713

Humira

C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

Yuflyma

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

Humira

C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694

Yuflyma

P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694

Humira

C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P11107 P12155 P12212 P13556 P13607 P13612 P13683

Yuflyma

P11107 P12155 P12212 P13556 P13607 P13612 P13683

Humira

C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

Yuflyma

C11526 C12116

C(100)

Humira

C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

Yuflyma

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

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

omit:

Tablet containing chlorpromazine hydrochloride 10 mg

Oral

Largactil

MP NP

100

[4] Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 30 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]

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

Cinacalcet Viatris

MP NP

C10068

[5] Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 30 mg (as hydrochloride) [Maximum Quantity: 56; Number of Repeats: 5]

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

Cinacalcet Viatris

C10063 C10067 C10073

C(100)

[6] Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

omit:

Blooms the Chemist Clopidogrel

MP NP

[7] Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

omit:

Epirube

See Note 3

D(100)

[8] Schedule 1, Part 1, entry for Ipilimumab in each of the forms: Injection concentrate for I.V. infusion 50 mg in 10 mL; and Injection concentrate for I.V. infusion 200 mg in 40 mL

(a) omit from the column headed “Circumstances”: C10122

(b) insert in numerical order in the column headed “Circumstances”: C13841

[9] Schedule 1, Part 1, omit entry for Losartan

[10] Schedule 1, Part 1, entry for Nitrofurantoin in each of the forms: Capsule 50 mg; and Capsule 100 mg

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

ARX-Nitrofurantoin

MP NP MW

[11] 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”: C9214

(b) omit from the column headed “Circumstances”: C10195

[12] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

Olamlo HCT 20/5/12.5

MP NP

C4311

[13] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

Olamlo HCT 40/5/12.5

MP NP

C4311

[14] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

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

Olamlo HCT 40/5/25

MP NP

C4311

[15] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

Olamlo HCT 40/10/12.5

MP NP

C4311

[16] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

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

Olamlo HCT 40/10/25

MP NP

C4311

[17] Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [Maximum Quantity: 10; Number of Repeats: 0]

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

			a	Oxycodone Viatris	MQ	MP NP	C10764 C10766 C10771 C10772	P10766	10	0	20
						PDP	C10766 C10768	P10766	10	0	20

[18] Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [Maximum Quantity: 20; Number of Repeats: 0]

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

			a	Oxycodone Viatris	MQ	MP NP	C10764 C10766 C10771 C10772	P10764 P10771 P10772	20	0	20
						PDP	C10766 C10768	P10768	20	0	20

[19] Schedule 1, Part 1, entry for Paclitaxel

omit:

Solution concentrate for I.V. infusion 30 mg in 5 mL

Injection

Paclitaxin

See Note 3

D(100)

[20] Schedule 1, Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL

omit:

Paclitaxin

See Note 3

D(100)

[21] Schedule 1, Part 1, entry for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

substitute:

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g	Application to the eye	Poly Visc	IQ	MP NP AO		1	5	1
		Refresh Night Time	AG	MP NP AO		1	5	1
		Poly Visc	IQ	MP	P4894	1	11	1
		Refresh Night Time	AG	MP	P4894	1	11	1

[22] Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)

omit:

Tevatrexed

See Note 3

D(100)

[23] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

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

PERISYL

MP NP

[24] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

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

PERISYL

MP NP

[25] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

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

PERISYL

MP NP

[26] Schedule 1, Part 1, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

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

PERISYL COMBI 4/1.25

MP NP

C4375

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

substitute:

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

[28] Schedule 1, Part 1, entry for Polyethylene glycol 400 with propylene glycol

omit:

Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28

Application to the eye

Systane

AO MP NP

C6172

[29] Schedule 1, Part 1, omit entry for Polyvinyl alcohol

[30] 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

omit:

Pregabalin-Teva

MP NP

C4172

[31] Schedule 1, Part 1, entry for Propranolol

omit:

Tablet containing propranolol hydrochloride 160 mg

Oral

Deralin 160

MP NP

[32] Schedule 1, Part 1, entry for Salbutamol

omit:

Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

Inhalation by mouth

Asmol CFC-free

MP NP

[33] Schedule 1, Part 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

insert in the column headed “Schedule Equivalent” (all instances): a

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

omit:

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

Injection

Humatrope

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

See Note 3

D(100)

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

Injection

Humatrope

See Note 3

D(100)

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

Injection

Humatrope

See Note 3

D(100)

[35] Schedule 1, Part 1, entry for Zanubrutinib

omit from the column headed “Circumstances”: C12573

[36] Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

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

Zoledronate-DRLA 4

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

PB(100)

[37] Schedule 1, Part 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

substitute:

Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

Injection

Aclasta

C5710 C6308 C6313 C6318

Osteovan

C5710 C6308 C6313 C6318

Zoledasta

C5710 C6308 C6313 C6318

Zoledronate-RDY 5

C5710 C6308 C6313 C6318

Zoledronic Acid SUN

C5710 C6308 C6313 C6318

[38] Schedule 1, Part 2, after entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre‑filled pen

insert:

Chlorpromazine

Tablet containing chlorpromazine hydrochloride 10 mg

Oral

Largactil

MP NP

100

[39] Schedule 1, Part 2, after entry for Interferon beta-1a in the form Solution for injection 132 micrograms in 1.5 mL multidose cartridge

insert:

Losartan

Tablet containing losartan potassium 25 mg

Oral

Cozavan

MP NP

Tablet containing losartan potassium 50 mg

Oral

Cozavan

MP NP

[40] Schedule 1, Part 2, after entry for Pindolol

insert:

Piroxicam

Dispersible tablet 10 mg

Oral

Mobilis D-10

PDP

C6214

MP NP

C6214

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28

Application to the eye

Systane

AO MP NP

C6172

Polyvinyl alcohol

Eye drops 14 mg per mL, 15 mL

Application to the eye

Liquifilm Tears

C6073 C6098

P6073

C6073

C6120

PVA Tears

C6073 C6098

P6073

C6073

C6120

Liquifilm Tears

C6073 C6098

P6098

PVA Tears

C6073 C6098

P6098

Propranolol

Tablet containing propranolol hydrochloride 160 mg

Oral

Deralin 160

MP NP

[41] Schedule 1, Part 2, omit entry for Rituximab

[42] Schedule 3, details relevant to Responsible Person code GO

omit from the column headed “Responsible Person”: Mylan Health Pty Ltd substitute: Viatris Pty Ltd

[43] Schedule 3, details relevant to Responsible Person code GT

omit from the column headed “Responsible Person”: Mylan Health Pty Ltd substitute: Viatris Pty Ltd

[44] Schedule 4, Part 1, entry for Donepezil

(a) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10099”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

(b) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10100”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

[45] Schedule 4, Part 1, entry for Galantamine

[46] Schedule 4, Part 1, entry for Ipilimumab

(a) omit:

C10122

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 10122

(b) omit from the column headed “Purposes Code” for the circumstance code “C11930”: P11930

C13841

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 13841

[47] Schedule 4, Part 1, entry for Memantine

(a) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10098”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

(b) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10184”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

[48] Schedule 4, Part 1, entry for Nivolumab

(a) omit:

C9214

Unresectable Stage III or Stage IV malignant melanoma
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 9214

(b) omit:

C10195

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.

Compliance with Authority Required procedures - Streamlined Authority Code 10195

C13839	Unresectable Stage III or Stage IV malignant melanoma Maintenance treatment Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND The treatment must be as monotherapy for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this PBS indication. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 13839
C13852	Unresectable Stage III or Stage IV malignant melanoma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for combination induction therapy Patient must have received non-PBS-subsidised treatment with nivolumab in combination with ipilimumab for this PBS indication prior to 1 March 2023; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to commencing non-PBS-subsidised treatment; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 13852
C13853	Unresectable Stage III or Stage IV malignant melanoma Induction treatment Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 13853
C13863	Unresectable Stage III or Stage IV malignant melanoma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for maintenance treatment Patient must have previously received of up to maximum 4 doses of PBS-subsidised ipilimumab combined therapy with non-PBS-subsidised nivolumab as induction for this condition prior to 1 March 2023; AND The treatment must be as monotherapy for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this PBS indication. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 13863

[49] Schedule 4, Part 1, omit entry for Rituximab

[50] Schedule 4, Part 1, entry for Rivastigmine

[51] Schedule 4, Part 1, entry for Somatropin

(a) omit:

C12734

Short stature associated with chronic renal insufficiency
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; 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 not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; 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 prepubertal.
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 the initial 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 initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; 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.
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

(b) omit:

C12835

Short stature associated with chronic renal insufficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency 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 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; 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; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
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.
Patient must be prepubertal.
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 (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; 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.
If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m2prescribers should seek reclassification to the indication short stature and slow growth.
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

	C12906			Short stature associated with chronic renal insufficiency 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 chronic renal insufficiency; 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 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 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 less than or equal to 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 an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; 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 height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm; 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 prepubertal. 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. 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; AND 4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND 5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND 6. Recent growth data (height and weight, not older than three months); AND 7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 8. 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
	C12907			Short stature associated with chronic renal insufficiency Continuing treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND Patient must not have been on the maximum dose of 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND Patient must be male and must not have a height greater than or equal to 167.7 cm; OR Patient must be female and must not have a height greater than or equal to 155.0 cm; 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 prepubertal. 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 (except for a patient whose chronological age is 2.5 years or less); 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

(d) omit:

C12922

Short stature associated with chronic renal insufficiency
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 chronic renal insufficiency; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 9.5mg/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 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 less than or equal to 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 an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; 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 height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; 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 prepubertal.
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.
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; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. 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
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
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

[52] Schedule 4, Part 1, entry for Zanubrutinib

omit:

C12573

Mantle cell lymphoma
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received treatment with this drug prior to 1 March 2022; AND
The condition must have relapsed or be refractory to at least one prior therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have had a WHO performance status of 0 or 1 at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have been untreated with Bruton's tyrosine kinase inhibitor therapy at treatment initiation with this drug; OR
Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures

[53] Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [GRP-25058]

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

[54] Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [GRP-25060]

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

[55] Schedule 5, after entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [GRP-25060]

insert:

GRP-27087	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Yuflyma
	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Amgevita Hadlima Hyrimoz Idacio
GRP-27088	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Yuflyma
	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Amgevita Hadlima Hyrimoz Idacio

[56] Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

omit from the column headed “Brand”: Blooms the Chemist Clopidogrel

[57] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]

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

[58] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]

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

[59] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]

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

[60] Schedule 5, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

insert in alphabetical order in the column headed “Brand”: PERISYL COMBI 4/1.25

[61] Schedule 5, entry for Salbutamol

omit:

	GRP-24211	Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	Asmol CFC-free
		Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)	Inhalation by mouth	Asmol CFC-Free with dose counter Ventolin CFC-Free with dose counter Zempreon CFC-Free with dose counter

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 March 2023	1 March 2023