National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 3) (PB 20 of 2020) (Cth)

PB 20 of 2020

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 3)

National Health Act 1953

________________________________________________________________________

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

Dated 30 March 2020

THEA DANIEL

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 3).

(2)This Instrument may also be cited as PB 20 of 2020.

Commencement

This Instrument commences on 1 April 2020.

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

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1 Amendments

Schedule 1, entry for Abacavir in each of the forms: Oral solution 20 mg (as sulfate) per mL, 240 mL; and Tablet 300 mg (as sulfate)

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Abacavir with lamivudine in the form Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Abacavir with lamivudine in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Abacavir with lamivudine and zidovudine

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Adefovir

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

omit from the column headed “Responsible Person” for the brand “Fosamax Plus”: MK substitute: MQ

Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

omit from the column headed “Responsible Person” for the brand “Fosamax Plus 70 mg/140 mcg”: MK substitute: MQ

Schedule 1, entry for Alendronic acid with colecalciferol and calcium

(a)omit:

Dronalen Plus
D-Cal

MP NP

C6306 C6319 C6325

(b)omit from the column headed “Schedule Equivalent” for the brand “ReddyMax Plus D-Cal”: a

Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

omit from the column headed “Responsible Person” for the brand “Norvasc”: PF substitute: UJ

Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

omit from the column headed “Responsible Person”: PF substitute: UJ

Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

omit from the column headed “Responsible Person”: PF substitute: UJ

Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)

omit from the column headed “Responsible Person”: PF substitute: UJ

Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)

omit from the column headed “Responsible Person”: PF substitute: UJ

Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

omit from the column headed “Responsible Person”: PF substitute: UJ

Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

omit from the column headed “Responsible Person”: PF substitute: UJ

Schedule 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate)

substitute:

Amoxicillin	Capsule 250 mg (as trihydrate)	Oral	a	Alphamox 250	AF	MP NP MW PDP	20	0	20
a	AMILOXYN	RF	MP NP MW PDP	20	0	20
a	Amoxil	AS	MP NP MW PDP	20	0	20
a	Amoxycillin AN	EA	MP NP MW PDP	20	0	20
a	Amoxycillin Ranbaxy	RA	MP NP MW PDP	20	0	20
a	Amoxycillin Sandoz	SZ	MP NP MW PDP	20	0	20
a	APO-Amoxycillin	TX	MP NP MW PDP	20	0	20
a	Cilamox	AL	MP NP MW PDP	20	0	20

Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate)

substitute:

Capsule 500 mg (as trihydrate)	Oral	a	Alphamox 500	AF	MP NP MW PDP	20	0	20
a	AMILOXYN	RF	MP NP MW PDP	20	0	20
a	Amoxil	AS	MP NP MW PDP	20	0	20
a	Amoxycillin AN	EA	MP NP MW PDP	20	0	20
a	Amoxycillin generichealth 500	GQ	MP NP MW PDP	20	0	20
a	Amoxycillin Ranbaxy	RA	MP NP MW PDP	20	0	20
a	Amoxycillin Sandoz	SZ	MP NP MW PDP	20	0	20
a	APO-Amoxycillin	TX	MP NP MW PDP	20	0	20
a	Cilamox	AL	MP NP MW PDP	20	0	20
a	Alphamox 500	AF	MP NP	P10326	40 CN10326	0 CN10326	20
a	AMILOXYN	RF	MP NP	P10326	40 CN10326	0 CN10326	20
a	Amoxil	AS	MP NP	P10326	40 CN10326	0 CN10326	20
a	Amoxycillin AN	EA	MP NP	P10326	40 CN10326	0 CN10326	20
a	Amoxycillin generichealth 500	GQ	MP NP	P10326	40 CN10326	0 CN10326	20
a	Amoxycillin Ranbaxy	RA	MP NP	P10326	40 CN10326	0 CN10326	20
a	Amoxycillin Sandoz	SZ	MP NP	P10326	40 CN10326	0 CN10326	20
a	APO-Amoxycillin	TX	MP NP	P10326	40 CN10326	0 CN10326	20
a	Cilamox	AL	MP NP	P10326	40 CN10326	0 CN10326	20

Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

substitute:

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)	Oral	a	AlphaClav Duo	AF	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	AMCLAVOX DUO 500/125	RW	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	AMOXICLAV AMNEAL 500/125	ED	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	Amoxycillin/Clavulanic Acid 500/125 APOTEX	TY	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	Amoxyclav AN 500/125	EA	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	APO-Amoxycillin/ Clavulanic Acid 500/125	TX	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	Augmentin Duo	AS	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	Curam Duo 500/125	SZ	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	Moxiclav Duo 500/125	LN	MP NP	C5832 C5893 C10319	P5832 P5893	10	0	10
					MW	C5832 C5893	10	0	10
					PDP	C5833 C5894	10	0	10
		a	AlphaClav Duo	AF	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	AMCLAVOX DUO 500/125	RW	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	AMOXICLAV AMNEAL 500/125	ED	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	Amoxycillin/Clavulanic Acid 500/125 APOTEX	TY	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	Amoxyclav AN 500/125	EA	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	APO-Amoxycillin/ Clavulanic Acid 500/125	TX	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	Augmentin Duo	AS	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	Curam Duo 500/125	SZ	MP NP	C5832 C5893 C10319	P10319	20	0	10
		a	Moxiclav Duo 500/125	LN	MP NP	C5832 C5893 C10319	P10319	20	0	10

Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

substitute:

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)	Oral	a	AlphaClav Duo Forte	AF	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	AlphaClav Duo Forte	AF	PDP	C5833 C5894	10	0	10
		a	AMCLAVOX DUO FORTE 875/125	RW	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	AMCLAVOX DUO FORTE 875/125	RW	PDP	C5833 C5894	10	0	10
		a	AMOXICLAV AMNEAL 875/125	ED	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	AMOXICLAV AMNEAL 875/125	ED	PDP	C5833 C5894	10	0	10
		a	Amoxyclav AN 875/125	EA	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	Amoxyclav AN 875/125	EA	PDP	C5833 C5894	10	0	10
		a	AmoxyClav generichealth 875/125	HQ	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	AmoxyClav generichealth 875/125	HQ	PDP	C5833 C5894	10	0	10
		a	APO-Amoxycillin and Clavulanic Acid	TX	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	APO-Amoxycillin and Clavulanic Acid	TX	PDP	C5833 C5894	10	0	10
		a	Augmentin Duo forte	AS	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	Augmentin Duo forte	AS	PDP	C5833 C5894	10	0	10
		a	Clavam 875 mg/125 mg	CR	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	Clavam 875 mg/125 mg	CR	PDP	C5833 C5894	10	0	10
		a	Curam Duo Forte 875/125	SZ	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	Curam Duo Forte 875/125	SZ	PDP	C5833 C5894	10	0	10
		a	Moxiclav Duo Forte 875/125	LN	MP NP	C5832 C5893 C10302	P5832 P5893	10	0	10
		a	Moxiclav Duo Forte 875/125	LN	PDP	C5833 C5894	10	0	10
		a	AlphaClav Duo Forte	AF	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	AMCLAVOX DUO FORTE 875/125	RW	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	AMOXICLAV AMNEAL 875/125	ED	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	Amoxyclav AN 875/125	EA	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	AmoxyClav generichealth 875/125	HQ	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	APO-Amoxycillin and Clavulanic Acid	TX	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	Augmentin Duo forte	AS	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	Clavam 875 mg/125 mg	CR	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	Curam Duo Forte 875/125	SZ	MP NP	C5832 C5893 C10302	P10302	20	0	10
		a	Moxiclav Duo Forte 875/125	LN	MP NP	C5832 C5893 C10302	P10302	20	0	10

Schedule 1, entry for Atazanavir

omit:

Capsule 150 mg (as sulfate)

Oral

Reyataz

C4454 C4512

120

D(100)

Schedule 1, entry for Atazanavir in each of the forms: Capsule 200 mg (as sulfate); and Capsule 300 mg (as sulfate)

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Atazanavir with cobicistat

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Atezolizumab

insert as first entry:

Solution concentrate for I.V. infusion 840 mg in 14 mL

Injection

Tecentriq

C10215 C10257 C10312

See Note 3

D(100)

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

(a)omit from the column headed “Circumstances”: C9567

(b)omit from the column headed “Circumstances”: C10143

(c)omit from the column headed “Circumstances”: C10190

(d)insert in numerical order in the column headed “Circumstances”: C10216 C10276 C10297

Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium)

omit from the column headed “Responsible Person” for the brand “Lipitor” (all instances): PF substitute: UJ

Schedule 1, entry for Azithromycin in the form Tablet 600 mg (as dihydrate)

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Bictegravir with emtricitabine with tenofovir alafenamide

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, after entry for Bimatoprost with timolol in the form Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL,
3 mL

insert:

Binimetinib	Tablet 15 mg	Oral	Mektovi	FB	MP	C10306 C10328	P10328	168	3	84
MP	C10306 C10328	P10306	168	5	84

Schedule 1, entry for Bortezomib in each of the forms: Powder for injection 1 mg; and Powder for injection 3 mg

(a)omit from the column headed “Circumstances”: C7992

(b)insert in numerical order in the column headed "Circumstances": C10338

Schedule 1, entry for Botulinum toxin type A purified neurotoxin complex

(a)omit from the column headed “Circumstances”: C5220

(b)insert in numerical order in the column headed “Circumstances”: C9547 C10298

Schedule 1, entry for Brivaracetam

substitute:

Brivaracetam	Oral solution 10 mg per mL, 300 mL	Oral	Briviact	UC	MP	C10251 C10330	1	5	1
	Oral solution 10 mg per mL, 300 mL	Oral	Briviact	UC	NP	C10330	1	5	1
	Tablet 25 mg	Oral	Briviact	UC	MP	C10208 C10210	56	5	56
	Tablet 25 mg	Oral	Briviact	UC	NP	C10208	56	5	56
	Tablet 50 mg	Oral	Briviact	UC	MP	C10208 C10210	56	5	56
	Tablet 50 mg	Oral	Briviact	UC	NP	C10208	56	5	56
	Tablet 75 mg	Oral	Briviact	UC	MP	C10208 C10210	56	5	56
	Tablet 75 mg	Oral	Briviact	UC	NP	C10208	56	5	56
	Tablet 100 mg	Oral	Briviact	UC	MP	C10208 C10210	56	5	56
	Tablet 100 mg	Oral	Briviact	UC	NP	C10208	56	5	56

Schedule 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate)

substitute:

Cefalexin	Capsule 250 mg (as monohydrate)	Oral	a	APO-Cephalexin	TX	MP NP MW PDP	20	0	20
a	Cefalexin Sandoz	SZ	MP NP MW PDP	20	0	20
a	Cephalexin AN	EA	MP NP MW PDP	20	0	20
a	Ibilex 250	AF	MP NP MW PDP	20	0	20
a	Keflex	AS	MP NP MW PDP	20	0	20
a	APO-Cephalexin	TX	MP NP MW	P10316	40 CN10316	0 CN10316	20
a	Cefalexin Sandoz	SZ	MP NP MW	P10316	40 CN10316	0 CN10316	20
a	Cephalexin AN	EA	MP NP MW	P10316	40 CN10316	0 CN10316	20
a	Ibilex 250	AF	MP NP MW	P10316	40 CN10316	0 CN10316	20
a	Keflex	AS	MP NP MW	P10316	40 CN10316	0 CN10316	20
a	APO-Cephalexin	TX	MP	P4243	40 CN4243	2 CN4243	20
a	Cefalexin Sandoz	SZ	MP	P4243	40 CN4243	2 CN4243	20
a	Cephalexin AN	EA	MP	P4243	40 CN4243	2 CN4243	20
a	Ibilex 250	AF	MP	P4243	40 CN4243	2 CN4243	20
a	Keflex	AS	MP	P4243	40 CN4243	2 CN4243	20

Schedule 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate)

substitute:

Capsule 500 mg (as monohydrate)	Oral	a	APO-Cephalexin	TX	MP NP MW PDP	20	0	20
a	Cefalexin Sandoz	SZ	MP NP MW PDP	20	0	20
a	Cephalex 500	CR	MP NP MW PDP	20	0	20
a	Cephalexin AN	EA	MP NP MW PDP	20	0	20
a	Cephalexin generichealth	GQ	MP NP MW PDP	20	0	20
a	Ibilex 500	AF	MP NP MW PDP	20	0	20
a	Keflex	AS	MP NP MW PDP	20	0	20
a	APO-Cephalexin	TX	MP NP MW	P10331	40 CN10331	0 CN10331	20
a	Cefalexin Sandoz	SZ	MP NP MW	P10331	40 CN10331	0 CN10331	20
a	Cephalex 500	CR	MP NP MW	P10331	40 CN10331	0 CN10331	20
a	Cephalexin AN	EA	MP NP MW	P10331	40 CN10331	0 CN10331	20
a	Cephalexin generichealth	GQ	MP NP MW	P10331	40 CN10331	0 CN10331	20
a	Ibilex 500	AF	MP NP MW	P10331	40 CN10331	0 CN10331	20
a	Keflex	AS	MP NP MW	P10331	40 CN10331	0 CN10331	20
a	APO-Cephalexin	TX	MP	P6188	40 CN6188	1 CN6188	20
a	Cefalexin Sandoz	SZ	MP	P6188	40 CN6188	1 CN6188	20
a	Cephalex 500	CR	MP	P6188	40 CN6188	1 CN6188	20
a	Cephalexin AN	EA	MP	P6188	40 CN6188	1 CN6188	20
a	Cephalexin generichealth	GQ	MP	P6188	40 CN6188	1 CN6188	20
a	Ibilex 500	AF	MP	P6188	40 CN6188	1 CN6188	20
a	Keflex	AS	MP	P6188	40 CN6188	1 CN6188	20

Schedule 1, entry for Celecoxib in each of the forms: Capsule 100 mg; and Capsule 200 mg

omit from the column headed “Responsible Person” for the brand “Celebrex”: PF substitute: UJ

Schedule 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL

omit:

Hospira Pty Limited

See Note 3

D(100)

Schedule 1, omit entry for Coal tar

Schedule 1, entry for Darunavir in each of the forms: Tablet 150 mg (as ethanolate); Tablet 600 mg (as ethanolate); and Tablet 800 mg
(as ethanolate)

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Darunavir with cobicistat

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, after entry for Darunavir with cobicistat

insert:

Darunavir with cobicistat, emtricitabine and tenofovir alafenamide

Tablet containing darunavir 800 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg

Oral

Symtuza

MP NP

C10317 C10324

D(100)

Schedule 1, entry for Desvenlafaxine in the form Tablet (extended release) 50 mg (as succinate)

omit from the column headed “Schedule Equivalent”: a

Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg

omit from the column headed “Schedule Equivalent” (all instances): a

Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg (as benzoate)

omit from the column headed “Schedule Equivalent” (all instances): a

Schedule 1, entry for Dexamethasone in the form Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL

(a)omit from the column headed “Schedule Equivalent” for the brand “Dexamethasone Mylan”: a

(b)omit:

Hospira Pty Limited

MP NP

Schedule 1, entry for Dexamethasone in the form Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

(a)omit from the column headed “Schedule Equivalent” for the brand “Dexamethasone Mylan”: a

(b)omit:

Hospira Pty Limited

MP NP

Schedule 1, entry for Dolutegravir

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Dolutegravir with abacavir and lamivudine

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Dolutegravir with lamivudine

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Dolutegravir with rilpivirine

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Doxorubicin - pegylated liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL [Maximum Quantity: 4; Number of Repeats: 5]

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Efavirenz in each of the forms: Oral solution 30 mg per mL, 180 mL; Tablet 200 mg; and Tablet 600 mg

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Eletriptan in each of the forms: Tablet 40 mg (as hydrobromide); and Tablet 80 mg (as hydrobromide)

omit from the column headed “Responsible Person”: PF substitute: UJ

Schedule 1, entry for Emtricitabine with rilpivirine with tenofovir alafenamide

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Emtricitabine with tenofovir alafenamide in each of the forms: Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg; and Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 10 mg

omit from the column headed “Responsible Person” for the brand “Renitec”: MK substitute: AF

Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 20 mg

omit from the column headed “Responsible Person” for the brand “Renitec 20”: MK substitute: AF

Schedule 1, entry for Enalapril with hydrochlorothiazide

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

Schedule 1, after entry for Enalapril with hydrochlorothiazide

insert:

Encorafenib	Capsule 50 mg	Oral	Braftovi	FB	MP	C6013 C10271	P10271	252	3	28
MP	C6013 C10271	P6013	252	5	28
Capsule 75 mg	Oral	Braftovi	FB	MP	C6013 C10271	P10271	168	3	42
MP	C6013 C10271	P6013	168	5	42

Schedule 1, entry for Enfuvirtide

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Entecavir in each of the forms: Tablet 0.5 mg (as monohydrate); and Tablet 1 mg (as monohydrate)

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

omit:

Pharmorubicin

See Note 3

D(100)

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

omit:

Pharmorubicin

See Note 3

D(100)

Schedule 1, entry for Eplerenone in each of the forms: Tablet 25 mg; and Tablet 50 mg

omit from the column headed “Responsible Person” for the brand “Inspra”: PF substitute: UJ

Schedule 1, entry for Etravirine

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Exemestane

omit:

a	Estamane	JU	MP	C4796 C5522	30	5	30
NP	C5522	30	5	30
a	Exemestane AN	EA	MP	C4796 C5522	30	5	30
NP	C5522	30	5	30

Schedule 1, entry for Ezetimibe

omit from the column headed “Responsible Person” for the brand “Ezetrol”: MK substitute: AL

Schedule 1, entry for Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg
(as calcium)

omit from the column headed “Responsible Person”: MK substitute: AL

Schedule 1, entry for Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg
(as calcium)

omit from the column headed “Responsible Person”: MK substitute: AL

Schedule 1, entry for Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg
(as calcium)

omit from the column headed “Responsible Person”: MK substitute: AL

Schedule 1, entry for Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg
(as calcium)

omit from the column headed “Responsible Person”: MK substitute: AL

Schedule 1, entry for Ezetimibe with atorvastatin in each of the forms: Tablet 10 mg-10 mg; Tablet 10 mg-20 mg; Tablet 10 mg-40 mg; and
Tablet 10 mg-80 mg

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

Schedule 1, entry for Ezetimibe with simvastatin in each of the forms: Tablet 10 mg-10 mg; Tablet 10 mg-20 mg; Tablet 10 mg-40 mg; and
Tablet 10 mg-80 mg

omit from the column headed “Responsible Person” for the brand “Vytorin”: MK substitute: AL

Schedule 1, entry for Fentanyl in the form Transdermal patch 2.1 mg

omit from the column headed “Schedule Equivalent” (all instances): a

Schedule 1, entry for Fentanyl in the form Transdermal patch 16.5 mg

omit from the column headed “Schedule Equivalent” (all instances): a

Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

omit:

Fludarabine ACT

See Note 3

PB(100)

Schedule 1, entry for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 125 micrograms per dose,
120 doses (CFC-free formulation)

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

Axotide

MP NP

Schedule 1, entry for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 250 micrograms per dose,
120 doses (CFC-free formulation)

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

Axotide

MP NP

Schedule 1, entry for Fosamprenavir

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; Capsule 400 mg; Tablet 600 mg; and Tablet 800 mg

omit from the column headed “Responsible Person” for the brand “Neurontin”: PF substitute: UJ

Schedule 1, entry for Ganciclovir

substitute:

Ganciclovir	Powder for I.V. infusion 500 mg (as sodium)	Injection	a	Cymevene	PB	MP	C4972 C4999 C5000 C9404 C9526	10	1	5	D(100)
NP	C5000	10	1	5	D(100)
a	GANCICLOVIR SXP	HN	MP	C4972 C4999 C5000 C9404 C9526	10	1	5	D(100)
NP	C5000	10	1	5	D(100)

Schedule 1, entry for Glecaprevir with pibrentasvir in the form Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir
[Maximum Quantity: 84; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C7594

(b)insert in numerical order in the column headed “Circumstances”: C10268

Schedule 1, entry for Glecaprevir with pibrentasvir in the form Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir
[Maximum Quantity: 84; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7594

(b)insert in numerical order in the column headed “Circumstances”: C10268

Schedule 1, entry for Glecaprevir with pibrentasvir in the form Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir
[Maximum Quantity: 84; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C7594

(b)insert in numerical order in the column headed “Circumstances”: C10268

(c)omit from the column headed “Purposes”: P7594 substitute: P10268

Schedule 1, entry for Guselkumab

(a)omit from the column headed “Circumstances”: C8978 C8999

(b)insert in numerical order in the column headed “Circumstances”: C10322 C10327

Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate)

(a)omit:

IMATINIB AN

C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296 C10010 C10026 C10035 C10048

P9203 P9207 P10010 P10026 P10035 P10048

(b)omit:

IMATINIB AN

C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296 C10010 C10026 C10035 C10048

P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate)

(a)omit:

IMATINIB AN

C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296 C10010 C10026 C10035 C10048

P9203 P9207 P10010 P10026 P10035 P10048

(b)omit:

IMATINIB AN

C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296 C10010 C10026 C10035 C10048

P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Interferon alfa-2a

substitute:

Interferon alfa-2a	Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	Roferon-A	RO	MP	C6632 C6648 C6672	P6648 P6672	15	4	1
MP	C4993 C5036 C5042 C6661 C6662 C6678 C9259	P6662 P6678	15	4	1	C(100)
MP	C6632 C6648 C6672	P6632	15	5	1
MP	C4993 C5036 C5042 C6661 C6662 C6678 C9259	P6661	15	5	1	C(100)
MP	C4993 C5036 C5042 C6661 C6662 C6678 C9259	P4993 P5036 P5042 P9259	30	5	1	C(100)
NP	C4993 C5036	30	5	1	C(100)
Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	Roferon-A	RO	MP	C6632 C6672	P6672	5	4	1
MP	C4993 C5036 C5042 C6661 C6678 C9259	P6678	5	4	1	C(100)
MP	C6632 C6672	P6632	5	5	1
MP	C4993 C5036 C5042 C6661 C6678 C9259	P6661	5	5	1	C(100)
MP	C4993 C5036 C5042 C6661 C6678 C9259	P4993 P5036 P5042 P9259	30	5	1	C(100)
NP	C4993 C5036	30	5	1	C(100)

Schedule 1, entry for Lamivudine in each of the forms: Oral solution 10 mg per mL, 240 mL; Tablet 100 mg; Tablet 150 mg; and Tablet 300 mg

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Lamivudine with zidovudine

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Latanoprost

(a)omit:

Lanpro

AO MP

(b)omit from the column headed “Responsible Person” for the brand “Xalatan”: PF substitute: UJ

Schedule 1, entry for Latanoprost with timolol

omit from the column headed “Responsible Person” for the brand “Xalacom”: PF substitute: UJ

Schedule 1, entry for Lenalidomide

substitute:

Lenalidomide	Capsule 5 mg	Oral	Revlimid	CJ	MP	See Note 3	See Note 3	See Note 3	See Note 3	21	D(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	28	D(100)
Capsule 10 mg	Oral	Revlimid	CJ	MP	See Note 3	See Note 3	See Note 3	See Note 3	21	D(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	28	D(100)
Capsule 15 mg	Oral	Revlimid	CJ	MP	See Note 3	See Note 3	See Note 3	See Note 3	21	D(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	28	D(100)
Capsule 25 mg	Oral	Revlimid	CJ	MP	See Note 3	See Note 3	See Note 3	See Note 3	21	D(100)

Schedule 1, entry for Levodopa with carbidopa in the form Tablet 100 mg-25 mg (as monohydrate)

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

APO-Levodopa/Carbidopa

MP NP

100

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

SINADOPA 100/25

MP NP

100

(c)omit from the column headed “Responsible Person” for the brand “Sinemet 100/25”: MK substitute: AL

Schedule 1, entry for Levodopa with carbidopa in the form Tablet (modified release) 200 mg-50 mg (as monohydrate)

omit from the column headed “Responsible Person”: MK substitute: AL

Schedule 1, entry for Levodopa with carbidopa in the form Tablet 250 mg-25 mg (as monohydrate)

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

APO-Levodopa/Carbidopa

MP NP

100

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

SINADOPA 250/25

MP NP

100

(c)omit from the column headed “Responsible Person”: MK substitute: AL

Schedule 1, entry for Lopinavir with ritonavir in each of the forms: Oral liquid 400 mg-100 mg per 5 mL, 60 mL; Tablet 100 mg-25 mg; and
Tablet 200 mg-50 mg

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Maraviroc in each of the forms: Tablet 150 mg; and Tablet 300 mg

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Mercaptopurine in the form Tablet containing mercaptopurine monohydrate 50 mg

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

MERCAPTOPURINE-LINK

100

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

Schedule 1, omit entry for Milk powder lactose intolerance formula

Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

omit:

Remeron SolTab

MP NP

C5650

Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

omit from the column headed “Responsible Person” for the brand “Avanza”: MK substitute: AL

Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

omit:

Remeron SolTab

MP NP

C5650

Schedule 1, entry for Mometasone in the form Cream containing mometasone furoate 1 mg per g, 15 g

omit from the column headed “Responsible Person” for the brand “Elocon Alcohol Free” (all instances): MK substitute: AL

Schedule 1, entry for Mometasone in each of the forms: Lotion containing mometasone furoate 1 mg per g, 30 mL; and Ointment containing mometasone furoate 1 mg per g, 15 g

omit from the column headed “Responsible Person” for the brand “Elocon” (all instances): MK substitute: AL

Schedule 1, entry for Montelukast in each of the forms: Tablet, chewable, 4 mg (as sodium); and Tablet, chewable, 5 mg (as sodium)

omit from the column headed “Responsible Person” for the brand “Singulair”: MK substitute: AF

Schedule 1, entry for Nevirapine in each of the forms: Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL; Tablet 200 mg; and Tablet
400 mg (extended release)

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Olmesartan in each of the forms: Tablet containing olmesartan medoxomil 20 mg; and Tablet containing olmesartan medoxomil 40 mg

omit from the column headed “Responsible Person” for the brand “Olmetec”: MK substitute: AL

Schedule 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

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

APO-Olmesartan/Amlodipine/HCTZ 20/5/12.5

MP NP

C4311

(b)insert in the column headed “Schedule Equivalent” for the brand “Sevikar HCT 20/5/12.5”: a

Schedule 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

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

APO-Olmesartan/Amlodipine/HCTZ 40/5/12.5 tablet

MP NP

C4311

(b)insert in the column headed “Schedule Equivalent” for the brand “Sevikar HCT 40/5/12.5”: a

Schedule 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

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

APO-Olmesartan/Amlodipine/HCTZ 40/5/25 tablet

MP NP

C4311

(b)insert in the column headed “Schedule Equivalent” for the brand “Sevikar HCT 40/5/25”: a

Schedule 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

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

APO-Olmesartan/Amlodipine/HCTZ 40/10/12.5

MP NP

C4311

(b)insert in the column headed “Schedule Equivalent” for the brand “Sevikar HCT 40/10/12.5”: a

Schedule 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

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

APO-Olmesartan/Amlodipine/HCTZ 40/10/25

MP NP

C4311

(b)insert in the column headed “Schedule Equivalent” for the brand “Sevikar HCT 40/10/25”: a

Schedule 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg

omit from the column headed “Responsible Person” for the brand “Olmetec Plus”: MK substitute: AL

Schedule 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg

omit from the column headed “Responsible Person” for the brand “Olmetec Plus”: MK substitute: AL

Schedule 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

omit from the column headed “Responsible Person” for the brand “Olmetec Plus”: MK substitute: AL

Schedule 1, entry for Pegfilgrastim

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

Fulphila

C7822 C7843 C9235 C9303

D(100)

Schedule 1, entry for Peginterferon alfa-2a in the form Injection 135 micrograms in 0.5 mL single use pre-filled syringe [Maximum Quantity: 8; Number of Repeats: 5]

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Peginterferon alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre-filled syringe

omit:

P6745

4
CN6745

2
CN6745

C(100)

Schedule 1, entry for Peginterferon alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre-filled syringe [Maximum Quantity: 8; Number of Repeats: 5]

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Pertuzumab

(a)omit from the column headed “Circumstances”: C9516

(b)insert in numerical order in the column headed “Circumstances”: C10275

Schedule 1, entry for Phenytoin in each of the forms: Capsule containing phenytoin sodium 30 mg; Capsule containing phenytoin sodium
100 mg; Oral suspension 30 mg per 5 mL, 500 mL; and Tablet 50 mg

omit from the column headed “Responsible Person”: PF substitute: UJ

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

omit from the column headed “Responsible Person” for the brand “Lyrica”: PF substitute: UJ

Schedule 1, after entry for Protein formula with carbohydrate, fat, vitamins and minerals in the form Oral liquid 500 mL, 8
(Nutrini Peptisorb Energy)

insert:

Oral liquid 500 mL, 12 (Nutrini Peptisorb Energy)

Oral

Nutrini Peptisorb Energy

MP NP

C6890

Schedule 1, entry for Raltegravir in each of the forms: Tablet 25 mg (as potassium); Tablet 100 mg (as potassium); Tablet 400 mg (as potassium); and Tablet 600 mg (as potassium)

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Rasagiline

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

Rasalect

MP NP

C5339

Schedule 1, entry for Rifabutin

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Rilpivirine

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Ritonavir

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Rituximab

substitute:

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Mabthera

See Note 3

PB(100)

Riximyo

See Note 3

PB(100)

Truxima

See Note 3

PB(100)

Mabthera

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Riximyo

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Truxima

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Solution for I.V. infusion 500 mg in 50 mL

Injection

Mabthera

See Note 3

PB(100)

Riximyo

See Note 3

PB(100)

Truxima

See Note 3

PB(100)

Mabthera

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Riximyo

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Truxima

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL

Injection

Mabthera SC

C6011 C6161 C7399 C7400 C10227

P10227

C(100)

C6011 C6161 C7399 C7400

P7399

C6011 C6161 C7399 C7400 C10227

P7399

C(100)

C6011 C6161 C7399 C7400

P7400

C6011 C6161 C7399 C7400 C10227

P7400

C(100)

C6011 C6161 C7399 C7400

P6011

C6011 C6161 C7399 C7400 C10227

P6011

C(100)

C6011 C6161 C7399 C7400

P6161

C6011 C6161 C7399 C7400 C10227

P6161

C(100)

Schedule 1, entry for Roxithromycin

substitute:

Roxithromycin	Tablet for oral suspension 50 mg	Oral	Rulide D	SW	PDP MP NP	10	0	10
Tablet 150 mg	Oral	a	APO-Roxithromycin	TX	MP NP PDP	10	0	10
a	Biaxsig	AV	MP NP PDP	10	0	10
a	Chem mart Roxithromycin	CH	MP NP PDP	10	0	10
a	Roxar 150	RW	MP NP PDP	10	0	10
a	Roximycin	AF	MP NP PDP	10	0	10
a	Roxithromycin AN	EA	MP NP PDP	10	0	10
a	Roxithromycin Sandoz	SZ	MP NP PDP	10	0	10
a	Roxithromycin-GA	ED	MP NP PDP	10	0	10
a	Rulide	SW	MP NP PDP	10	0	10
a	Terry White Chemists Roxithromycin	TW	MP NP PDP	10	0	10
Tablet 300 mg	Oral	a	APO-Roxithromycin	TX	PDP MP NP	5	0	5
a	Biaxsig	AV	PDP MP NP	5	0	5
a	Chem mart Roxithromycin	CH	PDP MP NP	5	0	5
a	Roxar 300	RW	PDP MP NP	5	0	5
a	Roximycin	AF	PDP MP NP	5	0	5
a	Roxithromycin AN	EA	PDP MP NP	5	0	5
a	Roxithromycin Sandoz	SZ	PDP MP NP	5	0	5
a	Roxithromycin-GA	ED	PDP MP NP	5	0	5
a	Rulide	SW	PDP MP NP	5	0	5
a	Terry White Chemists Roxithromycin	TW	PDP MP NP	5	0	5

Schedule 1, entry for Saquinavir

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Zoloft”: PF substitute: UJ

Schedule 1, entry for Sildenafil

omit from the column headed “Responsible Person” for the brand “Revatio”: PF substitute: UJ

Schedule 1, entry for Simvastatin in the form Tablet 10 mg

(a)omit from the column headed “Responsible Person” for the brand “Lipex 10” (all instances): FR substitute: AL

(b)omit from the column headed “Responsible Person” for the brand “Zocor” (all instances): MK substitute: MQ

Schedule 1, entry for Simvastatin in the form Tablet 20 mg

(a)omit from the column headed “Responsible Person” for the brand “Lipex 20” (all instances): FR substitute: AL

(b)omit from the column headed “Responsible Person” for the brand “Zocor” (all instances): MK substitute: MQ

Schedule 1, entry for Simvastatin in the form Tablet 40 mg

(a)omit from the column headed “Responsible Person” for the brand “Lipex 40” (all instances): FR substitute: AL

(b)omit from the column headed “Responsible Person” for the brand “Zocor” (all instances): MK substitute: MQ

Schedule 1, entry for Simvastatin in the form Tablet 80 mg

(a)omit from the column headed “Responsible Person” for the brand “Lipex 80” (all instances): FR substitute: AL

(b)omit from the column headed “Responsible Person” for the brand “Zocor” (all instances): MK substitute: MQ

Schedule 1, entry for Sofosbuvir with velpatasvir and voxilaprevir

omit from the column headed “Circumstances”: C5969 substitute: C10248

Schedule 1, entry for Temozolomide in the form Capsule 5 mg

(a)omit:

Temozolomide Amneal

(b)omit:

Temozolomide Amneal

P4897

Schedule 1, entry for Temozolomide in each of the forms: Capsule 20 mg; and Capsule 100 mg

(a)omit:

Temolide

(b)omit:

Temolide

P4897

Schedule 1, entry for Temozolomide in the form Capsule 180 mg

(a)omit:

Temozolomide Amneal

(b)omit:

Temozolomide Amneal

P4897

Schedule 1, entry for Temozolomide in the form Capsule 250 mg

(a)omit:

Temolide

(b)omit:

Temozolomide Amneal

Schedule 1, entry for Tenofovir in each of the forms: Tablet containing tenofovir disoproxil phosphate 291 mg; Tablet containing tenofovir disoproxil fumarate 300 mg; and Tablet containing tenofovir disoproxil maleate 300 mg

omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP

Schedule 1, entry for Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Tenofovir with emtricitabine

substitute:

Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg	Oral	Tenofovir EMT GH	GQ	MP NP	C7580	30	2	30
Tenofovir with emtricitabine		Oral	Tenofovir EMT GH	GQ	MP NP	C6985 C6986	60	5	30	C(100)
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine 300/200 APOTEX	TX	MP NP	C7580	30	2	30
	Oral	Tenofovir/Emtricitabine 300/200 APOTEX	MP NP	C6985 C6986	60	5	30	C(100)
Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Mylan 300/200	AF	MP NP	C7580	30	2	30
	Oral	Tenofovir Disoproxil Emtricitabine Mylan 300/200	MP NP	C6985 C6986	60	5	30	C(100)

Schedule 1, entry for Tenofovir with emtricitabine and efavirenz in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Tenofovir with emtricitabine and efavirenz in the form Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, omit entry for Tinidazole

Schedule 1, entry for Tipranavir

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Tolvaptan in each of the forms: Pack containing 28 tablets 15 mg and 28 tablets 45 mg; Pack containing 28 tablets 30 mg and 28 tablets 60 mg; and Pack containing 28 tablets 30 mg and 28 tablets 90 mg

(a)omit from the column headed “Circumstances”: C8287

(b)insert in numerical order in the column headed “Circumstances”: C10250

Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 60 mg

(a) omit from the column headed “Circumstances”: C9354 C9356 C9461

(b) omit from the column headed “Circumstances”: C9628

(c)insert in numerical order in the column headed “Circumstances”: C10213 C10293 C10294 C10296

Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg

(a) omit from the column headed “Circumstances” (all instances): C9354 C9356 C9461

(b) omit from the column headed “Circumstances” (all instances): C9628

(c)insert in numerical order in the column headed “Circumstances” (all instances): C10213 C10293 C10294 C10296

Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 420 mg

(a) omit from the column headed “Circumstances”: C9354 C9356 C9461

(b) omit from the column headed “Circumstances”: C9628

(c)insert in numerical order in the column headed “Circumstances”: C10213 C10293 C10294 C10296

Schedule 1, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL
[Maximum Quantity: 1; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C9351

(b)insert in numerical order in the column headed “Circumstances”: C10212

Schedule 1, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL
[Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C9351

(b)insert in numerical order in the column headed “Circumstances”: C10212

(c)omit from the column headed “Purposes”: P9351

(d)insert in numerical order in the column headed “Purposes”: P10212

Schedule 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

(a)omit from the column headed “Circumstances”: C9359

(b)insert in numerical order in the column headed “Circumstances”: C10214 C10255 C10273 C10295

Schedule 1, entry for Trifluridine with tipiracil in each of the forms: Tablet containing 15 mg trifluridine with 6.14 mg tipiracil (as hydrochloride); and Tablet containing 20 mg trifluridine with 8.19 mg tipiracil (as hydrochloride)

(a)omit from the column headed “Circumstances”: C8195

(b)insert in numerical order in the column headed “Circumstances”: C10252 C10309 C10310

Schedule 1, entry for Valganciclovir

substitute:

Valganciclovir	Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL	Oral	Valcyte	RO	MP	C4980 C4989 C9316	11	5	1	D(100)
		Oral	Valcyte	RO	NP	C4980	11	5	1	D(100)
	Tablet 450 mg (as hydrochloride)	Oral	a	Valcyte	RO	MP	C4980 C4989 C9316	120	5	60	D(100)
			a	Valcyte	RO	NP	C4980	120	5	60	D(100)
			a	Valganciclovir Mylan	AF	MP	C4980 C4989 C9316	120	5	60	D(100)
			a	Valganciclovir Mylan	AF	NP	C4980	120	5	60	D(100)
			a	Valganciclovir Sandoz	SZ	MP	C4980 C4989 C9316	120	5	60	D(100)
			a	Valganciclovir Sandoz	NP	C4980	120	5	60	D(100)

Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 37.5 mg (as hydrochloride); Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Efexor-XR”: PF substitute: UJ

Schedule 1, entry for Zidovudine in each of the forms: Capsule 100 mg; Capsule 250 mg; and Syrup 10 mg per mL, 200 mL

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

Schedule 1, entry for Ziprasidone in each of the forms: Capsule 20 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); Capsule 60 mg
(as hydrochloride); and Capsule 80 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Zeldox”: PF substitute: UJ

Schedule 3, after entry for Responsible Person TD

insert:

TI Teva Pharma Australia Pty Ltd 41 169 715 664

Schedule 3, after entry for Responsible Person UC

insert:

UJ 50 629 389 911

Schedule 4, Part 1, entry for Amoxicillin

insert in numerical order after existing text:

P10326

CN10326

Infection
Patient must be a male with acute cystitis; OR
Patient must have pyelonephritis; OR
Patient must have a tooth avulsion; OR
Patient must have salmonella enteritis; OR
Patient must have a condition requiring prolonged oral antibiotic therapy following initial intravenous antibiotic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10326

Schedule 4, Part 1, entry for Amoxicillin with clavulanic acid

(a)insert in the column headed “Purposes Code” for the circumstance code “C5832”: P5832

(b)insert in the column headed “Purposes Code” for the circumstance code “C5893”: P5893

(c)insert in numerical order after existing text:

C10302	P10302	Infection Patient must have periorbital (preseptal) cellulitis; OR Patient must have postpartum endometritis; OR Patient must have an exacerbation of bronchiectasis; OR Patient must have pyelonephritis; OR Patient must have pneumonia acquired in hospital or aged care; OR Patient must have a diabetic foot infection; OR Patient must have a condition requiring prolonged oral antibiotic therapy following initial intravenous antibiotic therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 10302
C10319	P10319	Acute cystitis Patient must be a male with acute cystitis.	Compliance with Authority Required procedures - Streamlined Authority Code 10319

Schedule 4, Part 1, entry for Atezolizumab

(a)omit:

C9567

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9567

(b)omit:

C10143

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

Compliance with Authority Required procedures - Streamlined Authority Code 10143

(c)omit:

C10190

Locally advanced or metastatic non-small cell lung cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10190

(d)insert in numerical order after existing text:

C10215	Locally advanced or metastatic non-small cell lung cancer Continuing treatment - 4 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 10215
C10216	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated. Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 10216
C10257	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen Patient must have experienced intolerance to combination treatment with bevacizumab; AND Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND Patient must have stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 10257
C10276	Locally advanced or metastatic non-small cell lung cancer Initial treatment - 3 weekly treatment regimen Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 10276
C10297	Locally advanced or metastatic non-small cell lung cancer Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 10297
C10312	Locally advanced or metastatic non-small cell lung cancer Initial treatment - 4 weekly treatment regimen Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 10312

Schedule 4, Part 1, after entry for Bimatoprost with timolol

insert:

Binimetinib	C10306	P10306	Unresectable Stage III or Stage IV malignant melanoma Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 10306
C10328	P10328	Unresectable Stage III or Stage IV malignant melanoma Initial treatment Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 10328

Schedule 4, Part 1, entry for Bortezomib

(a)omit entry for circumstances code “C7938” and substitute:

Bortezomib

C7938

Multiple myeloma
Retreatment of Progressive disease - Initial PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease; AND
Patient must have previously been treated with PBS-subsidised bortezomib; AND
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters that will be used to assess response, and diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously documented must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) must be documented in the patient's medical records. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7938

(b)omit from the column headed “Purposes Code” for circumstances code “C7939”: P7939
(c)omit from the column headed “Purposes Code” for circumstances code “C7940”: P7940
(d)omit from the column headed “Purposes Code” for circumstances code “C7941”: P7941
(e)omit from the column headed “Purposes Code” for circumstances code “C7960”: P7960
(f)omit entry for circumstances code “C7961” and substitute:

C7961

Multiple myeloma
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7961

(g)omit from the column headed “Purposes Code” for circumstances code “C7962”: P7962
(h)omit from the column headed “Purposes Code” for circumstances code “C7963”: P7963
(i)omit from the column headed “Purposes Code” for circumstances code “C7974”: P7974
(j)omit from the column headed “Purposes Code” for circumstances code “C7984”: P7984
(k)omit:

C7992

P7992

Symptomatic multiple myeloma
Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with chemotherapy; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7992

(l)insert in numerical order after existing text:

C10338

Symptomatic multiple myeloma
Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with chemotherapy.
Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10338

Schedule 4, Part 1, entry for Botulinum toxin type A purified neurotoxin complex

(a)omit:

C5220

Moderate to severe spasticity of the upper limb following a stroke
The condition must be moderate to severe spasticity of the upper limb/s following stroke, defined as a Modified Ashworth Scale rating of 3 or more; AND
The treatment must not be initiated until three months post-stroke; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (total Botox, Dysport, and Xeomin); AND
The treatment must not exceed 4 treatment periods (total Botox, Dysport, and Xeomin) per upper limb per lifetime; AND
Patient must not have established severe contracture in the limb to be treated.
Patient must be aged 18 years or older.
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
The date of the stroke must be documented in the patient's medical records when treatment is initiated.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 5220

(b)insert in numerical order after existing text:

C9547	Moderate to severe spasticity of the upper limb following an acute event The condition must be moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more; AND The treatment must only be used as second line therapy when standard management has failed; OR The treatment must only be used as an adjunct to physical therapy; AND The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND Patient must not have established severe contracture in the limb to be treated. Patient must be aged 18 years or older. Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon; OR Must be treated by a geriatrician. Standard management includes physiotherapy and/or oral spasticity agents.	Compliance with Authority Required procedures - Streamlined Authority Code 9547
C10298	Moderate to severe spasticity of the upper limb following an acute event Grandfather treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2020; AND The condition must have been moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND The treatment must only be used as second line therapy when standard management has failed; OR The treatment must only be used as an adjunct to physical therapy; AND The treatment must not continue if the patient did not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND Patient must not have established severe contracture in the limb to be treated. Patient must be aged 18 years or older. Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon; OR Must be treated by a geriatrician. Standard management includes physiotherapy and/or oral spasticity agents.	Compliance with Authority Required procedures - Streamlined Authority Code 10298

Schedule 4, Part 1, entry for Brivaracetam

substitute:

Brivaracetam	C10208	Intractable partial epileptic seizures Continuing treatment Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND The treatment must not be given concomitantly with levetiracetam.	Compliance with Authority Required procedures - Streamlined Authority Code 10208
C10210	Intractable partial epileptic seizures Initial treatment Must be treated by a neurologist. The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND The treatment must not be given concomitantly with levetiracetam, except for cross titration.	Compliance with Authority Required procedures - Streamlined Authority Code 10210
C10251	Intractable partial epileptic seizures Initial treatment Must be treated by a neurologist. The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND Patient must be unable to take a solid dose form of this drug; AND The treatment must not be given concomitantly with levetiracetam, except for cross titration.	Compliance with Authority Required procedures - Streamlined Authority Code 10251
C10330	Intractable partial epileptic seizures Continuing treatment Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND Patient must be unable to take a solid dose form of this drug; AND The treatment must not be given concomitantly with levetiracetam.	Compliance with Authority Required procedures - Streamlined Authority Code 10330

Schedule 4, Part 1, entry for Carfilzomib

substitute:

Carfilzomib	C7344	Multiple myeloma Grandfathering Patient must have received treatment with this drug for this condition prior to 1 January 2018; AND Patient must have a documented histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have had documented progressive disease after at least one prior therapy prior to commencing non-PBS subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
C7348	Multiple myeloma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not develop disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
C7355	Multiple myeloma Initial treatment The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not have previously received this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C10275

Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have received prior anti-HER2 therapy for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
The treatment must be in combination with trastuzumab and a taxane; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes details of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH).
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.

Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Rituximab

insert in numerical order after existing text:

C10227

P10227

Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Re-induction therapy
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 10227

Schedule 4, Part 1, entry for Sofosbuvir with velpatasvir and voxilaprevir

substitute:

Sofosbuvir with velpatasvir and voxilaprevir

C10248

Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
The application must include details of the prior treatment regimen containing an NS5A inhibitor.

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Tildrakizumab

(a)omit entry for circumstances code “C8933” and substitute:

C8933

P8933

Severe chronic plaque psoriasis
Initial treatment - Face, hand, foot, Grandfathered patients
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND
Patient must have had disease, prior to treatment with this drug for this condition, classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe; or (ii) the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The PASI assessment must be performed on the same affected area as assessed at baseline or prior to initiation of treatment with this drug.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment.
The most recent PASI assessment must be no more than 1 month old at the time of application.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

(b)omit entry for circumstances code “C8970” and substitute:

C8970

P8970

Severe chronic plaque psoriasis
Initial treatment - Whole body, Grandfathered patients
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND
Patient must have had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with this drug for this condition; AND
Patient must have demonstrated a response to treatment as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with this drug for this condition (whole body); AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheets including the date of the assessment of the patient's condition at baseline (prior to initiation of non-PBS subsidised therapy with this drug) and the most recent PASI assessment; and
(ii) the completed PASI calculation sheet demonstrating response.
The most recent PASI assessment must be no more than 1 month old at the time of application.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Tofacitinib

omit entry for circumstances code “C9170” and substitute:

C9170

P9170

Severe psoriatic arthritis
Initial treatment - Grandfather treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 May 2019; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) the date of commencement of this drug; and
(4) results of the baseline patient assessment prior to initiation of non-PBS subsidised therapy with this drug.

Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Tolvaptan

(a)omit:

C8287

Autosomal dominant polycystic kidney disease (ADPKD)
Initial treatment
Must be treated by a nephrologist.
Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min/1.73 m² at the initiation of treatment with this drug for this condition; AND
Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.
Rapidly progressing disease is defined as either of the following:
A decline in eGFR of greater than or equal to 5 mL/min/1.73 m² within one year;
OR
an average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m² per year over a five year period.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Autosomal dominant polycystic kidney disease PBS Authority Application - Supporting Information Form which includes the following:
(i) The eGFR at initiation of treatment; and
(ii) Confirmation that the patient has rapidly progressing disease or had rapidly progressing disease at the time treatment with this drug for this condition was initiated as defined as a decline in eGFR of greater than or equal to 5 mL/min/1.73 m² within one year or an average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m² per year over a five year period.

Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C10250

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Trastuzumab

(a)omit:

C9351

P9351

Early HER2 positive breast cancer
3 weekly treatment regimen
Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9351

(b)omit:

C9354	Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 9354
C9356	Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 9356
C9461	Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 9461

(c)omit:

C9628

Early HER2 positive breast cancer
Continuing treatment (weekly regimen)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9628

(d)insert in numerical order after existing text:

C10212	P10212	Early HER2 positive breast cancer 3 weekly treatment regimen Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 10212
C10213	Early HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.	Compliance with Authority Required procedures - Streamlined Authority Code 10213
C10293	Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 10293
C10294	Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.	Compliance with Authority Required procedures - Streamlined Authority Code 10294
C10296	Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 10296

Schedule 4, Part 1, entry for Trastuzumab emtansine

(a)omit:

C9359

Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
The treatment must not exceed a lifetime total of one continuous course.

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C10214	Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course for this PBS indication.	Compliance with Authority Required procedures
C10255	Early HER2 positive breast cancer Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.	Compliance with Written Authority Required procedures
C10273	Early HER2 positive breast cancer Grandfather adjuvant treatment Patient must have received non-PBS-subsidised treatment with this drug as adjuvant treatment of early HER2 positive breast cancer prior to 1 April 2020; AND The treatment must have been prescribed within 12 weeks after surgery prior to commencing treatment with this drug; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration using non-PBS-subsidised and PBS-subsidised drug supply obtained under the grandfather restriction and the continuing treatment restrictions combined. Authority applications for grandfather treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery and the number of non-PBS-subsidised cycles of treatment received by the patient.	Compliance with Written Authority Required procedures
C10295	Early HER2 positive breast cancer Continuing adjuvant treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.	Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Trifluridine with tipiracil

(a)omit:

C8195

Metastatic colorectal cancer
Initial treatment
Patient must have a WHO performance status of 1 or less; AND
Patient must have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; OR
Patient must not be a suitable candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-VEGF agent and an anti-EGFR agent for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 8195

(b)insert in numerical order after existing text:

C10252	Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction Initial treatment Patient must have a WHO performance status of 1 or less; AND Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND The treatment must be the sole PBS-subsidised therapy for this condition. The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 10252
C10309	Metastatic colorectal cancer Initial treatment Patient must have a WHO performance status of 1 or less; AND Patient must have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; OR Patient must not be a suitable candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-VEGF agent and an anti-EGFR agent for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 10309
C10310	Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 10310

Schedule 4, Part 3 - General statement for drugs for the treatment of hepatitis C

substitute:

Part 3—General statement for drugs for the treatment of hepatitis C

1 Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(1)the patient has been assessed in accordance with paragraph 2 of this Part; and

(2)the patient is:

(a)treated by a medical practitioner or an authorised nurse practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or

(b)treated by a medical practitioner or an authorised nurse practitioner in consultation with:

(i)a gastroenterologist; or

(ii)a hepatologist; or

(iii)an infectious diseases physician.

2 Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

(1)documented the following information in the patient’s medical records:

(a)evidence of chronic hepatitis C infection; and

(b)where possible, evidence of the patient’s hepatitis C virus genotype; and

(2)chosen a regimen in accordance with paragraph 3 of this Part; and

(3)collected the following information for the purposes of the authority application:

(a)whether the patient is:

(i)cirrhotic; or

(ii)non-cirrhotic

(b)details of the previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir or glecaprevir with pibrentasvir for 16 weeks’ treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).

(4)In this paragraph, evidence of chronic hepatitis C infection is documentation of:

(a)repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

(b)test result showing hepatitis C virus ribonucleic acid (RNA) positive.

3 Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

(1)is a kind of patient mentioned for an Item in column 2 of the following table; and

(2)is to receive one of the regimens mentioned in column 3 of the same Item of the following table.

Item

Kind of patient

Regimen

Patient:

(a) all genotypes (pan-genotypic); and

(b) who is treatment naïve; and

Either:

(a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b) GLECAPREVIR with PIBRENTASVIR for 8 weeks.

Patient:

(a) all genotypes (pan-genotypic); and

(b) who is treatment experienced; and

Either:

(a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(d) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(e) GLECAPREVIR with PIBRENTASVIR 16 weeks.

Patient:

(a) with Genotype 1; and

(b) who is treatment naïve; and

Either:

(a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(d) GRAZOPREVIR with ELBASVIR for 12 weeks.

Patient:

(a) with Genotype 1; and

(b) who is treatment experienced; and

Either:

(a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b) DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(d) GRAZOPREVIR with ELBASVIR for 12 weeks; or

(e) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.

Patient:

(a) with Genotype 2; and

(b) who is treatment naïve; and

SOFOSBUVIR and RIBAVIRIN for 12 weeks.

Patient:

(a) with Genotype 2; and

(b) who is treatment experienced; and

SOFOSBUVIR and RIBAVIRIN for 12 weeks.

Patient:

(a) with Genotype 3; and

(b) who is treatment naïve; and

Either:

(a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b) SOFOSBUVIR and RIBAVIRIN for 24 weeks.

Patient:

(a) with Genotype 3; and

(b) who is treatment experienced; and

Either:

(a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b) SOFOSBUVIR and RIBAVIRIN for 24 weeks.

Patient:

(a) with Genotype 4; and

(b) who is treatment naïve; and

GRAZOPREVIR with ELBASVIR for 12 weeks.

Patient:

(a) with Genotype 4; and

(b) who is treatment experienced; and

Either:

(a) GRAZOPREVIR with ELBASVIR for 12 weeks; or

(b) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.

Patient:

(a) with:

(i) Genotype 5; or

(ii) Genotype 6; and

(b) who is treatment naïve; and

Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).

Patient:

(a) with:

(i) Genotype 5; or

(ii) Genotype 6; and

(b) who is treatment experienced; and

Refer to item 1 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).

Patient:

(a) all genotypes (pan-genotypic); and

(b) who is treatment naïve; and

Either:

(a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b) GLECAPREVIR with PIBRENTASVIR for 12 weeks.

Patient:

(a) all genotypes (pan-genotypic); and

(b) who is treatment experienced; and

Either:

(a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(d) GLECAPREVIR with PIBRENTASVIR 16 weeks.

Patient:

(a) with Genotype 1; and

(b) who is treatment naïve; and

Either:

(a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(d) GRAZOPREVIR with ELBASVIR for 12 weeks.

Patient:

(a) with Genotype 1; and

(b) who is treatment experienced; and

Either:

(a) LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d) GRAZOPREVIR with ELBASVIR for 12 weeks; or

(e) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.

Patient:

(a) with Genotype 2; and

(b) who is treatment naïve; and

SOFOSBUVIR and RIBAVIRIN for 12 weeks.

Patient:

(a) with Genotype 2; and

(b) who is treatment experienced; and

SOFOSBUVIR and RIBAVIRIN for 12 weeks.

Patient:

(a) with Genotype 3; and

(b) who is treatment naïve; and

Either:

(a) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.

Patient:

(a) with Genotype 3; and

(b) who is treatment experienced; and

Either:

(a) DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.

Patient:

(a) with Genotype 4; and

(b) who is treatment naïve; and

GRAZOPREVIR with ELBASVIR for 12 weeks.

Patient:

(a) with Genotype 4; and

(b) who is treatment experienced; and

Either:

(a) GRAZOPREVIR with ELBASVIR for 12 weeks; or

(b) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.

Patient:

(a) with:

(i) Genotype 5; or

(ii) Genotype 6; and

(b) who is treatment naïve; and

Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).

Patient:

(a) with:

(i) Genotype 5; or

(ii) Genotype 6; and

(b) who is treatment experienced; and

Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).

Schedule 5, entry for Imatinib in the form Capsule 100 mg (as mesilate) [GRP-21074]

omit from the column headed “Brand”: IMATINIB AN

Schedule 5, entry for Imatinib in the form Capsule 100 mg (as mesilate) [GRP-21076]

omit from the column headed “Brand”: IMATINIB AN

Schedule 5, entry for Imatinib in the form Capsule 400 mg (as mesilate) [GRP-21079]

omit from the column headed “Brand”: IMATINIB AN

Schedule 5, entry for Imatinib in the form Capsule 400 mg (as mesilate) [GRP-21080]

omit from the column headed “Brand”: IMATINIB AN

Schedule 5, entry for Levodopa with carbidopa in the form Tablet 250 mg-25 mg (as monohydrate) [GRP-22958]

(a)insert in alphabetical order in the column headed “Brand”: APO-Levodopa/Carbidopa

(b)insert in alphabetical order in the column headed “Brand”: SINADOPA 250/25

Schedule 5, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg [GRP-21638]

omit from the column headed “Brand”: Truvada