National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 3) (PB 18 of 2016) (Cth)

PB 18 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 3)

National Health Act 1953

I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits 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 24 March 2016

PENNY SHAKESPEARE

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

1 Name of Instrument

(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 3).

(2) This Instrument may also be cited as PB 18 of 2016.

2 Commencement

This Instrument commences on 1 April 2016.

3 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 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 “Dronalen Plus”: FR substitute: AL

Schedule 1, entry for Alendronic acid with colecalciferol and calcium in the form Pack containing 4 tablets containing alendronic acid
70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate)

omit from the column headed “Responsible Person” for the brand “Dronalen Plus D-Cal”: FR substitute: AL

Schedule 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

insert:

Amino acid formula with fat, carbohydrate, without phenylalanine

Tablet: modified release, 70.8 g protein per 100 g, 110 g (PKU Easy Microtabs)

Oral

PKU Easy Microtabs

MP NP

C5970

Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan

insert as first item in the columns in the order indicated:

Sachets containing oral powder 18 g, 30 (GA1 Anamix Junior)

Oral

GA1 Anamix Junior

MP NP

C6007

Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine in the form Sachets containing oral powder 25 g, 30 (HCU express 15)

insert in the columns in the order indicated:

Sachets containing oral powder 36 g, 30 (HCU Anamix Junior)

Oral

HCU Anamix Junior

MP NP

C6038

Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

insert as first item in the columns in the order indicated:

Sachets containing oral powder 18 g, 30 (MMA/PA Anamix Junior)

Oral

MMA/PA Anamix Junior

MP NP

C5986 C6055

Schedule 1, entry for Anastrozole

(a)omit:

Anastrozole‑GA

MP NP

C5464

(b)omit:

Anzole

MP NP

C5464

Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL

(a)omit:

Apomine

C4833 C4860

360

D(100)

(b)omit from the column headed “Schedule Equivalent” for the brand “Movapo”: a

Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

(a)omit:

Apomine

C4833 C4860

180

D(100)

(b)omit from the column headed “Schedule Equivalent” for the brand “Movapo”: a

Schedule 1, entry for Arsenic

insert in numerical order in the column headed “Circumstances”: C5997 C6018

Schedule 1, entry for Artemether with lumefantrine in the form Tablet 20 mg-120 mg

omit from the column headed “Circumstances”: C5767 substitute: C5999

Schedule 1, entry for Artemether with lumefantrine in the form Tablet (dispersible) 20 mg‑120 mg

omit from the column headed “Circumstances”: C5632 substitute: C6036

Schedule 1, after entry for Atazanavir in the form Capsule 300 mg (as sulfate)

insert:

Atazanavir with cobicistat

Tablet containing 300 mg atazanavir and 150 mg cobicistat

Oral

Evotaz

C4454 C4512

D(100)

Schedule 1, entry for Atovaquone with proguanil

omit from the column headed “Circumstances”: C5714 substitute: C5981

Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)

(a)omit:

Zitrocin

MP NP

C5637 C5718 C5772

P5718 P5772

(b)omit:

Zitrocin

MP NP

C5637 C5718 C5772

P5637

Schedule 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL

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

Bacthecal

C5985 C5990 C6000 C6003 C6025 C6051 C6052 C6054

PB(100)

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

(c)omit from the column headed “Circumstances” for the brand “Lioresal Intrathecal”:
C1637 C1638 C1639 C1640 C3318 C3319 C3320 C3321
substitute: C5985 C5990 C6000 C6003 C6025 C6051 C6052 C6054

Schedule 1, entry for Bleomycin

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

CIPLA BLEOMYCIN

C1139 C1198

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms

(a)insert on the first line in the column headed “Manner of Administration”: Oral

(b)omit:

Oral	a	Dostan	GN	MP	C5136 C5137 C5357 C5172 C5398	P5172	2	0	2
NP	C5172	2	0	2

(c)omit:

Dostan

C5136 C5137 C5357 C5172 C5398

P5136 P5137 P5357 P5398

Schedule 1, entry for Cabergoline in each of the forms: Tablet 1 mg; and Tablet 2 mg

omit:

Cobasol

MP NP

C5168

Schedule 1, entry for Carmellose with glycerin

omit:

Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30	Application to the eye	Optive	AG	AO	C2802	3	5	1
MP NP	C1359	3	5	1

Schedule 1, entry for Carmustine

omit from the column headed “Circumstances”: C2462 substitute: C6056

Schedule 1, entry for Cephalexin in each of the forms: Granules for oral suspension 125 mg per 5 mL, 100 mL; and Granules for oral suspension 250 mg per 5 mL, 100 mL

(a)omit:

Cilex

PDP

(b)omit:

Cilex

MP NP

Schedule 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)

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

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

Citalopram AN

MP NP

C4755

Schedule 1, after entry for Citalopram in the form Tablet 40 mg (as hydrobromide) [Brand: Talam]

insert:

Citrulline

Tablet 1 g, 300 (Citrulline Easy)

Oral

Citrulline Easy

MP NP

C5984

Schedule 1, entry for Clindamycin

substitute:

Clindamycin	Capsule 150 mg (as hydrochloride)	Oral	a	APO-Clindamycin	TX	PDP	C5487	24	0	24
a	Calindamin	RW	PDP	C5487	24	0	24
a	Chem mart Clindamycin	CH	PDP	C5487	24	0	24
a	Cleocin	FZ	PDP	C5487	24	0	24
a	Clindamycin BNM	BZ	PDP	C5487	24	0	24
a	Clindamycin-Link	LM	PDP	C5487	24	0	24
a	Clindamyk	AF	PDP	C5487	24	0	24
a	Dalacin C	PF	PDP	C5487	24	0	24
a	Terry White Chemists Clindamycin	TW	PDP	C5487	24	0	24
a	APO-Clindamycin	TX	MP NP MW	C5470	48	1	24
a	Calindamin	RW	MP NP MW	C5470	48	1	24
a	Chem mart Clindamycin	CH	MP NP MW	C5470	48	1	24
a	Cleocin	FZ	MP NP MW	C5470	48	1	24
a	Clindamycin BNM	BZ	MP NP MW	C5470	48	1	24
a	Clindamycin-Link	LM	MP NP MW	C5470	48	1	24
a	Clindamyk	AF	MP NP MW	C5470	48	1	24
a	Dalacin C	PF	MP NP MW	C5470	48	1	24
a	Terry White Chemists Clindamycin	TW	MP NP MW	C5470	48	1	24

Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

omit:

Clopidogrel Actavis

MP NP

C5436 C5459 C5508 C5517 C5524 C5525

Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C5082 C5125 substitute: C6013 C6044

(b)omit from the column headed “Purposes”: P5082 substitute: P6044

Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5082 C5125 substitute: C6013 C6044

(b)omit from the column headed “Purposes”: P5125 substitute: P6013

Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C5082 C5125 substitute: C6013 C6044

(b)omit from the column headed “Purposes”: P5082 substitute: P6044

Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5082 C5125 substitute: C6013 C6044

(b)omit from the column headed “Purposes”: P5125 substitute: P6013

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

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

APO-Desvenlafaxine MR

MP NP

C4855

Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg (as benzoate)

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

APO-Desvenlafaxine MR

MP NP

C4855

Schedule 1, entry for Dexamethasone

omit:

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL	Injection	Dexmethsone	AF	MP NP	5	0	5
Hospira Pty Limited	HH	MP NP	5	0	5
Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL	Injection	Dexmethsone	AF	MP NP	5	1	5
Hospira Pty Limited	HH	MP NP	5	1	5

substitute:

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL	Injection	a	Dexamethasone Mylan	AF	MP NP	5	0	5
a	Hospira Pty Limited	HH	MP NP	5	0	5
Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL	Injection	a	Dexamethasone Mylan	AF	MP NP	5	1	5
a	Hospira Pty Limited	HH	MP NP	5	1	5

Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg

omit:

Enalapril‑GA

MP NP

Schedule 1, entry for Fenofibrate

substitute:

Fenofibrate	Tablet 48 mg	Oral	Lipidil	GO	MP	C6028 C6048	P6048	60	5	60
NP	C6048	60	5	60
MP	C6028 C6048	P6028	60	11	60
Tablet 145 mg	Oral	Lipidil	GO	MP	C6028 C6048	P6048	30	5	30
NP	C6048	30	5	30
MP	C6028 C6048	P6028	30	11	30

Schedule 1, after entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

insert in the columns in the order indicated:

Tablet (orally disintegrating) 100 microgram (as citrate)	Buccal	Fentora	TB	MP NP	C6026 C6027	P6026	8	0	4
MP NP	C6026 C6027	P6027	56	0	28
Tablet (orally disintegrating) 200 microgram (as citrate)	Buccal	Fentora	TB	MP NP	C6026 C6027	P6026	8	0	4
MP NP	C6026 C6027	P6027	56	0	28
Tablet (orally disintegrating) 400 microgram (as citrate)	Buccal	Fentora	TB	MP NP	C6026 C6027	P6026	8	0	4
MP NP	C6026 C6027	P6027	56	0	28
Tablet (orally disintegrating) 600 microgram (as citrate)	Buccal	Fentora	TB	MP NP	C6026 C6027	P6026	8	0	4
MP NP	C6026 C6027	P6027	56	0	28
Tablet (orally disintegrating) 800 microgram (as citrate)	Buccal	Fentora	TB	MP NP	C6026 C6027	P6026	8	0	4
MP NP	C6026 C6027	P6027	56	0	28

Schedule 1, entry for Flucloxacillin in each of the forms: Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL; and Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL

omit from the column headed “Number of Repeats” for Authorised Prescriber MP NP: 0 substitute: 1

Schedule 1, entry for Fluconazole in each of the forms: Capsule 50 mg; Capsule 100 mg; and Capsule 200 mg

omit from the column headed “Circumstances”: C5667 C5668 C5728 C5752 C5790 C5811
substitute: C5978 C5989 C5996 C6002 C6023 C6030

Schedule 1, entry for Fluconazole in the form Powder for oral suspension 50 mg in 5 mL, 35 mL

omit from the column headed “Circumstances”: C5625 C5652 C5675 C5758 C5759 C5815
substitute: C5982 C6006 C6031 C6032 C6045 C6046

Schedule 1, entry for Fluconazole in each of the forms: Solution for I.V. infusion 100 mg in 50 mL; Solution for I.V. infusion 200 mg in
100 mL; and Solution for I.V. infusion 400 mg in 200 mL

omit from the column headed “Circumstances”: C5667 C5668 C5728 C5752 C5790 C5811
substitute: C5978 C5989 C5996 C6002 C6023 C6030

Schedule 1, entry for Fluvastatin

substitute:

Fluvastatin	Tablet (prolonged release) 80 mg (as sodium)	Oral	Lescol XL	NV	MP	C4238 C4263	P4263	28	5	28
NP	C4263	28	5	28
MP	C4238 C4263	P4238	28	11	28

Schedule 1, entry for Gabapentin in the form Capsule 300 mg

omit:

Gabapentin‑GA

MP NP

C4928

100

Schedule 1, entry for Gemfibrozil

substitute:

Gemfibrozil	Tablet 600 mg	Oral	a	Ausgem	QA	MP	C6028 C6048	P6048	60	5	60
NP	C6048	60	5	60
a	Chem mart Gemfibrozil	CH	MP	C6028 C6048	P6048	60	5	60
NP	C6048	60	5	60
a	GenRx Gemfibrozil	GX	MP	C6028 C6048	P6048	60	5	60
NP	C6048	60	5	60
a	Lipigem	AF	MP	C6028 C6048	P6048	60	5	60
NP	C6048	60	5	60
a	Terry White Chemists Gemfibrozil	TW	MP	C6028 C6048	P6048	60	5	60
NP	C6048	60	5	60
a	Ausgem	QA	MP	C6028 C6048	P6028	60	11	60
a	Chem mart Gemfibrozil	CH	MP	C6028 C6048	P6028	60	11	60
a	GenRx Gemfibrozil	GX	MP	C6028 C6048	P6028	60	11	60
a	Lipigem	AF	MP	C6028 C6048	P6028	60	11	60
a	Terry White Chemists Gemfibrozil	TW	MP	C6028 C6048	P6028	60	11	60

Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (SensoCard)

insert in the columns in the order indicated:

Test strips, 50 (2in1 Smart)	For external use	2in1 smart glucose test strips	UB	MP NP	2	5	1
MP	P4241	2	11	1

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C5457 C5463 C5513 substitute: C6024 C6033 C6047

(b)omit from the column headed “Purposes”: P5457 P5513 substitute: P6024 P6033

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5457 C5463 C5513 substitute: C6024 C6033 C6047

(b)omit from the column headed “Purposes”: P5463 substitute: P6047

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of
Repeats: 3]

(a)omit from the column headed “Circumstances”: C5457 C5463 C5513 substitute: C6024 C6033 C6047

(b)omit from the column headed “Purposes”: P5457 P5513 substitute: P6024 P6033

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of
Repeats: 5]

(a)omit from the column headed “Circumstances”: C5457 C5463 C5513 substitute: C6024 C6033 C6047

(b)omit from the column headed “Purposes”: P5463 substitute: P6047

Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

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

MEDITAB IRINOTECAN

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Itraconazole

insert as first item in the columns in the order indicated:

Capsule 50 mg

Oral

Lozanoc

MP NP

C5988 C6005 C6016 C6022 C6035 C6037 C6057

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

omit from the column headed “Circumstances”: C5698 C5699 C5700 C5728 C5760 C5790 C5793
substitute: C5988 C6005 C6016 C6022 C6035 C6037 C6057

Schedule 1, entry for Lamotrigine in the form Tablet 25 mg

omit:

Torlemo DT 25

MP NP

C5138

Schedule 1, entry for Lamotrigine in the form Tablet 50 mg

omit:

Torlemo DT 50

MP NP

C5138

Schedule 1, entry for Lamotrigine in the form Tablet 100 mg

omit:

Torlemo DT 100

MP NP

C5138

Schedule 1, entry for Lamotrigine in the form Tablet 200 mg

omit:

Torlemo DT 200

MP NP

C5138

Schedule 1, entry for Letrozole

(a)omit:

Letrozole Actavis

MP NP

C5464

(b)omit:

Letrozole‑GA

MP NP

C5464

Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and
7 inert tablets

(a)insert in the column headed “Schedule Equivalent” for the brands “Eleanor 150/30 ED”, “Evelyn 150/30 ED”, “Femme‑Tab ED 30/150”, “Levlen ED”, “Microgynon 30 ED” and “Micronelle 30 ED”: b

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

Lenest 30 ED

MP NP

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

omit from the column headed “Maximum Quantity”: 60 substitute: 120

Schedule 1, entry for Minocycline

omit from the column headed “Circumstances” (twice occurring): C1347 substitute: C5995

Schedule 1, entry for Mirtazapine in each of the forms: Tablet 15 mg (orally disintegrating); Tablet 30 mg (orally disintegrating); and
Tablet 45 mg (orally disintegrating)

omit from the column headed “Responsible Person” for the brand “Remeron SolTab”: FR substitute: AF

Schedule 1, entry for Modafinil

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

Modafin

C5983 C6017

120

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

(c)omit from the column headed “Circumstances” for the brand “Modavigil”: C2090 C3145 substitute: C5983 C6017

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

omit from the column headed “Responsible Person” for the brand “Novasone”: FR substitute: AF

Schedule 1, after entry for Mycophenolic Acid in the form Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL,
165 mL

insert:

Nadroparin	Injection containing nadroparin calcium (1,900 I.U. anti-Xa) in 0.2 mL pre-filled syringe	Injection	Fraxiparine	AS	MP NP	4	0	2
MP NP	P6014	4	3	2
Injection containing nadroparin calcium (2,850 I.U. anti-Xa) in 0.3 mL pre-filled syringe	Injection	Fraxiparine	AS	MP NP	4	0	2
MP NP	P6014	4	3	2
Injection containing nadroparin calcium (3,800 I.U. anti-Xa) in 0.4 mL pre-filled syringe	Injection	Fraxiparine	AS	MP NP	4	0	2
MP NP	P6014	4	3	2
Injection containing nadroparin calcium (5,700 I.U. anti-Xa) in 0.6 mL pre-filled syringe	Injection	Fraxiparine	AS	MP NP	4	0	2
MP NP	P6014	4	3	2
Injection containing nadroparin calcium (7,600 I.U. anti-Xa) in 0.8 mL pre-filled syringe	Injection	Fraxiparine	AS	MP NP	2	1	2
MP NP	P6014	4	3	2
Injection containing nadroparin calcium (9,500 I.U. anti-Xa) in 1 mL pre-filled syringe	Injection	Fraxiparine	AS	MP NP	2	1	2
MP NP	P6014	4	3	2
Injection containing nadroparin calcium (11,400 I.U. anti-Xa) in 0.6 mL pre-filled syringe	Injection	Fraxiparine Forte	MP NP	2	1	2
Injection containing nadroparin calcium (15,200 I.U. anti-Xa) in 0.8 mL pre-filled syringe	Injection	Fraxiparine Forte	MP NP	2	1	2
Injection containing nadroparin calcium (19,000 I.U. anti-Xa) in 1 mL pre-filled syringe	Injection	Fraxiparine Forte	MP NP	2	1	2

Schedule 1, entry for Natalizumab

omit from the column headed “Circumstances”: C3423 C3424 C3425 substitute: C5987 C6012 C6043

Schedule 1, after entry for Nedocromil

insert:

Netupitant with Palonosetron

Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride)

Oral

Akynzeo

MP NP

C5991 C5994

Schedule 1, entry for Norfloxacin

omit:

Norfloxacin‑GA

MP NP

C5744 C5806

Schedule 1, entry for Palonosetron

omit from the column headed “Responsible Person”: TS substitute: ZD

Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

omit:

Torzole 20

MP NP

C5444 C5512 C5529

Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

(a)omit:

Torzole 40

MP NP

C5444 C5445 C5512 C5529

P5445

(b)omit:

Torzole 40

MP NP

C5444 C5445 C5512 C5529

P5444 P5512 P5529

Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)

(a)omit:

Cilopen VK

MP NP PDP

(b)omit:

Cilopen VK

MP NP

P5697

Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium)

omit:

Cilopen VK

MP NP PDP

Schedule 1, entry for Pindolol

omit:

Tablet 15 mg

Oral

Visken 15

MP NP

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Pravastatin Actavis 10	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Pravastatin Actavis 10

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047substitute: P4238

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Pravastatin Actavis 20	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Pravastatin Actavis 20

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Pravastatin Actavis 40	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Pravastatin Actavis 40

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Pravastatin Actavis 80	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Pravastatin Actavis 80

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238

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

omit:

Quetiapine‑GA

MP NP

C4385 C4391 C4396

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

omit:

Quetiapine‑GA

MP NP

C4246 C5611 C5639

Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)

omit:

Quetiapine‑GA

MP NP

C4246 C5611 C5639

Schedule 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

omit:

Quinapril‑GA

MP NP

Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

omit:

Rabeprazole‑GA

MP NP

C5444 C5512

Schedule 1, entry for Ramipril in the form Capsule 1.25 mg

omit:

Ramipril‑GA

MP NP

Schedule 1, entry for Rasagiline

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

Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C5897

(b)insert in numerical order: C5993

(c)omit from the column headed “Purposes”: P5897

(d)insert in numerical order: P5993

Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5897

(b)insert in numerical order: C5993

Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

Risperidone AMNEAL

MP NP

C5902 C5903 C5911 C6010

P5902 P5911 P6010

(b)omit:

Risperidone-GA

MP NP

C5902 C5903 C5908 C5911

P5902 P5908 P5911

(c)omit from the column headed “Circumstances” (all instances): C5908

(d)insert in numerical order (all instances): C6010

(e)omit from the column headed “Purposes” (all instances): P5908

(f)insert in numerical order (all instances): P6010

Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Risperidone AMNEAL

MP NP

C5902 C5903 C5911 C6010

P5903

(b)omit:

Risperidone-GA

MP NP

C5902 C5903 C5908 C5911

P5903

(c)omit from the column headed “Circumstances” (all instances): C5908

(d)insert in numerical order (all instances): C6010

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

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

Risperidone AMNEAL

MP NP

C4246 C5898 C5907 C5916 C5993

P5898 P5916 P5993

(b)omit:

Risperidone-GA

MP NP

C4246 C5897 C5898 C5907 C5916

P5897 P5898 P5916

(c)omit from the column headed “Circumstances” (all instances): C5897

(d)insert in numerical order (all instances): C5993

(e)omit from the column headed “Purposes” (all instances): P5897

(f)insert in numerical order (all instances): P5993

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

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

Risperidone AMNEAL

MP NP

C4246 C5898 C5907 C5916 C5993

P4246 P5907

(b)omit:

Risperidone-GA

MP NP

C4246 C5897 C5898 C5907 C5916

P4246 P5907

(c)omit from the column headed “Circumstances” (all instances): C5897

(d)insert in numerical order (all instances): C5993

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

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

Risperidone AMNEAL

MP NP

C4246 C5898 C5907 C5916

P5898 P5916

(b)omit:

Risperidone-GA

MP NP

C4246 C5898 C5907 C5916

P5898 P5916

Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Risperidone AMNEAL

MP NP

C4246 C5898 C5907 C5916

P4246 P5907

(b)omit:

Risperidone-GA

MP NP

C4246 C5898 C5907 C5916

P4246 P5907

Schedule 1, entry for Risperidone in each of the forms: Tablet 3 mg; and Tablet 4 mg

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

Risperidone AMNEAL

MP NP

C4246 C5907

(b)omit:

Risperidone-GA

MP NP

C4246 C5907

Schedule 1, entry for Rituximab

substitute:

Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Mabthera	RO	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
MP	C4706 C5980 C5998 C6001 C6009 C6034 C6039 C6040 C6058	See Note 3	See Note 3	See Note 3	2	PB(100)
Solution for I.V. infusion 500 mg in 50 mL	Injection	Mabthera	RO	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
MP	C4706 C5980 C5998 C6001 C6009 C6034 C6039 C6040 C6058	See Note 3	See Note 3	See Note 3	1	PB(100)
Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL	Injection	Mabthera SC	RO	MP	C5980 C5992 C5998 C6011	P5998	1	2	1
MP	C6004 C6008 C6039 C6040	P6039	1	2	1	C(100)
MP	C5980 C5992 C5998 C6011	P5980	1	6	1
MP	C6004 C6008 C6039 C6040	P6040	1	6	1	C(100)
MP	C5980 C5992 C5998 C6011	P6011	1	7	1
MP	C6004 C6008 C6039 C6040	P6008	1	7	1	C(100)
MP	C5980 C5992 C5998 C6011	P5992	1	11	1
MP	C6004 C6008 C6039 C6040	P6004	1	11	1	C(100)

Schedule 1, entry for Rizatriptan in the form Wafer 10 mg (as benzoate)

omit from the column headed “Responsible Person” for the brand “Rizatriptan Wafers-10mg”: FR substitute: AF

Schedule 1, entry for Salbutamol in each of the forms: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30; and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

omit:

Salbutamol‑GA

MP NP

C1754 C1755

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

(a)omit from the column headed “Circumstances” for Authorised Prescriber MP (twice occurring): C1540 C3047 substitute: C4238 C4263

(b)omit from the column headed “Purposes” for Authorised Prescriber MP (twice occurring): P1540 substitute: P4263

(c)omit from the column headed “Circumstances” for Authorised Prescriber NP (twice occurring): C1540 substitute: C4263

Schedule 1, entry for Simvastatin in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit from the column headed “Circumstances” (twice occurring): C1540 C3047 substitute: C4238 C4263

(b)omit from the column headed “Purposes” (twice occurring): P3047 substitute: P4238

Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Simvastatin‑DP	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Simvastatin‑DP

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238

Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Simvastatin‑DP	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Simvastatin‑DP

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047 substitute: P4263

Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Simvastatin‑DP	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Simvastatin‑DP

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238

Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

Simvastatin‑DP	UA	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” for Authorised Prescriber MP (all instances): P1540 substitute: P4263

(d)omit from the column headed “Circumstances” for Authorised Prescriber NP (all instances): C1540 substitute: C4263

Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

Simvastatin‑DP

C1540 C3047

P3047

(b)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263

(c)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238

Schedule 1, after entry for Sumatriptan in the form Tablet (fast disintegrating) 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 2]

insert in the columns in the order indicated:

MP NP

C5259

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

insert as first item in the columns in the order indicated:

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

Oral

Genvoya

C4470 C4522

D(100)

Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

(a)omit:

GA Tramadol 50mg	GN	MP NP	C5848 C5877	P5877	20	0	20
PDP	C5875 C5876	20	0	20

(b)omit:

GA Tramadol 50mg

MP NP

C5848 C5877

P5848

Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C5081 C5108 substitute: C6021 C6029

(b)omit from the column headed “Purposes”: P5108 substitute: P6021

Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5081 C5108 substitute: C6021 C6029

(b)omit from the column headed “Purposes”: P5018 substitute: P6029

Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C5081 C5108 substitute: C6021 C6029

(b)omit from the column headed “Purposes”: P5108 substitute: P6021

Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5081 C5108 substitute: C6021 C6029

(b)omit from the column headed “Purposes”: P5081 substitute: P6029

Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg

omit:

Trandolapril‑DP

MP NP

Schedule 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg; and Powder for I.V. infusion 150 mg

omit from the column headed “Section 100/ Prescriber Bag only”: D(100) substitute: PB(100)

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

insert in the columns in the order indicated:

Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL	Injection	Herceptin SC	RO	MP	C5024 C5032 C5041 C6059 C6060 C6061 C6062	P5032 P6059 P6060	1	0	1
MP	C5024 C5032 C5041 C6059 C6060 C6061 C6062	P5024 P5041 P6061 P6062	1	3	1

Schedule 1, entry for Valaciclovir

(a)omit:

Valaciclovir GA

MP NP

C5940 C5960 C5961 C5962 C5968

P5960

(b)omit:

Valaciclovir GA

MP NP

C5940 C5960 C5961 C5962 C5968

P5940 P5961

(c)omit:

Valaciclovir GA

MP NP

C5940 C5960 C5961 C5962 C5968

P5962 P5968

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

omit:

Venlexor XR

MP NP

C5650

Schedule 3, entry for Responsible Person code CS

omit from the column headed “Responsible Person”: bioCSL substitute: Seqirus

Schedule 3, after details relevant to Responsible Person code LO

insert:

Cipla Australia Pty Ltd

46 132 155 063

Schedule 3, after details relevant to Responsible Person code UA

insert:

Merchantshub Networks (AustPacific) Pty Ltd

89 164 346 794

Schedule 3

omit:

Actavis Pty Ltd

17 003 854 626

Schedule 3, after details relevant to Responsible Person code ZC

insert:

Specialized Therapeutics Pty Ltd

89 601 114 087

Schedule 4, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

insert in numerical order after existing text:

C5945

Eosinophilic oesophagitis

Initial treatment for up to 3 months

Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C5974

Eosinophilic oesophagitis

Continuing treatment

Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

Compliance with Authority Required procedures

Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

insert:

Amino acid formula with fat, carbohydrate, without phenylalanine

C5970

Phenylketonuria

Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan

insert in numerical order after existing text:

C6007

Proven glutaric aciduria type 1

Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without methionine

insert in numerical order after existing text:

C6038

Pyridoxine non-responsive homocystinuria

Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

(a)omit:

C5945

Eosinophilic oesophagitis

Initial treatment for up to 3 months

Compliance with Authority Required procedures

C5974

Eosinophilic oesophagitis

Continuing treatment

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C5986	Propionic acidaemia
C6055	Methylmalonic acidaemia

Schedule 4, Part 1, entry for Arsenic

insert in numerical order after existing text:

C5997

Acute promyelocytic leukaemia

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.

Compliance with Authority Required procedures - Streamlined Authority Code 5997

C6018

Acute promyelocytic leukaemia

Induction and consolidation treatment

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.

Compliance with Authority Required procedures - Streamlined Authority Code 6018

Schedule 4, Part 1, entry for Artemether with lumefantrine

substitute:

Artemether with lumefantrine

C5999

Confirmed or suspected Plasmodium falciparum malaria

C6036

Confirmed or suspected Plasmodium falciparum malaria

Patient must be unable to swallow a solid dosage form of artemether with lumefantrine.

Schedule 4, Part 1, after entry for Atanazavir

insert:

Atazanavir with cobicistat

C4454

HIV infection

Continuing

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents.

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

C4512

HIV infection

Initial

Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents.

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

Schedule 4, Part 1, entry for Atovaquone with proguanil

substitute:

Atovaquone with proguanil

C5981

Confirmed or suspected Plasmodium falciparum malaria

The treatment must be used where quinine containing regimens are inappropriate.
Patient must be aged 3 years or older.

Schedule 4, Part 1, entry for Baclofen

substitute:

Baclofen	C5985	Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity of cerebral origin.	Compliance with Written or Telephone Authority Required procedures
C5990	Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord injury.	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5990
C6000	Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity of cerebral origin.	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 6000
C6003	Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to multiple sclerosis.	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 6003
C6025	Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord disease.	Compliance with Written or Telephone Authority Required procedures
C6051	Where the patient is receiving treatment at/from a public hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord disease.	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 6051
C6052	Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to multiple sclerosis.	Compliance with Written or Telephone Authority Required procedures
C6054	Where the patient is receiving treatment at/from a private hospital Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord injury.	Compliance with Written or Telephone Authority Required procedures

Schedule 4, Part 1, entry for Carmellose with glycerin

(a)omit:

C1359

Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops

Compliance with Authority Required procedures – Streamlined Authority Code 1359

(b)omit:

C2802

Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Carmustine

substitute:

Carmustine

C6056

Glioblastoma multiforme

The condition must be suspected or confirmed at the time of initial surgery.

Schedule 4, Part 1, after entry for Citalopram

insert:

Citrulline

C5984

Urea cycle disorders

The treatment must be for preventing low plasma arginine levels; OR
The treatment must be for preventing low citrulline levels.

Schedule 4, Part 1, entry for Dabrafenib

substitute:

Dabrafenib

C6013

P6013

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 have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 6013

C6044

P6044

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS subsidised therapy; OR
Patient must have developed intolerance to another BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must have a WHO performance status of 2 or less.

Compliance with Authority Required procedures - Streamlined Authority Code 6044

Schedule 4, Part 1, entry for Fenofibrate

substitute:

Fenofibrate

C6028

P6028

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

C6048

P6048

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

Schedule 4, Part 1, entry for Fentanyl

insert in numerical order after existing text:

C6026

P6026

Breakthrough pain

Initial treatment for dose titration

Patient must have cancer; AND
Patient must have pain directly attributable to cancer; AND
Patient must be assessed as receiving adequate management of their persistent pain with opioids; AND
Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; OR
The treatment must be used as short acting opioids are considered clinically inappropriate; OR
Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain.
Patient must be undergoing palliative care.

Compliance with Written or Telephone Authority Required procedures

C6027

P6027

Breakthrough pain

Continuing treatment

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Fluconazole

substitute:

Fluconazole	C5978	Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed.
C5982	Candida infections The condition must be serious or life-threatening; AND Patient must be unable to take a solid dose form of fluconazole.
C5989	Oesophageal candidiasis Patient must be immunosuppressed.
C5996	Candida infections The condition must be serious or life-threatening.
C6002	Cryptococcal meningitis
C6006	Cryptococcal meningitis Patient must be unable to take a solid dose form of fluconazole.
C6023	Oropharyngeal candidiasis Patient must be immunosuppressed.
C6030	Oropharyngeal candidiasis The treatment must be for prophylaxis; AND Patient must be immunosuppressed.
C6031	Oropharyngeal candidiasis Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.
C6032	Oropharyngeal candidiasis The treatment must be for prophylaxis; AND Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.
C6045	Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.
C6046	Oesophageal candidiasis Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.

Schedule 4, Part 1, entry for Fluvastatin

substitute:

Fluvastatin

C4238

P4238

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

C4263

P4263

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

Schedule 4, Part 1, entry for Gemfibrozil

substitute:

Gemfibrozil

C6028

P6028

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

C6048

P6048

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

Schedule 4, Part 1, entry for Golimumab

(a)omit:

C5457

P5457

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
The authority application must be made in writing and must include:
(a) a completed authority prescription form and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
If a patient fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD.
An adequate response to treatment is defined as:
(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 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, cervical spine 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).

Compliance with Written Authority Required procedures

C5463

P5463

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a 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 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).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
All applications for continuing treatment with golimumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with golimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with golimumab.
If a patient fails to demonstrate a response to treatment with golimumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

C5513

P5513

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
The following 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) a total 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).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
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.
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.

Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C6024

P6024

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Compliance with Written Authority Required procedures

C6033

P6033

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Compliance with Written Authority Required procedures

C6047

P6047

Severe active rheumatoid arthritis

Continuing treatment

Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Itraconazole

substitute:

Itraconazole	C5988	Disseminated pulmonary histoplasmosis infection Treatment and maintenance therapy Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS).
C6005	Systemic sporotrichosis
C6016	Oropharyngeal candidiasis Patient must be immunosuppressed.
C6022	Systemic aspergillosis
C6035	Oesophageal candidiasis Patient must be immunosuppressed.
C6037	Chronic pulmonary histoplasmosis infection Treatment and maintenance therapy Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS).
C6057	Systemic histoplasmosis

Schedule 4, Part 1, entry for Minocycline

substitute:

Minocycline

C5995

Severe acne

The condition must not be responding to other tetracyclines.

Schedule 4, Part 1, entry for Modafinil

substitute:

Modafinil

C5983

Narcolepsy

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug.

Compliance with Authority Required procedures

C6017

Narcolepsy

Initial treatment

The treatment must be for use when therapy with dexamphetamine sulfate poses an unacceptable medical risk; OR
The treatment must be for use when intolerance to dexamphetamine sulfate is of a severity to necessitate treatment withdrawal; AND
Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND
Patient must have a definite history of cataplexy; OR
Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); OR
Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND
Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.
Must be treated by a qualified sleep medicine practitioner or neurologist.
The presence of any one of the following indicates treatment with dexamphetamine sulfate poses an unacceptable medical risk:
(a) a psychiatric disorder;
(b) a cardiovascular disorder;
(c) a history of substance abuse;
(d) glaucoma;
(e) any other absolute contraindication to dexamphetamine sulfate as specified in the TGA-approved Product Information.
The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.
The authority application must be made in writing and must include the following:
(a) a completed authority prescription form; and
(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and
(c) details of the contraindication or intolerance to dexamphetamine sulfate; and
(d) either:
(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or
(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.
The polysomnography, MSLT or EEG test reports must be provided with the authority application.

Compliance with Written Authority Required procedures

Schedule 4, Part 1, after entry for Mycophenolic Acid

insert:

Nadroparin

P6014

Haemodialysis

Schedule 4, Part 1, entry for Natalizumab

substitute:

Natalizumab

C5987

Where the patient is receiving treatment at/from a private hospital

Clinically definite relapsing-remitting multiple sclerosis

Initial treatment

The treatment must be as monotherapy; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
Patient must be aged 18 years or older.
Must be treated by a neurologist.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

Compliance with Written or Telephone Authority Required procedures

C6012

Where the patient is receiving treatment at/from a private hospital

Clinically definite relapsing-remitting multiple sclerosis

Continuing treatment

The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate, this therapy.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

Compliance with Written or Telephone Authority Required procedures

C6043

Where the patient is receiving treatment at/from a public hospital

Clinically definite relapsing-remitting multiple sclerosis

The treatment must be as monotherapy; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
Patient must be aged 18 years or older.
Must be treated by a neurologist.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 6043

Schedule 4, Part 1, after entry for Nebivolol

insert:

Netupitant with Palonosetron

C5991

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 5991

C5994

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 5994

Schedule 4, Part 1, entry for Pravastatin

substitute:

Pravastatin

C4238

P4238

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

C4263

P4263

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

Schedule 4, Part 1, entry for Risperidone

(a)omit:

C5908

P5908

Behavioural disturbances

The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia; AND
Patient must have failed to respond to non-pharmacological methods of treatment.
Patient must have failed to respond to non-pharmacological methods of treatment; AND
The treatment must be limited to a maximum duration of 12 weeks.

Compliance with Authority Required procedures - Streamlined Authority Code 5908

(b)insert in numerical order after existing text:

C5993

P5993

Behavioural disturbances

The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia of the Alzheimer type; AND
Patient must have failed to respond to non-pharmacological methods of treatment; AND
The treatment must be limited to a maximum duration of 12 weeks.

Compliance with Authority Required procedures - Streamlined Authority Code 5993

C6010

P6010

Behavioural disturbances

Compliance with Authority Required procedures - Streamlined Authority Code 6010

Schedule 4, Part 1, entry for Rituximab

(a)omit:

C4674	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4674
C4677	Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma Re-induction treatment 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 under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4677
C4678	Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma Re-induction treatment 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 under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4678
C4686	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4686
C4701	Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with chemotherapy; AND The condition must be previously untreated; AND The condition must be symptomatic; AND The treatment must be for induction treatment purposes only; AND Patient must not receive more than 8 doses under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4701

(b)omit:

C4726

Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses under this restriction

Compliance with Authority Required procedures - Streamlined Authority Code 4726

(c)insert in numerical order after existing text

C5980	Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with chemotherapy; AND The condition must be previously untreated; AND The condition must be symptomatic; AND The treatment must be for induction treatment purposes only; AND Patient must not receive more than 8 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 7 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 8 doses in total.	Compliance with Authority Required procedures - Streamlined Authority Code 5980
C5992	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 5992
C5998	Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma Re-induction treatment 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 5998
C6001	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6001
C6004	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6004
C6008	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6008
C6009	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6009
C6011	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6011
C6034	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6034
C6039	Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma Re-induction treatment 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 6039
C6040	Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with chemotherapy; AND The condition must be previously untreated; AND The condition must be symptomatic; AND The treatment must be for induction treatment purposes only; AND Patient must not receive more than 8 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 7 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 8 doses in total.	Compliance with Authority Required procedures - Streamlined Authority Code 6040
C6058	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6058

Schedule 4, Part 1, entry for Simvastatin

substitute:

Simvastatin

C4238

P4238

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

C4263

P4263

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

Schedule 4, Part 1, entry for Trametinib

substitute:

Trametinib

C6021

P6021

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment

Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND
Patient must not have had progressive disease when treated with a BRAF inhibitor.

Compliance with Authority Required procedures - Streamlined Authority Code 6021

C6029

P6029

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 dabrafenib concomitantly for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 6029

Schedule 4, Part 1, entry for Trastuzumab

insert in numerical order after existing text:

C6059	Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with adjuvant chemotherapy; AND Patient must have undergone 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 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). 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: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
C6060	Locally advanced HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with neoadjuvant chemotherapy; 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). 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: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
C6061	Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; 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 a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures
C6062	Locally advanced HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; 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 a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures

Schedule 5, insert as first entry

insert:

Desvenlafaxine	GRP-16219	Tablet (modified release) 100 mg	Oral	Desfax Desvenlafaxine Actavis
	Tablet (modified release) 100 mg (as benzoate)	Oral	APO-Desvenlafaxine MR Desvenlafaxine GH XR
	GRP-16220	Tablet (modified release) 50 mg	Oral	Desfax Desvenlafaxine Actavis
	Tablet (modified release) 50 mg (as benzoate)	Oral	APO-Desvenlafaxine MR Desvenlafaxine GH XR