Pharmaceutical Benefits [substance] Amendment Determination 2007 (No. )

Schedule 1 Amendments

substitute:

Adalimumab	Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Humira	AB	MP See Note 1	See Note 3	See Note 3	See Note 3	See Note 3	PB
	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Humira	AB	MP See Note 1	See Note 3	See Note 3	See Note 3	See Note 3	C
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P2986 P2987 P2990 P2991 P2993 P3695 P3696	2	2
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P3486 P3487 P3502 P3503 P3520 P3521 P3568 P3569	2	3
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P3265 P3266 P3267 P3268	2	4
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P2988 P2989 P2992 P2994 P2995 P3270 P3272 P3488 P3504 P3522 P3523 P3570 P3697 P3698	2	5
	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Humira	AB	MP See Note 1	See Note 3	See Note 3	See Note 3	See Note 3	C
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P2986 P2987 P2990 P2991 P2993 P3695 P3696	2	2
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P3486 P3487 P3502 P3503 P3520 P3521 P3568 P3569	2	3
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P3265 P3266 P3267 P3268	2	4
					MP	C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698	P2988 P2989 P2992 P2994 P2995 P3270 P3272 P3488 P3504 P3522 P3523 P3570 P3697 P3698	2	5
	Injection 40 mg in 0.8 mL pre-filled syringe, 6	Injection	Humira	AB	MP	C2986 C2987 C2990 C2991 C2993 C3695 C3696		1	0
	Injection 40 mg in 0.8 mL pre-filled pen, 6	Injection	Humira	AB	MP	C2986 C2987 C2990 C2991 C2993 C3695 C3696		1	0

[2] Schedule 1, after entry for Adalimumab

insert in the columns in the order indicated:

Adapalene with benzoyl peroxide	Gel 1 mg-25 mg per g, 30 g	Application	Epiduo	GA	MP	C3689 C3690	P3689	1	1
					MP	C3689 C3690	P3690	1	3
					NP	C3690		1	3

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

omit:

Perivasc

MP NP

[4] Schedule 1, entry for Atenolol in the form Tablet 50 mg

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

Atenolol generichealth

MP NP

[5] Schedule 1, entry for Carmellose

omit from the column headed “Responsible Person” (twice occurring): HA substitute: VT

[6] Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 250 mg (as hydrochloride); Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

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

C3680

[7] Schedule 1, entry for Clindamycin

omit from the column headed “Responsible Person”: KR substitute: FZ

[8] Schedule 1, omit entry for Dydrogesterone

[9] 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:

Alphapril

MP NP

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

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

DBL Epirubicin Hydrochloride Injection

See Note 1

[11] Schedule 1, entry for Filgrastim

omit from the column headed “Form”:

Injection 300 micrograms in 0.5 mL single use pre-filled syringe

substitute:

Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)

[12] Schedule 1, after entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)

insert in the columns in the order indicated:

Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)

Injection

Nivestim

MP
See Note 1

C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377

[13] Schedule 1, entry for Filgrastim

omit from the column headed “Form”:

Injection 480 micrograms in 0.5 mL single use pre-filled syringe

substitute:

Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)

[14] Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)

insert in the columns in the order indicated:

Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)

Injection

Nivestim

MP
See Note 1

[15] Schedule 1, entry for Flupenthixol Decanoate

omit:

	Oily I.M. injection 20 mg in 1 mL ampoule	Injection	Fluanxol Depot	LU	MP NP			5	0
	Oily I.M. injection 40 mg in 2 mL ampoule	Injection	Fluanxol Depot	LU	MP NP			5	0

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

omit from the column headed “Responsible Person”: AW substitute: GN

[17] Schedule 1, entry for Gabapentin in the form Capsule 400 mg

(a) omit:

Douglas Gabapentin 400 mg

MP NP

C2664

100

(b) omit from the column headed “Responsible Person”: AW substitute: GN

[18] Schedule 1, entry for Gabapentin in the form Tablet 600 mg

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

Pharmacor Gabapentin 600

MP NP

C2664

100

[19] Schedule 1, entry for Gabapentin in the form Tablet 800 mg

(a) omit from the column headed “Responsible Person”: AW substitute: GN

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

Pharmacor Gabapentin 800

MP NP

C2664

100

[20] Schedule 1, entry for Glucose Indicator—Blood

omit:

	Test strips, 50 (Glucostix)	For external use	Glucostix	BN	MP NP			2	5
					MP		P3035	2	11

[21] Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g

(a) omit:

Cortef

PDP

C1422

(b) omit:

Cortef

MP NP

C1422

[22] Schedule 1, entry for Idarubicin

omit:

Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL single use vial

Injection

Zavedos Solution

See Note 1

C1006

Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL single use vial

Injection

Zavedos Solution

See Note 1

C1006

substitute:

Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL	Injection	Idarubicin Ebewe	IT	MP See Note 1	C1006	3
		Zavedos Solution	PF	MP See Note 1	C1006	3
Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL	Injection	Idarubicin Ebewe	IT	MP See Note 1	C1006	6
		Zavedos Solution	PF	MP See Note 1	C1006	6

[23] Schedule 1, entry for Insulin Isophane

omit:

Protaphane NovoLet
3 mL

MP NP

[24] Schedule 1, entry for Isotretinoin in the form Capsule 10 mg

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

Rocta 10

C1354

[25] Schedule 1, entry for Isotretinoin in the form Capsule 20 mg

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

Rocta 20

C1354

[26] Schedule 1, entry for Medroxyprogesterone in each of the forms: Tablet containing medroxyprogesterone acetate 5 mg; Tablet containing medroxyprogesterone acetate 10 mg; and Injection containing medroxyprogesterone acetate 150 mg in 1 mL

omit from the column headed “Responsible Person” (all instances): KR substitute: FZ

[27] Schedule 1, entry for Methylprednisolone in the form Injection containing methylprednisolone acetate 40 mg in 1 mL

omit from the column headed “Responsible Person”: KR substitute: FZ

[28] Schedule 1, entry for Moclobemide

omit from the column headed “Responsible Person” (twice occurring): RO substitute: VP

[29] Schedule 1, entry for Norethisterone in the form Tablets 350 micrograms, 28

omit from the column headed “Responsible Person”: KR substitute: FZ

[30] Schedule 1, entry for Norethisterone with Ethinyloestradiol

(a) omit from the column headed “Responsible Person” (all instances): KR substitute: FZ

(b) omit:

Tablets 500 micrograms-35 micrograms, 21

Oral

Brevinor

MP NP

Tablets 1 mg-35 micrograms, 21

Oral

Brevinor-1

MP NP

[31] Schedule 1, entry for Norfloxacin in the form Tablet 400 mg (Norflohexal)

omit from the column headed “Responsible Person”: SZ substitute: HX

[32] Schedule 1, entry for Norfloxacin in the form Tablet 400 mg

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

Norfloxacin Sandoz

MP NP

C1002 C1070

[33] Schedule 1, after entry for Olanzapine in the form Wafer 10 mg

insert in the columns in the order indicated:

	Wafer 15 mg	Oral	Zyprexa Zydis	LY	MP NP	C1589 C2044		28	5
	Wafer 20 mg	Oral	Zyprexa Zydis	LY	MP NP	C1589 C2044		28	5

[34] Schedule 1, entry for Oxycodone in each of the forms: Tablet containing oxycodone hydrochloride 5 mg (controlled release); Tablet containing oxycodone hydrochloride 10 mg (controlled release); Tablet containing oxycodone hydrochloride 15 mg (controlled release); Tablet containing oxycodone hydrochloride 20 mg (controlled release); Tablet containing oxycodone hydrochloride 30 mg (controlled release); Tablet containing oxycodone hydrochloride 40 mg (controlled release); and Tablet containing oxycodone hydrochloride 80 mg (controlled release)

omit from the column headed “Max Quantity”: 20 substitute: 28

[35] Schedule 1, entry for Pancreatic Extract

omit:

	Capsule (containing enteric coated minimicrospheres) providing not less than 5,000 BP units of lipase activity	Oral	Creon 5000	SM	MP NP			500	10
					MP		P3046	500	21

[36] Schedule 1, entry for Pioglitazone

substitute:

Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Acpio 15	SI	MP NP	C3540 C3541 C3542	28	5
			Actos	LY	MP NP	C3540 C3541 C3542	28	5
			APOTEX-Pioglitazone	TX	MP NP	C3540 C3541 C3542	28	5
			Chem mart Pioglitazone	CH	MP NP	C3540 C3541 C3542	28	5
			Pharmacor Pioglitazone 15	CR	MP NP	C3540 C3541 C3542	28	5
			Pioglitazone generichealth 15	GQ	MP NP	C3540 C3541 C3542	28	5
			Pizaccord	MI	MP NP	C3540 C3541 C3542	28	5
			Terry White Chemists Pioglitazone	TW	MP NP	C3540 C3541 C3542	28	5
	Tablet 30 mg (as hydrochloride)	Oral	Acpio 30	SI	MP NP	C3540 C3541 C3542	28	5
			Actos	LY	MP NP	C3540 C3541 C3542	28	5
			APOTEX-Pioglitazone	TX	MP NP	C3540 C3541 C3542	28	5
			Chem mart Pioglitazone	CH	MP NP	C3540 C3541 C3542	28	5
			Pharmacor Pioglitazone 30	CR	MP NP	C3540 C3541 C3542	28	5
			Pioglitazone generichealth 30	GQ	MP NP	C3540 C3541 C3542	28	5
			Pizaccord	MI	MP NP	C3540 C3541 C3542	28	5
			Terry White Chemists Pioglitazone	TW	MP NP	C3540 C3541 C3542	28	5
	Tablet 45 mg (as hydrochloride)	Oral	Acpio 45	SI	MP NP	C3540 C3541 C3542	28	5
			Actos	LY	MP NP	C3540 C3541 C3542	28	5
			APOTEX-Pioglitazone	TX	MP NP	C3540 C3541 C3542	28	5
			Chem mart Pioglitazone	CH	MP NP	C3540 C3541 C3542	28	5
			Pharmacor Pioglitazone 45	CR	MP NP	C3540 C3541 C3542	28	5
			Pioglitazone generichealth 45	GQ	MP NP	C3540 C3541 C3542	28	5
			Pizaccord	MI	MP NP	C3540 C3541 C3542	28	5
			Terry White Chemists Pioglitazone	TW	MP NP	C3540 C3541 C3542	28	5

[37] Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg

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

APO-Risedronate	TX	MP NP	C2645 C2646 C3070	4	5
Chem mart Risedronate	CH	MP NP	C2645 C2646 C3070	4	5
Terry White Chemists Risedronate	TW	MP NP	C2645 C2646 C3070	4	5

[38] Schedule 1, after entry for Rizatriptan

insert in the columns in the order indicated:

Romiplostin

Powder for injection 375 micrograms

Injection

Nplate

See Note 1

See Note 3

Powder for injection 625 micrograms

Injection

Nplate

See Note 1

See Note 3

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

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

Sertraline-DRLA

MP NP

C1211

[40] Schedule 1, omit entry for Sitaxentan

[41] Schedule 1, entry for Sulfasalazine in the form Tablet 500 mg (enteric coated)

omit from the column headed “Responsible Person” (twice occurring): KR substitute: FZ

[42] Schedule 1, entry for Tinidazole

omit from the column headed “Responsible Person”: GP substitute: FZ

[43] Schedule 1, entry for Valaciclovir

substitute:

Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APO-Valaciclovir	TX	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			Chem mart Valaciclovir	CH	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			Terry White Chemists Valaciclovir	TW	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			Vaclovir	AF	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			Valaciclovir GA	GM	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			Valaciclovir Sandoz	SZ	MP NP	C3622 C3624 C3631 C3632	P3632	20	0
			Valnir	SI	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			Valtrex	GK	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			Zelitrex	RE	MP NP	C3622 C3623 C3624 C3631 C3632	P3632	20	0
			APO-Valaciclovir	TX	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			Chem mart Valaciclovir	CH	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			Terry White Chemists Valaciclovir	TW	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			Vaclovir	AF	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			Valaciclovir GA	GM	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			Valaciclovir RBX	RA	MP NP	C3622 C3623 C3624 C3631	P3623 P3624	30	5
			Valaciclovir Sandoz	SZ	MP NP	C3622 C3624 C3631 C3632	P3624	30	5
			Valaciclovir SZ	HX	MP NP	C3623 C3624	P3623 P3624	30	5
			Valnir	SI	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			Valtrex	GK	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			Zelitrex	RE	MP NP	C3622 C3623 C3624 C3631 C3632	P3623 P3624	30	5
			APO-Valaciclovir	TX	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			Chem mart Valaciclovir	CH	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			Terry White Chemists Valaciclovir	TW	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			Vaclovir	AF	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			Valaciclovir GA	GM	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			Valaciclovir RBX	RA	MP NP	C3622 C3623 C3624 C3631	P3622 P3631	42	0
			Valaciclovir Sandoz	SZ	MP NP	C3622 C3624 C3631 C3632	P3622 P3631	42	0
			Valnir	SI	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			Valtrex	GK	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			Zelitrex	RE	MP NP	C3622 C3623 C3624 C3631 C3632	P3622 P3631	42	0
			APO-Valaciclovir	TX	MP See Note 1	C1494 C3419		500	2	C
			Valtrex	GK	MP See Note 1	C1494 C3419		500	2	C

[44] Schedule 1, after entry for Vildagliptin

insert in the columns in the order indicated:

Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride	Oral	Galvumet 50/500	NV	MP NP	C3543 C3686	60	5
	Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride	Oral	Galvumet 50/850	NV	MP NP	C3543 C3686	60	5
	Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride	Oral	Galvumet 50/1000	NV	MP NP	C3543 C3686	60	5

[45] Schedule 1, after entry for Zolmitriptan

insert in the columns in the order indicated:

Zonisamide	Capsule 25 mg	Oral	Zonegran	SA	MP	C2664	56	5
	Capsule 50 mg	Oral	Zonegran	SA	MP	C2664	56	5
	Capsule 100 mg	Oral	Zonegran	SA	MP	C2664	112	5

[46] Schedule 1, omit entry for Zuclopenthixol Decanoate

[47] Schedule 3, after details relevant to Responsible person code FR

insert:

Pfizer Australia Pty Ltd

50 008 422 348

[48] Schedule 3

omit:

Pfizer Australia Pty Ltd

50 008 422 348

[49] Schedule 3

omit:

Pfizer Australia Pty Ltd

50 008 422 348

[50] Schedule 3

omit:

Novo Nordisk Pharmaceuticals Pty Limited

40 002 879 996

[51] Schedule 3, after details relevant to Responsible person code RZ

insert:

SciGen (Australia) Pty Limited

76 055 016 969

[52] Schedule 3, after details relevant to Responsible person code VI

insert:

Meda Valeant Pharma Australia Pty Ltd

[53] Schedule 4, Part 1, entry for Adalimumab

insert after existing text in the columns in the order indicated:

C3695	P3695	Fistulising Crohn disease — initial treatment 1 Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who: (a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and (b) has an externally draining enterocutaneous or rectovaginal fistula; and (c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) a signed patient acknowledgement; the most recent fistula assessment is no more than 1 month old at the time of application; a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment; the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment	Compliance with Written Authority Required procedures
		Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient with complex refractory fistulising Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures
C3696	P3696	Fistulising Crohn disease — initial treatment 2 (change or recommencement of PBS-subsidised treatment) Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who: (a) has a documented history of complex refractory fistulising Crohn disease; and (b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and (c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where TNF-alfa antagonist means adalimumab or infliximab; and where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment; the most recent fistula assessment is no more than 1 month old at the time of application; to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy; the assessment of response to the most recent course of TNF-alfa antagonist therapy must: (a) be provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and (b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab; if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment; the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment	Compliance with Written Authority Required procedures
		Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient who has a documented history of complex refractory fistulising Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures
C3697	P3697	Fistulising Crohn disease — initial treatment 3 (previous adalimumab treatment non-PBS-subsidised) Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria: (a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with adalimumab prior to 4 November 2010; and (b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with adalimumab; and (c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and (d) is receiving treatment with adalimumab at the time of application; and (e) has demonstrated or sustained an adequate response to treatment with adalimumab; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to adalimumab treatment is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient; the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and (ii) a signed patient acknowledgement; the current fistula assessment is no more than 1 month old at the time of application; the baseline fistula assessment is from immediately prior to commencing treatment with adalimumab; the course of treatment is limited to a maximum of 24 weeks of treatment; a patient is eligible for PBS-subsidised treatment under this restriction once only	Compliance with Written Authority Required procedures
		Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures
C3698	P3698	Fistulising Crohn disease — continuing treatment Continuing PBS-subsidised treatment with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who: (a) has a documented history of complex refractory fistulising Crohn disease; and (b) has demonstrated or sustained an adequate response to treatment with adalimumab; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient; the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition; the fistula assessment is no more than 1 month old at the time of application; the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy; where an assessment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment; patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response	Compliance with Written Authority Required procedures
		Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures

[54] Schedule 4, Part 1, after entry for Adalimumab

insert in the columns in the order indicated:

Adapalene with benzoyl peroxide	C3689	P3689	Acute treatment, in combination with an oral antibiotic, of severe acne vulgaris.
	C3690	P3690	Maintenance treatment of severe acne vulgaris.

[55] Schedule 4, Part 1, entry for Ciprofloxacin

omit:

C3680

For use in skin or soft tissue infections (wound management) where other antimicrobial agents are ineffective or inappropriate.

Compliance with Authority Required procedures

[56] Schedule 4, Part 1, entry for Valaciclovir

substitute:

Valaciclovir	C1494		Where the patient is receiving treatment at/from a private hospital Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease	Compliance with Written or Telephone Authority Required procedures
	C3419		Where the patient is receiving treatment at/from a public hospital Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3419
	C3622	P3622	Treatment of patients with herpes zoster within 72 hours of the onset of the rash	Compliance with Authority Required procedures - Streamlined Authority Code 3622
	C3623	P3623	Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3623
	C3624	P3624	Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3624
	C3631	P3631	Herpes zoster ophthalmicus	Compliance with Authority Required procedures - Streamlined Authority Code 3631
	C3632	P3632	Moderate to severe initial genital herpes	Compliance with Authority Required procedures - Streamlined Authority Code 3632

[57] Schedule 4, Part 1, after entry for Vildagliptin

insert in the columns in the order indicated:

Vildagliptin with metformin	C3543		Treatment of type 2 diabetes in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with metformin; or (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated	Compliance with Authority Required procedures - Streamlined Authority Code 3543
	C3686		Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and vildagliptin.	Compliance with Authority Required procedures - Streamlined Authority Code 3686

[58] Schedule 4, Part 1, after entry for Zolmitriptan

insert in the columns in the order indicated:

Zonisamide

C2664

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs

Compliance with Authority Required procedures - Streamlined Authority Code 2664

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

See http://www.frli.gov.au.