National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 7) (PB 67 of 2016) (Cth)

PB 67 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 7)

National Health Act 1953
___________________________________________________________________________

I, TONY WYND, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated 22 July 2016

Tony Wynd
Acting Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

Part 1        Preliminary

1                  Name of Instrument

(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 7).

(2)This instrument may also be cited as PB 67 of 2016.

2              Commencement

This instrument commences on 1 August 2016.

3              Amendment

The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule – Amendments

Schedule

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

1. Division 1, Section 4, definition for medication for the treatment of hepatitis B

   Substitute:
   medication for the treatment of hepatitis B means any of the following:

   (a)    adefovir

   (b)   entecavir monohydrate

   (c)    interferon alfa‑2a

   (d)   interferon alfa-2b

   (e)    lamivudine

   (f)    peginterferon alfa-2a

   (g)    tenofovir

1. Schedule 1, entry for Azacitidine

   Substitute:

Azacitidine	Powder for injection 100 mg	Injection	Azadine	RZ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	See Note 1	See Note 2	D
Celazadine	JU	EMP	C6132 C6143 C6144 C6177 C6186 C6199	See Note 1	See Note 2	D
Vidaza	CJ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	See Note 1	See Note 2	D

1. Schedule 1, entry for Tacrolimus

   Substitute:

Tacrolimus	Capsule 0.5 mg	Oral	Pharmacor Tacrolimus 0.5	CR	EMP	C5569 C5602	200	5	D
Prograf	LL	EMP	C5569 C5602	200	5	D
TACROLIMUS APOTEX	TX	EMP	C5569 C5602	200	5	D
Tacrolimus Sandoz	SZ	EMP	C5569 C5602	200	5	D
Capsule 0.75 mg	Oral	Tacrolimus Sandoz	SZ	EMP	C5569 C5602	200	5	D
Capsule 1 mg	Oral	Pharmacor Tacrolimus 1	CR	EMP	C5569 C5602	200	5	D
Prograf	LL	EMP	C5569 C5602	200	5	D
TACROLIMUS APOTEX	TX	EMP	C5569 C5602	200	5	D
Tacrolimus Sandoz	SZ	EMP	C5569 C5602	200	5	D
Capsule 2 mg	Oral	Tacrolimus Sandoz	SZ	EMP	C5569 C5602	200	5	D
Capsule 5 mg	Oral	Pharmacor Tacrolimus 5	CR	EMP	C5569 C5602	100	5	D
Prograf	LL	EMP	C5569 C5602	100	5	D
TACROLIMUS APOTEX	TX	EMP	C5569 C5602	100	5	D
Tacrolimus Sandoz	SZ	EMP	C5569 C5602	100	5	D
Capsule 0.5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	EMP	C5569 C5602	60	5	D
Prograf XL	LL	EMP	C5569 C5602	60	5	D
Capsule 1 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	EMP	C5569 C5602	120	5	D
Prograf XL	LL	EMP	C5569 C5602	120	5	D
Capsule 5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	EMP	C5569 C5602	60	5	D
Prograf XL	LL	EMP	C5569 C5602	60	5	D

1. Schedule 1, repeal entry for Telbivudine

2. Schedule 2, after entry for JC

   Insert:

JU Juno Pharmaceuticals Pty Ltd  55 156 303 650

1. Schedule 2, after entry for LL

   Insert:

LQ Astellas Pharma Australia Pty Ltd  81 147 915 482

1. Schedule 3, repeal entry for Telbivudine