National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 2) (PB 20 of 2017) (Cth)

Case

PB 20 of 2017

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 2)

National Health Act 1953

___________________________________________________________________________

I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Minister for Sport, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated 30 March 2017

Julianne Quaine

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 2017 (No. 2).

(2)This instrument may also be cited as PB 20 of 2017.

2              Commencement

This instrument commences on 1 April 2017.

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. Schedule 1, entry for Apomorphine

Substitute:

Apomorphine Injection containing apomorphine hydrochloride 10 mg in 1 mL Injection Apomine PF EMP

C4833 C4860 360 5 D
Injection containing apomorphine hydrochloride 20 mg in 2 mL Injection Movapo TD EMP

C4833 C4860 360 5 D
Injection containing apomorphine hydrochloride 50 mg in 5 mL Injection Movapo TD EMP C4833 C4860 180 5 D
Injection containing apomorphine hydrochloride 100 mg in 20 mL Injection Apomine Solution for Infusion PF EMP C4860 C6813 90 5 D
Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe Injection Movapo PFS TD EMP C4833 C4860 180 5 D
  1. Schedule 1, entry for Entecavir

Substitute:

Entecavir Tablet 0.5 mg (as monohydrate) Oral Baraclude BQ EMP

C4993 C5036 60 5 D
ENTAC LR EMP C4993 C5036 60 5 D
Entecavir Amneal EA EMP C4993 C5036 60 5 D
Entecavir APOTEX TX EMP C4993 C5036 60 5 D
Entecavir GH GQ EMP C4993 C5036 60 5 D
Entecavir Mylan AF EMP C4993 C5036 60 5 D
ENTECAVIR RBX RA EMP C4993 C5036 60 5 D
Entecavir Sandoz SZ EMP C4993 C5036 60 5 D
ENTECLUDE RW EMP C4993 C5036 60 5 D
Tablet 1 mg (as monohydrate) Oral Baraclude BQ EMP

C5037 C5044 60 5 D
ENTAC LR EMP C5037 C5044 60 5 D
Entecavir Amneal EA EMP C5037 C5044 60 5 D
Entecavir APOTEX TX EMP C5037 C5044 60 5 D
Entecavir GH GQ EMP C5037 C5044 60 5 D
Entecavir Mylan AF EMP C5037 C5044 60 5 D
ENTECAVIR RBX RA EMP C5037 C5044 60 5 D
Entecavir Sandoz SZ EMP C5037 C5044 60 5 D
ENTECLUDE RW EMP C5037 C5044 60 5 D
  1. Schedule 1, entry for Epoprostenol                          Substitute:

Epoprostenol Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set Injection Flolan Kit GK EMP C6123 C6734 C6748 C6762 C6763 1 0 D
Powder for I.V. infusion 500 micrograms (as sodium) Injection Veletri AT EMP C6123 C6734 C6748 C6762 C6763 1 0 D
Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL Injection Flolan GK EMP C6123 C6734 C6748 C6762 C6763 1 0 D
Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set Injection Flolan Kit GK EMP C6123 C6734 C6748 C6762 C6763 1 0 D
Powder for I.V. infusion 1.5 mg (as sodium) Injection Veletri AT EMP C6123 C6734 C6748 C6762 C6763 1 0 D
Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL Injection Flolan GK EMP C6123 C6734 C6748 C6762 C6763 1 0 D
  1. Schedule 1, entry for Pegfilgrastim  

    Insert:

Ristempa GV EMP C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 1 11 D
  1. Schedule 2, after entry for GQ         Insert:

GV Amgen Australia Pty Limited 31 051 057 428
  1. Schedule 4 – Patient Contributions

Substitute:

Listed Drug Form (strength, type, size, etc.) Manner of Administration Brand Pack Quantity

Approved Ex‑manufacturer Price or Proportional Ex‑manufacturer Price

$

Claimed price

$

Lamivudine Tablet 100 mg Oral Zeffix 28 $55.34 $56.30
Valaciclovir Tablet 500 mg (as hydrochloride) Oral Valtrex 100 $52.40 $52.92
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