National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 2) (PB 20 of 2017) (Cth)
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)
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 |
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 |
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 |
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 |
Schedule 2, after entry for GQ Insert:
| GV | Amgen Australia Pty Limited | 31 051 057 428 |
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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