National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 8) (No. PB 63 of 2011) (Cth)

Case

PB 63 of 2011

National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 8)

National Health Act 1953

___________________________________________________________________________

I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated 26 August 2011

FELICITY MCNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

___________________________________________________________________

1              Name of Instrument

(1)This Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No.8).

(2)This Instrument may also be cited as PB 63 of 2011.

2             Commencement

    This Instrument commences on 1 September 2011.

3              Amendments to PB 117 of 2010

 Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010).

.

Schedule 1                   Amendments

  1. Section 4, definition of  benefit card, paragraph (k)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Note following section 4

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Paragraph 12(2)(a)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Paragraph 12(2)(b)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Paragraph 12(3)(a)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Paragraph 12(3)(b)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Paragraph 13(1)(a)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Paragraph 13(1)(b)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

  1. Paragraph 13(1)(c)

omit (wherever occurring):

Medicare Australia CEO

substitute:

Chief Executive Medicare

[10]  Paragraph 13(1)(d)

omit (wherever occurring):

Medicare Australia CEO

substitute:

Chief Executive Medicare

[11]  Subsection 13(2)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[12]  Subsection 13(3)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[13]  Subsection 13(4)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[14]  Subsection 14(1)

omit (wherever occurring):

Medicare Australia CEO

substitute:

Chief Executive Medicare

[15]  Subsection 14(2)

omit (wherever occurring):

Medicare Australia CEO

substitute:

Chief Executive Medicare

[16]  Subsection 14(3)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[17]  Subsection 14(4)

omit (wherever occurring):

Medicare Australia CEO

substitute:

Chief Executive Medicare

[18]  Subsection 14(5)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[19]  Subsection 15(1)

omit(wherever occurring):

Medicare Australia CEO

substitute:

Chief Executive Medicare

[20]  Paragraph 15(3)(a)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[21]  Paragraph 15(3)(b)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[22]  Paragraph 16(a)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[23]  Subsection 17(2)

omit:

Medicare Australia CEO

substitute:

Chief Executive Medicare

[24]  Paragraph 28(2)(c)

omit (wherever occurring):

Medicare Australia CEO

substitute:

Chief Executive Medicare

[25]  Schedule 1, entry for Cetuximab

substitute:

Cetuximab Solution for I.V. infusion 100 mg in 20 mL Injection Erbitux SG EMP C2713 C2714 C2715 C3843 C3844 P2713 P2714 P3843 P3844 1 0
Erbitux SG EMP C2713 C2714 C2715 C3843 C3844 P2715 1 6
Solution for I.V. infusion 500 mg in 100 mL Injection Erbitux SG EMP C2713 C2714 C2715 C3843 C3844 P2713 P2714 P3843 P3844 1 0
Erbitux SG EMP C2713 C2714 C2715 C3843 C3844 P2715 1 6
  1. Schedule 1, entry for Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

substitute:

I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL Injection Ondansetron Alphapharm AF EMP C3050 1 0
Ondansetron-Claris AE EMP C3050 1 0
Ondaz SZ EMP C3050 1 0
Onsetron ZP EMP C3050 1 0
Pfizer Australia Pty Ltd PF EMP C3050 1 0
Zofran GK EMP C3050 1 0
  1. Schedule 1, entry for Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

substitute:

I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL Injection Ondansetron Alphapharm AF EMP C3050 1 0
Ondansetron-Claris AE EMP C3050 1 0
Ondaz SZ EMP C3050 1 0
Onsetron ZP EMP C3050 1 0
Pfizer Australia Pty Ltd PF EMP C3050 1 0
Zofran GK EMP C3050 1 0

[28]  Schedule 3, entry for Cetuximab

insert  following the last circumstance code:

C3843 P3843 Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy Compliance with Authority Required procedures
C3844 P3844 Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease. Compliance with Authority Required procedures

Note

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

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