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
[2] Note following section 4
omit:
Medicare Australia CEO
substitute:
Chief Executive Medicare
[3] Paragraph 12(2)(a)
omit:
Medicare Australia CEO
substitute:
Chief Executive Medicare
[4] Paragraph 12(2)(b)
omit:
Medicare Australia CEO
substitute:
Chief Executive Medicare
[5] Paragraph 12(3)(a)
omit:
Medicare Australia CEO
substitute:
Chief Executive Medicare
[6] Paragraph 12(3)(b)
omit:
Medicare Australia CEO
substitute:
Chief Executive Medicare
[7] Paragraph 13(1)(a)
omit:
Medicare Australia CEO
substitute:
Chief Executive Medicare
[8] Paragraph 13(1)(b)
omit:
Medicare Australia CEO
substitute:
Chief Executive Medicare
[9] 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
[26] 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
[27] 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.
See http://www.frli.gov.au.
