National Health Act 1953 Amendment Special Arrangements under subsection 100(1) Chemotherapy Pharmaceuticals Access Program (No. PB 70 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 70 of 2009

Amendment special arrangements under subsection 100(1) of the National Health Act 1953

I, DECLAN O’CONNOR-COX, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 10 July 2009

DECLAN O’CONNOR-COX

Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements — Chemotherapy Pharmaceuticals Access Program

1              Commencement

This instrument commences on 1 August 2009.

2              Amendment of PB 55 of 2009

Schedule 1 amends PB 55 of 2009.

Schedule 1        Amendments

1. Schedule 1, after item dealing with Aprepitant

insert in the columns in the order indicated:

Arsenic

In compliance with authority procedures set out in paragraph 14:

Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction

1. Schedule 2, after item dealing with Aprepitant

insert in the columns in the order indicated:

Arsenic Injection concentrate containing arsenic trioxide 10 mg in 10 mL Injection 60 2 Phenasen

1. Schedule 2, after item dealing with Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

insert in  the columns in the order indicated:

Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL Injection 4 2 Gemcitabine Ebewe

1. Schedule 2, item dealing with Paclitaxel in the forms Solution concentrate for I.V. infusion 30 mg in 5 mL, Solution concentrate for I.V. infusion 100 mg in 16.7 mL, Solution concentrate for I.V. infusion 150 mg in 25 mL and Solution concentrate for I.V. infusion 300 mg in 50 mL

in the column headed “Brand” insert in alphabetical order:

Paclitaxel Actavis

1. Schedule 4, item dealing with Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U.
   (Hospira Pty Limited)

(a)	omit from the column headed “Approved price”:
43.44
and substitute:
42.58

(b)	omit from the column headed “Price claimed by manufacturer”:
82.52
and substitute:
80.87

1. Schedule 4, item dealing with Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. (Blenamax)

(a)	omit from the column headed “Approved price”:
434.43
and substitute:
425.74
(b)	omit from the column headed “Price claimed by manufacturer”:
825.24
and substitute:
808.74

1. Schedule 4, item dealing with Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. (Blenoxane)

(a)	omit from the column headed “Approved price”:
434.43
and substitute:
425.74
(b)	omit from the column headed “Price claimed by manufacturer”:
892.58
and substitute:
808.74

1. Schedule 4, item dealing with Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

(a)	omit from the column headed “Approved price”:
201.24
and substitute:
198.32
(b)	omit from the column headed “Price claimed by manufacturer”:
201.40
and substitute:
197.37

1. Schedule 4, item dealing with Ondansetron in the form Wafer 4 mg

(a)	omit from the column headed “Approved price”:
27.81
and substitute:
27.25
(b)	omit from the column headed “Price claimed by manufacturer”:
28.37
and substitute:
27.81

1. Schedule 4, item dealing with Ondansetron in the form Wafer 8 mg

(a)	omit from the column headed “Approved price”:
43.56
and substitute:
42.68
(b)	omit from the column headed “Price claimed by manufacturer”:
44.13
and substitute:
43.25

1. Schedule 4, item dealing with Ondansetron in the form Tablet 4 mg
   (as hydrochloride dihydrate)

(a)	omit from the column headed “Approved price”:
27.81
and substitute:
27.25
(b)	omit from the column headed “Price claimed by manufacturer”:
28.37
and substitute:
27.81

1. Schedule 4, item dealing with Ondansetron in the form Tablet 8 mg
   (as hydrochloride dihydrate)

(a)	omit from the column headed “Approved price”:
43.56
and substitute:
42.68
(b)	omit from the column headed “Price claimed by manufacturer”:
44.13
and substitute:
43.25

1. Schedule 4, item dealing with Ondansetron in the form I.V. injection
   4 mg (as hydrochloride dihydrate) in 2 mL

(a)	omit from the column headed “Approved price”:
15.68
and substitute:
15.36
(b)	omit from the column headed “Price claimed by manufacturer”:
16.25
and substitute:
15.92

1. Schedule 4, item dealing with Ondansetron in the form I.V. injection
   8 mg (as hydrochloride dihydrate) in 4 mL

(a)	omit from the column headed “Approved price”:
24.91
and substitute:
24.40
(b)	omit from the column headed “Price claimed by manufacturer”:
25.47
and substitute:
24.95