National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (February Update) Instrument 2022 (Cth)

PB 5 of 2022

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (February Update) Instrument 2022

National Health Act 1953

I, DAVID LAFFAN, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Date     28 January 2022

DAVID LAFFAN

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Highly Specialised Drugs Program) Special Arrangement 2021
(PB 27 of 2021)   2

1. Name

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (February Update) Instrument 2022.

(2)This instrument may also be cited as PB 5 of 2022.

1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 February 2022	1 February 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

1. Schedule 1, entry for Atazanavir in the form Capsule 200 mg (as sulfate)

omit:

Atazanavir Mylan C4454 C4512 120 5

1. Schedule 1, entry for Atazanavir in the form Capsule 300 mg (as sulfate)

omit:

Atazanavir Mylan C4454 C4512 60 5

1. Schedule 1, entry for Azacitidine

omit:

Celazadine C6132 C6143 C6144 C6177 C6186 C6199 C12439 See Schedule 2 See Schedule 2

1. Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)

omit:

Bosentan Sandoz C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458 See Schedule 2 See Schedule 2

1. Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)

omit:

Bosentan Sandoz C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458 See Schedule 2 See Schedule 2

1. Schedule 1, entry for Pegfilgrastim

omit:

Fulphila C7822 C7843 C9235 C9303 1 11

1. Schedule 1, entry for Ribavirin

omit:

Tablet 400 mg	Oral	Ibavyr	C5957 C5958	P5957	28	2
C5957 C5958	P5958	28	5
Tablet 600 mg	Oral	Ibavyr	C5957 C5958	P5957	28	2
C5957 C5958	P5958	28	5

1. Schedule 3, entry for Ribavirin

(a)        omit from the column headed “Purposes Code” for circumstances code “C5957”: P5957

(b)      omit:

C5958 P5958 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks.
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child‑bearing age. Compliance with Authority Required procedures