National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 9) (Cth)

PB 98 of 2021

National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021
(No. 9)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 84AAA(2) of the National Health Act 1953.

Dated               28 September 2021

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy 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 (Pharmaceutical benefits—early supply) Instrument 2015
(PB 120 of 2015).  2

1. Name

(1)This instrument is the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 9).

(2)This Instrument may also be cited as PB 98 of 2021.

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 October 2021	1 October 2021

Note:          This table relates only to the provisions of this instrument as originally made.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 84AAA(2) of the National Health Act 1953.

4        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 (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015)

1. Schedule 1, omit entry for Captopril

1. Schedule 1, omit entry for Cimetidine

1. Schedule 1, entry for Nifedipine

omit:

Tablet 20 mg (controlled release) 20 30 5

1. Schedule 1, omit entry for Nilutamide

1. Schedule 1, after entry for Obeticholic acid in the form Tablet 10 mg

insert:

Ofatumumab	Solution for injection 20 mg in 0.4 mL pre-filled pen	20	1	5
20	3	0

1. Schedule 1, entry for Sertraline

(a)omit:

Tablet 50 mg (as hydrochloride) (USP) 20 30 5

(b)omit:

Tablet 100 mg (as hydrochloride) (USP) 20 30 5

1. Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate)

omit from the column headed “Form”: Capsule 12.5 mg (as malate)                 substitute: Capsule 12.5 mg

1. Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate)

omit from the column headed “Form”: Capsule 25 mg (as malate)                    substitute: Capsule 25 mg

1. Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate)

omit from the column headed “Form”: Capsule 37.5 mg (as malate)                 substitute: Capsule 37.5 mg

1. Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate)

omit from the column headed “Form”: Capsule 50 mg (as malate)                    substitute: Capsule 50 mg

1. Schedule 1, entry for Teriparatide

insert as first entry:

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge 20 1 5

1. Schedule 1, entry for Ustekinumab

substitute:

Ustekinumab	Injection 45 mg in 0.5 mL	20	1	0
20	1	1
20	1	2
20	2	0