National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2023 (No. 5) (Cth)

PB 55 of 2023

National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2023
(No. 5)

National Health Act 1953

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

Dated   29 June 2023

SOUMYA SUDARSHAN

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

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 2023 (No. 5).

(2)This instrument may also be cited as PB 55 of 2023.

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 July 2023	1 July 2023

Note:          This table relates only to the provisions of this instrument as originally made.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, after entry for Acalabrutinib in the form Capsule 100 mg

insert:

Tablet 100 mg 20 56 5

1. Schedule 1, entry for Buprenorphine

substitute:

Buprenorphine	Injection (modified release) 8 mg in 0.16 mL pre‑filled syringe	20	4	2
Injection (modified release) 16 mg in 0.32 mL pre‑filled syringe	20	4	2
Injection (modified release) 24 mg in 0.48 mL pre‑filled syringe	20	4	2
Injection (modified release) 32 mg in 0.64 mL pre‑filled syringe	20	4	2
Injection (modified release) 64 mg in 0.18 mL pre‑filled syringe	20	1	2
Injection (modified release) 96 mg in 0.27 mL pre‑filled syringe	20	1	2
Injection (modified release) 100 mg in 0.5 mL pre‑filled syringe	20	1	2
Injection (modified release) 128 mg in 0.36 mL pre‑filled syringe	20	1	2
Injection (modified release) 160 mg in 0.45 mL pre‑filled syringe	20	1	2
Injection (modified release) 300 mg in 1.5 mL pre‑filled syringe	20	1	2
Tablet (sublingual) 400 micrograms (as hydrochloride)	20	28	2
Tablet (sublingual) 2 mg (as hydrochloride)	20	84	2
Tablet (sublingual) 8 mg (as hydrochloride)	20	112	2

1. Schedule 1, after entry for Buprenorphine in the form Tablet (sublingual) 8 mg (as hydrochloride)

insert:

Buprenorphine with naloxone	Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)	20	84	2
Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)	20	112	2

1. Schedule 1, omit entry for Ertugliflozin with metformin

1. Schedule 1, after entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

insert:

Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL	20	840	2
Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL	20	840	2