National Health (April 2023 Price Reductions) (Exercise of Ministerial discretion) Determination (No.2) 2023
National Health Act 1953
I, NIKOLAI TSYGANOV, Assistant Secretary, 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 determination under subsection 99ACF(3) of the National Health Act 1953.
Nikolai Tsyganov
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Health Resourcing Group
Department of Health and Aged Care
1 Name of Determination
(1) This instrument is the National Health (April 2023 Price Reductions) (Exercise of Ministerial discretion) Determination (No.2) 2023.
(2) This instrument may also be cited as PB 31 of 2023.
2 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 | The day this instrument is registered. |
|
Note: This table relates only to the provisions of this instrument as originally made.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.
3 Definition
Note: A number of expressions used in this instrument are defined in Part VII the Act.
In this instrument:
Act means the National Health Act 1953.
catch-up price reduction day has the same meaning as in subsection 99ACN(6) of the Act.
4 Authority
This instrument is made under subsection 99ACF(3) of the Act.
5 Brand of pharmaceutical item (combination item) subject to a lower price reduction than would otherwise apply
I determine, under paragraph 99ACF(3)(b) of the Act, that the approved ex-manufacturer price, and each of the claimed prices (if applicable) of a brand of pharmaceutical item (combination item) specified in column 2 of an item in the table in Schedule 1 is reduced under a provision mentioned in item 8 of the table in subsection 99ACF(1) of the Act, as appropriate, in relation to the catch-up price reduction day by the percentage specified in column 3 of the table item.
6 Brand of pharmaceutical item not subject to a price reduction
I determine, under paragraph 99ACF(3)(a) of the Act, that the approved ex-manufacturer price, and each of the claimed prices (if applicable) of each brand of pharmaceutical item specified in column 2 as an item in the table in Schedule 2 is not reduced under a provision mentioned in item 8 of the table in subsection 99ACF(1) of the Act, as appropriate, in relation to the catch-up price reduction day.
7 Brand of pharmaceutical item subject to a lower price reduction than would otherwise apply
Column 1 | Column 2 | Column 3 | |||
Item | Brand of pharmaceutical item | % reduction | |||
| Drug | Form | Manner of administration | Brand |
|
1 | Buprenorphine with naloxone | Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride) | Sublingual | Suboxone Film 8/2 | 10% |
Schedule 2— Brands of pharmaceutical items with approved ex-manufacturer price not reduced
Column 1 | Column 2 | |||
Item | Brand of Pharmaceutical Item | |||
| Drug | Form | Manner of administration | Brand(s) |
1 | Pancrelipase | Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity (s19A) | Oral | Panzytrat 25 000 (Allergan) |
2 | Tenecteplase | Powder for injection 50 mg with solvent (s19A) | Injection | TNKase (Canada) |
Schedule 3 — Brands of pharmaceutical items with approved ex-manufacturer price reduced by a lower percentage than would otherwise apply
Column 1 | Column 2 | Column 3 | |||
Item | Brand of pharmaceutical item | % reduction | |||
| Drug | Form | Manner of administration | Brand |
|
1 | Buprenorphine | Injection (modified release) 8 mg in 0.16 mL pre-filled syringe | Injection | Buvidal Weekly | 5% |
2 | Buprenorphine | Injection (modified release) 16 mg in 0.32 mL pre-filled syringe | Injection | Buvidal Weekly | 5% |
3 | Buprenorphine | Injection (modified release) 24 mg in 0.48 mL pre-filled syringe | Injection | Buvidal Weekly | 5% |
4 | Buprenorphine | Injection (modified release) 32 mg in 0.64 mL pre-filled syringe | Injection | Buvidal Weekly | 5% |
4 | Buprenorphine | Injection (modified release) 64 mg in 0.18 mL pre-filled syringe | Injection | Buvidal Monthly | 5% |
5 | Buprenorphine | Injection (modified release) 96 mg in 0.27 mL pre-filled syringe | Injection | Buvidal Monthly | 5% |
6 | Buprenorphine | Injection (modified release) 128 mg in 0.36 mL pre-filled syringe | Injection | Buvidal Monthly | 5% |
7 | Buprenorphine | Injection (modified release) 160 mg in 0.45 mL pre-filled syringe | Injection | Buvidal Monthly | 5% |
8 | Buprenorphine | Injection (modified release) 100 mg in 0.5 mL pre-filled syringe | Injection | Sublocade | 5% |
9 | Buprenorphine | Injection (modified release) 300 mg in 1.5 mL pre-filled syringe | Injection | Sublocade | 5% |
10 | Buprenorphine | Tablet (sublingual) 2 mg (as hydrochloride) | Sublingual | Subutex | 15% |
11 | Buprenorphine | Tablet (sublingual) 400 micrograms (as hydrochloride) | Sublingual | Subutex | 14.89% |
12 | Buprenorphine | Tablet (sublingual) 8 mg (as hydrochloride) | Sublingual | Subutex | 16.12% |
13 | Insulin aspart | Injection (human analogue) (fast acting) 100 units per mL, 10 mL vial | Injection | Fiasp | 22.22% |
14 | Insulin aspart | Injections (human analogue) (fast acting), pre-filled pen, 100 units per mL, 3 mL, 5 | Injection | Fiasp FlexTouch | 22.22% |