Australian Coat of Arms

PB 31 of 2023

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.

Dated        30 March 2023

 

 

 

 

 

 

 

 

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Note: This table relates only to the provisions of this instrument as originally made.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

 

    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 specified in column 2 of an item in the table in Schedule 3 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. 

 

 

Schedule 1Brands of pharmaceutical items (combination 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 with naloxone

Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)

Sublingual

Suboxone Film 8/2

10%

Schedule 2Brands 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%