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PB 19 of 2023

National Health (April 2023 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 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 99ACC(5C) and subsection 99ACF(3) of the National Health Act 1953.

Dated      24 February 2023

 

 

 

 

 

 

 

 

Nikolai Tsyganov

Assistant Secretary

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.1) 2023.  

(2)   This instrument may also be cited as PB 19 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Note: This table relates only to the provisions of this instrument as originally made.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 99ACC(5C) and subsection 99ACF(3) of the Act.

 

 

 

 

 

5 Brand of pharmaceutical item (combination item) not subject to a price reduction

I determine, under paragraph 99ACC(5C)(a) of the Act, that the approved ex-manufacturer price, and each of the claimed prices (if applicable) of each single brand of combination item specified in column 2 as an item in the table in Schedule 1 is not reduced under subsection 99ACC(2) or subsection 99ACC(5) of the Act, as appropriate, in relation to the reduction day.

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 not reduced

 

Column 1

Column 2

Item

Brand of Pharmaceutical Item

 

Drug

Form

Manner of administration

Brand(s)

1

Nirmatrelvir and ritonavir

Pack containing 4 tablets nirmatrelvir 150 mg and 2 tablets ritonavir 100 mg, 5

Oral

Paxlovid

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

Buprenorphine with naloxone

Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)

Sublingual

Suboxone Film 2/0.5

2

Chorionic gonadotrophin

Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 (s19A)

Injection

Brevactid 1500 I.E

3

Chorionic gonadotrophin

Powder for injection 5,000 units with solvent (s19A)

Injection

Choriomon 5000 I.E

4

Colestyramine

Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50

Oral

Questran Lite

5

Erythromycin

Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL

Oral

E-Mycin 200

6

Erythromycin

Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL

Oral

E-Mycin 400

7

Estradiol

Tablet 2 mg

Oral

Zumenon

8

Estradiol and estradiol with dydrogesterone

Pack containing 14 tablets estradiol 1 mg and 14 tablets estradiol 1 mg with dydrogesterone 10 mg

Oral

Femoston 1/10

9

Estradiol and estradiol with dydrogesterone

Pack containing 14 tablets estradiol 2 mg and 14 tablets estradiol 2 mg with dydrogesterone 10 mg

Oral

Femoston 2/10

10

Hydralazine

Tablet containing hydralazine hydrochloride 50 mg

Oral

Alphapress 50

11

Hydromorphone

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL

Oral

Hydromorphone hydrochloride oral solution, USP (Medsurge)

12

Imipramine

Tablet containing imipramine hydrochloride 25 mg (s19A)

Oral

Imipramine (Leading)

13

Mianserin

Tablet containing mianserin hydrochloride 10 mg

Oral

Lumin 10

14

Mianserin

Tablet containing mianserin hydrochloride 20 mg

Oral

Lumin 20

15

Pancreatic extract

 

Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity

Oral

Creon 10,000

16

Pancreatic extract

 

Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity

Oral

Creon 25,000

17

Pancreatic extract

 

Capsule (containing enteric coated minimicrospheres) providing not less than 35,000 BP units of lipase activity

Oral

Creon 35,000

18

Pancreatic extract

 

Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g

Oral

Creon Micro

19

Penicillamine

Tablet 125 mg

Oral

D-Penamine

20

Penicillamine

Tablet 250 mg

Oral

D-Penamine

21

Phenelzine

Tablet 15 mg (as sulfate) s19A

Oral

Nardil (Canada)

22

Pyridostigmine

Tablet containing pyridostigmine bromide 180 mg (modified release) s19A

Oral

Pyridostigmine Bromide Extended-Release Tablets (Rising)

23

Tenecteplase

Powder for injection 50 mg with solvent (s19A)

Injection

TNKase (Canada) Medsurge Healthcare Pty Ltd

24

Warfarin

Tablet containing warfarin sodium 1 mg

Oral

Coumadin

25

Warfarin

Tablet containing warfarin sodium 1 mg

Oral

Marevan

26

Warfarin

Tablet containing warfarin sodium 2 mg

Oral

Coumadin

27

Warfarin

Tablet containing warfarin sodium 3 mg

Oral

Marevan

28

Warfarin

Tablet containing warfarin sodium 5 mg

Oral

Coumadin

29

Warfarin

Tablet containing warfarin sodium 5 mg

Oral

Marevan

 

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

Aripiprazole

Powder for injection 300 mg (as monohydrate) with diluent

Injection

Abilify Maintena

4.84%

2

Aripiprazole

Powder for injection 400 mg (as monohydrate) with diluent

Injection

Abilify Maintena

4.84%

3

Cladribine

 

Tablet 10 mg

 

Oral

 

Mavenclad

 

5%

 

4

Methylprednisolone

Cream containing methylprednisolone aceponate 1 mg per g, 15 g

Application

Advantan

19%

5

Methylprednisolone

Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g

Application

Advantan (Fatty)

19%

6

Methylprednisolone

Lotion containing methylprednisolone aceponate 1 mg per g, 20 g

Application

Advantan

16.67%

7

Methylprednisolone

Ointment containing methylprednisolone aceponate 1 mg per g, 15 g

Application

Advantan

19%