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Note: This table relates only to the provisions of this instrument as originally made.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