National Health (Weighted average disclosed price – April 2026 reduction day) Amendment Determination 2026

Administered by Department of Health, Disability and Ageing

Legislation au F2026L00193 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 26 of 2026

NATIONAL HEALTH ACT 1953

National Health (Weighted average disclosed price – April 2026 reduction day) Amendment Determination 2026

Authority 

This legislative instrument is made pursuant to subsection 99ADB(4) of the National Health Act 1953 (the Act), which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item (listed brand) in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).

Subsection 99ADB(7) of the Act further provides that a subsection 99ADB(4) determination for a listed brand may include the adjusted approved ex-manufacturer price (AAEMP) for the listed brand.

Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(4) for the medicines affected by this legislative instrument.

Purpose

This legislative instrument amends the National Health (Weighted average disclosed price – April 2026 reduction day) Determination 2025 (PB 161 of 2025) (the Principal Instrument) by:

  • removing from Schedule 1 and inserting in Schedule 2 WADPs for brands of pharmaceutical items containing:
    • Adalimumab, injection 20 mg in 0.4 mL pre-filled syringe, injection
    • Adalimumab, injection 40 mg in 0.4 mL pre-filled pen, injection
    • Adalimumab, injection 80 mg in 0.8 mL pre-filled pen, injection
    • Atomoxetine, capsule 10 mg (as hydrochloride), oral
    • Atomoxetine, capsule 100 mg (as hydrochloride), oral
    • Atomoxetine, capsule 18 mg (as hydrochloride), oral
    • Atomoxetine, capsule 25 mg (as hydrochloride), oral
    • Atomoxetine, capsule 40 mg (as hydrochloride), oral
    • Atomoxetine, capsule 60 mg (as hydrochloride), oral
    • Atomoxetine, capsule 80 mg (as hydrochloride), oral
    • Buprenorphine, transdermal patch 10 mg, transdermal
    • Buprenorphine, transdermal patch 15 mg, transdermal
    • Buprenorphine, transdermal patch 20 mg, transdermal
    • Buprenorphine, transdermal patch 25 mg, transdermal
    • Buprenorphine, transdermal patch 30 mg, transdermal
    • Buprenorphine, transdermal patch 40 mg, transdermal
    • Buprenorphine, transdermal patch 5 mg, transdermal
    • Deferasirox, tablet 180 mg, oral
    • Deferasirox, tablet 360 mg, oral
    • Deferasirox, tablet 90 mg, oral
    • Fulvestrant, injection 250 mg in 5 ml pre-filled syringe, injection
    • Hydromorphone, injection containing hydromorphone hydrochloride 10 mg in 1 mL, injection
    • Hydromorphone, injection containing hydromorphone hydrochloride 2 mg in 1 mL, injection
    • Lanreotide, injection 120 mg (as acetate) in single dose pre-filled syringe, injection
    • Lanreotide, injection 90 mg (as acetate) in single dose pre-filled syringe, injection
    • Latanoprost with timolol, eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL, application to the eye
    • Metoprolol succinate, tablet 190 mg (controlled release), oral
    • Metoprolol succinate, tablet 47.5 mg (controlled release), oral
    • Metoprolol succinate, tablet 95 mg (controlled release), oral
    • Palonosetron, injection 250 micrograms (as hydrochloride) in 5 mL, injection
    • Sitagliptin with metformin, tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride, oral
    • Sitagliptin with metformin, tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride, oral
    • Sitagliptin with metformin, tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride, oral
    • Sitagliptin with metformin, tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride, oral
    • Sitagliptin with metformin, tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride, oral
    • Valganciclovir, tablet 450 mg (as hydrochloride), oral
    • Varenicline, box containing 11 tablets 0.5 mg and 42 tablets 1 mg, oral
    • Varenicline, tablet 1 mg, oral
    • Zoledronic acid, solution for I.V. infusion 5 mg (as monohydrate) in 100 mL, injection
    • inserting into Schedule 2 WADPs for brands of pharmaceutical items containing:
      • Aripiprazole, powder for injection 300 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe, injection
      • Aripiprazole, powder for injection 400 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe, injection
      • Calcipotriol with betamethasone, cream containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g, application
      • Dapsone, tablet 50 mg, oral
      • Fludarabine, solution for I.V. injection 50 mg fludarabine phosphate in 2 mL (S19A), injection
      • Methylphenidate, tablet containing methylphenidate hydrochloride 27 mg (modified release) (Spain) (S19A), oral
      • Methylphenidate, tablet containing methylphenidate hydrochloride 54 mg (modified release) (Spain) (S19A), oral
      • Pioglitazone, tablet 15 mg (as hydrochloride), pack of 30, oral
      • Pioglitazone, tablet 30 mg (as hydrochloride), pack of 30, oral
      • Pioglitazone, tablet 45 mg (as hydrochloride), pack of 30, oral
      • Tenofovir with emtricitabine and efavirenz, tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg (S19A), oral
      • Teriparatide, injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge, injection

The Principal Instrument was made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act for brands of pharmaceutical items with a data collection period ending 30 September 2025 (2026 April Cycle).

Amendments

Revision of WADP determinations for brands of pharmaceutical items

Amendments to the Principal Instrument are being made following consideration of matters raised by Responsible Persons. These Amendments concern the determinations made in the Principal Instrument for brands of pharmaceutical items containing adalimumab, atomoxetine, buprenorphine, deferasirox, fulvestrant, hydromorphone, lanreotide, latanoprost with timolol, metoprolol succinate, palonosetron, sitagliptin with metformin, valganciclovir, varenicline and zoledronic acid, which will no longer take price disclosure reductions on 1 April 2026.

Insertion of WADP determinations for new brands of new pharmaceutical items

WADPs need to be determined for brands of new pharmaceutical items listing on the F2 formulary between 1 October 2025 and 31 March 2026 and where the drug is currently subject to price disclosure requirements.

 

There are 12 new pharmaceutical items which have been listed on or after 1 October 2025 and before the reduction day of 1 April 2026 that are included in this legislative instrument. All of these pharmaceutical items have been inserted into Schedule 2.

Consultation

This instrument affects Responsible Persons for all brands of the drug and manner of adalimumab, atomoxetine, buprenorphine, deferasirox, fulvestrant, hydromorphone, lanreotide, latanoprost with timolol, metoprolol succinate, palonosetron, sitagliptin with metformin, valganciclovir, varenicline and zoledronic acid.

A review of all determinations made in the Principal Instrument was conducted in accordance with the Price Disclosure Dispute Resolution Administrative Process, which provided Responsible Persons the opportunity to identify to the Department of Health, Disability and Ageing any perceived issues with WADP determinations in the Principal Instrument. The Department conducted investigations to ensure the reductions were calculated correctly and that the reductions do not increase the risk of shortages in supply or unmet patient need.

Consultation with medical officers employed by the Department was undertaken for some of the disputed drugs. Consultation with affected Responsible Persons also drew on the knowledge of persons with relevant expertise.

To the extent that this instrument affects Responsible Persons for brands of the drugs adalimumab, atomoxetine, buprenorphine, deferasirox, fulvestrant, hydromorphone, lanreotide, latanoprost with timolol, metoprolol succinate, palonosetron, sitagliptin with metformin, valganciclovir, varenicline and zoledronic acid, it was considered that no consultation was necessary as the effect of the amendments is that a price reduction will not occur for those brands. The changed outcome for those brands should not increase the risk of shortages in supply or unmet patient need.

This instrument commences on the day after registration. This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Weighted average disclosed price – April 2026 reduction day) Amendment Determination 2026

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

This instrument amends the National Health (Weighted average disclosed price – April 2026 reduction day) Determination 2025 (the Principal Instrument) to a) remove brands of pharmaceutical items which will no longer have a price reduction on reduction day from Schedule 1 and insert them in Schedule 2 and b) insert the WADP for brands of new pharmaceutical items in Schedule 2.

Part VII of the Act is the legislative basis for the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Price disclosure provides for the ‘approved ex-manufacturer price’ of a ‘brand of a pharmaceutical item’ to be reduced on a reduction day in certain specified circumstances. The reduction is based on sales revenue, incentives and volume data collected from responsible persons (drug companies) and occurs in accordance with the Act and the Regulations.

The amendments are made to provide for appropriate and effective reductions, consistent with the intent of the price disclosure policies for prices for pharmaceutical benefits on 1 April 2026 under the statutory provisions for price disclosure.

Human rights implications

This Determination engages Article 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme that assists providing subsidised access to medicines for people. This is a positive and supportive step towards attaining the highest standard of health for all Australians. The price disclosure program progressively reduces the price of some PBS medicines, which are subject to competition, ensuring better value for money from these medicines. These reductions may also result in patients accessing these medicines at lower prices.

Conclusion 

This Determination is compatible with human rights because it advances the protection of human rights.
 

Rebecca Richardson

Assistant Secretary

PBS Listing, Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health, Disability and Ageing

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.