National Health (Weighted average disclosed price – October 2025 reduction day) Amendment Determination 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01008 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 102 of 2025

NATIONAL HEALTH ACT 1953

National Health (Weighted average disclosed price – October 2025 reduction day) Amendment Determination 2025

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 – October 2025 reduction day) Determination 2025 (PB 71 of 2025) (the Principal Instrument) by:

  • removing from Schedule 1 and inserting in Schedule 2 WADPs for brands of pharmaceutical items containing:
    • Adalimumab, injection 40 mg in 0.8 mL pre-filled pen, injection
    • Adalimumab, injection 40 mg in 0.8 mL pre-filled syringe, 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
    • Ezetimibe with atorvastatin, tablet 10 mg-10 mg, oral
    • Ezetimibe with atorvastatin, tablet 10 mg-20 mg, oral
    • Hydromorphone, injection containing hydromorphone hydrochloride 10 mg in 1 mL, injection
    • Hydromorphone, injection containing hydromorphone hydrochloride 2 mg in 1 mL, injection
    • Infliximab, solution for injection 120 mg in 1 mL pre-filled pen, injection
    • Latanoprost with timolol, eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL, application to the eye
    • Morphine, injection containing morphine sulfate pentahydrate 10 mg in 1 mL, injection
    • Palonosetron, injection 250 micrograms (as hydrochloride) in 5 mL, injection
    • Risperidone, oral solution 1 mg per mL, 100 mL, oral
    • Tenofovir, tablet containing tenofovir disoproxil fumarate 300 mg, oral
    • Trastuzumab, powder for I.V. infusion 150 mg, injection
    • Valganciclovir, tablet 450 mg (as hydrochloride), oral
    • Zoledronic acid, solution for I.V. infusion 5 mg (as monohydrate) in 100 mL, injection

 

  • inserting into Schedule 1 WADPs for brands of pharmaceutical items containing:
    • Rivaroxaban, capsule 15 mg, oral
    • Rivaroxaban, capsule 20 mg, oral

 

  • inserting into Schedule 2 WADPs for brands of pharmaceutical items containing:
    • Azithromycin, tablet 500 mg (as dihydrate) (S19A), oral
    • Hydromorphone, oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL (S19A), oral
    • Methylphenidate, capsule containing methylphenidate hydrochloride 10 mg (modified release) (s19A), oral
    • Methylphenidate, capsule containing methylphenidate hydrochloride 20 mg (modified release) (s19A), oral
    • Methylphenidate, capsule containing methylphenidate hydrochloride 30 mg (modified release) (s19A), oral
    • Methylphenidate, capsule containing methylphenidate hydrochloride 60 mg (modified release) (s19A), oral
    • Methylphenidate, tablet containing methylphenidate hydrochloride 18 mg (extended release) (S19A), oral
    • Methylphenidate, tablet containing methylphenidate hydrochloride 18 mg (extended release) Concerta (Switzerland) (S19A), oral
    • Methylphenidate, tablet containing methylphenidate hydrochloride 27 mg (extended release) (S19A), oral
    • Methylphenidate, tablet containing methylphenidate hydrochloride 36 mg (extended release) (S19A), oral
    • Methylphenidate, tablet containing methylphenidate hydrochloride 36 mg (extended release) Concerta (Switzerland) (S19A), oral
    • Methylphenidate, tablet containing methylphenidate hydrochloride 54 mg (extended release) (S19A), oral
    • Methylphenidate, tablet containing methylphenidate hydrochloride 54 mg (extended release) Concerta (Switzerland) (S19A), oral
    • Naproxen, oral suspension 125 mg per 5 mL, 474 mL (S19A), oral
    • Omalizumab, injection 150 mg in 1 mL single dose pre-filled pen, injection
    • Omalizumab, injection 300 mg in 2 mL single dose pre-filled pen, injection
    • Omalizumab, injection 75 mg in 0.5 mL single dose pre-filled pen, injection
    • Prazosin, capsule 2 mg (as hydrochloride) (S19A), oral

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 31 March 2025 (2025 October 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, ezetimibe with atorvastatin, hydromorphone, infliximab, latanoprost with timolol, morphine, palonosetron, risperidone, tenofovir, trastuzumab, valganciclovir and zoledronic acid, which will no longer take price disclosure reductions on 1 October 2025.

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 2024 and 31 March 2025 and where the drug is currently subject to price disclosure requirements.

 

There are 20 new pharmaceutical items which have been listed after 31 March 2025 and before the reduction day of 1 October 2025 that are included in this legislative instrument. 2 of these new pharmaceutical items have been inserted into Schedule 1, and 18 have been inserted into Schedule 2.

Consultation

This instrument affects Responsible Persons for all brands of the drug and manner of adalimumab, atomoxetine, ezetimibe with atorvastatin, hydromorphone, infliximab, latanoprost with timolol, morphine, palonosetron, risperidone, rivaroxaban, tenofovir, trastuzumab, valganciclovir 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, ezetimibe with atorvastatin, hydromorphone, infliximab, latanoprost with timolol, morphine, palonosetron, risperidone, tenofovir, trastuzumab, valganciclovir 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 – October 2025 reduction day) Amendment Determination 2025

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 – October 2025 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, b) update WADPs for brands of pharmaceutical items in Schedule 1, and c) insert the WADP for brands of new pharmaceutical items in Schedules 1 and 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 October 2025 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.