PB 165 of 2025
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2025
I, Rebecca Richardson, as delegate of the Minister for Health, Disability and Ageing, make the following Determination.
Dated 18 December 2025
Rebecca Richardson
Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing
Contents
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments—Additional designated brands effective from 1 June 2026
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023
1 Name
(1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2025.
(2) This instrument may also be cited as PB 165 of 2025.
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. Sections 1 to 4 and anything in this instrument not elsewhere covered by this table | The day after this instrument is registered. | |
3. Schedule 1 | 1 June 2026. | 1 June 2026 |
Note: This table relates only to the provisions of this instrument as originally made.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 Authority
This instrument is made under subsection 99ADHC(2) of the National Health Act 1953.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments—Additional designated brands effective from 1 June 2026
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023
1 Section 5 (after table item dealing with the brand Estalis continuous 50/140 of the drug Estradiol with norethisterone in the form Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8)
Insert:
Repatha | Evolocumab | Injection 140 mg in 1 mL single use pre-filled pen | Injection |
Overview
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2025, also known as PB 165 of 2025, was introduced to address the need for adjusting the floor price of certain pharmaceutical items to ensure their affordability and accessibility within the Australian healthcare system. Enacted by Rebecca Richardson, as delegate of the Minister for Health, Disability and Ageing, under subsection 99ADHC(2) of the National Health Act 1953, this amendment aims to implement changes to the pricing of designated pharmaceutical brands. The policy objective is to maintain the balance between the affordability of medications and the sustainability of the Pharmaceutical Benefits Scheme (PBS), ensuring that essential pharmaceutical items remain accessible to the public. The amendments will take effect from 1 June 2026, with the primary focus being the introduction of additional designated brands into the pricing framework.
Scope and Application
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2025 applies to pharmaceutical items listed under the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023, with specific amendments taking effect from 1 June 2026. This determination is applicable to entities and individuals involved in the supply of pharmaceutical items, particularly those engaged in the manufacturing, distribution, and sale of designated brands. The geographic reach of this Act is national, as it pertains to the Commonwealth of Australia and is enforced under the National Health Act 1953. Notably, the amendment includes additional designated brands, such as Repatha and Evolocumab, which will now be subject to the floor price provisions set forth in the determination. The determination is made by Rebecca Richardson, acting as the delegate of the Minister for Health, Disability and Ageing, and comes into effect on the day after registration, with specific sections and schedule amendments coming into force on 1 June 2026. This instrument does not include any exclusions or exemptions and extends its application to all relevant pharmaceutical brands within the specified timeframe.
Key Provisions
The main sections of the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2025 (section 1) establish the name and the commencement date of the instrument. This instrument may also be cited as PB 165 of 2025 (section 1(2)). Section 2 outlines the commencement date for different parts of the instrument, with most provisions commencing on the day after registration, while Schedule 1 amendments come into effect on 1 June 2026. The authority for this determination is provided under subsection 99ADHC(2) of the National Health Act 1953 (section 3). Schedule 1 details amendments to the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023, introducing new designated brands effective from 1 June 2026.
The obligations imposed by this determination primarily involve the amendment of the existing National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. Specifically, it mandates the addition of new designated brands, such as Repatha and Evolocumab, to the list of pharmaceutical items subject to floor pricing. These amendments mean that entities involved in the supply or pricing of these pharmaceutical items must comply with the new pricing regulations. Additionally, the determination affects stakeholders such as pharmaceutical manufacturers, wholesalers, and retailers by imposing specific pricing requirements that must be adhered to from the effective date of the amendments.
Breaches of the provisions in this determination can lead to various penalties and consequences. Under the National Health Act 1953, there may be civil or criminal penalties for non-compliance. Specifically, entities that fail to adhere to the mandated floor pricing for designated pharmaceutical brands could face financial penalties. The exact penalties are not specified in this determination but are likely to be outlined in the primary legislation or related regulations. Furthermore, ongoing non-compliance could result in further regulatory action, including potential legal proceedings against the entities involved. It is crucial for all parties governed by this determination to ensure full compliance to avoid any adverse legal consequences.