National Health (Price and Special Patient Contribution) Amendment Determination 2023 (No. 9)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2023 (No. 9)

PB 121 of 2023

Authority

This legislative instrument, made under section 85B of the National Health Act 1953 (the Act), amends the National Health (Price and Special Patient Contribution) Determination 2022 (PB 98 of 2022) (the Principal Determination).

Subsections 85B(2), (3) and (4) of the Act provide for the Minister to determine, respectively, determined prices, claimed prices and the circumstances in which the Commonwealth will pay a special patient contribution. The Principal Determination contains determinations of these matters.

Variation and revocation

Unless there is an express power to revoke or vary PB 98 of 2022 cited in this instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 98 of 2022.

Purpose

The Act provides for the Minister and the responsible person to agree a price that is taken to be the appropriate maximum price of a brand of a pharmaceutical item for the purposes of Part VII of the Act (section 85AD). Section 85B of the Act applies if the Minister and the responsible person have been unable to reach an agreement on a price for the pricing quantity. Whether or not an agreement is made for the pricing quantity, section 85B also applies if the responsible person is dissatisfied with the proportional ex-manufacturer prices that will apply to other pack quantities.

Subsection 85B(2) provides that the Minister may determine, by reference to the pricing quantity of a brand of a pharmaceutical item, an amount that is taken to be the appropriate maximum price of the brand for the purposes of Part VII of the Act. This is termed the ‘Determined Price’ in this Determination.

Subsection 85B(3) provides that the Minister may determine, by reference to a pack quantity of a brand of the pharmaceutical item, an amount that is taken to be the price claimed by the responsible person for the pack quantity of the brand, for the purposes of Part VII of the Act. This is termed the ‘Claimed Price’ in this Determination.

The Determined Price is the Approved Ex-Manufacturer Price (AEMP) and is used as the basis for working out the Commonwealth price for the brand of the pharmaceutical item (section 98B of the Act); for pack quantities other than the pricing quantity, the proportional ex-manufacturer price (PEMP) is used as the basis. Approved pharmacists are entitled to receive a payment from the Commonwealth equal to the Commonwealth price less the applicable patient co-payment (section 99 of the Act).

The difference between the Responsible Person’s Commonwealth price for a pack quantity (i.e., the price that would be the Commonwealth price if the responsible person’s claimed price had become the approved ex-manufacturer price or the proportional ex-manufacturer price for that pack quantity) and the Commonwealth price for the pack quantity is defined in subsection 85B(5) of the Act as the special patient contribution. An approved pharmacist may charge a patient an amount equal to the special patient contribution, in addition to any other amount that may be charged (subsection 87(2A) of the Act).

Subsection 85B(4) of the Act provides that the Minister may determine the circumstances in which the Commonwealth is to pay the Special Patient Contribution for a brand. In such cases, the Commonwealth payment to the pharmacist is increased by the amount of the special patient contribution (subsection 99(2AA) of the Act) and the pharmacist may not charge the patient this amount (subsection 87(2A) of the Act). 

The purpose of making subsection 85B(4) determinations is to enable patients for whom the base-priced brands (the ones without a special patient contribution) are not suitable, to obtain the higher priced brand (the one with the special patient contribution) without the need to pay the higher price. In such cases the Commonwealth pays the special patient contribution.

This instrument (the Amendment Determination) amends the Principal Determination by removing the brand premium for two pharmaceutical items due to the delisting of the only generic brands from the PBS. This is consistent with the Department’s policy that pharmaceutical companies are only able to charge brand premiums where there is at least one premium-free brand of the same medicine available on the PBS to allow for equitable access to medicines. It also removes one brand of one pharmaceutical item that is delisting from the PBS as requested by the responsible person.

The amendments provided by this instrument take effect on 1 December 2023. 

Consultation

This Determination affects certain responsible persons with medicines listed on the PBS. Before a pharmaceutical benefit is listed on the PBS, and from time to time thereafter, price negotiations occur between the Responsible Person and the Minister for the purpose of reaching a price agreement for section 85AD of the Act. If the Minister and the Responsible Person do not agree on a price, further consultation occurs with the Responsible Person, and thereafter the Minister determines the price that will be the approved ex-manufacturer price for the brand. The Minister also determines the corresponding price claimed by the responsible person which is used to calculate the special patient contribution that will apply to the brand.

For the brand Zofran Zydis, the claimed price and brand premium will be removed from the 4 pack listing of this brand consistent with the request made by the responsible person to delist this brand from the PBS. For the brands Fosamax Plus and Fosamax Plus 70 mg/140 mcg, the claimed price and brand premium will be removed due to the delisting of the only premium free brands listed on the PBS schedule from 1 December 2023. The responsible person of these brands agreed to the removal of these brand premiums. No additional consultation with experts was undertaken regarding this Determination because consultation with affected responsible persons, which informed the making of this Determination, drew on the knowledge of persons with relevant expertise.

A provision by provision description of the Determination is contained in the Attachment.

This Determination commences on 1 December 2023.

This Determination is a legislative instrument for the purposes of the Legislation Act 2003.

ATTACHMENT 

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2023 (No .9)

(PB 121 of 2023)

Section 1   Name of Determination

This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2023 (No. 9) and may also be cited as PB 121 of 2023.

Section 2   Commencement

This section provides that the Determination commences on 1 December 2023.

Section 3   Amendment of the National Health (Price and Special Patient Contribution) Determination 2022 (PB 98 of 2022).

This section provides that Schedule 1 amends the National Health (Price and Special Patient Contribution) Determination 2022 (PB 98 of 2022).

Schedule 1 Amendments commencing 1 December 2023

Schedule 1 sets out the amendments to the Principal Determination which commence on 1 December 2023.

SUMMARY OF CHANGES

SCHEDULE 1

Brands with brand price premiums removed

• Alendronic acid with colecalciferol

• tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol, 4, (oral), Fosamax Plus 70 mg/140 mcg
• tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol, 4, (oral), Fosamax Plus                           

Deletion of brand

• Ondansetron

• wafer 8 mg, (oral), Zofran Zydis (4 pack)

Brands with brand price premiums imposed

• Budesonide with formoterol

• pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses (Inhalation by mouth), Symbicort Rapihaler 100/3
• pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses (Inhalation by mouth), Symbicort Rapihaler 200/6

Brands with brand price premiums varied

• Cefuroxime (oral)
  • tablet 250 mg (as axetil), Zinnat

• Donepezil (oral)

• tablet containing donepezil hydrochloride 5 mg, Aricept
• tablet containing donepezil hydrochloride 10 mg, Aricept

• Flecainide (oral)

• tablet containing flecainide acetate 50 mg, Tambocor
• tablet containing flecainide acetate 100 mg, Tambocor

• Fluticasone propionate with salmeterol (inhalation by mouth)

• pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation), Seretide MDI 125/25
• pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation), Seretide MDI 250/25
• powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses, Seretide Accuhaler 250/50
• powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses, Seretide Accuhaler 500/50

• Indapamide (oral)

• tablet containing indapamide hemihydrate 1.5 mg (sustained release), Natrilix SR

• Naproxen (oral)

• tablet containing naproxen sodium 550 mg, Anaprox 550
• tablet 750 mg (sustained release), Naprosyn SR750
• tablet 1 g (sustained release), Naprosyn SR1000

• Rosuvastatin (oral)

• tablet 5 mg (as calcium), Crestor
• tablet 10 mg (as calcium), Crestor
• tablet 15 mg (as calcium), Crestor
• tablet 40 mg (as calcium), Crestor

Statement of Compatibility with Human Rights

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

National Health (Price and Special Patient Contribution) Amendment Determination 2023 (No. 9) (PB 121 of 2023)

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 legislative instrument, made under section 85B of the National Health Act 1953 (the Act), amends the National Health (Price and Special Patient Contribution) Determination 2022 (the Principal Determination), which provides for price determinations in relation to brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) for which the Minister and the responsible person have not been able to make a price agreement. It also provides for the circumstances in which the Commonwealth will pay the special patient contribution resulting from these price determinations. This instrument amends the Principal Determination by removing the brand premium for two pharmaceutical items due to delisting of the only generic brands from the PBS. It also removes one brand of one pharmaceutical item that is delisting from the PBS as requested by the responsible person. These changes take effect on 1 December 2023. 

Human rights implications

This legislative instrument engages Articles 2 and 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 which assists with advancement of this human right by providing for subsidised access by patients to medicines. Addition of a brand premium for the two brands (budesonide with formotorol) and the variation of several brand premiums are unlikely to result in negative financial impact on patient access therefore ensuring their rights to social security are maintained. Premium free alternatives to these brands remain available on the PBS.

Eligible Australians may continue to access any one of the remaining brands for these pharmaceutical items at subsidised prices as they are flagged for substitution by pharmacists against the brands with brand premiums.

It is longstanding Government policy that pharmaceutical companies are only able to charge brand price premiums where there is at least one premium-free brand of that medicine available through the PBS. All brands subsidised by the PBS are evaluated by the Therapeutic Goods Administration for quality and safety and determined to be bioequivalent, which means they are clinically equivalent and work in the same way. Removing items with brand price premiums will not result in negative financial impact for patients, therefore ensuring their rights to social security are maintained. The recommendatory role of the Pharmaceutical Benefits Advisory Committee ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

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

Nikolai Tsyganov

 Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care