National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 5)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01061 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 5)

 

PB 81 of 2021

 

Authority

 

This instrument, made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021) (the Principal Determination).

 

The Principal Determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).

 

Purpose

 

This instrument makes amendments to the Principal Determination.

 

The Act provides that PBS listed drugs may be assigned to formularies identified as F1 and F2. F1 is intended for single branded drugs and F2 for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to the provisions of the Act relating to price disclosure and guarantee of supply.

 

Section 84AC of the Act provides that a drug is on F1 or F2 if there is a determination in force under section 85AB that the drug is on F1 or F2.

 

Subsection 85AB(1) of the Act empowers the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2.  For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4). This requires that there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar. It also requires that the drug was not on F2 the day before the determination comes into effect. A drug may only be determined to be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)).

 

When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the PBS, the listed drug is not placed on F1 or F2, but on the administrative combination drug list (CDL).

 

This Instrument amends the Principal Determination by adding to F1 three new drugs, alirocumab, fremanezumab and risdiplam. In addition, it also moves one currently listed F1 drug, deferasirox, to F2.  

 

 

 

 

 

Variation and revocation

 

Unless there is an express power to revoke or vary PB 33 of 2021 cited in this Instrument, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 33 of 2021.

 

Consultation

 

This instrument affects pharmaceutical companies with new medicines listing on the PBS.  Alirocumab, fremanezumab and risdiplam meet the criteria for F1 under subsection 85AB(4). Deferasirox no longer meets the criteria for F1 under subsection 85AB(3), so is required to be moved to F2.

 

Before a drug is PBS listed and allocated to a formulary, there are detailed consultations about the drug with the responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of a submission made by the affected pharmaceutical company. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.

 

No additional consultation with experts was undertaken regarding this determination because consultation with the affected responsible persons and the PBAC drew on the knowledge of persons with relevant expertise.

 

Commencement

 

This Instrument commences on 1 August 2021.

 

This Instrument constitutes a legislative instrument for the purpose 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 (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 5)
(PB 81 of 2021)

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 is made pursuant to subsection 85AB(1) of the National Health Act 1953 (the Act), which relates to listed drugs on F1 or F2.  This Instrument amends the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021) (the Principal Determination) which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).

 

This Instrument amends the Principal Determination by adding to F1 three new drugs, alirocumab, fremanezumab and risdiplam. In addition, it also moves one currently listed F1 drug; deferasirox, to F2. 

 

Human rights implications

This Legislative Instrument engages Article 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 assists with advancement of this human right by providing for subsidised access of medicines to patients. 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. Human rights continue to be protected by retaining clinically important medicines on the PBS and placing them in formularies that ensure the most cost effective pricing for supply of each medicine to Australians.

 

 

Nikolai Tsyganov

  Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 5) is an amendment to the National Health (Listed Drugs on F1 or F2) Determination 2021, which itself provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This amendment was enacted by the Minister for Health under subsection 85AB(1) of the National Health Act 1953. The determination introduces three new drugs, alirocumab, fremanezumab and risdiplam, to F1 and moves deferasirox from F1 to F2. The policy objective of this amendment is to ensure that drugs are appropriately allocated to the most cost-effective formularies on the PBS, thereby facilitating access to affordable medications for Australian patients. The determination is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health by providing subsidised access to medicines through the PBS.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 5) amends the National Health (Listed Drugs on F1 or F2) Determination 2021, which pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This instrument adds three new drugs, alirocumab, fremanezumab, and risdiplam, to the F1 formulary, which is reserved for single-branded drugs with no bioequivalent or biosimilar listed brands and drugs that were not previously on F2. Additionally, it moves deferasirox from F1 to F2, as it no longer meets the criteria for F1. This amendment affects pharmaceutical companies with new medicines listed on the PBS, and ensures that decisions regarding the allocation of drugs to the PBS formularies are evidence-based through consultation with the Pharmaceutical Benefits Advisory Committee. The instrument commenced on 1 August 2021, and constitutes a legislative instrument under the Legislation Act 2003.

Key Provisions

The main operative sections of the National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 5) (PB 81 of 2021) focus on the amendment of the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021) concerning the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This amendment, pursuant to subsection 85AB(1) of the National Health Act 1953, adds three new drugs, alirocumab, fremanezumab, and risdiplam, to the F1 formulary. Additionally, it moves the drug deferasirox from the F1 formulary to the F2 formulary (subsection 85AB(3)). The criteria for drugs to be placed on F1 or F2 are outlined in subsection 85AB(4) and (3) of the Act, respectively. The obligations imposed by the Act on the parties involved primarily revolve around the process of drug listing and formulary allocation. Pharmaceutical companies must ensure that their submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) are comprehensive and based on the latest evidence. The PBAC, in turn, has the responsibility to review these submissions and provide recommendations on whether a drug should be listed on the PBS and which formulary it should be placed in. The Minister or their delegate is empowered to make the final determination under section 85AB of the Act, based on the criteria specified in subsections 85AB(4) and (3). The Act ensures that these decisions are made with appropriate consultation and consideration of the relevant expertise. Offences and penalties under this legislation are not explicitly stated in the Amendment Determination. However, breaches of the National Health Act 1953 or related regulations could lead to civil or criminal consequences, depending on the nature and severity of the breach. The maximum penalties for such offences can vary widely, depending on the specific provision of the Act or related legislation that is breached. For instance, under section 112 of the Act, a person who contravenes certain provisions relating to the supply of scheduled medicines could face a maximum penalty of up to $22,200 for an individual offence or $111,000 for a corporate offence. Additionally, section 115 of the Crimes Act 1914 could apply if a contravention is deemed to be a serious offence, leading to further criminal penalties. The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 5) ensures that the allocation of drugs to the F1 and F2 formularies of the PBS is done in a manner that is both evidence-based and cost-effective. This is achieved through the detailed consultation process involving pharmaceutical companies and the PBAC, which ensures that all decisions are made with the necessary expertise and consideration. The amendments to the formularies aim to enhance access to necessary medications while maintaining the integrity and sustainability of the PBS.

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