National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020 (PB 29 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00307 In force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020

 

PB 29 of 2020

 

Authority

 

This legislative instrument is made pursuant to subsection 84AG(1) of the National Health Act 1953 (the Act), which gives the Minister the power to determine a therapeutic group and that two or more listed drugs are in the same therapeutic group.

 

Purpose

 

The purpose of the National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020 is to determine the number of therapeutic groups and the listed drugs that are in those therapeutic groups, specifically that eprosartan and losartan are the listed drugs in the angiotensin II receptor antagonist (ATRA) therapeutic group.  

This legislative instrument repeals and replaces National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2010, which sunsets on 1 April 2020.

 

The Drugs listed within a therapeutic group are therapeutically interchangeable with other drugs in the same group. That is, they are of similar safety, efficacy and provide similar health outcomes.

The Government subsidises all drugs within a group up to the level of the lowest price drug. Any difference between the subsidised price and the price of the drug used by the patient is due to a claimed price determined under section 85B of the Act. The additional amount is paid by the patient as a Special Patient Contribution (SPC).

When the Minister determines a SPC for a pharmaceutical item under section 85B of the Act, the Minister does so having regard to whether the drug has been determined to be within a therapeutic group under section 84AG of the Act.

The Minister has determined a SPC for eprosartan, as it was in the ATRA therapeutic group along with losartan, under section 85B of the Act. This instrument determines that eprosartan and losartan are the listed drugs that are in the ATRA therapeutic group. This allows the SPC under section 85B of the Act to continue.

 

Consultation

 

This legislative instrument affects the pharmaceutical company that supplies eprosartan and losartan medicines listed on the PBS.

The pharmaceutical company with a listed brand of eprosartan and losartan was consulted about whether it considered these drugs should continue to be determined in the ATRA therapeutic group. The pharmaceutical company requested that the instrument be remade to enable the SPC that currently applies to eprosartan to continue.

Further, the Pharmaceutical Benefits Advisory Committee (PBAC) provided advice to the Minister under section 101(4AA) of the Act that eprosartan should be treated as interchangeable on an individual patient basis with losartan and that the Minister should determine that eprosartan and losartan should be included in an ATRA therapeutic group.

This instrument commences on the date after this instrument is registered.

 

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

 

A provision-by-provision description of this instrument is contained in the Attachment.

 


ATTACHMENT

 

 

DETAILS OF THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – THERAPEUTIC GROUPS) DETERMINATION 2020

 

Section 1            Name of Determination

 

This section provides that the name of this instrument is the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2020 and that it may also be cited as PB 29 of 2020.

 

Section 2            Commencement

 

This section provides that this instrument commences on the date after this instrument is registered.

 

Section 3            Authority

 

This section provides that this instrument is made under subsection 84AG(1) of the National Health Act 1953.

 

Section 4            Repeal of previous instrument

 

This section provides that the National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2010 is repealed. 

 

Section 5            Definitions

 

This section provides definitions of the ‘Act’ meaning the National Health Act 1953 and ‘ATRA group’ meaning the Angiotensin II receptor antagonist group.

 

Section 6            Therapeutic groups

 

This section provides that for paragraph 84AG(1)(a) of the Act, a therapeutic group is a group mentioned in a Part of Schedule 1.

 

Section 7            Drugs in therapeutic groups

 

This section provides that for paragraph 84AG(1)(b) of the Act, each listed drug mentioned in a Part of Schedule 1 is in the therapeutic group mentioned in the Part.

 

Schedule 1         Therapeutic groups and listed drugs

 

This schedule lists the therapeutic groups and listed drugs within those groups. Part 1 is the ATRA group and lists Item 1 as eprosartan and Item 2 as losartan.

 

 

 


Statement of Compatibility with Human Rights

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

National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020

 (PB 29 of 2020)

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 84AG(1) of the National Health Act 1953 (the Act), which relates to therapeutic groups. This legislative instrument determines the angiotensin II receptor antagonist (ATRA) therapeutic group and determines that eprosartan and losartan are the listed drugs that are in the ATRA therapeutic group.

 

Drugs listed within a therapeutic group are therapeutically interchangeable with other drugs in the same group. That is, they are of similar safety, efficacy and provide similar health outcomes. The independent Pharmaceutical Benefits Advisory Committee (PBAC) provides this advice.

 

Human rights implications

This legislative instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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 Pharmaceutical Benefits Scheme is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the PBAC 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.

 

 

Thea Daniel

 Assistant Secretary

Pricing and PBS Branch

Technology Assessment and Access Division

 Department of Health

 

 

Overview

The National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020, enacted in 2020, addresses the need to clarify the therapeutic groups and the listed drugs within these groups under the National Health Act 1953. This legislative instrument, made by the Minister for Health under the authority granted by the Act, specifically aims to determine that eprosartan and losartan are the listed drugs within the angiotensin II receptor antagonist (ATRA) therapeutic group. It serves to replace the previous determination made in 2010, ensuring that the Government’s subsidisation policies and Special Patient Contributions (SPC) for these drugs remain consistent and aligned with therapeutic interchangeability principles. The policy objective of this determination is to maintain the therapeutic interchangeability of listed drugs, ensuring patients receive similar health outcomes while the Government effectively manages pharmaceutical benefits.

Scope and Application

The National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020 applies to the Minister for Health under the National Health Act 1953, specifically focusing on the establishment and maintenance of therapeutic groups and the classification of listed drugs within these groups. This legislative instrument determines the therapeutic groups for pharmaceutical benefits, with a particular focus on the angiotensin II receptor antagonist (ATRA) therapeutic group, which includes the listed drugs eprosartan and losartan. The drugs within a therapeutic group are considered therapeutically interchangeable, meaning they are of similar safety, efficacy, and provide similar health outcomes. The government subsidises all drugs within a group up to the level of the lowest price drug, with any difference in price being covered by a Special Patient Contribution (SPC) paid by the patient. This determination ensures that the SPC for eprosartan, which was previously in the ATRA therapeutic group, continues to apply, facilitating ongoing access to subsidised medication under the Pharmaceutical Benefits Scheme (PBS). The determination repeals and replaces the previous National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2010, ensuring updated and relevant classifications for therapeutic groups and listed drugs. This legislative instrument extends its application across Australia, affecting pharmaceutical companies supplying eprosartan and losartan medicines listed on the PBS, and patients who use these drugs. The instrument does not specify exclusions or thresholds beyond the listed drugs within the determined therapeutic groups. The authority to make this determination is derived from subsection 84AG(1) of the National Health Act 1953, and it does not introduce new subordinate instruments but rather updates existing classifications and related provisions within the PBS framework.

Key Provisions

The National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020 (sections 1 to 7) specifies the angiotensin II receptor antagonist (ATRA) therapeutic group and identifies eprosartan and losartan as the drugs within this group. This determination is made under the authority of subsection 84AG(1) of the National Health Act 1953 and serves to replace the previous determination from 2010. The listed drugs in a therapeutic group are considered interchangeable, meaning they have similar safety profiles, efficacy, and health outcomes, as advised by the Pharmaceutical Benefits Advisory Committee (PBAC). This interchangeability allows for the government to subsidise all drugs within a group up to the lowest price, with any additional cost borne by the patient as a Special Patient Contribution (SPC). The obligations imposed by this determination include ensuring that eprosartan and losartan are recognised as interchangeable drugs within the ATRA therapeutic group. Pharmaceutical companies supplying these drugs must list them accordingly on the Pharmaceutical Benefits Scheme (PBS). The government's role includes setting the subsidised price for these drugs and determining any special patient contributions. The PBAC's role involves providing evidence-based recommendations to the Minister regarding the interchangeability and pricing of these drugs. Breaching the obligations set forth in this determination could lead to civil consequences. Pharmaceutical companies failing to list drugs correctly may face penalties under the National Health Act 1953. Additionally, any misrepresentation of drug interchangeability or pricing could result in legal action. The Minister, in setting the SPC, must consider the therapeutic grouping of drugs, and any misapplication of the criteria could also lead to corrective measures. While specific penalties are not detailed in the determination itself, they would likely be aligned with the broader provisions of the National Health Act 1953.

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