National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 6) (PB 72 of 2020)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 6)

PB 72 of 2020

 

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

Purpose

This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No.6) (this Instrument).  The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs program.

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Schedule 1 to this Instrument provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs adalimumab, etanercept and tocilizumab and for the alteration of authority requirements for select circumstances codes applicable to the listed drugs azacitidine, benralizumab, mepolizumab, midostaurin, nusinersen and omalizumab (nine circumstances codes in total).  It also provides for the addition of a brand to an existing pharmaceutical item, the alteration of responsible person codes for four existing brands of pharmaceutical benefits and the deletion of a responsible person from the list of responsible persons. These changes are summarised, by subject matter, in the Attachment.

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.

PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  In addition, an industry nominee has been appointed to the PBAC membership.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS.  This includes consultation through the PBAC process.

Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.

Details of this Instrument are set out in the Attachment.

This Instrument commences on 1 August 2020.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 6)

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 6) and may also be cited as
PB 72 of 2020.

Section 2 Commencement

This section provides that this Instrument commences on 1 August 2020.

Section 3 Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition of a brand, the alteration of responsible person codes for brands of pharmaceutical benefits, the deletion of a responsible person code from the list of responsible persons, the alteration of authority requirements for a number of circumstances applicable to listed drugs and the alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement.  These changes are summarised below.

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT 2010 MADE BY THIS INSTRUMENT

Brand Added

Listed Drug

Form

Pegfilgrastim

Injection 6 mg in 0.6 mL single use pre‑filled syringe (Pelgraz)

Alteration of Responsible Person Code

Listed Drug

Form

Brand Name

Responsible Person

Lanthanum

Tablet, chewable, 500 mg
(as carbonate hydrate)

Fosrenol

From: ZI

To: TK

Tablet, chewable, 750 mg
(as carbonate hydrate)

Fosrenol

From: ZI

To: TK

Tablet, chewable, 1000 mg
(as carbonate hydrate)

Fosrenol

From: ZI

To: TK

Teduglutide

Powder for injection 5 mg with diluent

Revestive

From: ZI

To: TK

Deletion of Responsible Person Code

Responsible Person and Code

Shire Australia Pty Limited (ZI)

 

Alteration of Authority Requirements

Listed Drug

Circumstances Code

Authority Requirements ‑ Part of Circumstances

Azacitidine

C6144

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

 

C6186

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

 

C6199

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

Benralizumab

 

C9887

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

Mepolizumab

C9885

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

Midostaurin

C8138

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

 

C8193

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

Nusinersen

C10112

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

Omalizumab

C9855

From: Compliance with Written Authority Required procedures

To: Compliance with Authority Required procedures

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Adalimumab

Etanercept

Tocilizumab

Document/s incorporated by reference

Listed Drug

Document incorporated

Document access

Adalimumab

Etanercept

Tocilizumab

 

Therapeutic Goods Administration (TGA)-approved Product Information. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine.

TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0

 

 

 

 

 

 

 

 


Statement of Compatibility with Human Rights

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

National Health (Highly specialised drugs program)
Special Arrangement Amendment Instrument 2020 (No. 6)

(PB 72 of 2020)

This 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 Instrument

The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs program.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.

The amendments in Schedule 1 involve the addition of a brand, the alteration of responsible person codes for brands of pharmaceutical benefits, the deletion of a responsible person code from the list of responsible persons, the alteration of authority requirements for a number of circumstances applicable to listed drugs and the alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement.

Human Rights Implications

This 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 (PBS) 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 Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

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

 

 

 

Ben Sladic

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2020 (No. 6) (PB 72 of 2020) is an amendment made under the authority of the National Health Act 1953. This Act enables the Minister for Health to create special arrangements for the supply of pharmaceutical benefits, particularly those related to highly specialised drugs. The purpose of this amendment is to update and align the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These updates include alterations to prescription requirements and authority codes for certain drugs, as well as modifications to responsible person codes and the addition of a new brand to the pharmaceutical benefits list. The amendments were made in consultation with the Pharmaceutical Benefits Advisory Committee, which ensures recommendations are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. This Instrument is designed to enhance access to highly specialised drugs for patients with chronic conditions, thereby supporting the broader policy objective of improving health outcomes through the Pharmaceutical Benefits Scheme. The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2020 (No. 6) was enacted by the Australian Parliament to address gaps in the supply and regulation of highly specialised drugs under the National Health Act 1953. The Instrument modifies existing special arrangements to better align with recent amendments to the Pharmaceutical Benefits Scheme, ensuring that the supply of these drugs is managed in accordance with the latest evidence and regulatory standards. The changes include updating prescription and authority requirements, adjusting responsible person codes, and incorporating new pharmaceutical brands. These amendments are intended to facilitate improved access to necessary treatments for patients with chronic conditions, thereby supporting the overarching goal of enhancing public health through accessible and effective pharmaceutical benefits.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2020 (No. 6) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to update the listing and supply arrangements for certain pharmaceutical benefits under the Highly Specialised Drugs program. This Instrument applies to pharmaceutical benefits supplied under the Special Arrangement, which are for the treatment of chronic conditions that may only be supplied to patients receiving specialised treatment. The changes involve the addition of a brand, the alteration of responsible person codes, the deletion of a responsible person code, the alteration of authority requirements, and the alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement. The Instrument's amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and are effective from 1 August 2020. The Instrument is compatible with human rights as it advances the protection of the right to the enjoyment of the highest attainable standard of physical and mental health through the provision of subsidised access to medicines under the Pharmaceutical Benefits Scheme. The Instrument applies nationally and is made under the authority of the National Health Act 1953, which enables the Minister to make special arrangements for the supply of pharmaceutical benefits. The Instrument's amendments are incorporated by reference to Therapeutic Goods Administration-approved Product Information. The Instrument does not specify any exclusions, exemptions, or thresholds, and its application may be extended or restricted through subordinate instruments made under the Act.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2020 (No. 6) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to update the Special Arrangement relating to the Highly Specialised Drugs program. The changes, detailed in Schedule 1, include the addition of a brand (Section 1), alteration of responsible person codes for brands of pharmaceutical benefits, the deletion of a responsible person code from the list of responsible persons, alteration of authority requirements for a number of circumstances applicable to listed drugs and alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement. The instrument is effective from 1 August 2020 (Section 2). This Act imposes obligations on pharmaceutical companies and healthcare providers to comply with the updated requirements for the supply and prescription of highly specialised drugs. Pharmaceutical companies must ensure that the drugs listed in the amended Schedule are supplied in accordance with the new specifications, including any changes to responsible person codes or brand additions. Healthcare providers, particularly those prescribing highly specialised drugs, must adhere to the updated circumstances and authority requirements for prescriptions, ensuring compliance with the new regulatory framework (Section 3). Failure to comply with the amended provisions of the Special Arrangement may result in civil or criminal consequences. The specific penalties for non-compliance are not detailed in the Act but are generally subject to the provisions of the National Health Act 1953 and related regulations. In cases of serious or repeated breaches, the Minister may take enforcement actions, which could include fines or other penalties as prescribed by law (Section 100). The exact penalties depend on the nature and severity of the breach and are determined in accordance with the relevant legislative provisions. This amendment process reflects recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the National Health Act 1953. The PBAC ensures that decisions about which drugs are available as pharmaceutical benefits are evidence-based and consider factors such as clinical effectiveness, safety, and cost-effectiveness. The ongoing consultation process with stakeholders, including pharmaceutical companies and healthcare providers, ensures that the amendments are aligned with the latest medical evidence and regulatory standards. Overall, this Instrument is designed to enhance the efficiency and effectiveness of the Highly Specialised Drugs Program by updating the regulatory framework to reflect current medical practices and industry standards. It ensures that patients have access to the latest treatments while maintaining high standards of safety and efficacy.

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