Federal Register of Legislation - Australian Government

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PB 92 of 2021 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to add, delete and make changes to drugs, forms, manners of administration, brands, responsible person codes, authorised prescribers, maximum quantities/amounts and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 31 Aug 2021
Tabling HistoryDate
Tabled HR01-Sep-2021
Tabled Senate02-Sep-2021
To be repealed 11 Feb 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY)
SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2021 (No. 8)

PB 92 of 2021

 

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

The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement) to make changes relating to the Efficient Funding of Chemotherapy.

The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (‘chemotherapy pharmaceutical benefits’) to eligible patients being treated for cancer, to reflect the 2010 Budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’.  The Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (‘related pharmaceutical benefits’) at certain public hospitals.

This Instrument makes amendments to the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) which commences on the same day. 

Schedule 1 to this Instrument provides for the deletion of the drug interferon alfa-2a from the Special Arrangement and the alteration of circumstances in which a prescription may be written for the supply of the listed drug brentuximab vedotin. These changes are summarised, by subject matter, in the Attachment.

Consultations

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 Pharmaceutical Benefits Advisory Committee (PBAC).  The 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.  Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

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 these interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.

Pharmaceutical companies are consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process and agreement to final listing details.

It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that has already taken place.

General

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

This Instrument commences on 1 September 2021.

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


 

ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2021 (No. 8)

Section 1         Name of Instrument

This section provides the name of this Instrument as the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 8) and may also be cited as
PB 92 of 2021.

Section 2         Commencement

This section provides that this Instrument commences on 1 September 2021.

Section 3         Authority

This section states that this instrument is made under subsection 100(2) of the National Health Act 1953.

Section 4         Schedules

Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.

Schedule 1 Amendments

The amendments in Schedule 1 involve the deletion of a drug and the alteration of circumstances for prescribing a pharmaceutical benefit available on the Special Arrangement.  These changes are summarised below.

 

SUMMARY OF CHANGES TO THE EFFICIENT FUNDING OF
CHEMOTHERAPY PROGRAM MADE BY THIS INSTRUMENT

 

Listed Drug Deleted

Listed Drug

Interferon alfa-2a

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Brentuximab vedotin

 

 


 

Diagnostic tools referenced in the Instrument

The following standard medical diagnostic tools are referenced in the Instrument but are not intended to incorporate a document by reference.

Listed Drug

Diagnostic tool

Purpose and use in the Instrument

Reason this reference does not serve to incorporate a document

Brentuximab vedotin

Lugano Classification

The Lugano Classification provides guidance to clinicians on how to objectively assess a patient’s response to treatment for Non-Hodgkin Lymphoma.

 

Patient response must be reported on as part of the authority application for this PBS listed drug.

The Lugano Classification provides guidance to assess a patient’s response to treatment for Non-Hodgkin Lymphoma and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met.

The response criteria has been reproduced within the restriction text for Brentuximab vedotin. This restriction text is included in the current month amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

 

 

 

 


 

Statement of Compatibility with Human Rights

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

National Health (Efficient Funding of Chemotherapy) Special Arrangement
Amendment Instrument 2021 (No. 8)

(PB 92 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

The purpose of this Legislative Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement) to make changes relating to the Efficient Funding of Chemotherapy.

The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (‘chemotherapy pharmaceutical benefits’) to eligible patients being treated for cancer, to reflect the 2010 Budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’.  The Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (‘related pharmaceutical benefits’) at certain public hospitals.

This Instrument provides for amendments to the Special Arrangement to ensure that the Special Arrangement accurately reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act, which commences on the same day.

The amendments in Schedule 1 involve the deletion of a drug and the alteration of circumstances for prescribing a pharmaceutical benefit available on the Special Arrangement.

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 (PBS) is a benefit scheme which assists with the 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 Legislative Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

 

 

Mariana Crank

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health