National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7) (PB 66 of 2017)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 7)

PB 66 of 2017

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 2017 (No. 7) (the Amendment Instrument). The purpose of the Amendment Instrument 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 (HSD) program.

The amendment made by this Instrument reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

The amendments in PB 66 of 2017 include the addition of two new listed drugs, the addition of a number of new brands of already listed drugs, deletion of a number of brands of listed drugs and changes to the circumstances for prescribing for a number of listed drugs (including maximum quantities and numbers of repeats). These changes are summarised, by drug name, in the Attachment.

A provision by provision Description of this instrument is contained 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. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), the 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 the instrument are set out in the Attachment.

This Instrument commences on 1 September 2017.

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

ATTACHMENT

Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7)

PART 1 PRELIMINARY

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 2017 (No. 7). It can also be cited as PB 66 of 2017.

Section 2 Commencement

This section provides that this instrument commences on 1 September 2017.

Section 3 Amendment

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

Schedule - Amendments

Item 1 Part 1, Division 1, Section 4

Adds two new drugs to the definition of a ‘CAR drug’.

Item 2 Part 2, Division 4, Section 24(2)

Adds details of the maximum quantities applicable to the following CAR drugs:

Infliximab

Omalizumab

Pasireotide

Pegvisomant

Ustekinumab

Item 3 Part 2, Division 4, Section 25(2)

Adds details of the number of repeats applicable to the following CAR drugs:

Infliximab

Omalizumab

Pasireotide

Pegvisomant

Ustekinumab

Items 4 to 28 Schedules 1 and 3

Items 4 to 28 provide for the addition of two new listed drugs, the addition of a number of new brands of already listed drugs, deletion of a number of brands of listed drugs and changes to the circumstances for prescribing for a number of listed drugs. These changes are summarised below.

SUMMARY OF CHANGES

Listed Drugs Added

Brands Added

Brands Deleted

Alteration of Circumstances

Item 29 Schedule 3, Part 1, Section 3, Treatment regimen

Adds the drug sofosbuvir with velpatasvir to the table which describes the treatment regimens for drugs for the treatment of hepatitis C.