National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 12) (PB) 113 of 2016)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 12)

PB 113 of 2016

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 2016 (No. 12) (the Amending Instrument).  The purpose of the Amending 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 113 of 2016 include amendments to the definition of a CAR drug, addition of quantity exceptions, addition of repeat exceptions, amendments to the definition for eligible medical practitioner, removing a responsible person code, amending manufacturer codes, adding and amending restrictions, removing a pharmaceutical item, addition of new pharmaceutical items, and amendments to the General statement for drugs for the treatment of hepatitis C. 

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.

Details of the instrument are set out in the Attachment.

This Instrument commences on 1 January 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 2016

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 2016 (No. 12).  It can also be cited as PB 113 of 2016.

Section 2 Commencement
This section provides that this instrument commences on 1 January 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

Items 1 to 2    Section 4

Items 1 to 2 amend Section 4 (Definitions) of the Special Arrangements to add the listed drugs ‘Mepolizumab’ and ‘Riociguat’ to the definition of CAR drug and to add the listed drugs ‘Paritaprevir with ritonavir with ombitasvir and dasabuvir’, ‘Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin’ and ‘Grazoprevir with elbasvir’to the definition of eligible medical practitioner.

Items 3 to 4  Section 24 and Section 25                Items 3 to 4 add quantity exceptions and repeat exceptions for the listed drug ‘Riociguat’.

Items 5 to 22 and Items 24 to 33 Schedule 1 and 3

Items 5 to 22 and 24 to 33 provide for amending manufacturer codes, adding and amending restrictions, removing a pharmaceutical item, and addition of new pharmaceutical items.  These changes are summarised below:                             

Item 23  Schedule 2

Item 23 amends Schedule 2 of the Special Arrangement by removing the responsible person HH, ‘Hospira Pty Limited’ from the list of Responsible Person Codes.

Item 34  Schedule 3 Part 1

Item 34 amends Schedule 3 Part 1 of the Special Arrangements by adding the listed drug ‘Grazoprevir with elbasvir’ to the treatment regimen.