National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11) (PB 107 of 2015)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2015 (No. 11)

PB 107 of 2015

Purpose

The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.

PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantity and pack quantity, section 100‑only status and prescriber bag only status).

Authority

This Instrument exercises various powers in Part VII of the Act, as set out below:

Pharmaceutical benefits listed on the PBS

Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies.  A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 4(1)).  Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug.  A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB).  Subsection 85(6) provides that the the Minister may determine a brand of a pharmaceutical item.

The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).  Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.

Prescribing pharmaceutical benefits

Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit.  Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).

Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.

Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion.  Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.  The maximum quantities and repeats may be determined for all purposes or for particular purposes.

Supplying pharmaceutical benefits

Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the PBAC has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.

Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.

Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).

Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.

Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions. 

New subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.

Variation and revocation

Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.

Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation.  Advice from the Pharmaceutical Benefits Advisory Committee (PBAC) is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).

Changes to PB 71 of 2012 made by this instrument

Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), equivalent brands, determined quantities, pack quantities, section 100 only status and prescriber bag only status.  These changes are summarised, by subject matter, in the Attachment.

The amendments to PB 71 of 2012 relating to the determination under subsection 85(6A) of brands to be treated as equivalent are necessary to implement a measure contained in the PBS Access and Sustainability Package announced by the Australian Government in May 2015.  Amendments to the Act for that purpose were made by the National Health Amendment (Pharmaceutical Benefits) Act 2015 (the Amending Act).  The Amending Act also provides in new subsection 85(6B) that, in deciding whether a brand of a pharmaceutical item is to be treated as equivalent, the Minister must have regard to any advice given by the PBAC and in new subsection 101(4AACC) that the PBAC may give such advice.  New subsection 85(6C) provides that a brand specified in the Schedule of Pharmaceutical Benefits on 1 November 2015 as equivalent to one or more other brands of pharmaceutical items is taken to have been determined to that effect under subsection 85(6A).

This instrument amends PB 71 of 2012 to insert a new section 8A as a consqence of the Amending Act.  Section 8A provides that equivalence of an added brand under subsection 85(6A) to a new or existing brand of the same pharmaceutical item is shown by the inclusion of an ‘a’ against those brands in the column headed ‘Schedule Equivalent’ in Schedule 1.  Where an added brand is equivalent to a new or existing brand of a different pharmaceutical item, the brands are included in new Schedule 5 together with any new or existing brands of the same pharmaceutical item to which the added brand is equivalent and as part of the same schedule equivalent group.

Schedule 1 includes an added biosimilar brand for the listed drug infliximab.  The PBAC recommended that the biosimilar brand of infliximab be treated as equivalent to the existing brand.  The determination of this added brand as schedule equivalent to the existing brand is the first occurrence of a biosimilar brand being treated as equivalent to another brand.

Consultation

The involvement of interested parties through the membership of PBAC constitutes a formal and ongoing process of consultation.  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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the 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 are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings.  This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, guarantee of supply and agreement to final listing details.

Since the announcement of the PBS Medication Charts for Public and Private Hospitals measure in 2014, the Department of Health has undertaken an extensive consultation process involving all key health stakeholders.  These consultations indicate widespread and strong support for the trial of the PBS Hospital Medication Chart and amendments required to the Regulations and associated legislative instruments to support the measure.  Consulted stakeholders include States and Territories, Australian Private Hospital Association, Society of Hospital Pharmacists of Australia, Pharmaceutical Society of Australia, Pharmacy Guild of Australia, Australian Medical Association, Cancer Voices Australia, Consumers Health Forum of Australia, National Prescribing Service, the ACSQHC, and the National E-Health Transition Authority.  Similarly, the Department of Human Services has received strong support from a range of stakeholders for the implementation of paperless (electronic) claiming of PBS/RPBS medicines.  This includes support for transitional arrangements to ensure stakeholder readiness for the implementation of paperless PBS/RPBS claiming.

The PBS Access and Sustainability Package (the PBS Package) includes measures relating to the Sixth Community Pharmacy Agreement between the Commonwealth of Australia and the Pharmacy Guild of Australia and the Strategic Agreement with the Generic Medicines Industry Association (now known as the Generic and Biosimilar Medicines Association).  The measures were negotiated following consultations during the first half of 2015 by the Minister for Health and the Department of Health with stakeholders from the pharmaceutical sector including industry, consumer, medical, pharmacist and wholesaler groups.  Organisations represented included Medicines Australia, the Generic Medicines Industry Association, the Consumers Health Forum, NPS MedicineWise, the Australian Medical Association, the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia, the Society of Hospital Pharmacists of Australia, and the National Pharmaceutical Services Association. 

The PBAC has advised that biosimilars should be considered substitutable at the pharmacy level where the data to support that are available and that each biosimilar would be considered on a case-by-case basis.

In July 2015, the PBAC held a consumer hearing regarding the use of biosimilars in Australia.  Representatives of consumer organisations, clinical groups and industry groups attended.  Fact sheets on biosimilar medicines for health professionals and consumers were published on the PBS website on 21 August 2015.

The PBS Package includes a $20 million awareness initiative to support the use of biosimilar medicines by patients, pharmacists and specialists.  The initiative aims to raise awareness among prescribers, patients and pharmacists of the issues and responsibilities around biosimilars.  It aims also to contribute to the sustainability of the PBS by encouraging biosimilar manufacturers to enter the market and deliver savings from increased biosimilar uptake.  There is a range of opportunities for stakeholders across the sector and the wider community to provide input.

The Department of Health developed an Implementation Framework for the project, which was made available for comment via an online survey between 8 and 26 October 2015.  The Department will continue to develop and implement biosimilars awareness activities with on‑going input from stakeholders.

General

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

This Instrument commences on 1 December 2015.

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

ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2015 (No. 11)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11) and may also be cited as PB 107 of 2015.

Section 2 Commencement

This section provides that this Instrument commences on 1 December 2015.

Section 3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1   Amendments

The amendments in Schedule 1 involve additions, deletions and changes to forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements and brand equivalence), determined quantities, pack quantities and section 100 only status.  These changes are summarised below.

SUMMARY OF CHANGES

Listed Drugs Added

Forms Added

Forms Deleted

Schedule Equivalent

A column has been added preceding the column headed “Brand” for the purpose of indicating brands which may be equivalent for the purpose of substitution

Brands Added

Brands Deleted

Alteration of Responsible Person

Addition of Responsible Person Code

Alteration of Circumstances

Alteration of Circumstances Code

The circumstances codes for the following drugs in Schedule 1 and the corresponding circumstances codes in Schedule 4 to the principal instrument have changed.  Any other changes to these listings are detailed under the relevant headings in this summary.

Addition of Schedule 5 ─ Schedule Equivalent

Schedule 5 provides details of pharmaceutical items which are deemed to be equivalent within specified groups for the purpose of substitution