National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 4) (PB 33 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L00607 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 4)

 

PB 33 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. 4) (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 33 of 2016 include adding, removing and changing the circumstances for prescribing various pharmaceutical benefits, and amendments to responsible person codes.

These changes are summarised, by drug name, in the Attachment.

Additionally, from 1 May 2016, the Department of Human Services will have an automated authority system which will enable authorised prescribers to seek and obtain authority approvals via their desktop software, in real time.  Changes to this instrument have been made to provide for the electronic authority approval. Sections 10 (1) has been amended and 10 (1A)  has been inserted to override out of date authority tags which appear in Schedule 3, column headed Authority Requirements - Part of Circumstances.  The override is necessary to allow for electronic authority methods. Technical amendments to sections 11 to 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) have been made to allow authorised prescribers to submit details of a prescription by means of electronic communication to obtain an electronic authority.

Further changes narrow the scope of amendments that were previously made by the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 2) (the Previous Instrument), which commenced on 1 March 2016.  The Previous Instrument broadly removed restrictions that were imposed with respect to the supply of HSD pharmaceutical benefits.  The Amending Instrument largely re-establishes those restrictions, with some clarifications to provide patients with greater access to these medicines while still ensuring appropriate specialist facilities for patients receiving these medicines. 

One of the restrictions that the Previous Instrument had removed related to the supply of HSD pharmaceutical benefits by an approved hospital authority in circumstances where an eligible patient was receiving treatment at or from a hospital that was not a hospital governed by that particular approved hospital authority. Such a supply would not have fallen within the scope of the Special Arrangement prior to the removal of the restriction. This was the case even where the treating hospital was governed by another approved hospital authority.

The Amending Instrument does not seek to reinstate this restriction. This is because such a restriction would adversely affect patient access and the quality use of medicines in contemporary settings. Thus the supply remains within the scope of the Special Arrangement.

The Attachment explains, in further detail, when the supply of an HSD pharmaceutical benefit is now within the scope of the Special Arrangement.

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 and for this Instrument.  This includes consultation through the PBAC process, and agreement to final listing details.

On 15 January 2014, the Minister for Human Services endorsed a number of efficiency measures that was inclusive of the Automated PBS authority approvals measure.  Consultation with the Department of Human Services and the PBAC has occurred in relation to policy matters regarding the implementation of automated electronic authority decision making.

Details of the instrument are set out in the Attachment.

This Instrument commences on 1 May 2016.

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. 4).  It can also be citied as PB 33 of 2016.

 

Section 2 Commencement
This section provides that this instrument commences on 1 May 2016.

 

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

 

Item 1     Section 4 [Definitions]

Item 1 inserts a definition for approved private hospital.

 

Item 2          Section 10 (1)

Item 2 amends section 10 (1) to include reference to ‘Compliance with Authority Required Procedures’ and ‘Compliance with Written Authority Required procedures’. 

 

It also inserts a new subsection at 1A which allows for an authority approval to be obtained via electronic authority methods where ‘Compliance with Written or Telephone Authority Required procedures’ was previously required.  That is, where a medicine is listed with the words ‘Compliance with Written or Telephone Authority Required procedures’ in schedule 3, column headed ‘Authority Requirements – Part of Circumstances’, it is intended that the prescriber may seek authority approval via an automated electronic approval process.

 

The provision for a prescriber to seek an authority approval via electronic means does not extend to those medications listed with ‘Compliance with modified Authority Required procedures’ and ‘Compliance with Written Authority Required procedures’. 

 

Item 3   Section 18

Item 2 defines the scope of when the Special Arrangement applies to the supply of highly specialised drug (HSD) pharmaceutical benefits.

 

The table, set out below, summarises the circumstances in which the supply of an HSD pharmaceutical benefit will be within the scope of the Special Arrangement. The table refers to CAR drugs; these are Complex Authority Required (CAR) drugs.

 

Supplier type

May supply to:

Approved public hospital authority

  • For medication for the treatment of hepatitis B - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For medication for the treatment of HIV or AIDS, other than the drugs azithromycin, doxorubicin - pegylated liposomal and rifabutin - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For medication for the treatment of schizophrenia when used in continuing therapy - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital; and
  • For all other HSD pharmaceutical benefits (including those that have a CAR drug) - an eligible patient receiving treatment at or from an approved public hospital.

Approved private hospital authority

  • For medication for the treatment of hepatitis B - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For medication for the treatment of HIV or AIDS, other than the drugs azithromycin, doxorubicin - pegylated liposomal and rifabutin - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For medication for the treatment of schizophrenia when used in continuing therapy - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital; and
  • For all other HSD pharmaceutical benefits (including those that have a CAR drug) - an eligible patient receiving treatment at or from an approved private hospital.

Approved pharmacist

  • For medication for the treatment of hepatitis B - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For medication for the treatment of HIV or AIDS, other than the drugs azithromycin, doxorubicin - pegylated liposomal and rifabutin - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For medication for the treatment of schizophrenia when used in continuing therapy - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For a pharmaceutical benefit that has a CAR drug – an eligible patient receiving treatment at or from an approved public or private hospital; and
  • For all other HSD medicines - an eligible patient receiving treatment at or from an approved private hospital.

Approved medical practitioner

  • For medication for the treatment of hepatitis B - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital;
  • For medication for the treatment of HIV or AIDS, other than the drugs azithromycin, doxorubicin - pegylated liposomal and rifabutin - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital; and
  • For medication for the treatment of schizophrenia when used in continuing therapy - an eligible patient receiving treatment in or at an approved public or private hospital, or outside of an approved public or private hospital.

 

Item 4   Schedule 1

Item 4 removes the references to ‘MP’ in Schedule 1 column headed ‘Authorised Prescriber’.

 

Items 5 to 28   Schedules 1 and 3     

Items 5 to 28 provide for additions of and changes to pharmaceutical items and circumstances for prescribing.  These changes are summarised below:

 

Listed Drug

Type of Change

Ambrisentan, Apomorphine, Atazanavir with cobicistat, Baclofen, Bosentan, Epoprostenol, Iloprost, Infliximab, Macitentan, Sildenafil, Tadalafil and Tenofovir with emtricitabine, elvitegravir and cobicistat

Remodelled restrictions

Paritaprevir with ritonavir with ombitasvir and dasabuvir and Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin

Addition of new pharmaceutical items

 

Item 29   Schedule 3 Part 1

Item 29 amends Schedule 3 Part 1 by adding the new pharmaceutical benefits Paritaprevir with ritonavir with ombitasvir and dasabuvir and Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin

 

 

 

Interactions

Authorises

All Versions

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