EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 10)
PB 102 of 2018
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 2018 (No. 10) (this Instrument). The purpose of this Instrument, made under subsection 100(2) of the Act, 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 program.
The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
The amendments made by this Instrument include additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
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. In addition, an industry nominee has been appointed to the PBAC membership. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), 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 this Instrument are set out in the Attachment.
This Instrument commences on 1 December 2018.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 10)
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 2018 (No. 10). It can also be cited as PB 102 of 2018.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2018.
Section 3 Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule Amendments
The amendments in Schedule 1 provide for additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). These changes are summarised below.
SUMMARY OF CHANGES
Listed drugs added
Benralizumab |
Dolutegravir with rilpivirine |
Midostaurin |
Form added
Deferasirox | Tablet 90 mg |
Deferasirox | Tablet 180 mg |
Deferasirox | Tablet 360 mg |
Brands added
Abacavir with Lamivudine | Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg (ABACAVIR/LAMIVUDINE 600/300 SUN) |
Alteration of circumstances
Filgrastim (Nivestim & Zarzio brands only) |
Infliximab |
Lanreotide |
Mepolizumab |
Octreotide |
Omalizumab |
Addition of responsible person
AstraZeneca Pty Ltd (AP) |
Novartis Pharmaceuticals Australia Pty Limited (NM) |
Addition of listed drug to definition for ‘CAR drug’
Benralizumab |
Midostaurin |
* To make the insertion points for the above two drugs clearer, this amendment instrument instructs the substitution of the entire definition for ‘CAR drugs’. The substituted definition incorporates the above two drugs into the list of drugs included in the definition, and re-numbers that list.
Addition of listed drug to definition for ‘medication for the treatment of HIV or AIDS’
Dolutegravir with rilpivirine |
* To make the insertion point for the above drug clearer, this amendment instrument instructs the substitution of the entire definition for ‘medication for the treatment of HIV or AIDS’. The substituted definition incorporates the above drug into the list of drugs included in the definition, and re-numbers that list.
Document/s incorporated by reference
Listed Drug/s | Document incorporated | Document access |
Benralizumab Mepolizumab Omalizumab | Asthma Control Questionnaire (ACQ-5). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The ACQ-5 is a widely used tools for measuring asthma control. | Prescribers can contact the suppliers of these asthma medications directly to obtain free copies of the ACQ calculation sheets. Contact details for the suppliers can be found online at www.pbs.gov.au |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 10)
(PB 102 of 2018)
This 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 Instrument
The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), 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 program.
The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.
Human rights implications
This 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 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 Instrument is compatible with human rights because it advances the protection of human rights.
Julianne Quaine
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health