EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 10)
PB 76 of 2011
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.
This instrument amends the circumstances associated with 6 listed drugs for the treatment of Hepatitis B, the listed drug ‘Peginterferon Alfa 2a’ for the treatment of Hepatitis C and the listed drug ‘Zoledronic Acid’ for the treatment of prostate cancer, adds a new restriction for the listed drug ‘Romiplostin’and adds a new listed drug ‘Eltrombopag’ 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 treatment at or from a public or private hospital having access to appropriate specialised facilities.
Section 100 special arrangements and Part VII of the Act
Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:
(a) who are living in isolated areas: or
(b) who are receiving treatment in circumstances in which generally available pharmaceutical benefits are inadequate for that treatment; or
(c) if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.
Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1). A section 100 arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments.
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).
Changes to the Special Arrangement made by this Instrument
This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the Highly specialised drugs program for hospitals. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commences on the same day.
This instrument:
- amends the circumstances associated with the listed drugs ‘Adefovir’, ‘Entecavir’, ‘Interferon Alfa-2a’, ‘Interferon Alfa-2b’, ‘Lamivudine’, ‘Peginterferon Alfa 2a’, ‘Romiplostin’, ‘Telbivudine’, ‘Tenofovir’ and ‘Zoledronic Acid’; and
- adds 2 pharmaceutical benefits with the listed drug ‘Eltrombopag’
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), 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 prescribing circumstances for listings on the PBS and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
General
This Instrument commences on 1 November 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision by provision description of this Instrument is contained in the Attachment.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No.10)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No.10) and that it may also be cited as PB 76 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 November 2011.
Section 3 Amendments to PB 116 of 2010
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Principal Instrument).
Schedule 1
Item 1 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Adefovir’ in the form ‘Tablet containing adefovir dipivoxil 10 mg’ to replace the circumstance codes ‘C2931’ and ‘C3313’ with ‘C3863’ and ‘C3864’.
Item 2 inserts two new pharmaceutical benefits for the new listed drug ‘Eltrombopag’ with manner of administration Oral and brand Revolade, and the forms
- Tablet 25 mg (as olamine)
- Tablet 50 mg (as olamine)
Item 3 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Entecavir’ in the form ‘Tablet containing entecavir monohydrate 0.5 mg’ to replace the circumstance codes ‘C2937’ and ‘C3352’ with ‘C3871’ and ‘C3872’.
Item 4 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Entecavir’ in the form ‘Tablet containing entecavir monohydrate 1 mg’ to replace the circumstance codes ‘C2935’ and ‘C3353’ with ‘C3873’ and ‘C3874’.
Item 5 amends the entry in Schedule 1 of the Principal Instrument for pharmaceutical benefits that have the listed drug ‘Interferon Alfa-2a’ to remove the circumstance codes ‘C2939’ and ‘C3383’ and insert circumstances codes ‘C3869’ and ‘C3870’.
Item 6 amends the entry in Schedule 1 of the Principal Instrument for pharmaceutical benefits that have the listed drug ‘Interferon Alfa-2b’ to remove the circumstance codes ‘C2939’ and ‘C3383’ and insert circumstances codes ‘C3869’ and ‘C3870’.
Item 7 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Lamivudine’ in the form Tablet 100 mg to replace the circumstance codes ‘C2932’ and ‘C3386’ with ‘C3871’ and ‘C3872’.
Item 8 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Lamivudine’ in the form Oral solution 5 mg per mL, 240 mL to replace the circumstance codes ‘C2932’ and ‘C3386’ with ‘C3871’ and ‘C3872’.
Item 9 amends the entry in Schedule 1 of the Principal Instrument for pharmaceutical benefits that have the listed drug ‘Peginterferon Alfa-2a’ to remove the circumstance codes ‘C2940’ and ‘C3411’ and insert the circumstances codes ‘C3867’ and ‘C3868’.
Item 10 amends the entry in Schedule 1 of the Principal Instrument for pharmaceutical benefits that have the listed drug ‘Romiplostin’ to replace the circumstance codes ‘C3699’, ‘C3700’, ‘C3701’ and ‘C3702’ with ‘C3851’, ‘C3852’, ‘C3853’ and ‘C3854’.
Item 11 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Telbivudine’ to replace the circumstance codes ‘C3052’ and ‘C3416’ with ‘C3865’ and ‘C3866’.
Item 12 amends the entry in Schedule 1 of the Principal Instrument for pharmaceutical benefits that have the listed drug ‘Tenofovir’ to remove the circumstance codes ‘C2931’, ‘C3203’, ‘C3313’ and ‘C3417’ and insert new circumstance codes ‘C3863’, ‘C3864’, ‘C3865’ and ‘C3866’.
Item 13 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Zoledronic Acid’ to remove the circumstances codes ‘C1797’ and ‘C3422’ and insert new circumstance codes ‘C3881’ and ‘C3882’.
Item 14 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Adefovir’ to remove the circumstances codes ‘C2931’ and ‘C3313’ and the descriptions that go along with them and to replace with the circumstance codes ‘C3863’, ‘C3864’ and the descriptions that go along with them.
Item 15 inserts a new entry in Schedule 3 of the Principal Instrument for the new listed drug ‘Eltrombopag’ with the circumstance codes ‘C3855’, ‘C3856’, ‘C3857’ and ‘C3858’ and the descriptions that go along with them.
Item 16 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Entecavir’ to remove the circumstances codes ‘C2935’ and ‘C3353’ and the descriptions that go along with them and replace with the circumstance codes ‘C3871’, ‘C3872’, ‘C3873’ and ‘C3874’ and the descriptions that go along with them.
Items 17, 18 and 19 amend the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Interferon Alfa-2a’ to remove the circumstances codes ‘C2939’ and ‘C3383’ and the descriptions that go along with them and insert the circumstance codes ‘C3869’ and ‘C3870’ and the descriptions that go along with them.
Items 20, 21 and 22 amend the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Interferon Alfa-2b’ to remove the circumstances codes ‘C2939’ and ‘C3383’ and ther descriptions that go along with them and insert the circumstance codes ‘C3869’ and ‘C3870’ and the descriptions that go along with them.
Item 23 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Lamivudine’ to remove the circumstances codes ‘C2932’ and ‘C3386’ and the dscriptions that go along with them and insert the circumstance codes ‘C3871’ and ‘C3872’ and the descriptions that go along with them.
Item 24 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Peginterferon Alfa-2a’ to remove the circumstances codes ‘C2940’ and ‘C3411’ and the descriptions that go along with them and insert the circumstance codes ‘C3867’ and ‘C3868’ and the descriptions that go along with them.
Item 25 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Romiplostin’ to remove the circumstances codes ‘C3699’, ‘C3700’, ‘C3701’ and ‘C3702’ and the descriptions that go along with them and replace with the circumstance codes ‘C3851’, ‘C3852’, ‘C3853’ and ‘C3854’ and the descriptions that go along with them.
Item 26 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Telbivudine’ to remove the circumstances codes ‘C3052’ and ‘C3416’ and the descriptions that go along with them and replace with the circumstance codes ‘C3865’ and ‘C3866’ and the descriptions that go along with them.
Item 27 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Tenofovir’ to remove the circumstances codes ‘C2931’, ‘C3203’, ‘C3313’ and ‘C3417’ and the descriptions that go along with them and insert the circumstance codes ‘C3863’, ‘C3864’, ‘C3865’ and ‘C3866’ and the descriptions that go along with them.
Items 28, 29 and 30 amend the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Zoledronic Acid’ to remove the circumstances codes ‘C1797’ and ‘C3422’ and the descriptions that go along with them and insert the circumstance codes ‘C3881’ and ‘C3882’ and the descriptions that go along with them.