EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 2)
PB 20 of 2012
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
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the 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.
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.
This instrument makes changes to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commence on the same day.
This instrument:
- amends the circumstances associated with pharmaceutical benefits with the listed drugs ‘Ambrisentan’, ‘Bosentan’, ‘Epoprostenol’, ‘Iloprost’, ‘Sildenafil’ and ‘Tosilizumab’;
- adds two new pharmaceutical benefits with the new listed drugs ‘Rilpivirine’ and ‘Tadalafil’;
- adds eight new pharmaceutical benefits with the listed drug ‘Mycophenolic acid’;
- adds a new pharmaceutical benefit with the listed drug ‘Nevirapine’; and
- removes two pharmaceutical benefit with the listed drug ‘Epoprostenol’.
This instrument makes changes to insert the maximum quantity and number of repeats for the new listed drug Tadalafil.
This instrument also makes changes to the Special Arrangement to reflect the commencement of section 98AC of the Act on 1 April 2012 and the rules made under subsection 98AC(4). Section 98AC was included in the amendments to the Act made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2010. This instrument makes modifications to the operation of the rules under subsection 98AC(4) to reflect other modifications made to Part VII of the Act by this Special Arrangement.
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 listings on the PBS and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
This Instrument commences on 1 April 2012.
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 2012 (No. 2)
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 2012 (No. 2) and that it may also be cited as PB 20 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2012.
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 Special Arrangement).
Schedule 1
Item 1 amends Section 4 of the Special Arrangement by inserting ‘Tadalafil’ into the definition of ‘CAR drug’.
Item 2 amends Section 4 of the Special Arrangement by inserting ‘Rilpivirine’ into the definition of ‘medication for the treatment of HIV or AIDS’.
Item 3 amends Section 4 of the Special Arrangement by inserting a definition for ‘under co-payment data’.
Item 4 amends paragraph 24(2)(a) of the Special Arrangement by inserting the listed drug Tadalafil as a CAR drug for which the maximum quantity is enough for 1 month of treatment.
Item 5 amends paragraph 25(2)(l) of the Special Arrangement by inserting the listed drug Tadalafil as a CAR drug for which there is a maximum of 5 repeats.
Item 6 modifies the operation of the rules made under sections 99AAA(8) and 98AC(4) of the Act to adjust to the Special Arrangement.
Item 7 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Ambrisentan’ by omitting the circumstances codes ‘C3211’ and ‘C3212’ and inserting the circumstances codes ‘C4019’ and ‘C4020’.
Item 8 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Bosentan’ by omitting the circumstances codes ‘C3013’, ‘C3155’, ‘C3156’, ‘C3157’, ‘C3158’, ‘C3159’, ‘C3160’ and ‘C3161’ and inserting the circumstances codes ‘C4009’, ‘C4010’, ‘C4011’ and ‘C4012’.
Item 9 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Epoprostenol’ by omitting 2 pharmaceutical benefits, which are ‘Epoprostenol’ in the forms ‘Powder for I.V. infusion 500 micrograms (as sodium) with diluent’ and ‘Powder for I.V. infusion 1.5 mg (as sodium) with diluent’ with manner of administration ‘Injection’ and brand ‘Flolan’, and by omitting the circumstances codes ‘C3163’, ‘C3164’ ‘C3165’ and ‘C3166’ and inserting the circumstances codes ‘C4013’ and ‘C4014’.
Item 10 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Iloprost’ by omitting the circumstances codes ‘C3168’ and ‘C3169’ and inserting the circumstances codes ‘C4015’ and ‘C4016’.
Item 11 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Mycophenolic Acid’ by inserting 8 new pharmaceutical benefits, which are:
- ‘Mycophenolic Acid’ in the form ‘Capsule containing mycophenolate mofetil 250 mg’ with manner of administration ‘Oral’ and brands ‘APO-Mycophenolate’, ‘Ceptolate’, ‘Imulate’ and ‘Mycophenolate Sandoz’; and
- ‘Mycophenolic Acid’ in the form ‘Capsule containing mycophenolate mofetil 500 mg’ with manner of administration ‘Oral’ and brands ‘APO-Mycophenolate’, ‘Ceptolate’, ‘Imulate’ and ‘Mycophenolate Sandoz’.
Item 12 amends the entry in Schedule 1 of the Special Arrangement for ‘Nevirapine’ by inserting a new pharmaceutical benefit, which is ‘Nevirapine’ in the form ‘Tablet 400 mg (extended release)’ with manner of administration ‘Oral’ and brand ‘Viramune XR’.
Item 13 amends Schedule 1 of the Special Arrangement to insert a new pharmaceutical benefit, which is the listed drug ‘Rilpivirine’ in the form ‘Tablet 25 mg (as hydrochloride)’ with manner of administration ‘Oral’ and brand ‘Edurant’.
Item 14 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Sildenafil’ by omitting the circumstances codes ‘C3172’ and ‘C3173’ and inserting the circumstances codes ‘C4017’ and ‘C4018’.
Item 15 amends Schedule 1 of the Special Arrangement to insert a new pharmaceutical benefit, which is the listed drug ‘Tadalafil’ in the form ‘Tablet 20 mg’ with manner of administration ‘Oral’ and brand ‘Adcirca’.
Item 16 amends the entry in Schedule 1 of the Special Arrangement for the listed drug ‘Tocilizumab’ by omitting the circumstance code ‘C3480’.
Item 17 amends Schedule 2 of the Special Arrangement by inserting the Responsible Person Code ‘AF’ and associated Responsible Person ‘Alphapharm Pty Ltd’.
Item 18 amends Schedule 2 of the Special Arrangement by inserting the Responsible Person Code ‘LY’ and associated Responsible Person ‘Eli Lilly Australia Pty Ltd’.
Item 19 amends Schedule 2 of the Special Arrangement by inserting the Responsible Person Code ‘QA’ and associated Responsible Person ‘Aspen Pharma Pty Ltd’.
Item 20 amends Schedule 2 of the Special Arrangement by inserting the Responsible Person Code ‘TX’ and associated Responsible Person ‘Apotex Pty Ltd’.
Item 21 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Ambrisentan’ by omitting the circumstances codes ‘C3211’ and ‘C3212’ and the circumstances associated with them and inserting the circumstances codes ‘C4019’ and ‘C4020’ and the circumstances associated with them.
Item 22 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Bosentan’ by omitting the circumstances codes ‘C3013’, ‘C3155’, ‘C3156’, ‘C3157’, ‘C3158’, ‘C3159’, ‘C3160’ and ‘C3161’ and the circumstances associated with them and inserting the circumstances codes ‘C4009’, ‘C4010’, ‘C4011’ and ‘C4012’ and the circumstances associated with them.
Item 23 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Epoprostenol’ by omitting the circumstances codes ‘C3163’, ‘C3164’ ‘C3165’ and ‘C3166’ and the circumstances associated with them and inserting the circumstances codes ‘C4013’ and ‘C4014’ and the circumstances associated with them.
Item 24 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Iloprost’ by omitting the circumstances codes ‘C3168’ and ‘C3169’ and inserting the circumstances codes ‘C4015’ and ‘C4016’.
Item 25 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Nevirapine’ by inserting the circumstances codes ‘C3994’ and ‘C3995’ and the circumstances associated with them.
Item 26 amends the entry in Schedule 3 of the Special Arrangement to insert the new listed drug ‘Rilpivirine’ and the relevant circumstances codes ‘C3586’, ‘C3587’, ‘C3588’ and ‘C3589’ and the circumstances associated with them.
Item 27 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Sildenafil’ by omitting the circumstances codes ‘C3172’ and ‘C3173’ and the circumstances associated with them and inserting the circumstances codes ‘C4017’ and ‘C4018’ and the circumstances associated with them.
Item 28 amends the entry in Schedule 3 of the Special Arrangement to insert the new listed drug ‘Tadalafil’ and the relevant circumstances codes ‘C4021’, ‘C4022’, ‘C4023’, and ‘C4024’ and the circumstances associated with them.
Item 29 amends the entry in Schedule 3 of the Special Arrangement for the listed drug ‘Tocilizumab’ by omitting the circumstance code ‘C3480’ and the circumstance associated with it.