EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 8)
PB 62 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.
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 arising as a consequence of the commencement of the Human Services Legislation Amendment Act 2011, including changes to the circumstances for which various pharmaceutical benefits may be prescribed.
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 September 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.8)
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.8) and that it may also be cited as PB 62 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 September 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
Items 1 to 18 change references to ‘Medicare Australia CEO’ in the Principal Instrument to the new title ‘Chief Executive Medicare’. This change in title occurred on 1 July 2011 as a result of paragraph 99(2)(a) of Schedule 1 to the Human Services Legislation Amendment Act 2011 (“HSLA Act”), which provided that a reference to the Medicare Australia CEO in an instrument that was in effect prior to 1 July 2011 is to be read as a reference to the Chief Executive Medicare. Items 1 to 18 merely update the Principal Instrument to reflect the change that occurred on 1 July 2011.
Item 19 changes a reference to ‘Medicare Australia’ in the Principal Instrument to ‘the Department of Human Services’. This change occurred on 1 July 2011 as a result of paragraph 99(2)(b) of Schedule 1 to the HSLA Act which provided that a reference to Medicare Australia in an instrument that was in effect prior to 1 July 2011 is to be read as a reference to the Department of Human Services. Item 19 merely updates the Principal Instrument to reflect the change that occurred on 1 July 2011.
Item 20 changes a reference to ‘Medicare Australia’ in the Principal Instrument to ‘the Chief Executive Medicare’. Paragraph 99(2)(b) of Schedule 1 to the HSLA Act has the effect that, from 1 July 2011 a reference to Medicare Australia in an instrument that was in effect prior to 1 July 2011 was to be read as a reference to the Department of Human Services. Item 20 amends the Principal Instrument so that this particular reference is to the Chief Executive Medicare, rather than the Department of Human Services, as it is considered more appropriate that this function be performed by the Chief Executive Medicare.
Items 21 to 28 change references to ‘Medicare Australia CEO’ in the Principal Instrument to the new title ‘Chief Executive Medicare’.
Item 29 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Abatacept’ in Schedule 1 to replace the previously listed circumstance codes with ‘C3712’ , ‘C3796’ and ‘C3797’.
Item 30 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Adalimumab’ in each of the forms ‘Injection 20 mg in 0.4 mL pre-filled syringe’, ‘Injection 40 mg in 0.8 mL pre-filled syringe’ and ‘Injection 40 mg in 0.8 mL pre-filled pen’ to replace the previous circumstance codes with ‘C3527’, ‘C3529’, ‘C3798’, ‘C3799’.
Item 31 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Deferasirox’ in each of the forms ‘Tablet, dispersible 125 mg’, ‘Tablet, dispersible, 250 mg’ and ‘Tablet, dispersible, 500 mg’ to replace the previous circumstance codes with ‘C3828’and ‘C3829’.
Item 32 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Etanercept’ in the form ‘Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL’ to replace the previous circumstance codes with ‘C3531’, ‘C3800’, and ‘C3801’.
Item 33 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Etanercept’ in each of the forms ‘Injections 50 mg in 1 mL single use pre-filled syringes, 4’ and ‘Injection 50 mg in 1 mL single use auto-injector, 4’ to replace the previous circumstance codes with ‘C3802’.
Item 34 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Filgrastim’ in each of the forms ‘Injection 120 micrograms in 0.2 mL single use pre-filled syringe’, ‘Injection 300 micrograms in 1 mL’, ‘Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)’, ‘Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)’, ‘Injection 480 mL in 1.6 mL’, ‘Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)’ and ‘Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)’ to add the new circumstance codes ‘C3833’ and ‘C3834’.
Item 35 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Infliximab’ to replace the previous circumstance codes with ‘C2996’, ‘C2999’, ‘C3002’, C3004’, ‘C3005’, ‘C3008’, ‘C3259’, ‘C3262’, ‘C3492’, ‘C3513’, ‘C3585’, ‘C3691’, ‘C3693’, ‘C3710’, ‘C3803’, ‘C3804’, ‘C3805’, ‘C3806’, ‘C3807’, ‘C3808’, ‘C3809’, ‘C3810’, ‘C3811’, ‘C3812’, ‘C3813’, ‘C3814’, ‘C3815’, ‘C3816’, ‘C3817’, ‘C3818’, ‘C3819’ and ‘C3820’.
Item 36 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Lenalidomide’ in each of the forms ‘Capsule 5 mg’, ‘Capsule 10 mg’ ‘Capsule 15 mg’ and ‘Capsule 25 mg’ to replace the previous circumstance codes with ‘C3205’ and ‘C3821’.
Item 37 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Omalizumab’ to replace the previous circumstance codes with ‘C3740’, ‘C3742’ and ‘C3822’.
Item 38 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Pegfilgrastim’ to add the new circumstance codes ‘C3833’, ‘C3834’.
Item 39 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Rituximab’ to replace the previous circumstance codes with ‘C3720’, ‘C3823’ and ‘C3824’.
Item 40 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Tocilizumab’ in each of the forms ‘Concentrate for injection 80 mg in 4 mL’, ‘Concentrate for injection 200 mg in 10 mL’ and ‘Concentrate for injection 400 mg in 20 mL’ to replace the previous circumstance codes with ‘C3480’, ‘C3716’, ‘C3825’ and ‘C3826’.
Item 41 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Abatacept’ to replace the descriptions for the previous circumstance codes with descriptions for the circumstance codes ‘C3712’, ‘C3796’ and ‘C3797’.
Item 42 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Adalimumab’ to replace the descriptions for the previous circumstance codes with descriptions for the circumstance codes ‘C3527’, ‘C3529’, ‘C3798’ and ‘C3799’.
Item 43 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Deferasirox’ to replace the descriptions for the previous circumstance codes with descriptions for the circumstance codes ‘C3828’and ‘C3829’,
Item 44 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Etanercept’ to omit the descriptions for the circumstance codes ‘C3532’, ‘C3533’, ‘C3534’ and to insert descriptions for the following new circumstance codes ‘C3800’, ‘C3801’ and ‘C3802’.
Item 45 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Filgrastim’ to insert descriptions for the new circumstance codes ‘C3833’ and ‘C3834’.
Item 46 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Infliximab’ to replace the descriptions for the previous circumstance codes with descriptions for the circumstance codes ‘C2996’, ‘C2999’, ‘C3002’, ‘C3004’, ‘C3005’, ‘C3008’, ‘C3259’, ‘C3262’, ‘C3492’, ‘C3513’, ‘C3585’, ‘C3691’, ‘C3693’, ‘C3710’, ‘C3803’, ‘C3804’, ‘C3805’, ‘C3806’, ‘C3807’, ‘C3808’, ‘C3809’, ‘C3810’, ‘C3811’, ‘C3812’, ‘C3813’, ‘C3814’, ‘C3815’, ‘C3816’, ‘C3817’, ‘C3818’, ‘C3819’ and ‘C3820’.
Item 47 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Lenalidomide’ to replace the descriptions for the previous circumstance codes with descriptions for the circumstance codes ‘C3205’and ‘C3821’.
Item 48 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Omalizumab’ to omit the description for the circumstance code ‘C3741’ and to insert a description for the new circumstance code ‘C3822’.
Item 49 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Pegfilgrastim’ to insert descriptions for the new circumstance codes ‘C3833’ and ‘C3834’.
Item 50 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Rituximab’ to replace the descriptions for the previous circumstance codes with descriptions for the circumstance codes ‘C3720’, ‘C3823’and ‘C3824’.
Item 51 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Tocilizumab’ to replace the descriptions for the previous circumstance codes with descriptions for the circumstance codes ‘C3480’, ‘C3716’, ‘C3825’ and ‘C3826’.