EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 6)
PB 47 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 and other instruments under the Act, which commence on the same day.
This instrument:
- adds 3 pharmaceutical benefits;
- removes 1 pharmaceutical benefit;
- adds 3 responsible persons;
- removes 1 responsible person; and
- removes the additional patient contribution for 2 listed brands.
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), 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 August 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 6)
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.6) and that it may also be cited as PB 47 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 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
SUMMARY OF CHANGES
Listed Drug Added to this Special Arrangement
Listed Drug | Form |
Mannitol | Pack containing 280 capsules containing powder for inhalation 40mg and 2 inhalers |
Forms deleted from this Special Arrangement
Listed Drug | Form |
Tipranavir | Oral liquid 100 mg per mL, 95 mL |
Brands added to this Special Arrangement
Listed Drug | Form | Brand |
Lamivudine | Tablet 150 mg | Lamivudine RBX |
Lamivudine | Tablet 300 mg | Lamivudine RBX |
Alteration of Responsible Persons in this Special Arrangement
Listed Drug | Form | Brand | Responsible Person |
Adalimumab | Injection 20mg in 0.4 mL pre-filled syringe | Humira | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Adalimumab | Injection 40mg in 0.8 mL pre-filled syringe | Humira | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Adalimumab | Injection 40mg in 0.8 mL pre-filled pen | Humira | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Levodopa with Carbidopa | Intestinal gel 20 mg-5mg per mL, 100mL | Duodopa | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Lopinavir with Ritonavir | Tablet 100 mg-25 mg | Kaletra | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Lopinavir with Ritonavir | Tablet 200 mg-50 mg | Kaletra | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Lopinavir with Ritonavir | Oral Liquid 400 mg-100mg per 5mL, 60mL | Kaletra | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Octreotide MaxRx | From: Max Pharma Pty Ltd (XF) To: Generic Health Pty Ltd (GQ) |
Octreotide | Injection 100 micrograms (as acetate) in 1 mL | Octreotide MaxRx | From: Max Pharma Pty Ltd (XF) To: Generic Health Pty Ltd (GQ) |
Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Octreotide MaxRx | From: Max Pharma Pty Ltd (XF) To: Generic Health Pty Ltd (GQ) |
Ritonavir | Tablet 100mg | Novir | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Ritonavir | Oral solution 600 mg per 7.5 mL (80mg per mL), 90 mL | Novir | From: Abbott Australasia Pty Ltd (AB) To: AbbVie Pty Ltd (VE) |
Addition of Responsible Person Codes to this Special Arrangement
Code | Responsible Person |
GQ | Generic Health Pty Ltd |
VE | AbbVie Pty Ltd |
XA | Pharmaxis Ltd |
Deletion of Responsible Person Code from this Special Arrangement
Code | Responsible Person |
XF | Max Pharma Pty Ltd |
Deletion of Additional Patient Contributions in this Special Arrangement
Listed Drug | Form | Brand |
Cyclosporin | Capsule 50 mg | Neoral 50 |
Cyclosporin | Capsule 100 mg | Neoral 100 |