EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No.2)
PB 87 of 2014
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 (2) of the Act, is to amend the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011) (the Special Arrangement) to make changes relating to the Botulinum Toxin Program.
The purpose of the Special Arrangement is to allow for botulinum toxin to be supplied to specific patients through eligible medical practitioners.
Schedule 1 to this instrument inserts one new treatment condition for the treatment of urinary incontinence due to idiopathic overactive bladder under the Special Arrangement to commence on 1 November 2014. The restriction details for this indication are:
(a) the condition must be due to idiopathic overactive bladder; and
(b) the condition must have been inadequately controlled by therapy involving at least two alternative anti-cholinergic agents (two entities, not two brands); and
(c) the patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with a botulinum toxin pharmaceutical benefit; and
(d) the patient must be aged 18 years or older; and
(e) the patient must be willing and able to self-catheterise; and
(f) treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment.
In addition this instrument makes consequential changes to reflect the new treatment condition.
Consultation
The addition of these amendments was made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (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 has broad representation with members appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists; at least one member is 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 are consulted throughout the process for additions and changes to listings on the PBS and for this Special Arrangement. This includes consultation through the PBAC process, which provides for consumers making submissions to the Committee in respect of proposals to be discussed, and agreement to final listing details.
General
This instrument commences on 1 November 2014.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (BOTULINUM TOXIN PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 2)
Section 1 Name of Instrument
This section provides that this instrument is the National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No. 2) and that it may also be cited as PB 87 of 2014.
Section 2 Commencement
This section provides that this instrument commences on 1 November 2014.
Section 3 Amendments to PB 89 of 2011
This section provides that Schedule 1 and Schedule 3 amends the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011) (the Special Arrangement).
Schedule 1
Item 1 makes a consequential amendment to subsection 10(1) of the Special Arrangement to reflect the insertion of new section 12C.
Item 2 inserts a new section 12C into the Special Arrangement that provides the criteria a person needs to meet to be eligible to receive a botulinum toxin pharmaceutical benefit for the treatment of urinary incontinence due to idiopathic overactive bladder.
Item 3 inserts a new section 17B into the Special Arrangement that provides that a medical practitioner with the specialist qualification of urology or urogynaecology for other indications under the Program is taken to be an eligible medical practitioner in relation to urinary incontinence due to idiopathic overactive bladder.
Item 4 makes a consequential amendment to subsection 18(3) of the Special Arrangement to reflect the insertion of new subsection 18(8).
Item 5 amends subsection 18(6) to align the evidence of practitioner training requirements for urinary incontinence due to neurogenic detrusor overactivity with evidence of practitioner training requirements for urinary incontinence due to idiopathic overactive bladder.
Item 6 inserts a new subsection 18(8) into the Special Arrangement detailing the evidence of training that needs to be provided for authorisation of an applicant practitioner to administer botulinum toxin pharmaceutical benefits for the treatment of urinary incontinence due to idiopathic overactive bladder.
Schedule 3
Item 7 amends Schedule 3 of the Special Arrangement by adding new treatment condition number 11, i.e. urinary incontinence due to idiopathic overactive bladder.