EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER
SUBPARAGRAPH 100(1)(b)(i)
BOTULINUM TOXIN PROGRAM
No. PB 29 of 2009
The Pharmaceutical Benefits Scheme (PBS) provides timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
The PBS is regulated by Part VII of the National Health Act 1953 (the Act) which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits, and for the supply of special pharmaceutical products.
Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
a) who are living in isolated areas; or
b) who are receiving medical treatment in such circumstances that pharmaceutical benefits:
- cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
- are inadequate for that medical treatment.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Section 100AA(1) provides that a special pharmaceutical product includes a drug or medicinal preparation declared under section 85(2) of the Act.
The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies. Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
The drugs that are the subject of the Botulinum Toxin Program Special Arrangement made under subparagraph 100(1)(b)(i) of the Act (these Arrangements) are declared under subsection 85(2) of the Act.
Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1). Therefore, in the case of inconsistency between these Arrangements and other provisions of Part VII of the Act, then these Arrangements will prevail.
These Arrangements relate specifically to the supply of two forms of botulinum toxin to patients who are receiving treatment for the following conditions:
(a) Botulinum Toxin Type A Purified Neurotoxin Complex, lyophilised powder for intramuscular injection 100 units (Botox) (manufactured by Allergan Australia Pty Ltd) for:
- the treatment of blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients 12 years and older; or
- the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive; or
- continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patient 18 years of age or older who was commenced on PBS-subsidised treatment with botulinum toxin as a paediatric patient; or
- the treatment of spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care; or
- the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older; or
- the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limbs in adults following a stroke as second line therapy when standard management has failed ( e.g. physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy. Maximum number of treatments of botulinum toxin to be authorised is 4 per upper limb per lifetime. Treatment should not be initiated until 3 to 6 months post-stroke in patients who do not have established severe contracture. Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments. Contra-indications to treatment include established severe contracture and known sensitivity to botulinum toxin.
(b) Clostridium Botulinum Type A Toxin–Haemagglutinin Complex lyophilised powder for intramuscular injection 500 units (Dysport) (manufactured by Ipsen Pty Limited, and distributed by Clifford Hallam Pharmaceutical) for:
- the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive; or
- continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patient 18 years of age or older who was commenced on PBS-subsidised treatment with botulinum toxin as a paediatric patient; or
- the treatment of spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care; or
- the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limbs in adults following a stroke as second line therapy when standard management has failed ( e.g. physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy. Maximum number of treatments of botulinum toxin to be authorised is 4 per upper limb per lifetime. Treatment should not be initiated until 3 to 6 months post-stroke in patients who do not have established severe contracture. Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments. Contra-indications to treatment include established severe contracture and known sensitivity to botulinum toxin.
The high cost of botulinum toxin and the need for cold storage means that the drug is unlikely to be held as part of an approved pharmacist’s normal stock. This makes it difficult for patients who require botulinum toxin for treatment of their conditions referred to in these Arrangements to access it, causing undue delay in their treatment.
The purpose of these Arrangements is therefore to ensure that an adequate supply of botulinum toxin is available for the treatment of certain patients, in circumstances where botulinum toxin cannot otherwise be conveniently or efficiently supplied in accordance with Part VII of the Act.
The Special Arrangements for the Botulinum Toxin Program made on the 27th day of November 2008, which commenced on 1 December 2008, referred to as No PB 122 of 2008 (the Principal Arrangements) are amended by these Amendment Arrangements.
These Amendment Arrangements, which have effect from 1 April 2009, now extend to supply of the Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) under these Arrangements to treat patients who are 2 years of age or older for upper limb spasticity due to cerebral palsy, and to treat adult patients with moderate to severe spasticity of the upper limbs following stroke as a second line therapy when standard management has failed.
These Amendment Arrangements commence on 1 April 2009.
Consultations
These Amendment Arrangements have been made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits or as special pharmaceutical products. When making recommendations, the PBAC takes into account the medical conditions for which a medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
PBAC members are selected 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
Medicare Australia has also been consulted and had provided advice on the program management aspects for these Amendment Arrangements because order and payment for the supply of botulinum toxin under these Arrangements is managed by Medicare Australia.
The Australian suppliers of the two forms of botulinum toxin that are affected by this Amendment Arrangement have been consulted.
These Amendment Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Details of the Amendments to the Principal Arrangements are set out in the Attachment
ATTACHMENT
Paragraph 1 provides that these Amendment Special Arrangements commence on 1 April 2009.
Paragraph 2 provides that the Schedule to this Instrument amends the Special Arrangements made under subparagraph 100(1)(b)(i) of the National Health Act 1953 (Botulinum Toxin Program) on 27 November 2008 (known as PB 122 of 2008) (the Principal Arrangements.
Schedule 1 sets out the amendments to the Principal Arrangements.
Summary of Changes
Paragraph 3(A)(i) has been amended to include the new indications which Botox may be used to treat which are moderate to severe upper limb spasticity in cerebral palsy patients 2 years of age or older, and (where special conditions are met) moderate to severe spasticity of the upper limbs in adults following stroke.
Paragraph 3(A)(ii)(d) has been amended to note the maximum number of treatments of botulinum toxin per upper limb per lifetime is 4, regardless of the form of botulinum toxin used.
Paragraph 5(A) has been amended to include that medical practitioners that hold certain specialist qualifications are eligible to be registered to participate in the Botulinum Toxin Program Special Arrangements for treatment of upper limb spasticity in cerebral palsy patients 2 years of age or older.
Paragraph 5(C) has been amended to include the requirements for applications to be made in writing to the Medicare Australia CEO for practitioners who wish to use botulinum toxin for the treatment of upper limb spasticity in cerebral palsy patients.
Paragraph 5(D)(iii)(b) has been amended to state that applicant practitioners need to be involved in at least 20 procedures using botulinum toxin rather than being the primary operator in these procedures.
Paragraph 6(B) has been amended to include that medical practitioners registered to participate under the arrangements for the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older, or moderate to severe spasticity of the upper limbs in adults following stroke may retain a maximum of 5 vials of Botox.
Paragraph 7(A)(Part 1) has been amended to state that this part also refers to each administration of botulinum toxin made for moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older.
Paragraph 7 (Part 2) has been amended to ensure that the part relates to both forms of botulinum toxin for the treatment of moderate to severe spasticity of the upper limbs in adults following stroke.
Paragraph 7(B) has been amended to ensure that the appropriate information is included in the Patient Usage Form given the addition of the new indications in Paragraph 3(A)(i).
Paragraph 7(C) has been amended to clearly indicate that this paragraph only refers to upper limb spasticity following stroke.