EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
ARRANGEMENTS UNDER SECTION 100
BOTULINUM TOXIN PROGRAM
NO. PB 39 OF 2005
Authority for the Arrangements
1. The Pharmaceutical Benefits Scheme (PBS) provides timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
2. 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.
3. Subsection 84(1) of the Act defines ‘pharmaceutical benefit’ as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Subsection 85(2) of the Act empowers the Minister to declare drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. Schedule 6 of the declaration under subsection 85(2) of the Act lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
5. 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:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
6. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
7. Subsection 100(3) of the Act provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
Purpose of the Arrangements
8. These Arrangements for the Botulinum Toxin Program 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 vial (Botox) for the treatment of:
(i) blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients 12 years and older; or
(ii) dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 years of age or older; or(iii) spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care
(b) Clostridium Botulinum Type A Toxin–Haemagglutinin Complex, lyophilised powder for intramuscular injection 500 units vial (Dysport) for the treatment of:
(i) dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 years of age or older; or
(ii) spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care
9. The high cost of botulinum toxin and its specific storage requirements required for treatment mean that an adequate supply of botulinum toxin for the treatment of patients for the conditions referred to above cannot be conveniently or efficiently supplied otherwise in accordance with Part VII of the Act.
10. 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, making it difficult for patients to access botulinum toxin and causing undue delay in their treatment. Making these Arrangements enables botulinum toxin to be supplied to patients more conveniently and efficiently than would otherwise be possible.
11. 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.
12. The arrangements for the Botulinum Toxin Program made on the 30 July 2004, with effect from 1 August 2004, are repealed and replaced with these Arrangements.
13. These Arrangements have been re-made, with effect from 1 December 2005, to extend the medical practitioners who are eligible to be registered to participate under these Arrangements to medical practitioners with specialist qualifications in plastic surgery for the treatment of:
(a) blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients who are 12 years and older; or
(b) spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care.
Consultations
14. These 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. Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC. When making recommendations, the 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.
15. 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.
16. These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
17. Details of these Arrangements are set out in the Attachment.
ATTACHMENT
Paragraph 1(a) provides that these Arrangements commence on 1 December 2005.
Paragraph 2 provides that the arrangements made on 30 July 2004 are repealed on commencement of these Arrangements.
Paragraph 3 describes the two forms of botulinum toxin that are available under these Arrangements, namely:
(i) Botulinum Toxin Type A Purified Neurotoxin Complex, lyophilised powder for intramuscular injection 100 units vial (Botox); and
(ii) Clostridium Botulinum Type A Toxin–Haemagglutinin Complex, lyophilised powder for intramuscular injection 500 units vial (Dysport).
Both Botox and Dysport may be used to treat dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 years of age or older and spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care. Only Botox may be used under these Arrangements to treat blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients 12 years and older.
Paragraph 4 describes the patients who may be treated under these Arrangements.
Paragraph 4(A) provides that botulinum toxin may only be supplied under these Arrangements to a patient holding, or whose parent or legal guardian holds, a Medicare Card, and who is an Australian resident under the Health Insurance Act 1973.
Paragraph 4(B) provides that supply of botulinum toxin under these Arrangements is only permitted to patients suffering from one of the conditions described in Paragraph 3.
Paragraph 4(C) prohibits supply of botulinum toxin to patients admitted to a public hospital, unless they are admitted as a day patient or for a period of not more than 24 hours.
Paragraph 4(C) provides that supply of botulinum toxin under these Arrangements is available free of charge to eligible patients.
Paragraph 5(A) lists the specialist qualifications required by medical practitioners participating in these Arrangements for administration of treatment of each of the three (3) conditions described in Paragraph 3.
Paragraph 5(B) lists the written evidence required by Medicare Australia’s CEO for registration of medical practitioners as participants in these Arrangements for the treatment of blepharospasm or hemifacial spasm. The written evidence required includes evidence of the applicant’s qualifications, training and experience in the use of botulinum toxin. The applicant is also required to provide a written undertaking to comply with the requirements of these Arrangements and written consent for supply of the applicant’s name and address to the manufacturer of Botox in relation to the supply and use of Botox.
Paragraph 5(C) lists the written evidence required by Medicare Australia’s CEO for registration of medical practitioners as participants in these Arrangements for the treatment of dynamic equinus foot deformity or spasmodic torticollis. The written evidence required to be supplied by the applicant in relation to registration for the treatment of dynamic equinus foot deformity or spasmodic torticollis is similar to the type of evidence required for registration for the treatment of blepharospasm or hemifacial spasm (see Paragraph 5(B)).
Paragraph 6(A) provides that vials of botulinum toxin unused from a previous supply ordered under these Arrangements must be used when the medical practitioner next treats patients under these Arrangements. This is the case unless vials are being retained by the medical practitioner for emergency purposes (see Paragraph 6(B)).
Paragraph 6(B) provides that medical practitioners may retain a small quantity of vials of botulinum toxin under these Arrangements for emergency purposes, that is, either 5 vials of Botox or 5 vials of Dysport, according to the conditions for which the medical practitioner is registered to treat.
Paragraph 7(A) describes the requirement for a Patient Usage Form signed jointly by the medical practitioner and the patient, for each administration of botulinum toxin and the information that must be provided on the form, including the date of administration; patient identification information; patient agreement to receive the treatment; quantity of the drug administered; the condition for which the drug is administered; and medical practice identification information.
Paragraph 7(B) describes the way in which the different conditions for which botulinum toxin may be supplied under these Arrangements is described on the Patient Usage Form for the purposes of identification by the medical practitioner of the condition being treated by a particular administration.
Paragraph 7(C) provides that it is mandatory for Patient Usage Forms and delivery documentation to be forwarded to Medicare Australia’s CEO at the conclusion of each treatment period.
Paragraph 7(D) describes the verification and crosschecking process undertaken by Medicare Australia’s CEO before payment will be made by Medicare Australia to the supplier for the supply of botulinum toxin under these Arrangements.
Paragraph 7(E) provides that payment to the supplier is subject to the receipt by Medicare Australia’s CEO’s of all relevant documentation for a particular order from the medical practice; and that further supplies of the drug for that practice will not be authorised until documentation of supplies already made have been received and verified by Medicare Australia’s CEO.
Paragraph 7(F) provides that private orders for botulinum toxin to treat conditions other than those specified in these Arrangements cannot be combined with orders for botulinum toxin that will be used to treat patients under these Arrangements. Suppliers of botulinum toxin have agreed to provide accounts for private orders separately from accounts lodged under these Arrangements.
Paragraph 7(G) provides that Medicare Australia’s CEO will pay for supplies of botulinum toxin used under these Arrangements.
Paragraph 7(H) describes the process for the submission of invoices to Medicare Australia’s CEO for payment to suppliers by Medicare Australia’s CEO for supplies of botulinum toxin under these Arrangements. Invoices submitted to Medicare Australia’s CEO for supplies of botulinum toxin for treatment of patients not covered by these Arrangements will be returned to the medical practice for payment.
Paragraph 7(I) provides that supply of botulinum toxin to a medical practitioner is subject to adherence by that practitioner to the management and storage conditions of botulinum toxin advised by the supplier.
Paragraph 8 requires that a medical practice place an order for the supply of botulinum toxin under these Arrangements with Medicare Australia’s Hobart office; and that orders placed with suppliers will be for delivery to medical practices.
Paragraph 9 requires that medical practitioners forward Patient Usage Forms along with signed delivery documentation for botulinum toxin to Medicare Australia’s CEO on the completion of treatment.