EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
ARRANGEMENTS UNDER SECTION 100
BOTULINUM TOXIN PROGRAM
NO. PB 38 OF 2008
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, and for the supply of special pharmaceutical products.
3. 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.
4. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
5. Section 100AA(1) provides that a special pharmaceutical product includes a drug or medicinal preparation declared under section 85(2) of the Act.
6. 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.
7. The drugs that are the subject of this Arrangement are declared under subsection 85(2) of the Act.
8. 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 this Arrangement and other provisions of Part VII of the Act, then this arrangement will prevail.
Purpose of the Arrangements
9. 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 to 17 years of age inclusive; 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 to 17 years of age inclusive; or
(ii) spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care; or
(iii) 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 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 patient does not respond (decrease of MAS>1 in at least one joint) after two treatments
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. This makes it difficult for patients who require botulinum toxin for treatment of the conditions referred to in this Arrangement to access it, causing undue delay in their treatment.
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 23 November 2005, with effect from 1 December 2005, are repealed and replaced with these Arrangements.
13. These Arrangements, which have effect from 1 April 2008, now extend to supply of Clostridium Botulinum Type A Toxin–Haemagglutinin Complex by medical practitioners with specialist qualifications in neurology and rehabilitation for 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.
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 or special pharmaceutical products. Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC. When making recommendations for the listing of drugs or medicinal preparations under s85(2) of the Act, 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. Medicare Australia has also been consulted to provide advice on the program management aspects for these Arrangements because orders for, and payment for the supply of, botulinum toxin under these Arrangements is managed by Medicare Australia.
17. These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
18. Details of these Arrangements are set out in the Attachment.
ATTACHMENT
Paragraph 1(a) provides that these Arrangements commence on 1 April 2008.
Paragraph 2 provides that the Arrangements made on 23 November 2005 for the Botulinum Toxin Program (PB 39 of 2005) are repealed.
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 (clostridium botulinum toxin), 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 to 17 years of age inclusive 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.
Only Dysport may be used for the treatment of moderate to severe spasticity 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 to be authorised is 4 per upper limb per lifetime.
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 in the case of a dependent child 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 under these Arrangements 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 4D) 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 four (4) 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 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 botulinum toxin in relation to the supply and use of botulinum toxin.
Paragraph 5 (D) lists the written evidence required by Medicare Australia’s CEO for registration of medical practitioners as participants in these Arrangements for the treatment of moderate to severe spasticity 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. The written evidence required includes evidence of the applicant’s qualifications, training and experience in the use of clostridium 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 botulinum toxin in relation to the supply and use of clostridium botulinum toxin.
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 as permitted under Paragraph 6(B).
Paragraph 6(B) provides that registered medical practitioners may retain a small quantity of vials of botulinum toxin under these Arrangements for emergency purposes. That is, up to 5 vials of Botox and/or Dysport.
Paragraph 6 (C) states that Medicare Australia will not replace vials that have expired or damaged, and also stipulates that medical practitioners must monitor vials of botulinum toxin for correct storage conditions and expiry dates.
Paragraph 7(A) - Part 1 describes the forms required to be completed concerning supply of botulinum toxin under these Arrangements for blepharospasm, associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients 12 years and older, dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive or spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care. This part also sets out the information which must be provided on the Patient Usage Form, including the date of administration; patient identification information (including full Medicare number); patient agreement to receive the treatment; quantity of the botulinum toxin administered; the number of botulinum toxin vials on hand; the condition for which the drug is administered; and medical practice identification information and the signature of the administering medical practitioner.
The Patient Usage Form must be signed jointly by the medical practitioner and the patient (or in the case of a patient who is less than 16, their agent or legal guardian), for each administration of botulinum toxin.
Paragraph 7(A) – Part 2 describes the forms required to be completed concerning supply of clostridium botulinum toxin under these Arrangements for treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using modified Ashworth scale) of the upper limb in adults following a stroke, as second line therapy when standard management has failed (eg physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy. Maximum number of treatments to be authorised is 4 per upper limb per lifetime. This part also sets out the information which must be provided on the Patient Usage Form. For initial applications only for treatment of patients with focal spasticity using clostridium botulinum toxin a Patient Acknowledgement Form must be signed by patient and doctor and must be provided to Medicare Australia with the paperwork for the initial supply.
This Patient Acknowledgement Form will require details of the stroke, MAS scores and acknowledgement that only 4 supplies of clostridium botulinum toxin can be made in a lifetime. The remaining arrangements are similar to those for Paragraph 7(A) - Part 1.
Paragraph 7(B) describes the way in which the different conditions for which botulinum toxin may be supplied under these Arrangements are referred to in the Patient Usage Form so that the medical practitioner can identify 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. For patients being treated for spasticity of the upper limbs due to a stroke each initial application must also have the signed Patient Acknowledgement form attached to the Patient Usage Form.
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 made available until documentation for supplies already made has 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 sent 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 7(J) sets out where the required Patient Usage Forms and Patient Acknowledgement Forms may be found.
Paragraph 8 requires that orders for the supply of botulinum toxin under these Arrangements be placed with Medicare Australia’s Hobart office; and that orders will be placed by Medicare Australia with suppliers for delivery to the registered medical practitioner.
Paragraph 9 requires that medical practitioners forward Patient Usage Forms (and where applicable Patient Acknowledgement Forms) along with signed delivery documentation for botulinum toxin to Medicare Australia’s CEO on the completion of treatment.