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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.