Botulinum toxin
Authority to supply botulinum toxin through the Pharmaceutical Benefits Scheme (PBS) under Section 100 of the National Health Act 1953.
The Australian Government funds the botulinum toxin program to finance the full cost of either Botox® or Dysport® to eligible patients.
Section 100 arrangements
Special pharmaceutical products such as Botox® and Dysport® will not be supplied under these arrangements for administration to a patient who is admitted to a public hospital, unless the patient is admitted as a day patient, or is admitted for a period of not more than 24 hours.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Restriction details
Botulinum toxin is available in two forms, Botox® and Dysport®, for the treatment of:
- dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two to 17 years of age inclusive
- spasmodic torticollis
- blepharospasm associated with dystonia, in patients 12 years and older—Botox® only
- moderate to severe spasticity [defined as greater than or equal to three using the Modified Ashworth Scale (MAS)] of the upper limbs in adults following a stroke—Dysport® only
- patients are eligible for a maximum of four treatments in their lifetime per upper limb provided that the MAS assessment has decreased by more than one, in at least one joint, after two treatments
- a completed patient and provider acknowledgment form must be supplied with all initial applications.
View a full transcript of the Schedule of Pharmaceutical Benefits
restriction details
The following indications covered under the Medicare items are not eligible indications under this program:
- focal spascity in adults (Item 18360)
- severe primary hyperhidrosis of the axillae (Item 18362)
- strabismus (Item 18366) and
- spasmodic dysphonia (Item 18368).
Medical practitioners
Eligibility requirements
Only medical practitioners who hold the following specialist qualifications are eligible to be registered to prescribe botulinum toxin:
- in the case of treatment of blepharospasm associated with dystonia—including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients who are 12 years and older
- ophthalmology
- neurology
- plastic surgery
or - otolaryngology head and neck surgery
or
- in the case of treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients who are two to 17 years of age inclusive
- rehabilitation
- paediatrics
- neurology
or - orthopaedic surgery
or
- in the case of treatment of spasmodic torticollis, either as monotherapy or adjunctive therapy to current standard care
- neurology
- rehabilitation
or - plastic surgery
or
- in the case of moderate to severe spasticity [defined as greater than or equal to three using the modified Ashworth Scale (MAS)] of the upper limbs in adults following a stroke
- neurology
or - rehabilitation
- neurology
How to register to prescribe
A medical practitioner who wishes to use botulinum toxin under the Arrangements for the Botulinum Toxin program (Arrangements) specified for the treatment of eligible patients must first apply in writing to Medicare Australia stating
- details of their specialist qualification
- details of their training in the use of botulinum toxin, and
- an undertaking to comply with the requirements of the Arrangements.
The letter of application should be accompanied by evidence of the training, and a letter from another authorised injector who is already registered with the program and is able to confirm that the applicant has undertaken procedures under supervision. The written application should be mailed to Medicare Australia. All applicants will be notified in writing of the result of their application.
Full details of the requirements necessary for registration are available from Medicare Australia.
Call 1800 700 270** and select option 4 (8.30 am to 5.00 pm EST Monday to Friday).
** Call charges apply from mobile or pay phones only
Patient forms
All patients
A completed botulinum toxin request for reimbursement and authorisation form must be completed by the patient and the medical practitioner after each treatment.
Adult patients who are to receive treatment for moderate to severe spasticity of the upper limb following a stroke are required to complete a patient and provider acknowledgment form before the initial treatment only.
Delivery dockets
All orders will be accompanied by a delivery docket. The docket needs to be signed and dated to indicate that the correct order was received. The delivery docket should then be faxed or mailed to Medicare Australia as soon as possible, so that payment can be made to the relevant supplier.
If there is a problem with the order please call the supplier concerned or
Medicare Australia—1800 700 270** and select option 4 (8.30 am to 5.00 pm EST Monday to Friday).
** Call charges apply from mobile or pay phones only
Emergency vials
The legislation governing the administration of the botulinum toxin program limits each approved medical practitioner to an emergency stock of five vials only.
How to authorise others to order
Any medical practitioner who is registered with the program may wish to authorise others in the medical practice to place orders on their behalf. This authorisation must be done in writing by completing and signing the Authorisation form (Form 4087) [PDF, 87Kb]
. A separate form should be completed and signed for each provider number and location, which will be used for injections. The form should then be mailed or faxed to Medicare Australia.
Lodgment
Mail: Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
GPO Box 9826
Hobart Tas 7001
(No stamp required if posted in Australia)
Fax: (03) 6215 5640
Call: 1800 700 270** and select option 4 (8.30 am to 5.00 pm EST Monday to Friday).
** Call charges apply from mobile or pay phones only
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Last updated: 20 June, 2008