Botulinum toxin
Authority to supply botulinum toxin, to eligible patients, 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® for eligible patients.
Section 100 arrangements
Special pharmaceutical products such as Botox® and Dysport® will not be supplied under these arrangements for administration to patients who are admitted to public hospitals, unless the patient is admitted as a day patient, or is admitted for a period of less 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
- continuing treatment of dynamic equinus foot deformity due to spasticity in an ambulant cerebral palsy patient 18 years of age or older who started on PBS subsidised treatment with botulinum toxin as a paediatric patient
- moderate to severe spasticity of the upper limbs in cerebral palsy patients, two to 17 years of age inclusive (Botox® only)
- continuing treatment of moderate to severe spasticity of the upper limbs in a cerebral palsy patient, 18 years of age or older, who started on PBS subsidised treatment with botulinum toxin as a paediatric patient (Botox® only)
- 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, providing:
- patients are eligible for a lifetime maximum of four treatments (total Botox® and Dysport®) 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 acknowledgement form must be supplied with all initial applications, including the date of the stroke.
View a full transcript of the restriction details
The following indications covered under the Medicare items are not eligible indications under this program:
- focal spasticity in adults (Item 18360)
- severe primary hyperhidrosis of the axillae (Item 18362)
- strabismus (Item 18366)
- 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:
- for the 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
- otolaryngology head and neck surgery
- for the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients who are two to 17 years of age inclusive and for the continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patients 18 years of age or older who started on PBS subsidised treatment with botulinum toxin as a paediatric patient
- rehabilitation
- paediatrics
- neurology
- orthopaedic surgery
- for the treatment of moderate to severe spasticity of the upper limbs in paediatric cerebral palsy patients who are two to 17 years of age inclusive and for the continuing treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 18 years of age or older who started on PBS subsidised treatment with botulinum toxin as a paediatric patient
- rehabilitation
- paediatrics
- neurology
- orthopaedic surgery
- for the treatment of spasmodic torticollis, either as monotherapy or adjunctive therapy to current standard care
- neurology
- rehabilitation
- plastic surgery
- for the treatment of moderate to severe spasticity (defined as greater than or equal to three using the MAS) of the upper limbs in adults following a stroke
- neurology
- rehabilitation
- geriatric medicine
- orthopaedic surgery
- plastic surgery.
How to register to prescribe
A medical practitioner who wishes to use Section 100 botulinum toxin under the Arrangements for the Botulinum Toxin program specified for the treatment of eligible patients must first apply in writing to Medicare Australia stating:
- details of their specialist qualification/s
- details of their training in the use of botulinum toxin, including details of supervision and the names of patients treated by them under supervision
- an undertaking that they agree to comply with the requirements of the Arrangements
- agreement to provide their name and address to Allergan Australia Pty Ltd in relation to the supply and use of Botulinum Toxin Type A Purified Neurotoxin Complex, and/or Ipsen Pty Ltd (and their distributor) in relation to the supply and use of Clostridium Botulinum Type A Toxin–Haemagglutinin Complex and
- a letter of support from a registered practitioner in the botulinum toxin program confirming details of the applicant’s training.
Clarification about the evidence required by Medicare Australia can be found in paragraphs 5(B)(iii), 5(C)(iii), or 5(D)(iii) of the Arrangements.
To view a copy of the Arrangements, go to the Attorney-General's website.
The written application and supporting evidence should be mailed to Medicare Australia at the following address:
Botulinum Toxin Program
PBS Services Branch
Medicare Australia
GPO Box 9826
HOBART TAS 7001
All applicants will be notified in writing of the result of their application.
For full details of the requirements necessary for registration call Medicare Australia on 1800 700 270** (option 4) between 8.30am to 5.00pm 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 acknowledgement 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** (option 4) between 8.30am and 5.00pm EST Monday to Friday.
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 want 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, 128Kb]
. A separate form must 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.
Ordering procedure
See the attached flowchart for the procedure to be followed when ordering botulinum toxin.
Lodgement
Please send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
Fax: 1300 154 190*
Call: 1800 700 270** (option 4) between 8.30am and 5.00pm EST Monday to Friday.
* Call charges apply
** Call charges apply from mobile and pay phones only
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Last updated: 4 February, 2010