Botulinum toxin

The Pharmaceutical Benefits Scheme subsidises botulinum toxin for eligible patients.

For eligible patients, botulinum toxin (Botox®, Xeomin® or Dysport®) can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953.

The Australian Government funds the botulinum toxin program to cover the full cost of these products for eligible patients. These products will not be supplied for patients who are admitted to public hospitals, unless the patient is admitted as a day patient, or for less than 24 hours.

Patient eligibility

Patients must meet the relevant eligibility criteria as indicated in the restrictions on the PBS website.

Botulinum toxin is available as Botox® and Xeomin® 100 U vial, and Dysport®, 300 U vial and 500 U vial, for the treatment of:

  • dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients aged 2 or more and less than 18, Botox ® and Dysport® only
  • continuing treatment of dynamic equinus foot deformity due to spasticity in an ambulant cerebral palsy patient aged 18 years or older who started on PBS-subsidised treatment with botulinum toxin as a paediatric patient, Botox ® and Dysport® only
  • moderate to severe spasticity of the upper limbs in cerebral palsy patients aged 2 or more and less than 18, Botox® only
  • continuing treatment of moderate to severe spasticity of the upper limbs in a cerebral palsy patient aged 18 years or older who started on PBS-subsidised treatment with botulinum toxin as a paediatric patient, Botox® only
  • spasmodic torticollis
  • blepharospasm or hemifacial spasm in patients aged 12 years or older, Botox® only
  • blepharospasm in adult patients Xeomin® and Dysport®
  • moderate to severe spasticity, defined as greater than or equal to 3 using the Modified Ashworth Scale [MAS] of the upper limbs in adults following a stroke. Patients are eligible for a lifetime maximum of 4 treatments, total Botox®, Dysport® and Xeomin® per upper limb as long as the MAS assessment has decreased by more than 1, in at least 1 joint, after 2 treatments. A completed patient and provider acknowledgement form must be supplied with all initial applications, including the date of the stroke
  • severe primary axillary hyperhidrosis in patients aged 12 years or older who have failed or are intolerant to topical aluminium chloride hexahydrate after 1 or 2 months of treatment, Botox® only
  • urinary incontinence due to neurogenic detrusor overactivity as demonstrated by urodynamic study. The condition must be inadequately controlled by anticholinergic therapy, and the patient must experience at least 14 episodes of urinary incontinence per week. Treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6 to 12 weeks after first treatment, Botox® only
  • urinary incontinence due to idiopathic overactive bladder. The condition must be inadequately controlled by anti-cholinergic therapy with at least two alternative agents and the patient must experience at least 14 episodes of urinary incontinence per week. Treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after first treatment, Botox® only
  • chronic migraine in patients who are 18 years or older. The patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, before commencement of treatment with botulinum toxin. The patient must have achieved and maintained a 50% or greater reduction from baseline in the number of headache days per month after 2 treatment cycles, each of 12 weeks duration to be eligible for continuing PBS-subsidised treatment, Botox® only

Patients must be eligible for the Pharmaceutical Benefits Scheme.

Medical practitioner eligibility

Only medical practitioners who hold the following specialist qualifications can be registered to prescribe and administer botulinum toxin.

For treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients aged 2 or more and less than 18, and for continuing treatment of the same condition in ambulant cerebral palsy patients aged 18 years or older who started on PBS-subsidised treatment with botulinum toxin as paediatric patients:

  • rehabilitation
  • paediatrics
  • neurology
  • orthopaedic surgery

For treatment of moderate to severe spasticity of the upper limbs in paediatric cerebral palsy patients aged 2 or more and less than 18 and for continuing treatment of the same condition in cerebral palsy patients aged 18 years or older who started on PBS-subsidised treatment with botulinum toxin as paediatric patients:

  • rehabilitation
  • paediatrics
  • neurology
  • orthopaedic surgery
  • plastic surgery

For treatment of spasmodic torticollis, as either monotherapy or adjunctive therapy to current standard care:

  • neurology
  • rehabilitation
  • plastic surgery

For treatment of blepharospasm or hemifacial spasm in patients aged 12 years or older:

  • ophthalmology
  • neurology
  • plastic surgery
  • otolaryngology head and neck surgery

For treatment of blepharospasm or hemifacial spasm in adult patients:

  • ophthalmology
  • neurology
  • plastic surgery
  • otolaryngology head and neck surgery

For treatment of moderate to severe spasticity (defined as greater than or equal to 3 using the MAS) of the upper limbs in adults following a stroke:

  • neurology
  • rehabilitation
  • geriatric medicine
  • orthopaedic surgery
  • plastic surgery

For treatment of severe primary axillary hyperhidrosis in patients aged 12 years or older who have failed or are intolerant to topical aluminium chloride hexahydrate after 1 or 2 months of treatment:

  • dermatology
  • neurology
  • paediatrics

For treatment of urinary incontinence due to neurogenic detrusor overactivity:

  • urology
  • urogynaecology

For treatment of chronic migraine in adults:

  • neurology

How to register to prescribe

If you want to prescribe botulinum toxin under the section 100 arrangements, you need to write to us with the following information:

  • the condition(s) you would like to be authorised to treat
  • details of your specialist qualification(s)
  • details of your training in the use of botulinum toxin, including supervision and the names of patients treated by you under supervision if required
  • agreement to provide your 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 its distributor) in relation to the supply and use of Clostridium Botulinum Type A Toxin - Haemagglutinin Complex, and/or
    • Merz Australia Pty Ltd in relation to the supply and use of Incobotulinumtoxin A, and
  • a letter of support from a registered practitioner in the botulinum toxin program confirming your training, and
  • written confirmation that you will comply with the requirements of the section 100 special arrangements

More information about the evidence we need can be found in paragraph 5 of the section 100 arrangements.

A copy of the National Health (Botulinum Toxin Program) Special Arrangement 2011 is on the ComLaw website.

To ensure that you are sending all the required information for your specialist qualification(s), use our Botulinum Toxin program checklist. We will notify you in writing of the result of your application.

Patient forms

Adult patients receiving treatment for moderate to severe spasticity of the upper limb following a stroke need to complete a Botulinum toxin acknowledgement - focal spasticity form (PB124) before the initial treatment.

Patients aged 12 years or older who are to receive treatment for severe primary axillary hyperhidrosis need to complete a Botulinum toxin acknowledgement - hyperhidrosis form (PB002) before the initial treatment.

Patients who are to receive treatment for urinary incontinence need to complete a Botulinum toxin acknowledgement - urinary incontinence form (PB001) before the initial treatment.

Adult patients receiving treatment for chronic migraine need to complete a Botulinum toxin acknowledgement – chronic migraine form (PB064) before the initial treatment.

The patient and medical practitioner need to complete a Botulinum toxin - Request for reimbursement and authorisation form (PB003) after each treatment.

Ordering procedure

Botulinum toxin MUST be ordered through us. We will not replace private stock or stock that has been ordered directly from a pharmacy or pharmaceutical company (supplier).

Follow these steps to order botulinum toxin:

  1. estimate the amount of botulinum toxin required
  2. assess how much botulinum toxin stock is on hand; no more than 5 vials may be retained for emergency purposes
  3. order stock (quantity = prescriber estimate - stock on hand)
  4. contact us on the Complex Drug enquiry line
  5. after botulinum toxin arrives from supplier to nominated delivery address, store it separately under the approved injector’s name and location-specific provider number
  6. sign the delivery docket and return it to us by fax or post
  7. treat the patient and complete the Botulinum toxin - Request for reimbursement and authorisation form (PB003), and a relevant acknowledgement form if required
  8. ensure that the patient signs the request for reimbursement and authorisation form
  9. record stock on hand for each provider
  10. post or fax request for reimbursement forms to us as soon as possible
  11. before the next order, store any remaining botulinum toxin as part of your PBS supply

How to authorise others to order

You can authorise other people in your practice to place orders on your behalf by completing and signing the Authority to order botulinum toxin form (PB080). A separate form must be completed and signed for each provider number and location that will be used for injections.

Delivery dockets

All orders will include a delivery docket. Sign and date the docket to show that the correct order was received. Send the delivery docket to us as soon as possible, so that payment can be made to the supplier.

Lodging an application

To lodge an application go to Register to prescribe on the contact us page.

Further information

For more information contact us on the Complex Drug Enquiry line.

This information was printed from humanservices.gov.au It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.