What's new?

July 2014

Improvements will be made to the way some PBS medicines are processed under the Highly Specialised Drugs Programme from 1 July 2015.

Botulinum toxin

Botulinum toxin can be supplied to eligible patients through the Pharmaceutical Benefits Scheme (PBS) as authorised by Section 100 of the National Health Act 1953.

The Australian Government funds the botulinum toxin program to cover the full cost of Botox® or Dysport® for eligible patients.

Section 100 Arrangements

Special pharmaceutical products such as Botox® and Dysport® won’t be supplied under these arrangements 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 criteria as indicated in the restrictions.

For more information see who is eligible for the PBS?

Restriction details

Botulinum toxin is available as Botox® (100U vial) and Dysport® (300U vial and 500U vial, 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 or hemifacial spasm in patients 12 years and older (Botox® only).
  • blepharospasm or hemifacial spasm in adult patients (Dysport® 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. Patients are eligible for a life time maximum of four treatments (total Botox® and Dysport®) per upper limb as long as 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.
  • severe primary axillary hyperhidrosis in patients 12 years or older who have failed or are intolerant to topical aluminium chloride hexahydrate after one or two months of treatment (Botox® only).
  • urinary incontinence due to neurogenic detrusor overactivity as demonstrated by urodynamic study. The condition must be inadequately controlled by anti-cholinergic 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 6-12 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 for adult patients. 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, prior to commencement of treatment with botulinum toxin.  Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration) in order to be eligible for continuing PBS-subsidised treatment (Botox® only).

View a full transcript of the restriction detailsExternal link 

Medical practitioners

Eligibility requirements

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

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

  • Ophthalmology
  • Neurology
  • Plastic surgery, and
  • Otolaryngology head and neck surgery.

For the treatment of blepharospasm or hemifacial spasm in adult patients:

  • Ophthalmology
  • Neurology
  • Plastic surgery, and
  • 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 the same condition 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, and
  • 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 the same condition 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, and
  • Plastic surgery.

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

  • Neurology
  • Rehabilitation, and
  • 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, and
  • Plastic surgery.

For the 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 one or two months of treatment:

  • Dermatology
  • Neurology, and
  • Paediatrics.

For the treatment of urinary incontinence due to neurogenic detrusor overactivity:

  • Urology
  • Urogynaecology.

 For the treatment of chronic migraine for adults:

  • Neurology.

How to register to administer

If you want to administer botulinum toxin under the Section 100 Arrangements you need to write to us with the following information:

  • the treatment condition/s you would like to be authorised
  • details of your specialist qualification/s
  • details of your training in the use of botulinum toxin, including details of supervision and the names of patients treated by you under supervision
  • 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 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 your training, and
  • written confirmation that you will comply with the requirements of the Special Arrangements.

More information about the evidence we need can be found in paragraph 5, of the Section 100 Arrangements.

To view a copy of the Arrangements, go to the Attorney-General'sExternal link website.

To check you are sending all the required information for your specialist qualification/s, use our check list [PDF, 91Kb]PDF reader required.

Your written application and supporting evidence can be sent to:

Listings and Complex Programs Section
Pharmaceutical Benefits Branch
Medicare

Department of Human Services
PO Box 1001
TUGGERANONG ACT 2901

We will notify you in writing of the result of your application.

Patient forms

All patients

The patient and medical practitioner need to complete a botulinum toxin Patient Usage form after each treatment.

Adult patients receiving treatment for moderate to severe spasticity of the upper limb following a stroke need to complete a patient and provider acknowledgement form before the initial treatment.

Patients aged 12 years or older who are to receive treatment for severe primary axillary hyperhidrosis need to complete a patient and provider acknowledgement form before the initial treatment.

Patients who are to receive treatment for urinary incontinence need to complete a patient and provider acknowledgement form before the initial treatment.

Adult patients receiving treatment for chronic migraine need to complete a patient and provider acknowledgement form before the initial treatment.

Delivery dockets

All orders will include a delivery docket. The docket must be signed and dated by the Provider or Authorised person to show the correct order was received. The delivery docket needs to be sent to us as soon as possible, so payment can be made to the relevant supplier. You can send the dockets to the lodgement address listed below.

Emergency vials

You can have an emergency stock of five vials only.

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 Authorisation form (Form 4087) [PDF, 128Kb]PDF reader required. A separate form must be completed and signed for each provider number and location which will be used for injections.

Ordering procedure

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

Lodgement

Send all written applications and forms to:

Department of Human Services
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001

Fax: 1300 154 190*
Call: 1800 700 270**  Monday to Friday 8.30 am to 5.00 pm EST.

*    Call charges apply
**  Call charges apply from mobile and pay phones only

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Last updated: 21 October, 2014