Medicare Benefits Schedule - Item 18374

Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) or IncobotulinumtoxinA (Xeomin), injection of, for the treatment of bilateral blepharospasm in a patient who is at least 18 years of age, including all such injections on any one day

(Anaes.)

Fee: $142.25 Benefit: 75% = $106.70 85% = $120.95

(See para TN.11.1 of explanatory notes to this Category)

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The Therapeutic Goods Administration (TGA) assesses each indication for the therapeutic use of botulinum toxin on an individual basis.  There are currently three botulinum toxin agents with TGA registration (Botox®, Dysport® and Xeomin®).  Each has undergone a separate evaluation of its safety and efficacy by the TGA as they are neither bioequivalent, nor dose equivalent.  When claiming under an item for the injection of botulinum toxin, only the botulinum toxin agent specified in the item can be used.  Benefits are not payable where an agent other than that specified in the item is used. 

The TGA assesses each indication for the therapeutic use of botulinum toxin by assessment of clinical evidence for its use in paediatric or adult patients.  Where an indication has been assessed for adult use, data has generally been assessed using patients over 12 years of age.  Paediatric indications have been assessed using data from patients under 18 years of age.  Botulinum toxin should only be administered to patients under the age of 18 where an item is for a paediatric indication, and patients over 12 years of age where the item is for an adult indication, unless otherwise specified. 

Items for the administration of botulinum toxin can only be claimed by a medical practitioner who is recognised as an eligible medical practitioner for the relevant indication under the arrangements under Section 100 of the National Health Act 1953 (the Act) relating to the use and supply of botulinum toxin.  The specialist qualifications required to administer botulinum toxin vary across the indications for which the medicine is listed on the PBS, and are detailed within the relevant PBS restrictions available at: www.pbs.gov.au/browse/section100-mf 

Item 18354 for the treatment of equinus, equinovarus or equinovalgus is limited to a maximum of 4 injections per patient on any day (2 per limb).  Accounts should be annotated with the limb which has been treated.  Item 18292 may not be claimed for the injection of botulinum toxin, but may be claimed where a neurolytic agent (such as phenol) is used, in addition to botulinum toxin injection(s), to treat the obturator nerve in patients with a dynamic foot deformity. 

Treatment under item 18375 or 18379 can only continue if the patient achieves at least a 50% reduction in urinary incontinence episodes from baseline from the start of week 6 through to the end of week 12 after the first treatment.  The term 'continue' means the patient can be retreated under item 18375 or 18379 at some point after the 12 week period (for example; 6 to 12 months after the first treatment).  This requirement is in line with the PBS listing for the supply of the medicine for this indication under Section 100 of the Act. 

Item 18362 for the treatment of severe primary axillary hyperhidrosis allows for a maximum number of 3 treatments per patient in a 12 month period, with no less than 4 months to elapse between treatments. 

Botulinum toxin which is not supplied and administered in accordance with the arrangements under Section 100 of the Act is not required to be provided free of charge to patients.  Where a charge is made for the botulinum toxin administered, it must be separately listed on the account and not billed to Medicare.  Since 1 September 2015, PBS patient co-payments have applied to botulinum toxin supplied and administered in accordance with the arrangements under Section 100 of the Act. 

Services Australia (SA), in consultation with the Department of Health and Aged Care, has developed a Health Practitioner Guideline to substantiate that a patient had a pre-existing condition at the time of the service which is located on the Department of Health and Aged Care's website.

Related Items: 18350 18351 18353 18354 18360 18361 18362 18365 18366 18368 18369 18370 18372 18374 18375 18377 18379