Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p33
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 33/191)
Character Range: 9834474–9846850

be treated by a neurologist.  or
                                                                                                                                                                                                                               Must be treated by an ophthalmologist.  or
                                                                                                                                                                                                                               Must be treated by an otolaryngology head and neck surgeon.  or
                                                                                                                                                                                                                               Must be treated by a plastic surgeon.
C5406               P5406          CN5406           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Spasmodic torticollis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 5406
                                                                                                                                                                                                                               Patient must have spasmodic torticollis; AND
                                                    Clostridium botulinum type A toxin - haemagglutinin complex                                                                                                                The treatment must be as monotherapy; or
                                                                                                                                                                                                                               The treatment must be as adjunctive therapy to current standard care; AND
                                                                                                                                                                                                                               Must be treated by a neurologist.  or
                                                                                                                                                                                                                               Must be treated by a plastic surgeon.  or
                                                                                                                                                                                                                               Must be treated by a rehabilitation specialist.
C5408               P5408          CN5408           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Severe primary axillary hyperhidrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 5408
                                                                                                                                                                                                                               Patient must have previously failed topical aluminium chloride hexahydrate after one to two months of treatment; or
                                                                                                                                                                                                                               Patient must be intolerant to topical aluminium chloride hexahydrate treatment;
                                                                                                                                                                                                                               Patient must be aged 12 years or older;
                                                                                                                                                                                                                               Must be treated by a dermatologist.  or
                                                                                                                                                                                                                               Must be treated by a neurologist.  or
                                                                                                                                                                                                                               Must be treated by a paediatrician.
                                                                                                                                                                                                                               Maximum number of treatments per year is 3, with no less than 4 months to elapse between treatments.
C5409               P5409          CN5409           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Urinary incontinence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 5409
                                                                                                                                                                                                                               The condition must be due to neurogenic detrusor overactivity, as demonstrated by urodynamic study; AND
                                                                                                                                                                                                                               The condition must be inadequately controlled by anti-cholinergic therapy; AND
                                                                                                                                                                                                                               Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with Botulinum Toxin Type A Neurotoxin Complex; AND
                                                                                                                                                                                                                               Patient must be willing and able to self-catheterise; AND
                                                                                                                                                                                                                               The 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 the first treatment; AND
                                                                                                                                                                                                                               Patient must have multiple sclerosis; or
                                                                                                                                                                                                                               Patient must have a spinal cord injury; or
                                                                                                                                                                                                                               Patient must be aged 18 years or older and have spina bifida; AND
                                                                                                                                                                                                                               Must be treated by a urologist.  or
                                                                                                                                                                                                                               Must be treated by a urogynaecologist.
C5411               P5411          CN5411           Pramipexole                                                                                                                                                                Primary severe restless legs syndrome
                                                                                                                                                                                                                               Patient must manifest all 4 diagnostic criteria for Restless Legs Syndrome; AND
                                                                                                                                                                                                                               Patient must have a baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score greater than or equal to 21 points prior to initiation of pramipexole.
                                                                                                                                                                                                                               The date and IRLSRS score must be documented in the patient's medical records at the time pramipexole treatment is initiated.
                                                                                                                                                                                                                               The diagnostic criteria for Restless Legs Syndrome are
                                                                                                                                                                                                                               (a) An urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and
                                                                                                                                                                                                                               (b) The urge