Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p109
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 109/191)
Character Range: 10714681–10725977

resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                                                                               If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
                                                                                                                                                                                                                               A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C8902               P8902          CN8902           Esomeprazole                                                                                                                                                               Gastro-oesophageal reflux disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor.
C8921               P8921          CN8921           Febuxostat                                                                                                                                                                 Chronic gout                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 8921
                                                                                                                                                                                                                               The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND
                                                                                                                                                                                                                               Patient must have a medical contraindication to allopurinol.  or
                                                                                                                                                                                                                               Patient must have a documented history of allopurinol hypersensitivity syndrome.  or
                                                                                                                                                                                                                               Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation.
C8929               P8929          CN8929           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Moderate to severe spasticity of the upper limb                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 8929
                                                                                                                                                                                                                               Patient must have cerebral palsy;
                                                    Clostridium botulinum type A toxin - haemagglutinin complex                                                                                                                Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Must be treated by a neurologist.  or
                                                                                                                                                                                                                               Must be treated by an orthopaedic surgeon.  or
                                                                                                                                                                                                                               Must be treated by a paediatrician.  or
                                                                                                                                                                                                                               Must be treated by a rehabilitation specialist.  or
                                                                                                                                                                                                                               Must be treated by a plastic surgeon.
C8955               P8955          CN8955           Etanercept                                                                                                                                                                 Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 8955
                                                                                                                                                                                                                               Subsequent continuing treatment, face, hand, foot
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                                                                                                               Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
                                                                                                                                                                                                                               The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                                                                               Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Must be treated by a dermatologist.
                                                                                                                                                                                                                               An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing
                                                                                                                                                                                                                               (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
                                                                                                                                                                                                                               (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for