Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p122
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 122/191)
Character Range: 10810447–10818437

with this drug.
                                                                                                                                                                                                                               If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                                                                               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.
C9122               P9122          CN9122           Ustekinumab                                                                                                                                                                Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient)
                                                                                                                                                                                                                               Must be treated by a rheumatologist; or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                                                                                                                                                               Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                                                                               Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
                                                                                                                                                                                                                               Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or
                                                                                                                                                                                                                               Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
                                                                                                                                                                                                                               Patient must not receive more than 28 weeks of treatment under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
                                                                                                                                                                                                                               Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
                                                                                                                                                                                                                               The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application
                                                                                                                                                                                                                               an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
                                                                                                                                                                                                                               either
                                                                                                                                                                                                                               (a) an active joint count of at least 20 active (swollen and tender) joints; or
                                                                                                                                                                                                                               (b) at least 4 active joints from the following list of major joints
                                                                                                                                                                                                                               (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                                                                                                                               (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not