Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p130
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 130/476)
Character Range: 1658672–1665177

ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
                                                                                                                                            Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity 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.
                                                                       C9065                                                                Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Subsequent continuing treatment
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                                            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 treatment with this drug; 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.
                                                                                                                                            An adequate response to treatment is defined as:
                                                                                                                                            an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
                                                                                                                                            either of the following:
                                                                                                                                            (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                                            (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
                                                                                                                                            (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 irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                                            The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose