Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p177
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 177/476)
Character Range: 1925013–1931051

same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
                                                                                                                                            The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                                            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 they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. 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.
                                                                       C13640                                                               Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                            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 received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                            Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
                                                                                                                                            Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                                                                            Patient must not receive more than 22 weeks of treatment under this restriction.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            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