Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p135
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 135/476)
Character Range: 1689463–1695929

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.
                                                                                                                                            The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records.
                                                                                                                                            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.
                                                                       C9559                                                                Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
                                                                                                                                            Patient must have received