Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p423
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 423/476)
Character Range: 3586932–3592749

the preceding seven days; and/or
                                                                                                                                            (ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
                                                                                                                                            (iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
                                                                                                                                            The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                                                            Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
                                                                                                                                            The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
                                                                                                                                            At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
                                                                                                                                            The assessment of the patient's response to the most recent course of biological medicine 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 that most recent course of treatment in this treatment cycle.
                                                                                                                                            The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
                                                                                                                                            If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                       C14485                                                               Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 14485
                                                                                                                                            Subsequent continuing treatment
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction;