Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p159
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 159/381)
Character Range: 12550027–12555712

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 continuing treatment course authorised under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    An adequate response to treatment is defined as
                                                                                                                                                                    an ESR no greater than 25 mm per hour or a 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) an active joint count of fewer than 10 active (swollen and tender) joints; or
                                                                                                                                                                    (b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
                                                                                                                                                                    (c) a reduction in the number of the following 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, cervical spine 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).
                                                                                                                                                                    Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (1) a completed authority prescription form; and
                                                                                                                                                                    (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                                                    An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                    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