Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p39
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 39/162)
Character Range: 14867687–14872064

in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                         The condition must have either:
                                                                                                          (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                         Active joints are defined as
                                                                                                         (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).
                                                                                                         All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
                                                                                                         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 active joints, the response must be demonstrated on the total number of active joints.
                                                                                                         At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
                                                                                                         The following information must be provided by the prescriber at the time of application and documented in the patient's medical records
                                                                                                         (a) the date of assessment of severe active juvenile idiopathic; and
                                                                                                         (b) the date of the last continuing prescription.
                                                                                                         An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
                                                                                                         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.
                                                                                                         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