Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p41
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 41/162)
Character Range: 14876692–14882331

the initial application
                                                                                                         (a) an active joint count of at least 20 active (swollen and tender) joints; OR
                                                                                                         (b) at least 4 active joints from the following list
                                                                                                         (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).
                                                                                                         The assessment of response to prior treatment must be documented in the patient's medical records.
                                                                                                         The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
                                                                                                         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 arthritis; and
                                                                                                         (b) details of prior treatment including dose and duration of treatment.
                                                                                                         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 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.
                                                                                                         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.
C14068              P14068         CN14068          Etanercept                                           Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
                                                                                                         Must be treated by a paediatric rheumatologist; or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND
                                                                                                         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 this drug for this condition during the current treatment cycle; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         (a) a