Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p155
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 155/381)
Character Range: 12526379–12533213

(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 joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
                                                                                                                                                                    If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (1) completed authority prescription form(s); and
                                                                                                                                                                    (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
                                                                                                                                                                    An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                    Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                                                    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.
C12194              P12194         CN12194          Adalimumab                                                                                                      Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 2 (change or recommencement of treatment after break in biological medicine of less than 24 months)
                                                                                                                                                                    Must be treated by a rheumatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                                                                                    Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; 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