Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p137
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 137/161)
Character Range: 14524388–14529682

period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
                                                                                   The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application
                                                                                   an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
                                                                                   either
                                                                                   (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 of major joints
                                                                                   (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                   (ii) shoulder 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).
                                                                                   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. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
                                                                                   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 assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of 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 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.
C13681              P13681         CN13681          Adalimumab                     Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                   Initial treatment - Initial 1 (new patient)
                                                                                   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