Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p37
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 37/312)
Character Range: 15675548–15681202

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.
                                                                                                                           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) 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 failure.
C14652              P14652         CN14652          Tofacitinib                                                            Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (new patient)
                                                                                                                           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 not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or
                                                                                                                           Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens:
                                                                                                                            (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular