Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p60
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 60/162)
Character Range: 14970315–14974675

must have had a break in treatment of 12 months or more from this drug for this condition; AND
                                                                                                         Patient must have polyarticular course disease and the condition must have at least one of:
                                                                                                          (a) an active joint count of at least 20 active (swollen and tender) joints; (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); (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); or
                                                                                                         Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction; AND
                                                                                                         Must be treated by a rheumatologist; or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre;
                                                                                                         Patient must be under 18 years of age.
                                                                                                         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 systemic juvenile idiopathic arthritis.
                                                                                                         The following reports must be documented in the patient's medical records where appropriate
                                                                                                         (a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
                                                                                                         The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
                                                                                                         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 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a