Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p35
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 35/312)
Character Range: 15663904–15670509

change in treatment has been made for reasons other than the 2 mentioned above
                                                                                                                           (i) an absence of an adequate response; or
                                                                                                                           (ii) an intolerance to that treatment; or
                                                                                                                           (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.
                                                                                                                           Recommencing therapy
                                                                                                                           If the patient is recommencing therapy, in relation to the last administered dose, state whether there was
                                                                                                                           (i) an absence of an adequate response; or
                                                                                                                           (ii) an intolerance to that treatment; or
                                                                                                                           (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.
                                                                                                                           The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records.
C14649              P14649         CN14649          Tofacitinib                                                            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 reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                           (b) a reduction in the number of the following active joints, from at least 4, by at least 50%
                                                                                                                           (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 treatment must be documented in the patient's medical records.
                                                                                                                           An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or 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.