Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p36
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 36/312)
Character Range: 15670146–15676031

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.
                                                                                                                           A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
                                                                                                                           If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C14650              P14650         CN14650          Tofacitinib                                                            Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more 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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           The condition must have either:
                                                                                                                            (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
                                                                                                                           Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                           Active joints are defined as
                                                                                                                           (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).
                                                                                                                           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