Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p153
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 153/191)
Character Range: 11075565–11083863

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 5 years 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 (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C9391               P9391          CN9391           Tocilizumab                                                                                                                                                                Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                                                                                                                                                               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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                                                                               Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or
                                                                                                                                                                                                                               Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND
                                                                                                                                                                                                                               The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                                                                                                                                                               The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                                                                                                                                                               The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
                                                                                                                                                                                                                               Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               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 measures of joint count must be no more than 4 weeks old at the time of this application.
                                                                                                                                                                                                                               The authority application must be made in writing and must include
                                                                                                                                                                                                                               (1) completed authority prescription form(s); and
                                                                                                                                                                                                                               (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
                                                                                                                                                                                                                               Where the most recent course of PBS-subsidised biological medicine treatment was approved under