Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p62
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 62/162)
Character Range: 14979398–14984909

in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                         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.
C14153              P14153         CN14153          Tocilizumab                                          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.
                                                                                                         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 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.
                                                                                                         Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
                                                                                                         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