Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p57
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 57/162)
Character Range: 14955263–14960191

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 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.
C14121              P14121         CN14121          Tocilizumab                                          Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg)
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient 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