Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p49
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 49/162)
Character Range: 14915168–14920941

will be deemed to have failed that most recent course of treatment in this treatment cycle.
                                                                                                         The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
                                                                                                         If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring 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 prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C14088              P14088         CN14088          Tocilizumab                                          Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 14088
                                                                                                         Continuing treatment in a patient weighing at least 30 kg
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                         Patient must not receive more than 24 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.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         (a) in a patient with polyarticular course disease
                                                                                                         (i) 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
                                                                                                         (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%
                                                                                                         (b) in a patient with refractory systemic symptoms
                                                                                                         (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
                                                                                                         (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
                                                                                                         (iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
                                                                                                         - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                         - 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).
                                                                                                         (b) in a patient with refractory systemic symptoms
                                                                                                         (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
                                                                                                         (ii)