Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p67
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 67/162)
Character Range: 15002857–15008973

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.
C14175              P14175         CN14175          Tocilizumab                                          Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg)
                                                                                                         Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND
                                                                                                         Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                         Patient must be under 18 years of age;
                                                                                                         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) 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.
                                                                                                         The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                         The following reports must be documented in the patient's medical records where appropriate
                                                                                                         (a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
                                                                                                         An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to