Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p69
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 69/162)
Character Range: 15014138–15018808

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 the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
                                                                                                         The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from 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 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