Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p47
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 47/162)
Character Range: 14905061–14910897

the upper limits of normal (ULN).
                                                                                                         The assessment of response to prior treatment must be documented in the patient's medical records.
                                                                                                         The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
                                                                                                         The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
                                                                                                         Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
                                                                                                         Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
                                                                                                         If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.
                                                                                                         If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
                                                                                                         The assessment of the patient's response to the initial course of treatment 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 this course of treatment in this treatment cycle.
                                                                                                         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 systemic juvenile idiopathic arthritis; and
                                                                                                         (b) details of prior treatment including dose and duration of treatment.
                                                                                                         The following reports must be documented in the patient's medical records where appropriate
                                                                                                         (a) the date of assessment of severe active systemic juvenile idiopathic arthritis;
                                                                                                         (b) details of prior treatment including dose and duration of treatment; and
                                                                                                         (c) the pathology reports detailing CRP and platelet count where appropriate.
C14084              P14084         CN14084          Tocilizumab                                          Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 14084
                                                                                                         Continuing treatment 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 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