Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p43
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 43/162)
Character Range: 14885589–14891025

biological medicine was prescribed 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.
C14070              P14070         CN14070          Etanercept                                           Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 1 (new patient)
                                                                                                         Must be treated by a paediatric rheumatologist; or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND
                                                                                                         Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or
                                                                                                         Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens:
                                                                                                          (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                         Patient must be under 18 years of age.
                                                                                                         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 another DMARD 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 following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application
                                                                                                         (a) an active joint count of at least 20 active (swollen and tender) joints; OR
                                                                                                         (b) at least 4 active joints from the following list