Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p111
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 111/381)
Character Range: 12239333–12247916

according to the relevant TGA-approved Product Information, details must be provided at the time of application.
                                                                                                                                                                    Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
                                                                                                                                                                    The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application
                                                                                                                                                                    an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
                                                                                                                                                                    either
                                                                                                                                                                    (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 of major joints
                                                                                                                                                                    (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                                                                    (ii) shoulder 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).
                                                                                                                                                                    If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (a) a completed authority prescription form(s); and
                                                                                                                                                                    (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C11930              P11930         CN11930          Ipilimumab                                                                                                      Unresectable malignant mesothelioma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 11930
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                    The treatment must be in combination with PBS-subsidised nivolumab for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                                                                    The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.
C11937              P11937         CN11937          Pazopanib                                                                                                       Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11937
                                                                                                                                                                    Continuing treatment beyond 3 months
                                                                                                                                                                    Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                    Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
                                                                                                                                                                    A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
                                                                                                                                                                    PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of