Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p102
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 102/381)
Character Range: 12179876–12188347

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 (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.
C11878              P11878         CN11878          Sunitinib                                                                                                       Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11878
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
                                                                                                                                                                    PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.
C11883              P11883         CN11883          Tofacitinib                                                                                                     Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                    Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                    Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
                                                                                                                                                                    Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                                                                                    At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
                                                                                                                                                                    An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                    Where a response