Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p112
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 112/381)
Character Range: 12247497–12255436

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.
C11939              P11939         CN11939          Pazopanib                                                                                                       Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11939
                                                                                                                                                                    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
                                                                                                                                                                    Patient must require dose adjustment; 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.
C11940              P11940         CN11940          Tofacitinib                                                                                                     Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 1 (new patient)
                                                                                                                                                                    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 failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
                                                                                                                                                                    Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or
                                                                                                                                                                    Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or
                                                                                                                                                                    Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
                                                                                                                                                                    Patient must have a Mayo clinic score greater than or equal to 6; or
                                                                                                                                                                    Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater