Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p165
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 165/476)
Character Range: 1861839–1868176

to respond to PBS‑subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle.
                                                                       C12313                                                               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)]; OR
                                                                                                                                            Must be treated by a paediatrician; OR
                                                                                                                                            Must be treated by a specialist paediatric gastroenterologist.
                                                                                                                                            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 (for a child, 1 to 2 mg/kg up to 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 if an adult patient; 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 than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
                                                                                                                                            Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
                                                                                                                                            Patient must be 6 years of age or older.
                                                                                                                                            Application for authorisation must be made in writing and must include:
                                                                                                                                            (1) a completed authority prescription form; and
                                                                                                                                            (2) 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), which includes the following:
                                                                                                                                            (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment