Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p464
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 464/476)
Character Range: 3803416–3809153

resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            An adequate response to this drug defined as:
                                                                                                                                            a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or
                                                                                                                                            (a) an improvement of intestinal inflammation as demonstrated by:
                                                                                                                                            (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or
                                                                                                                                            (ii) faeces: normalisation of lactoferrin or calprotectin level; or
                                                                                                                                            (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
                                                                                                                                            (b) reversal of high faecal output state; or
                                                                                                                                            (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
                                                                       C15933                                                               Moderate to severe ulcerative colitis
                                                                                                                                            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)].
                                                                                                                                            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 than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            Application for authorisation of initial