Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p60
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 60/312)
Character Range: 15805706–15810898

and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
                                                                                                                           Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or
                                                                                                                           Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or
                                                                                                                           Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
                                                                                                                           Patient must have evidence of intestinal inflammation; or
                                                                                                                           Patient must be assessed clinically as being in a high faecal output state; or
                                                                                                                           Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           The authority application 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).
                                                                                                                           Provide at least one of the following
                                                                                                                           (i) the current Crohn Disease Activity Index (CDAI) score, including the date this score was calculated on;
                                                                                                                           (ii) confirmation that there is a documented history of intestinal inflammation plus diagnostic imaging/surgical evidence of at least one of (a) short gut syndrome, (b) ileostomy, (c) colostomy;
                                                                                                                           (iii) confirmation that there is a documented history and radiological evidence of intestinal inflammation from extensive small intestinal disease affecting more than 50 cm of the small intestine where the CDAI score is at least 220, but below 300.
                                                                                                                           Evidence of intestinal inflammation includes
                                                                                                                           (i) blood higher than normal platelet count, or, 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; or
                                                                                                                           (ii) faeces higher than normal lactoferrin or calprotectin level; or
                                                                                                                           (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
                                                                                                                           Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment