Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p65
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 65/312)
Character Range: 15834218–15839500

220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
                                                                                                                           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).
                                                                                                                           Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following
                                                                                                                           (a) patient must have evidence of intestinal inflammation;
                                                                                                                           (b) patient must be assessed clinically as being in a high faecal output state;
                                                                                                                           (c) 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.
                                                                                                                           (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.
                                                                                                                           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.
                                                                                                                           All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
                                                                                                                           If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
                                                                                                                           If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
                                                                                                                           Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                                                                           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 restriction. However, the same criterion must be used for any subsequent determination of response to treatment,