Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p450
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 450/476)
Character Range: 3737751–3743479

ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
                                                                                                                                            Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            Applications for authorisation must be made in writing and must include:
                                                                                                                                            (a) details of the proposed prescription; and
                                                                                                                                            (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
                                                                                                                                            (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
                                                                                                                                            (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
                                                                                                                                            (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
                                                                                                                                            (iv) the date of the most recent clinical assessment.
                                                                                                                                            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.
                                                                                                                                            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.