Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p456
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 456/476)
Character Range: 3766198–3772164

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 received prior PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                            Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic 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; AND
                                                                                                                                            The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
                                                                                                                                            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) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
                                                                                                                                            (iii) the date of the most recent clinical assessment.
                                                                                                                                            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