Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p169
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 169/476)
Character Range: 1883624–1888972

by a consultant physician [general medicine specialising in gastroenterology (code 82)].
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            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 failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
                                                                                                                                            The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
                                                                                                                                            Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
                                                                                                                                            Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
                                                                                                                                            Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
                                                                                                                                            Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
                                                                                                                                            Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an 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.
                                                                                                                                            Applications for authorisation must be made in writing and must include:
                                                                                                                                            (a) a completed authority prescription form; 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