Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p254
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 254/312)
Character Range: 17066270–17070961

Required procedures
                                                                                                                           Initial treatment with subcutaneous form
                                                                                                                           Must be treated by a gastroenterologist (code 87); OR
                                                                                                                           Must be treated by a 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 at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); OR
                                                                                                                           Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR
                                                                                                                           Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR
                                                                                                                           Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years).
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16.
                                                                                                                           Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (a) details of the proposed prescription(s); and
                                                                                                                           (b) 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).
                                                                                                                           The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                           Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to