Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p263
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 263/312)
Character Range: 17113745–17119075

this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                           Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                           If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                           A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C15944              P15944         CN15944          Vedolizumab                                                            Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority 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