Document ID: chunk:federal_register_of_legislation:F2024L01736:schedule:1:p6
Version: federal_register_of_legislation:F2024L01736
Segment Type: schedule
Provision Reference: sch 1 (pt 6/6)
Character Range: 18896–20922

AND
              Patient must not receive more than 14 weeks of treatment under this restriction.
              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)].
              The treatment must be initiated in combination with standard of care antibiotic.
              The assessment of a patient's response to this initial course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.
              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.
              Application for authorisation of initial treatment must be in writing and must include:
              (a) details of the proposed prescription; 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) which includes the details of prior biological medicine therapy for this condition [date of commencement and duration of therapy].
              The prescriber must have excluded secondary causes of pouchitis, for example:
              (a) Ischaemia;
              (b) Crohn's disease (CD) or CD of the pouch;
              (c) Irritable pouch syndrome;
              (d) Predominant cuffitis;
              (e) Pouch stricture or pouch fistula;
              (f) Active infection;
              (g) NSAIDs;
              (h) Coeliac disease.