Document ID: chunk:federal_register_of_legislation:F2024L01542:reg:52:p4
Version: federal_register_of_legislation:F2024L01542
Segment Type: reg
Provision Reference: reg 52 (pt 4/6)
Character Range: 14829–18430

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 an application is not made within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
              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
   C16216     Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
              Initial 1 treatment (new patient)
              Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis (UC) at least one year previously; AND
              Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
              The condition must be confirmed based on the patient's symptoms, treatment history and baseline endoscopic examination of the pouch (pouchoscopy); AND
              Patient must have a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5; AND
              Patient must have a minimum endoscopic mPDAI sub-score of at least 2; AND
              Patient must have had at least 3 recurrent episodes of pouchitis within the previous year each of which was treated with at least: (i) 2 weeks of antibiotic, (ii) other prescription therapy; OR
              The condition must have required maintenance antibiotic therapy taken continuously for at least 4 weeks before commencing treatment with this drug; 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 an 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 this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
              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 following:
              (i) the patient's baseline Modified Pouchitis Disease Activity Index (mPDAI) score and endoscopic mPDAI subscore; and
              (ii) details of prior drug therapy