Document ID: chunk:federal_register_of_legislation:F2024L01542:reg:52:p3
Version: federal_register_of_legislation:F2024L01542
Segment Type: reg
Provision Reference: reg 52 (pt 3/6)
Character Range: 11291–15081

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 following:
              (i) the patient's baseline Modified Pouchitis Disease Activity Index (mPDAI) score and minimum endoscopic mPDAI sub-score; and
              (ii) details of prior biological medicine therapy for this condition, [date of commencement and duration of therapy].
              The endoscopic assessment contributing to the Modified Pouchitis Disease Activity Index score to confirm the patient's condition at baseline must have been performed no more than 4 weeks prior to the application.
              Applications for treatment of this condition must be received within 4 weeks of the endoscopy to confirm diagnosis.
              The prescriber must exclude 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.
   C16181     Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
              Continuing treatment
              Patient must have previously received this drug as their most recent course of PBS-subsidised biological medicine for this condition; AND
              Patient must have demonstrated or sustained a partial or complete response, as determined by the treating clinician, to the most recent PBS-subsidised course of treatment with this drug for this condition.
              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)].
              Patients who have failed to demonstrate a partial or complete response with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
              Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
              An application for the continuing treatment must be made following the third dose with this drug and requested 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