Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p468
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 468/476)
Character Range: 3826625–3834333

of prior drug therapy for this condition [dosage, 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.
                                                                       C16217                                                               Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                            Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                                            Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 December 2024; AND
                                                                                                                                            Patient must be receiving treatment with this drug for this condition at the time of application; AND
                                                                                                                                            Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis at least one year prior to initiating non-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 had a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5 at the time of initiating treatment with this drug for this condition; AND
                                                                                                                                            Patient must have had a minimum endoscopic mPDAI sub-score of at least 2 at the time of initiating treatment with this drug for this condition; AND
                                                                                                                                            Patient must have had at least 3 recurrent episodes of pouchitis within the year prior to initiating treatment with this drug for this condition, each of which was treated with at least 2 weeks of antibiotic or 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 24 weeks of treatment under this restriction; AND
                                                                                                                                            The treatment must have been initiated in combination with standard of care antibiotic; AND
                                                                                                                                            Patient must have demonstrated a partial or complete response to treatment with this drug as determined by the treating clinician, for this condition if the patient has received non-PBS-subsidised treatment for the first three doses of induction.
                                                                                                                                            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 assessment of a patient's response to this course of treatment must be made after