Document ID: chunk:federal_register_of_legislation:F2024L01736:schedule:1:p4
Version: federal_register_of_legislation:F2024L01736
Segment Type: schedule
Provision Reference: sch 1 (pt 4/6)
Character Range: 12172–15799

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.

          1.            omit entry for Circumstances Code "C16217" and substitute:
   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