Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p469
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 469/476)
Character Range: 3833773–3841637

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 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.
                                                                                                                                            The application for authorisation of 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 drug therapy for the condition [dosage, date of commencement and duration of therapy]; and
                                                                                                                                            (iii) the date of commencement of this drug for this condition.
                                                                                                                                            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 initiation with non-PBS-subsidised treatment with this drug.
                                                                                                                                            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.
                                                                       C16239                                                               Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                            Initial 2 treatment (Recommencement of treatment after a break in biological medicine)
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition; 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.