Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p27
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 27/31)
Character Range: 91089–95091

patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
                      Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND
                      The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
                      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)].
   C14802  P14802     Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                      Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                      Patient must have had prior to commencing non-PBS-subsidised treatment: (1) confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; (2) an externally draining enterocutaneous or rectovaginal fistula; AND
                      Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2024; AND
                      Patient must be receiving treatment with this drug for this condition at the time of application; AND
                      Patient must have demonstrated an adequate response to treatment with this drug for this condition if received at least 12 weeks of initial non-PBS-subsidised therapy.
                      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 authority application must be made in writing and must include:
                      (1) a completed authority prescription form; and
                      (2) 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:
                      (i) the completed baseline Fistula Assessment Form prior to initiating treatment including the date of assessment;
                      (ii) the completed current Fistula Assessment Form including the date of assessment demonstrating the patient's adequate response to treatment if the patient has received at least 12 weeks of treatment.
                      An adequate response is defined as:
                      (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
                      (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
                      At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is