Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p28
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 28/31)
Character Range: 94817–98868

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 every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks. No repeats will be authorised for patients transitioning from non-PBS-subsidised to PBS-subsidised treatment who have only received the first infusion of ustekinumab.
                      The most recent fistula assessment must be no more than 1 month old at the time of application.
   C14806  P14806     Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                      Continuing treatment
                      Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                      Patient must have demonstrated an adequate response to treatment with this drug.
                      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).
                      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.
                      The most recent fistula assessment must be no more than 1 month old at the time of application.
                      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 every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.

     [112]           Schedule 4, Part 1, entry for Venetoclax
         (a)           omit:
   C14325        Chronic lymphocytic leukaemia (CLL)                                                                                                                                                                                                 Compliance with Authority Required procedures
                 Dose titration occurring at the start of treatment for relapsed/refractory disease
                 The condition must have relapsed or be refractory to at least one prior therapy; AND
                 The treatment must be the sole PBS-subsidised therapy for this condition; AND
                 The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.
                 Patient must not be undergoing retreatment with this drug where prior, active treatment