Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p142
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 142/381)
Character Range: 12447233–12454851

specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                    Patient must have 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; AND
                                                                                                                                                                    Patient must have an externally draining enterocutaneous or rectovaginal fistula.
                                                                                                                                                                    Applications for authorisation must be made in writing and must include
                                                                                                                                                                    (1) two completed authority prescription forms; 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 a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application.
                                                                                                                                                                    A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
                                                                                                                                                                    An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                                                                                                                                    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, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
C12148              P12148         CN12148          Adalimumab                                                                                                      Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                    Subsequent continuing treatment
                                                                                                                                                                    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)]; AND
                                                                                                                                                                    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 for this condition.
                                                                                                                                                                    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.
                                                                                                                                                                    Applications for authorisation 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 a completed Fistula Assessment form including the date of the assessment of the patient's condition.
                                                                                                                                                                    The most recent fistula assessment must be no more than 4 weeks old at the time of application.
                                                                                                                                                                    An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of