Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p147
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 147/476)
Character Range: 1766520–1773408

received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have demonstrated an adequate response to treatment with this drug.
                                                                                                                                            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:
                                                                                                                                            (a) a completed authority prescription form; and
                                                                                                                                            (b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form 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 1 month old at the time of application.
                                                                                                                                            The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
                                                                                                                                            Where a response assessment is not provided within this 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.
                                                                                                                                            A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
                                                                                                                                            Up to a maximum of 2 repeats will be authorised.
                                                                       C9787                                                                Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 9787
                                                                                                                                            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)].
                                                                                                                                            Patient must have received this drug as their most recent course of PBS‑subsidised biological agent treatment for this condition in this treatment cycle; AND
                                                                                                                                            Patient must have demonstrated an adequate response to treatment with this drug.
                                                                                                                                            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