Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p148
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 148/476)
Character Range: 1773038–1779545

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 measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
                                                                       C9803                                                                Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                            Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)
                                                                                                                                            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 prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                            Patient must not have failed PBS‑subsidised therapy with this drug for this condition more than once in the current treatment cycle.
                                                                                                                                            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 the following:
                                                                                                                                            (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
                                                                                                                                            (ii) details of prior biological medicine treatment including details of date and duration of treatment.
                                                                                                                                            The most recent fistula assessment must be no more than 1 month old at the time of application.
                                                                                                                                            Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
                                                                                                                                            To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
                                                                                                                                            If the response assessment