Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p143
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 143/476)
Character Range: 1740706–1748239

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 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.
                                                                       C9751                                                                Moderate to severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                            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)]; OR
                                                                                                                                            Must be treated by a paediatrician; OR
                                                                                                                                            Must be treated by a specialist paediatric gastroenterologist.
                                                                                                                                            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, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND
                                                                                                                                            The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
                                                                                                                                            Patient must be aged 6 to 17 years inclusive.
                                                                                                                                            Application for authorisation must be made in writing and must include:
                                                                                                                                            (a) a completed authority prescription form; and
                                                                                                                                            (b) a completed Paediatric Crohn Disease PBS Authority Application ‑Supporting Information Form which includes the following:
                                                                                                                                            (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
                                                                                                                                            (ii) details of prior biological medicine treatment including details of