Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p183
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 183/476)
Character Range: 1958801–1963835

kg daily for 3 or more months, or, 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
                                                                                                                                            Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra‑indication to each of prednisolone (or equivalent), azathioprine, 6‑mercaptopurine and methotrexate; AND
                                                                                                                                            Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment; 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) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and
                                                                                                                                            (ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
                                                                                                                                            The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose.
                                                                                                                                            If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
                                                                                                                                            If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
                                                                                                                                            Details of the accepted toxicities including severity can be found on the Department of Human Services website.
                                                                                                                                            A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
                                                                                                                                            If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
                                                                                                                                            A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the