Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p153
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 153/476)
Character Range: 1799730–1806113

must include:
                                                                                                                                            (a) a completed authority prescription form; and
                                                                                                                                            (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
                                                                                                                                            (i) the completed Crohn Disease Activity Index (CDAI) Score; or
                                                                                                                                            (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
                                                                                                                                            (iii) the date of the most recent clinical assessment.
                                                                                                                                            All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
                                                                                                                                            Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.
                                                                                                                                            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 within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                                                                                            Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate quantity 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.
                                                                                                                                            If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment 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 continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.
                                                                       C12042                                                               Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 12042
                                                                                                                                            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)]; OR
                                                                                                                                            Must be treated by a paediatrician; OR
                                                                                                                                            Must be treated by a specialist