Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p107
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 107/381)
Character Range: 12213419–12218760

is an ostomy patient; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    Applications for authorisation must be made in writing and 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 calculation sheet including the date of the assessment of the patient's condition, if relevant; 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 clinical assessment.
                                                                                                                                                                    An application for the continuing treatment must be accompanied with the assessment of response conducted up to 12 weeks of therapy and no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                    The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed within 4 weeks prior to completing their current course of treatment.
                                                                                                                                                                    Where a response assessment is not conducted within the required 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.
                                                                                                                                                                    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.
                                                                                                                                                                    At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
                                                                                                                                                                    If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone or electronically via the Online PBS Authorities system and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will immediate assessment approvals