Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p261
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 261/312)
Character Range: 17103713–17108514

(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; OR
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Applications for authorisation must be made in writing and must include:
                                                                                                                           (a) details of the proposed prescription; 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 following a minimum of 12 weeks of therapy with this drug and submitted 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.
                                                                                                                           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.
                                                                                                                           Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
                                                                                                                           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.
                                                                                                                           Up to a maximum of 5 repeats will be authorised.
                                                                                                                           If fewer than 5 repeats are requested at the time of the application, authority