Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p23
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 23/162)
Character Range: 14778300–14784113

ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy
C14011              P14011         CN14011          Upadacitinib                                         Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         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)]; AND
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
                                                                                                         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 sufficient quantity for up to 24 weeks of treatment under this restriction.
                                                                                                         An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course 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.
                                                                                                         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.
C14014              P14014         CN14014          Upadacitinib                                         Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological