Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p19
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 19/162)
Character Range: 14758295–14763679

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.
C14003              P14003         CN14003          Ozanimod                                             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 medicine of less than 5 years)
                                                                                                         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 received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                         Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         The authority application must be made in writing and must include
                                                                                                         (1) a completed authority prescription form; and
                                                                                                         (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes
                                                                                                         (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition;