Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p180
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 180/191)
Character Range: 11301068–11308238

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 to the Department of Human Services 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 the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                                                                                                               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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                                                                               Details of the accepted toxicities including severity can be found on the Department of Human Services website.
C9710               P9710          CN9710           Ustekinumab                                                                                                                                                                Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient)
                                                                                                                                                                                                                               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)];
                                                                                                                                                                                                                               Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
                                                                                                                                                                                                                               Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
                                                                                                                                                                                                                               Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or
                                                                                                                                                                                                                               Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or
                                                                                                                                                                                                                               Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
                                                                                                                                                                                                                               The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND
                                                                                                                                                                                                                               Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy.  or
                                                                                                                                                                                                                               Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy