Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p224
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 224/312)
Character Range: 16893351–16898904

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.
                                                                                                                           If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
                                                                                                                           If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
                                                                                                                           A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
C15853              P15853         CN15853          Etrasimod                                                              Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements
                                                                                                                           Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2024; AND
                                                                                                                           Patient must be receiving treatment with this drug for this condition at the time of application; AND
                                                                                                                           The condition must have responded inadequately to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for at least 3 consecutive months prior to treatment initiation with this drug; OR
                                                                                                                           Patient must have experienced a severe intolerance to the above therapy leading to permanent treatment discontinuation; AND
                                                                                                                           The condition must have responded inadequately to azathioprine at a dose of at least 2 mg per kg daily for at least 3 consecutive months prior to treatment initiation with this drug; OR
                                                                                                                           The condition must have responded inadequately to 6-mercaptopurine at a dose of at least 1 mg per kg daily for at least 3 consecutive months prior to treatment initiation with this drug; OR
                                                                                                                           The condition must have responded inadequately to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period, followed by an inadequate response to at least 3 consecutive months of treatment with an appropriately dosed thiopurine agent, prior to treatment initiation with this drug; OR
                                                                                                                           Patient must have experienced a severe intolerance to each of the above 3 therapies leading to permanent treatment discontinuation; AND
                                                                                                                           Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing non-PBS-subsidised treatment with this drug