Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p179
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 179/191)
Character Range: 11295220–11301295

of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                                                                                                               Patient must have a Mayo clinic score greater than or equal to 6; or
                                                                                                                                                                                                                               Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score);
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               Application for authorisation must be made in writing and must include
                                                                                                                                                                                                                               (a) a completed authority prescription form; and
                                                                                                                                                                                                                               (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following
                                                                                                                                                                                                                               (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
                                                                                                                                                                                                                               (ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
                                                                                                                                                                                                                               A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.
                                                                                                                                                                                                                               All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
                                                                                                                                                                                                                               The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
                                                                                                                                                                                                                               A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
                                                                                                                                                                                                                               An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
                                                                                                                                                                                                                               Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
                                                                                                                                                                                                                               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 to the Department of Human Services no later than 4 weeks from the date of