Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p454
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 454/476)
Character Range: 3756634–3762476

have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.
                                                                       C15844                                                               Moderate to severe ulcerative colitis
                                                                                                                                            Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more 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)].
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have had a break in treatment 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 at least 18 years of age.
                                                                                                                                            Application for authorisation must be made in writing and must include:
                                                                                                                                            (a) details of the proposed prescription; 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 quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
                                                                                                                                            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