Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p458
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 458/476)
Character Range: 3775472–3781684

in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                       C15909                                                               Moderate to severe ulcerative colitis
                                                                                                                                            Balance of supply
                                                                                                                                            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 received insufficient therapy with this drug for this condition under the Initial 1 (new patient) 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 Initial 2 (change or recommencement of treatment after a break in biological medicine of less 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 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 3 doses 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.
                                                                       C15910                                                               Moderate to severe ulcerative colitis
                                                                                                                                            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)].
                                                                                                                                            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.
                                                                                                                                            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 if relevant; and
                                                                                                                                            (ii) the details of prior biological medicine treatment including the