Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p262
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 262/312)
Character Range: 17108027–17114122

medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
                                                                                                                           Up to a maximum of 5 repeats will be authorised.
                                                                                                                           If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone or electronically via the Online PBS Authorities system and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will immediate assessment approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.
C15943              P15943         CN15943          Vedolizumab                                                            Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                           Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
                                                                                                                           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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; OR
                                                                                                                           Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction; AND
                                                                                                                           Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
                                                                                                                           Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                                           At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
                                                                                                                           Up to a maximum of 5 repeats will be authorised.
                                                                                                                           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 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 a response assessment is not conducted within the