Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p466
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 466/476)
Character Range: 3813093–3820572

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.
                                                                                                                                            Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                       C16169                                                               Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                            Balance of Supply - Initial 1 treatment (new patient) and Initial 2 treatment (recommencement of treatment after a break in biological medicine)
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Initial 1 treatment (new patient) restriction to complete 14 weeks of treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Initial 2 treatment (recommencement of treatment after a break in biological medicine) to complete 14 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 14 weeks treatment available under the above treatment phases.
                                                                                                                                            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)].
                                                                       C16181                                                               Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received this drug as their most recent course of PBS-subsidised biological medicine for this condition; AND
                                                                                                                                            Patient must have demonstrated or sustained a partial or complete response, as determined by the treating clinician, to the most recent PBS-subsidised course of treatment with this drug for this condition.
                                                                                                                                            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)].
                                                                                                                                            Patients who have failed to demonstrate a partial or complete response with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
                                                                                                                                            Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                                                            An application for the continuing treatment must be made following the third dose with this drug and requested 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 an application is not made within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this