Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p88
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 88/381)
Character Range: 12093672–12102815

this condition.
C11815              P11815         CN11815          Obinutuzumab                                                                                                    Stage II bulky or Stage III/IV follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                    Induction treatment
                                                                                                                                                                    The condition must be CD20 positive; AND
                                                                                                                                                                    The condition must be previously untreated; AND
                                                                                                                                                                    The condition must be symptomatic; AND
                                                                                                                                                                    The treatment must be for induction treatment purposes only; AND
                                                                                                                                                                    The treatment must be in combination with chemotherapy; AND
                                                                                                                                                                    The treatment must not exceed 10 doses for induction treatment with this drug for this condition.
                                                                                                                                                                    A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under
                                                                                                                                                                    i) the previously untreated induction treatment restriction; or
                                                                                                                                                                    ii) the rituximab-refractory re-induction restriction.
C11826              P11826         CN11826          Infliximab                                                                                                      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)]; AND
                                                                                                                                                                    Patient must have received this drug (in any form) 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 infliximab 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 aged 18 years or older.
                                                                                                                                                                    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.
                                                                                                                                                                    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.
                                                                                                                                                                    The patient remains eligible to receive continuing treatment with the