Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p185
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 185/191)
Character Range: 11335479–11345548

14 weeks of treatment (weeks 0, 2, 6 and 10); 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 14 weeks of treatment (weeks 0, 2, 6 and 10); AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment.
C9762               P9762          CN9762           Lanthanum                                                                                                                                                                  Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9762
                                                                                                                                                                                                                               Initiation and stabilisation
                                                    Sevelamer                                                                                                                                                                  The condition must not be adequately controlled by calcium; AND
                                                                                                                                                                                                                               Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or
                                                    Sucroferric oxyhydroxide                                                                                                                                                   The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
                                                                                                                                                                                                                               The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND
                                                                                                                                                                                                                               Patient must be undergoing dialysis for chronic kidney disease.
C9764               P9764          CN9764           Ciclosporin                                                                                                                                                                Management of transplant rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9764
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               Patient must have had an organ or tissue transplantation; AND
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit.
C9770               P9770          CN9770           Golimumab                                                                                                                                                                  Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               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 previously received PBS-subsidised treatment with this drug for this condition; 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;
                                                                                                                                                                                                                               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