Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p184
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 184/191)
Character Range: 11326973–11335933

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)]; or
                                                                                                                                                                                                                               Must be treated by a paediatrician; or
                                                                                                                                                                                                                               Must be treated by a specialist paediatric gastroenterologist; AND
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; 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 16 weeks treatment; 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 16 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
C9742               P9742          CN9742           Ciclosporin                                                                                                                                                                Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9742
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or
                                                                                                                                                                                                                               The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND
                                                                                                                                                                                                                               Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist.
C9745               P9745          CN9745           Golimumab                                                                                                                                                                  Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - 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)]; AND
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 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 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 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