Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p145
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 145/476)
Character Range: 1751629–1759819

failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                       C9754                                                                Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            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)]; OR
                                                                                                                                            Must be treated by a paediatrician; OR
                                                                                                                                            Must be treated by a specialist paediatric gastroenterologist.
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); 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 the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); 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 the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; OR
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.
                                                                       C9775                                                                Moderate to severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9775
                                                                                                                                            Subsequent 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)]; OR
                                                                                                                                            Must be treated by a paediatrician; OR
                                                                                                                                            Must be treated by a specialist paediatric gastroenterologist.
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                            Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
                                                                                                                                            Patient must have a total PCDAI score of 30 points or less; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                                            Patient must be aged 6 to 17 years inclusive.
                                                                                                                                            The PCDAI assessment must be no more than 1 month