Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p139
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 139/476)
Character Range: 1714715–1722568

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 old at the time of prescribing.
                                                                                                                                            The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.
                                                                                                                                            Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
                                                                       C9669                                                                Moderate to severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Balance of supply for paediatric patient
                                                                                                                                            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 first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 14 weeks 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.
                                                                       C9677                                                                Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                            Subsequent continuing