Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p75
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 75/381)
Character Range: 12005031–12011743

paediatric patient
                                                                                                                                                                    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; 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 16 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 first continuing treatment or subsequent continuing treatment; AND
                                                                                                                                                                    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.
C11715              P11715         CN11715          Adalimumab                                                                                                      Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 1 (new patient)
                                                                                                                                                                    Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
                                                                                                                                                                    Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including:
                                                                                                                                                                     (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or
                                                                                                                                                                    Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
                                                                                                                                                                    Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal