Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p76
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 76/381)
Character Range: 12011301–12018298

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 to 40 preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment and which is no more than 4 weeks old at the time of application; AND
                                                                                                                                                                    Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                    Patient must be aged 6 to 17 years inclusive;
                                                                                                                                                                    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.
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (1) two completed authority prescription forms; and
                                                                                                                                                                    (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                                                    If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website (www.servicesaustralia.gov.au).
                                                                                                                                                                    An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                                                                                                                                    Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have 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.
C11716              P11716         CN11716          Adalimumab                                                                                                      Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                                                                    Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                    Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                                                    Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis