Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p78
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 78/381)
Character Range: 12024370–12032248

PCDAI
                                                                                                                                                                    Patient must have a documented history of severe Crohn disease; AND
                                                                                                                                                                    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 40 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;
                                                                                                                                                                    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) a completed authority prescription form; 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).
                                                                                                                                                                    The PCDAI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                                                                    An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised 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.
                                                                                                                                                                    Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
                                                                                                                                                                    Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.
C11718              P11718         CN11718          Adalimumab                                                                                                      Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 11718
                                                                                                                                                                    Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
                                                                                                                                                                    Patient must have a documented history of severe Crohn disease; AND
                                                                                                                                                                    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