Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p127
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 127/161)
Character Range: 14478321–14483764

sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                   The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                   The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
                                                                                   Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                   Patient must be at least 18 years of age.
                                                                                   Active joints are defined as
                                                                                   (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                   (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                   All measurements must be no more than 4 weeks old at the time of this application.
                                                                                   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).
                                                                                   To demonstrate a response to treatment the application 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 biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                   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.
                                                                                   If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C13602              P13602         CN13602          Adalimumab                     Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                   Initial treatment - Initial 1 (new 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)];
                                                                                   Patient must be at least 18 years of age;
                                                                                   Patient must have confirmed severe