Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p238
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 238/312)
Character Range: 16970656–16977086

arterial stenosis.
                                                                                                                           c) Asymptomatic carotid artery disease with at least 70% carotid arterial stenosis per angiography or duplex ultrasound.
                                                                                                                           d) History of carotid revascularisation (catheter-based or surgical).
                                                                                                                           (iii) Documented peripheral arterial disease; one or more of the following primary criteria must have been satisfied:
                                                                                                                           a) Ankle brachial index (ABI) less than 0.9 with symptoms of intermittent claudication.
                                                                                                                           b) History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical).
C15890              P15890         CN15890          Bimekizumab                                                            Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                           The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2024; AND
                                                                                                                           Patient must have had at least 2 of the following prior to commencing non-PBS-subsidised treatment with this drug for this condition: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
                                                                                                                           Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months prior to commencing non-PBS-subsidised treatment; AND
                                                                                                                           Patient must have demonstrated an adequate response after 16 weeks of treatment if the patient has been treated with this drug for this condition for 16 weeks or longer; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Must be treated by a rheumatologist; OR
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
                                                                                                                           The application must include details of the NSAIDs trialled, their doses and duration of treatment.
                                                                                                                           If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
                                                                                                                           If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
                                                                                                                           If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
                                                                                                                           The following criteria indicate failure to achieve an adequate response to NSAIDs