Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p44
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 44/312)
Character Range: 15713943–15719065

have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                    Golimumab                                                              The condition must be either radiologically (plain X-ray) confirmed:
                                                                                                                            (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
                                                    Ixekizumab                                                             Patient must have at least 2 of the following:
                                                                                                                            (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
                                                    Secukinumab                                                            Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
                                                                                                                           Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or
                                                    Tofacitinib                                                            Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or
                                                                                                                           Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
                                                    Upadacitinib                                                           Patient must not receive more than 16 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 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 following must be provided at the time of application and documented in the patient's medical records
                                                                                                                           (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
                                                                                                                           (ii) a baseline BASDAI score; and
                                                                                                                           (iii) a baseline ESR and/or CRP level.
                                                                                                                           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