Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p93
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 93/312)
Character Range: 16056428–16061784

back pain and stiffness for 3 or more months that is relieved by exercise but not rest; 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; AND
                                                                                                                           Patient must have one or more of the following:
                                                                                                                            (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND
                                                                                                                           The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND
                                                                                                                           The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND
                                                                                                                           The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND
                                                                                                                           The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND
                                                                                                                           The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND
                                                                                                                           The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND
                                                                                                                           Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.
                                                                                                                           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 and must be demonstrated at the time of the initial application
                                                                                                                           (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and
                                                                                                                           (b) C-reactive protein (CRP) level greater than 10 mg per L.
                                                                                                                           The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.
                                                                                                                           If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher