Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p101
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 101/312)
Character Range: 16102607–16109090

time of application and documented in the patient's medical records
                                                                                                                           (a) the BASDAI score; and
                                                                                                                           (b) the C-reactive protein (CRP) level.
C15127              P15127         CN15127          Secukinumab                                                            Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (New patient)
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have had chronic lower 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
                                                                                                                           Patient must not receive more than 20 weeks of treatment 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 stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.
                                                                                                                           State in the application whether a loading dose regimen is intended or not.
                                                                                                                           Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.
                                                                                                                           Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.
                                                                                                                           The application must include details of the NSAIDs trialled, their doses and duration of treatment.
                                                                                                                           If