Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p94
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 94/312)
Character Range: 16061435–16067746

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 daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
                                                                                                                           The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (a) a completed authority prescription form(s); and
                                                                                                                           (b) 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 baseline BASDAI score and CRP level must also be documented in the patient's medical records.
C15103              P15103         CN15103          Certolizumab pegol                                                     Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           Patient must have received prior 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 had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND
                                                                                                                           Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise