Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p91
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 91/312)
Character Range: 16042917–16049211

(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 duration 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 following must be provided at the time of application and documented in the patient's medical records
                                                                                                                           (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 BASDAI score and CRP level must be no more than 4 weeks old at the time of this 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.
C15085              P15085         CN15085          Tebentafusp                                                            Advanced (unresectable or metastatic) uveal melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 15085
                                                                                                                           Continuing treatment
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; or
                                                                                                                           Patient must have previously received inpatient treatment with this drug for this condition in the public hospital setting; AND
                                                                                                                           Patient must not receive PBS-subsidised treatment with this drug for this condition if it is no longer determined to be clinically beneficial by the treating clinician.
                                                                                                                           According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the