Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p98
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 98/312)
Character Range: 16084931–16091698

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 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.
C15118              P15118         CN15118          Fluticasone propionate with salmeterol                                 Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 15118
                                                                                                                           Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
C15124              P15124         CN15124          Acalabrutinib                                                          Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           First line drug treatment of this indication - in