Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p239
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 239/312)
Character Range: 16976700–16981807

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 have been demonstrated prior to initiation of non-PBS subsidised treatment with this biological medicine for this condition:
                                                                                                                           (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and
                                                                                                                           (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
                                                                                                                           The baseline BASDAI score and ESR or CRP level must have been determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. If the above requirement to demonstrate an elevated ESR or CRP could not be met, the application must state the reason this criterion could not be satisfied.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) details of the proposed prescription; and
                                                                                                                           (2) 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 following must be provided at the time of application and documented in the patient's medical records:
                                                                                                                           (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
                                                                                                                           (ii) baseline and current BASDAI scores; and
                                                                                                                           (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
                                                                                                                           (iv) baseline ESR and/or CRP level.
                                                                                                                           An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:
                                                                                                                           (a) an ESR measurement no greater than 25 mm per hour; or
                                                                                                                           (b) a CRP measurement no greater than 10 mg per L; or
                                                                                                                           (c) an ESR or CRP measurement reduced by at least 20% from baseline.
                                                                                                                           Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
                                                                                                                           The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                                           To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the