Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p27
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 27/51)
Character Range: 90304–95738

treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
                                                (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
                                                (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.
                                                One or more of the following must be documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:
                                                (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or
                                                (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or
                                                (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or
                                                (iv) diabetes mellitus with microalbuminuria; or
                                                (v) diabetes mellitus and age 60 years or more; or
                                                (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or
                                                (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher.
                                                A patient may qualify for PBS-subsidised treatment under this restriction once only.
                                                For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
                                                Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.
C16315  P16315  CN16315  Dimethyl fumarate      Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16315
                         Diroximel fumarate     Continuing treatment
                         Teriflunomide          The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
                                                The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must not show continuing progression of disability while on treatment with this drug.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
                                                Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C16317  P16317  CN16317  Osilodrostat           Endogenous Cushing's syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                Continuing treatment
                                                Patient must have received PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have demonstrated a complete response after at least 26