Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p153
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 153/312)
Character Range: 16421530–16427918

statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
                                                                                                                           In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
                                                                                                                           One of the following must be documented in the patient's medical records regarding prior statin treatment:
                                                                                                                           (i) the patient was 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 of 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
                                                                                                                           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.
C15406              P15406         CN15406          Deucravacitinib                                                        Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 15406
                                                                                                                           Patient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; OR
                                                                                                                           Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; OR
                                                                                                                           Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND
                                                                                                                           The condition must have caused significant interference with quality of life; AND
                                                                                                                           Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) apremilast.
                                                                                                                           Must be treated by a medical practitioner who is either: