Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p237
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 237/312)
Character Range: 16964170–16971326

treatment restriction.
C15889              P15889         CN15889          Icosapent ethyl                                                        Established atherosclerotic cardiovascular disease with hypertriglyceridaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 15889
                                                                                                                           Initial treatment
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           Patient must have at least one of (i) coronary artery disease, (ii) cerebrovascular or carotid disease, (iii) peripheral arterial disease; AND
                                                                                                                           Patient must be treated with a stable dose of a HMG CoA reductase inhibitor (statin) to achieve target secondary prevention LDL-c levels for at least 12 consecutive weeks; OR
                                                                                                                           Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment; OR
                                                                                                                           Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
                                                                                                                           Patient must have LDL cholesterol level between 1.0 millimoles per litre and 2.6 millimoles per litre; OR
                                                                                                                           Patient must have a non-HDL cholesterol between 1.5 millimoles per litre and 3.5 millimoles per litre if LDL cannot be measured/detected; AND
                                                                                                                           Patient must have fasting triglyceride level between 1.7 millimoles per litre and 5.6 millimoles per litre.
                                                                                                                           The qualifying fasting triglyceride level and LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, dietary therapy and exercise should be documented in the patient's medical records and must be no more than 8 weeks old.
                                                                                                                           A clinically important product-related adverse event is defined as follows:
                                                                                                                           (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
                                                                                                                           (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
                                                                                                                           (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
                                                                                                                           Atherosclerotic cardiovascular disease is defined as:
                                                                                                                           (i) Documented coronary artery disease (CAD); one or more of the following primary criteria must have been satisfied:
                                                                                                                           a) Documented multi-vessel CAD (at least 50% stenosis in at least two major epicardial coronary arteries, with or without antecedent revascularisation).
                                                                                                                           b) Documented prior MI.
                                                                                                                           c) Hospitalisation for high-risk non-ST-segment elevation acute coronary syndrome, with objective evidence of ischemia: ST-segment deviation or biomarker positivity.
                                                                                                                           (ii) Documented cerebrovascular or carotid disease; one of the following primary criteria must have been satisfied:
                                                                                                                           a) Documented prior ischemic stroke.
                                                                                                                           b) Symptomatic carotid artery disease with at least 50% carotid arterial stenosis.
                                                                                                                           c) Asymptomatic carotid artery disease with at least 70% carotid arterial stenosis per angiography or duplex ultrasound.
                                                                                                                           d) History of carotid revascularisation (catheter-based or surgical).
                                                                                                                           (iii) Documented peripheral arterial disease; one or more of the following primary criteria