Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p46
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 46/51)
Character Range: 170426–174980

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.
C16352  P16352  CN16352  Inclisiran             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 16352
                                                Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2024; AND
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                The condition must have been confirmed by genetic testing prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6 prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have had an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease at the time non-PBS-subsidised treatment with this drug for this condition was initiated; OR
                                                Patient must have had an LDL cholesterol level in excess of 5 millimoles per litre at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
                                                Patient must have been treated with the maximum recommended dose of