Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p142
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 142/312)
Character Range: 16359954–16366038

form baseline measurements upon which the extent of response to treatment is to be considered under the Continuing treatment listing.
                                                                                                                           The observations of continuous sleep/sleep latency may be based on any of the following, including a mix of: patient self-reporting, parental observation, documented medical history, sleep studies conducted by health professionals.
C15338              P15338         CN15338          Inclisiran                                                             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                           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
                                                                                                                           Patient must have had symptomatic atherosclerotic cardiovascular disease 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 prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have had atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories) prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have had severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have had diabetes mellitus with microalbuminuria prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have had diabetes mellitus and be aged 60 years of more prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus that was present prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have had a Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention of 4 or higher prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have developed a clinically important product-related adverse event necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must be contraindicated to