Abstract Body (Do not enter title and authors here): Introduction: Inclisiran is a novel small interfering RNA indicated to reduce LDL-C as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). It is administered subcutaneously initially, again at 3 months, and then every six months by an HCP. Subsequent doses may be administered within three months after the scheduled dose without restarting a new dose schedule. Few studies have investigated out of pocket (OOP) costs for patients receiving inclisiran. Metro Infusion Center (MIC) is one of the largest infusion centers across the US with over 200 centers in 38 states.
Objective: To describe the real-world changes in LDL-C levels and OOP costs associated with inclisiran use at MICs.
Methods: Patient charts for those who initiated inclisiran between March 1, 2022 and November 30, 2022 and who received ≥2 doses were reviewed retrospectively. Patient characteristics at initiation were collected and patients were followed until February 2024. Study outcomes included changes in LDL-C levels from baseline and OOP cost by payer type. The incidence of adverse events (AEs) was extracted from the chart if documented.
Results: A total of 534 patients who initiated inclisiran received ≥2 doses. Mean (SD) age was 70.2 (10.3) years and 50% were male. The majority of patients (81%) were covered by Medicare. A total of 479 (90%) patients had a history of ASCVD and 55 (10%) had HeFH. Prior PCSK9i use was reported in 35% of patients, and 54% had concurrent statin therapy. Among 274 patients with LDL-C measurements, mean (SD) baseline LDL-C was 147.2 (59.7) mg/dL. After initiating inclisiran, the average reduction in LDL-C from baseline was 47%. The average OOP costs for the initial dose was $37 ($0-$2950) for Medicare insured patients and $115 ($0-$1300) for patients covered by commercial insurance. Among patients insured by Medicare, 96% paid $0 OOP for both doses. A total of 24 (4%) patients reported an AE, and half discontinued treatment. The most commonly reported AEs were muscle weakness and joint pain in 5 patients.
Conclusion: These real-world data demonstrate significant LDL-C reductions within 1 year in patients who initiated inclisiran, which is consistent with the ORION clinical development program. Most patients were covered by Medicare, nearly all of whom had $0 for OOP costs compared with average costs of $115 for initial dose for commercially insured patients.