J Clin Lipidol. 2026 Feb 16:S1933-2874(26)00043-7. doi: 10.1016/j.jacl.2026.02.010. Online ahead of print.
ABSTRACT
BACKGROUND: Inclisiran is approved to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). Cost-related nonadherence remains a significant challenge underlying the use and optimization of lipid-lowering therapies.
OBJECTIVE: To describe the real-world changes in LDL-C levels and the out-of-pocket (OOP) costs associated with inclisiran in patients initiating treatment in infusion centers.
METHODS: This retrospective, observational study reviewed electronic medical records of patients with a history of atherosclerotic cardiovascular disease or HeFH initiating inclisiran treatment between March 1, 2022, and November 30, 2022; patients were followed up until February 2024. Study outcomes included changes in LDL-C levels from baseline, OOP cost by payer type, and adverse events (AEs), if documented.
RESULTS: Among 562 patients included in this analysis, the mean (SD) age at index was 70.6 (9.6) years, and 50.9% of patients were male. Most patients (80.2%) were covered by Medicare. In 274 patients with LDL-C measurements, mean (SD) baseline LDL-C was 147.2 (59.7) mg/dL. The average percent reduction from mean baseline LDL-C to mean follow-up was 51%. The median (IQR) OOP costs for the initial dose were $0 ($0-$0) for Medicare-insured patients and $0 ($0-$95) for patients covered by commercial insurance. Of patients insured by Medicare, 96% paid $0 OOP for both doses. AEs were reported by 24 patients (4%), of whom 12 (50%) discontinued treatment.
CONCLUSION: These real-world data demonstrate significant LDL-C reductions within 1 year in patients who initiated inclisiran. Nearly all patients with Medicare had no OOP costs.
PMID:41794574 | DOI:10.1016/j.jacl.2026.02.010