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Low-density lipoprotein cholesterol lowering and out-of-pocket cost of inclisiran therapy in the United States

Year: 2026
Type: article
Study design: Observational Study
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.
Language: English
Subfield: Surgery
Field: Medicine
Open Access status: hybrid
Estimated APC paid: $3,510
Award: G200894337
OpenAlex ID: W7129105362
FWCI: 6.412
Cites: 20
Cited by: 1
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