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

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.