Evolocumab Is Cost-Effective Before a First MI or Stroke

Adding evolocumab (Repatha; Amgen) to background lipid-lowering therapy was cost-effective for patients at high cardiovascular risk who have not had a myocardial infarction (MI) or stroke, according to a late-breaking health economic analysis of the phase 3 VESALIUS-CV (NCT03872401) trial presented at the American Heart Association (AHA) Scientific Sessions 2026.^1,2

The analysis, led by the Duke Clinical Research Institute in collaboration with the TIMI Study Group, found the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be cost-effective at approximately 36% below the American College of Cardiology (ACC)/AHA benchmark, according to a press release from Amgen, the company sponsoring the trial.² The release described it as the first independent health economic analysis to use individual participant data from VESALIUS-CV.

Trial Showed Fewer First Cardiovascular Events With Evolocumab

VESALIUS-CV randomly assigned 12,257 patients with atherosclerosis or high-risk diabetes and a low-density lipoprotein cholesterol (LDL-C) level of at least 90 mg/dL to evolocumab or placebo between June 2019 and November 2021. None had a prior MI or stroke. The median patient age was 66 years, and 43% of patients were women. Qualifying atherosclerosis was present in 67% of participants, and 33% had high-risk diabetes without qualifying atherosclerosis.¹

By 5 years, the 3-component end point of coronary heart disease death, MI, or ischemic stroke, 1 of the trial's 2 primary end points, had occurred in 6.2% of the evolocumab group vs 8.0% of the placebo group (HR, 0.75; 95% CI, 0.65-0.86). All-cause mortality, a secondary end point, was 7.9% with evolocumab vs 9.7% with placebo by 5 years (HR, 0.80; 95% CI, 0.70-0.91).

Those primary results were first presented at AHA 2025 and published in The New England Journal of Medicine, where patients received evolocumab 140 mg every 2 weeks or placebo over a median follow-up of 4.6 years.³ Before VESALIUS-CV, the effect of evolocumab on cardiovascular events in patients without a previous MI or stroke was unknown.

How the Cost-Effectiveness Analysis Was Built

The investigators conducted a trial-based, patient-level cost-effectiveness analysis from the US health care sector perspective over a lifetime horizon.¹ Life expectancy was estimated from the trial's survival data using an age-based extrapolation method with a Cox proportional hazards model.

Health care resource use from the start of treatment through the end of follow-up was collected on the trial case report forms. Hospitalization costs were estimated primarily from 2023 National Inpatient Sample data, supplemented with Medicare reimbursement data for outpatient care. Because utility weights were not collected in VESALIUS-CV, the team estimated them from secondary sources. The analysis plan called for costs in 2025 US dollars, a 3% annual discount rate for costs and benefits, and results expressed as cost per life-year and cost per quality-adjusted life-year (QALY), interpreted against ACC/AHA value benchmarks.

Neither the abstract nor the press release disclosed the incremental cost-effectiveness ratio, the drug price used in the model, or the specific dollar threshold behind the benchmark comparison. The 2025 AHA/ACC statement on cost/value methodology defines the US cost-effectiveness threshold as $120,000 per QALY gained.⁴

Access and Pricing Context

Amgen is positioning evolocumab for use earlier in the cardiovascular risk continuum, and the FDA expanded the drug's US indication in August 2025 to include adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C.²

“With more than a decade of clinical research with Repatha and growing evidence supporting earlier LDL-C lowering, no one should have to wait for a first heart attack or stroke to take more aggressive action against cardiovascular risk,” Murdo Gordon, executive vice president of Global Markets and Policy at Amgen, said in a statement. “For high-risk patients with a guideline-recommended LDL-C goal below 55 mg/dL, we need to help make reaching that goal sooner a reality. That means pairing strong clinical data with continued efforts to address barriers to care. We've taken actions to make Repatha more affordable and accessible, and these findings add to the evidence of its benefit to patients.”

References

1. Mark D, Li Y, Chew D, et al. Health economic outcomes in the effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke: a randomized trial. Presented at: AHA Scientific Sessions 2026; November 6-9, 2026; Chicago, IL. Abstract 2026-LBS-27982-AHA.
2. New data at AHA 2026 demonstrates the value of treatment with Repatha earlier in the cardiovascular risk continuum. News release. Amgen. November 9, 2026. Accessed November 9, 2026. https://www.prnewswire.com/news-releases/new-data-at-aha-2026-demonstrates-the-value-of-treatment-with-repatha-earlier-in-the-cardiovascular-risk-continuum-302932775.html
3. Bohula EA, Marston NA, Bhatia AK, et al. Evolocumab in patients without a previous myocardial infarction or stroke. N Engl J Med. 2026;394(2):117-127. doi:10.1056/NEJMoa2514428
4. Kazi DS, Abdullah AR, Arnold SV, et al. 2025 AHA/ACC statement on cost/value methodology in clinical practice guidelines (update from 2014 statement): a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;152(18):e332-e358. doi:10.1161/CIR.0000000000001377