Cited by 5Lipoproteins and Cardiovascular HealthHealth Systems, Economic Evaluations, Quality of LifePharmaceutical Economics and Policy

Cost-Effectiveness of Bempedoic Acid in High Cardiovascular Risk Patients with Statin Intolerance: An Analysis of the CLEAR Outcomes Trial

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Nicholls, Stephen J., Ray, Kausik K., Lincoff, A. Michael, Sarnes, Evelyn, Gillard, Kristin K., Bloedon, LeAnne, Migliaccio-Walle, Kristen, Elsea, David +1 more·2026·American Journal of Cardiovascular Drugs

Abstract

BACKGROUND: In the CLEAR Outcomes study, 13,970 high cardiovascular risk patients with hypercholesterolemia and statin intolerance were randomized to treatment with bempedoic acid or standard of care (placebo). Bempedoic acid reduced the risk of major adverse cardiovascular events by 13%. However, the cost-effectiveness of bempedoic acid in this patient population is unknown. METHODS: Markov modeling estimated cost-effectiveness of bempedoic acid versus standard of care alone to reduce cardiovascular risk from a US third-party payer perspective. Baseline risk was estimated by applying individual patient characteristics from the trial to established risk equations. Treatment benefit was extrapolated over a lifetime horizon using hazard ratios for individual major adverse cardiovascular event (MACE) components from CLEAR Outcomes. Scenario analyses included on-treatment analysis, alternate bempedoic acid costs, and modeling effects of the fixed-dose combination with ezetimibe on low-density lipoprotein cholesterol (LDL-C) reduction and predicted MACE. RESULTS: Bempedoic acid was estimated to reduce lifetime MACE (1.58 versus 1.95 per patient) versus standard of care. At list price, bempedoic acid was associated with increased costs (+ $22,600) and improved quality-adjusted life-years (QALYs, + 0.14), resulting in an incremental cost-effectiveness ratio (ICER) of $166,830 per QALY. The on-treatment analysis resulted in an ICER of $70,279 per QALY. Reduction in bempedoic acid price by 25% resulted in lower incremental total costs and an ICER of $99,993 per QALY. Modeling the effects of the fixed-dose combination resulted in an ICER of $40,317 per QALY. CONCLUSIONS: Use of bempedoic acid offers improved lifetime cardiovascular (CV) risk reduction over standard of care in patients with or at high risk for CV disease (CVD) at common cost-effectiveness thresholds ($150,000 per QALY). TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02993406 (CLEAR Outcomes study).

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  • Bempedoic acid has also been shown to provide improved lifetime cardiovascular risk reduction compared with standard of care at common cost-effectiveness thresholds ($150,000 per QALY), with additional value when combined with ezetimibe ($40,000 per QALY), and in those with statin-intolerance or those with heterozygous familial hypercholesterolemia.

    “Further, bempedoic acid has also been shown to provide improved lifetime cardiovascular risk reduction compared with standard of care at common cost-effectiveness thresholds ($150,000 per QALY), with additional value when combined with ezetimibe ($40,000 per QALY), and in those with statin-intolerance or those with heterozygous familial hypercholesterolemia [47].”

    From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [47]

    The Abstract Results and Conclusions report improved lifetime cardiovascular outcomes versus standard care and a modeled $40,317-per-QALY estimate for the ezetimibe combination. But the list-price estimate was $166,830 per QALY—above the $150,000 threshold—and the Discussion says discounted prices fell below it. The analysis concerns patients with statin intolerance; heterozygous familial hypercholesterolemia appears in a cited report’s title, not as a population evaluated in this paper. (LLM, conf=0.90)

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Research works printed but not linked: 3

  1. [18]Lin GA, Kazi DS, Jih J, Agboola F, Chapman R, Pearson SD. Inclisiran and bempedoic acid for patients with heterozygous familial hypercholesterolemia and for secondary prevention of ascvd: effectiveness and value; evidence report. Institute for Clinical and Economic Review. 2021. https://icer.org/assessment/high-cholesterol-2021/#timeline
  2. [32]Ollendorf D, et al. Additive therapies for cardiovascular disease: effectiveness and value. Boston: Institute for Clinical and Economic Review; 2019.
  3. [42]Pearson SD, et al. Assessment of barriers to fair access. Boston: Institute for Clinical and Economic Review; 2023.

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Authors
Nicholls, S. J., Ray, K. K., Lincoff, A. M., Sarnes, E., Gillard, K. K., Bloedon, L., Migliaccio-Walle, K., Elsea, D., & Nissen, S. E.
Affiliations
  • Monash University (AU)
  • Imperial College London (GB)
  • Cleveland Clinic (US)
  • Esperion Therapeutics (United States) (US)
Corresponding author
Nicholls, Stephen J.
Venue
American Journal of Cardiovascular Drugs
Published
2025-08-20
Volume
26
Issue
1
Pages
59-70
ISSN
  • 1175-3277 (ISSN-L)
  • 1179-187X
OpenAlex
W4413357189
Cited by
4
References
45
Citations by year
2026: 3 · 2025: 1
FWCI
3.76
Type
journal article
Language
en
Open access
Locations
  • American Journal of Cardiovascular Drugs (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion, cc-by-nc)
  • Spiral (Imperial College London) (submittedVersion, cc-by-nc)
Funders
  • Esperion Therapeutics
  • Monash University
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Keywords
bempedoic acid, cost-effectiveness, statin intolerance, hypercholesterolemia, major adverse cardiovascular events, LDL cholesterol lowering, quality-adjusted life years, incremental cost-effectiveness ratio, high cardiovascular risk patients, drug pricing
MeSH terms
Ezetimibe, Heart Disease Risk Factors, Aged, Anticholesteremic Agents, Cardiovascular Diseases, Cost-Benefit Analysis, Dicarboxylic Acids, Fatty Acids, Female, Humans, Hypercholesterolemia, Cholesterol, LDL, Male, Markov Chains, Middle Aged, Quality-Adjusted Life Years, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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