Cost-effectiveness of bempedoic acid in high cardiovascular risk patients with statin intolerance: an analysis of the CLEAR outcomes trial
File(s)
Published version
Author(s)
Type
Journal Article
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).
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).
Date Issued
2026-01-01
Date Acceptance
2025-07-14
Citation
American Journal of Cardiovascular Drugs, 2026, 26 (1), pp.59-70
ISSN
1175-3277
Publisher
Springer
Start Page
59
End Page
70
Journal / Book Title
American Journal of Cardiovascular Drugs
Volume
26
Issue
1
Copyright Statement
© The Author(s) 2025 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/40833562
PII: 10.1007/s40256-025-00753-w
Subjects
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
EVENTS
Life Sciences & Biomedicine
Pharmacology & Pharmacy
Science & Technology
THERAPY
Publication Status
Published
Coverage Spatial
New Zealand
Date Publish Online
2025-08-20