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

IF 3 4区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

American Journal of Cardiovascular Drugs Pub Date : 2025-08-20 DOI:10.1007/s40256-025-00753-w

Stephen J Nicholls, Kausik K Ray, A Michael Lincoff, Evelyn Sarnes, Kristin K Gillard, LeAnne Bloedon, Kristen Migliaccio-Walle, David Elsea, Steven E Nissen

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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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本培多酸治疗他汀类药物不耐受的高危心血管患者的成本-效果：CLEAR结局试验分析

背景：在CLEAR Outcomes研究中，13970名患有高胆固醇血症和他汀类药物不耐受的高危心血管患者被随机分为两组，一组接受双苯醚酸治疗，另一组接受标准治疗（安慰剂）。苯甲多酸使主要不良心血管事件的风险降低了13%。然而，在这一患者群体中，苯戊酸的成本效益尚不清楚。方法：从美国第三方付款人的角度，马尔可夫模型估计了苯甲醚酸与单独标准护理相比降低心血管风险的成本效益。基线风险通过将试验中的个体患者特征应用于建立的风险方程来估计。使用CLEAR Outcomes中单个主要心血管不良事件（MACE）成分的风险比，推断整个生命周期的治疗获益。方案分析包括治疗分析、替代苯甲醚酸成本、固定剂量联合依折替米贝对低密度脂蛋白胆固醇（LDL-C）降低和预测MACE的建模效应。结果：与标准护理相比，苯甲多酸估计可降低终生MACE（1.58对1.95）。按目录价格计算，苯二甲酸与成本增加（+ 22,600美元）和质量调整生命年（QALYs, + 0.14）相关，导致每个QALY的增量成本效益比（ICER）为166,830美元。治疗分析的结果是每个QALY的ICER为70,279美元。苯二甲酸价格降低25%导致增量总成本降低，每QALY的ICER为99,993美元。对固定剂量组合的影响进行建模后，每个QALY的ICER为40,317美元。结论：在常见的成本-效果阈值（每个QALY $150,000）下，与标准护理相比，使用苯戊酸可改善心血管疾病（CV）高风险患者的终生心血管（CV）风险降低。试验注册：ClinicalTrials.gov标识符：NCT02993406 （CLEAR Outcomes study）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Cardiovascular Drugs 医学-心血管系统

CiteScore

6.70

自引率

3.30%

发文量

审稿时长

>12 weeks

期刊介绍： Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents. Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations. The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.