贝派地酸在他汀类药物不耐受的高心血管风险患者中的成本效益：CLEAR Outcomes试验分析

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

作者信息

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

机构信息

Victorian Heart Institute, Monash University, 631 Blackburn Road, Clayton, VIC, 3168, Australia.

Imperial College London, London, UK.

出版信息

Am J Cardiovasc Drugs. 2025 Aug 20. doi: 10.1007/s40256-025-00753-w.

DOI:10.1007/s40256-025-00753-w

PMID:40833562

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).

摘要

背景

在“CLEAR Outcomes研究”中，13970例患有高胆固醇血症且不耐受他汀类药物的心血管疾病高风险患者被随机分配接受贝派地酸或标准治疗（安慰剂）。贝派地酸使主要不良心血管事件风险降低了13%。然而，贝派地酸在该患者群体中的成本效益尚不清楚。

方法

马尔可夫模型从美国第三方支付方的角度估计了贝派地酸与单纯标准治疗相比降低心血管风险的成本效益。通过将试验中的个体患者特征应用于既定的风险方程来估计基线风险。使用“CLEAR Outcomes研究”中个体主要不良心血管事件（MACE）组成部分的风险比，将治疗益处外推至终身。情景分析包括治疗期分析、贝派地酸的替代成本，以及与依折麦布固定剂量联合用药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

与标准治疗相比，估计贝派地酸可降低终身MACE（每位患者1.58次与1.95次）。按标价计算，贝派地酸与成本增加（增加22600美元）和质量调整生命年改善（QALY，增加0.14）相关，导致每QALY的增量成本效益比（ICER）为166830美元。治疗期分析得出的ICER为每QALY 70279美元。贝派地酸价格降低25%导致增量总成本降低，ICER为每QALY 99993美元。对固定剂量联合用药的效应进行建模得出的ICER为每QALY 40317美元。