Abstract
Introduction: Non-statin therapies may improve long-term outcomes in patients with atherosclerotic cardiovascular disease (ASCVD) who experience statin-associated side effects (SASE). Objective: To examine the cost-effectiveness of a newly approved combination of bempedoic acid and ezetimibe (BAEze) in patients with ASCVD from a U.S. healthcare sector perspective. Methods: State-transition Markov model of US adults with ASCVD and low-density lipoprotein cholesterol (LDL-C) ≥70mg/dL on maximally tolerated statin and ezetimibe. The study cohort was stratified by concurrent statin use: high-intensity (group1), moderate-/low-intensity (group 2), or no statin due to severe SASE (group 3). The intervention group received BAEze (annual cost $2,447) instead of ezetimibe. We estimated baseline LDL-C from NHANES; relative LDL-C lowering and rate of adverse events from randomized trials; and the relationship between LDL-C lowering and cardiovascular events from meta-analyses of statin trials. The main outcome was lifetime incremental cost-effectiveness ratio (ICER), with a threshold of $100,000 per quality-adjusted-life-year (QALY) gained. Results: BAEze had an ICER of $188,000/QALY in group 1 (95% UI: 141,500-284,600; cost-effective in 0% of 10,000 probabilistic simulations) and $175,600/QALY (132,700-264,700; cost-effective in 0% simulations) in group 2. In group 3, BAEze produced 0.28 incremental QALYs at a lifetime cost of $25,600, yielding an ICER of $92,600/QALY (66,000-152,100; cost-effective in 59% simulations). Conclusions: Among US adults with ASCVD, cost-effectiveness of BAEze varies substantially by concurrent statin use, and only meets conventional cost-effectiveness thresholds among patients unable to take a statin due to severe SASE. Our findings argue for the selective use of BAEze among patients with ASCVD and severe SASE but should be updated when more data on long-term effectiveness and safety become available.
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