Abstract

BACKGROUND: The ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial included participants with a recent acute coronary syndrome. Compared with participants receiving statins alone, those receiving a statin plus alirocumab had lower rates of a composite outcome including myocardial infarction (MI), stroke, and death. OBJECTIVE: To determine the cost-effectiveness of alirocumab in these circumstances. DESIGN: Decision analysis using the Cardiovascular Disease Policy Model. DATA SOURCES: Data sources representative of the United States combined with data from the ODYSSEY Outcomes trial. TARGET POPULATION: U.S. adults with a recent first MI and a baseline low-density lipoprotein cholesterol level of 1.81 mmol/L (70 mg/dL) or greater. TIME HORIZON: Lifetime. PERSPECTIVE: U.S. health system. INTERVENTION: Alirocumab or ezetimibe added to statin therapy. OUTCOME MEASURES: Incremental cost-effectiveness ratio in 2018 U.S. dollars per quality-adjusted life-year (QALY) gained. RESULTS OF BASE-CASE ANALYSIS: Compared with a statin alone, the addition of ezetimibe cost $81 000 (95% uncertainty interval [UI], $51 000 to $215 000) per QALY. Compared with a statin alone, the addition of alirocumab cost $308 000 (UI, $197 000 to $678 000) per QALY. Compared with the combination of statin and ezetimibe, replacing ezetimibe with alirocumab cost $997 000 (UI, $254 000 to dominated) per QALY. RESULTS OF SENSITIVITY ANALYSIS: The price of alirocumab would have to decrease from its original cost of $14 560 to $1974 annually to be cost-effective relative to ezetimibe. LIMITATION: Effectiveness estimates were based on a single randomized trial with a median follow-up of 2.8 years and should not be extrapolated to patients with stable coronary heart disease. CONCLUSION: The price of alirocumab would have to be reduced considerably to be cost-effective. Because substantial reductions already have occurred, we believe that timely, independent cost-effectiveness analyses can inform clinical and policy discussions of new drugs as they enter the market. PRIMARY FUNDING SOURCE: University of California, San Francisco, and Institute for Clinical and Economic Review.