Cost-Effectiveness of Alirocumab: A Just-in-Time Analysis Based on the ODYSSEY Outcomes Trial.

Abstract

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. To determine the cost-effectiveness of alirocumab in these circumstances. Decision analysis using the Cardiovascular Disease Policy Model. Data sources representative of the United States combined with data from the ODYSSEY Outcomes trial. 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. Lifetime. U.S. health system. Alirocumab or ezetimibe added to statin therapy. Incremental cost-effectiveness ratio in 2018 U.S. dollars per quality-adjusted life-year (QALY) gained. Compared with a statin alone, the addition of ezetimibe cost $81000 (95% uncertainty interval [UI], $51000 to $215000) per QALY. Compared with a statin alone, the addition of alirocumab cost $308000 (UI, $197000 to $678000) per QALY. Compared with the combination of statin and ezetimibe, replacing ezetimibe with alirocumab cost $997000 (UI, $254000 to dominated) per QALY. The price of alirocumab would have to decrease from its original cost of $14560 to $1974 annually to be cost-effective relative to ezetimibe. 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. 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. University of California, San Francisco, and Institute for Clinical and Economic Review.