Abstract

Background: The Reduction of Cardiovascular Events with Icosapent Ethyl (IE)-Intervention Trial (REDUCE-IT) demonstrated the efficacy of IE among patients with elevated triglyceride levels despite the use of statins. This study aimed to examine the cost-effectiveness (CE) of IE among US adults using both in-trial and lifetime time horizons. Methods: US patients in REDUCE-IT were included in the in-trial analysis. We included all cardiovascular and serious adverse events from the REDUCE-IT database where rates differed between the study arms; we used patient-level data from REDUCE-IT USA based on 2019 US costs and $4.16/day for IE. The lifetime analysis used a microsimulation Markov model. Both analyses considered value from a US health sector perspective. The primary result is the incremental CE ratio (ICER), measured as incremental costs divided by incremental quality-adjusted life-years (QALY) of IE compared with placebo. We performed univariate and probabilistic sensitivity analyses (PSA) to capture the uncertainties involved in the estimation of costs and QALYs. Results: Based on 3146 REDUCE-IT USA participants, there was an incremental gain in QALYs with IE compared with placebo using in-trial (3.28 vs. 3.13) and lifetime (10.36 vs. 9.83) time horizons. Total healthcare costs were lower with IE compared with placebo for both in-trial ($20,221 vs. $20,357) and lifetime ($201,842 vs. $204,701). IE was a dominant strategy compared to placebo using a lifetime time horizon with a 74.8% probability of being more effective and costing less and had a 99.6% probability of costing below $50,000 per QALY. The lifetime PSA showed that IE was a dominant strategy in 65.6% of simulations and cost-effective in 98.8%, 99.6%, and 99.9% of simulations at the $50,000, $100,000, and $150,000 per QALY gained thresholds, respectively. Conclusions: The REDUCE-IT USA cost-effectiveness analysis has shown that IE provides better outcomes with lower costs, dominant both in-trial and lifetime as well in the majority of sensitivity analyses and subgroups, both in primary and secondary prevention. These results, with the clinical evidence of efficacy, suggest that at $4.16 per day, IE therapy should be strongly considered in patients similar to those enrolled in REDUCE-IT USA.

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