Study Details Cost-Effectiveness of Icosapent Ethyl in Hypertriglyceridemia

William Weintraub, MD

A cost-effectiveness analysis using data from the REDUCE-IT trial is providing clinicians with insight into the cost-effectiveness of icosapent ethyl in high-risk patients with hypertriglyceridemia despite statin treatment.

An in-trial cost-effectiveness analysis and a lifetime analysis using a microsimulation model, results indicate use of icosapent ethyl was associated with a greater number of quality-adjusted life-years (QALYs) than standard care in both the trial and over a lifetime projection, with data demonstrating use offered better cardiovascular outcomes than standard care at common willingness-to-pay thresholds.

“This study suggests that, for high-risk patients with hypertriglyceridemia despite statin treatment, icosapent ethyl may be cost-effective at commonly accepted willingness-to-pay thresholds,” wrote investigators.

The landmark REDUCE-IT trial has been among the most discussed trials in cardiovascular health since its release at ACC.19. Although recent discussions have sometimes centered around the potential influence of mineral oil placebo on results, icosapent ethyl received approval from the US FDA as adjunct therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 mg/dL or greater in December 2019.

Since then, the potential cost-effectiveness of the therapy has become a research interest for many. With this in mind, the current study was led by William Weintraub, MD, with the intent of providing cost-effectiveness estimates to clinicians. To do so, investigators performed an in-trial cost-effectiveness analysis using patient-level data from REDUCE-IT and a lifetime analysis using data from a microsimulation model and published literature.

Briefly, in the REDUCE-IT trial, 8179 patients were randomized to 4 grams of icosapent ethyl per day or placebo and followed for a median of 4.9 years. In the trial, use of icosapent ethyl was associated with a 25% risk reduction for cardiovascular events and a 20% reduction in cardiovascular mortality.

For the purpose of analysis, the cost of icosapent ethyl was sourced from SSR Health net costs. In the analyses, the SSR cost was $4.16 per day and the wholesale acquisition cost was $9.28. Primary outcomes of interest were incremental QALYs, total direct health care costs, and cost-effectiveness. Investigators noted total direct health care costs were measured in 2019 US dollars. Additionally, icosapent ethyl would be considered highly cost-effective if the ICER was less than $50,000 per QALY gained and intermediate if it was between $50,000-$150,000.

In the investigators’ analyses, results indicated treatment with icosapent ethyl yielded more QALYs than standard care in both the in-trial analysis (3.34 vs 3.27; mean difference, 0.07 [95% CI, 0.01-0.12]) and lifetime projection model (10.59 vs 10.35; mean difference, 0.24 [95% CI, 0.15-0.33]). In the in-trial analysis, results suggested total health care costs were higher with icosapent ethyl using either SSR cost or the wholesale acquisition cost than with standard care (mean difference from SSR cost, $1513 [95% CI, $155-$2870]; mean difference from wholesale acquisition cost, $7271 [95% CI, $5911-$8630]).

Additionally, results indicated icosapent ethyl cost $22,311 per QALY gained using SSR cost and $107,218 per QALY using the wholesale acquisition cost. In the lifetime analysis, results suggested icosapent ethyl use was projected to be cost saving when using SSR cost compared against standard care (mean difference, -$1788 [95% CI, -$9735 to $6159]), but to have higher costs when using the wholesale acquisition cost compared with standard care (mean difference, $5766 [95% CI, $1094-$10,438]). Results also demonstrated Icosapent Ethyl and a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than $50,000 per QALY gained when using SSR cost. The probability of costing less than $50,000 per QALY gained dropped to 72.5% when using wholesale acquisition cost.

In an invited commentary, Dariush Mozaffarian, MD, DrPH, noted the importance of findings given the risk associated with elevated triglyceride levels in high-risk patients, but also pointed out 3 specific caveats to consider when interpreting the results of the current study. The first caveat was the reliance on patient-level data from more than 450 sites in 11 countries creates the possibility for varying costs across countries. Second, investigators did not include estimated costs of icosapent ethyl, such as incremental physician visits, screening for eligibility, or laboratory testing of triglyceride levels, that would be associated with treatment. The final caveat was concern over the influence of mineral oil placebo on results of the REDUCE-IT trial.

“Continued development of cost-effective medical treatments such as IPE is important. At the same time, nations will not achieve better health, more health equity, or lower health care spending until they equally emphasize and invest in public health and prevention policy to reduce lifestyle-related chronic diseases,” Mozaffarian wrote.

This study, “Cost-effectiveness of Icosapent Ethyl for High-risk Patients with Hypertriglyceridemia Despite Statin Treatment,” was published in JAMA Network Open.