Icosapent ethyl is a cost-effective medical treatment to prevent cardiovascular events in patients with high triglyceride levels despite being on statin therapy with well-controlled low-density lipoprotein-cholesterol (LDL-C), according to a preliminary cost-effectiveness analysis to be presented at the American Heart Association’s Scientific Sessions 2019.
The analysis showed that icosapent ethyl (Vascepa, Amarin Corporation) shows “exceptional benefit” when compared to placebo in patients who were part of the REDUCE-IT randomized controlled trial, according to an abstract by William S. Weintraub, MD, of MedStar Heart & Vascular Institute, Washington, D.C., and colleagues released online Monday in advance of the annual Scientific Sessions, which is scheduled to take place Saturday through Nov. 18 in Philadelphia.
The top-line REDUCE-IT results were presented by Deepak L. Bhatt, MD, MPH, of Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, at the 2018 Scientific Sessions and published in January in The New England Journal of Medicine. These results showed that the risk of ischemic events, including cardiovascular-related death, was significantly lower among those who received 2 grams of icosapent ethyl twice daily than among those who received placebo.
Weintraub and colleagues used patient-level data from the REDUCE-IT trial to perform the in-trial cost-effectiveness analysis and lifetime simulation modeling to project the trial results through lifetime. In the cost-effectiveness analysis abstract, Weintraub and colleagues wrote that icosapent ethyl was a “dominant strategy (i.e., cost saving) in 70% of simulations … offering the rare finding of better outcomes at lower healthcare costs.” Icosapent ethyl added 3.34 quality-adjusted life-years (QALYs) per patient during the trial period (5 years) and 11.61 lifetime QALYs, while placebo added 3.27 QALYs in the trial period and 11.35 lifetime QALYs, the results show.
The mean costs of icosapent ethyl were $27,576 during the trial and $235,352 lifetime as compared with $28,205 during the trial and $236,636 lifetime for placebo, according to the results.
“What we found is that because of the event reduction, it’s very close to cost-neutral or actually, perhaps, saves a little bit of money,” Weintraub said in an interview. “That means it’s a dominant strategy – at least within the trial, it’s a dominant strategy – and maybe long term as well, where you have both better outcomes and lower costs. This is very unusual. Usually, new therapies, especially if they are still branded, may get better outcomes but usually at considerable cost.”
Weintraub emphasized that these results are preliminary and that there is still much work to do before the analysis can be finalized.
Icosapent ethyl is a highly purified prescription eicosapentaenoic (EPA) omega-3 acid in ethyl ester form. In a news release accompanying the release of the abstract, Amarin explained that icosapent ethyl “is not fish oil, but is derived from fish through a stringent and complex (Food and Drug Administration)-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient from degradation.”
The FDA has approved icosapent ethyl to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. The REDUCE-IT trial showed benefit of icosapent ethyl in patients with triglyceride levels of 135 to 499 mg/dL. European guidelines classify the use of the medication in patients meeting REDUCE-IT criteria as a class IIa, Level B recommendation, Amarin said in its news release.
Weintraub is scheduled to present the cost-effectiveness analysis results Saturday morning at the Scientific Sessions.
The REDUCE-IT trial was funded by Amarin Corporation.