New analysis shows Vascepa is cost effective and offers better outcomes at lower cost for high risk patients with CV Disease .-Amarin Corporation

Amarin Corporation plc announced a summary of results from a patient-level, cost-effectiveness analysis of icosapent ethyl (Vascepa). This comprehensive analysis evaluated the cost-effectiveness of icosapent ethyl in reducing cardiovascular (CV) risk among high-risk patients as demonstrated in the landmark REDUCE-IT cardiovascular outcomes study. In this newly reported analysis, use of icosapent ethyl was projected to not only be cost-effective but also to reduce long-term health care costs in a majority of the scenarios analyzed.

The findings were disclosed in an abstract titled, �Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT,� in connection with the 2019 Scientific Sessions of the American Heart Association (AHA), scheduled for November 16 � 18 in Philadelphia, PA. William S. Weintraub, M.D., director of Outcomes Research with MedStar Cardiovascular Research Network, is lead author of the analysis, Dr. Weintraub and the MedStar Cardiovascular Research Network, known for conducting thoughtful pharmacoeconomic analysis, used available data for cost information for treatment and rehabilitation of patients from stroke, myocardial infarction, revascularization, hospitalization and cardiovascular death and assessed how such costs decline relative to the cost of patient treatment with icosapent ethyl based on the results of the REDUCE-IT study.

Background : Despite statin therapy and well-controlled LDL-C, many high CV risk patients continue to experience CV events. This �persistent� CV risk was evaluated via REDUCE-IT, which enrolled statin-treated patients with controlled LDL-C (>40 - ?100 mg/dL) and elevated triglycerides ( greater than 135 - less than 500 mg/dL), with established CV disease or diabetes combined with other CV risk factors. Over 4.9 years median follow-up, REDUCE-IT showed that icosapent ethyl lowered risk of first and total CV events by 25% and 30%, respectively. In REDUCE-IT, adverse events occurring with icosapent ethyl use at greater than 5% and greater than placebo were: peripheral edema (6.5% Vascepa versus 5.0%), although there was no increase in the rate of heart failure in Vascepa patients; constipation (5.4% Vascepa versus 3.6%), although mineral oil, as used as placebo, is known to lower constipation; and atrial fibrillation (5.3% Vascepa versus 3.9%), although there were reductions in rates of cardiac arrest, sudden death and myocardial infarctions observed in Vascepa patients. More information on safety data associated with REDUCE-IT is provided further below. Methods : The analysis applied treatment effects from REDUCE-IT, health care costs from national sources, including private insurance and Medicare, and conducted a combination cost-effectiveness analysis utilizing both patient-level in-trial cost and clinical outcomes and long-term costs, events and life expectancy derived from Markov simulation models. The model projected lifetime healthcare costs, CV events, survival and quality-adjusted life-years (QALYs) for icosapent ethyl versus placebo in REDUCE-IT eligible patients. Results : 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. In probabilistic sensitivity analysis, >85% of simulations indicated that icosapent ethyl would be cost-effective (i.e., below $50,000 per QALY gained) compared with placebo. Conclusion: In this combined patient-level and simulation cost-effectiveness analysis, icosapent ethyl in high CV risk patients shows exceptional benefit with CV event reduction as well as cost-savings in-trial and over patients� lifetime in the majority of simulations.

The patient cost and actuarial information used by MedStar in this cost-effective analysis were derived from sources independent of Amarin. Data regarding cardiovascular risk reduction demonstrated by Vascepa was sourced from previously published information from the total cohort of the REDUCE-IT study (not from the REDUCE-IT USA cohort published in Circulation which showed even more pronounced results albeit subject to the limitations of subset analysis) with support provided by Amarin in making the data available to MedStar for analysis.