ICER report: Icosapent ethyl offers ‘high long-term value’
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Amarin announced that the Institute for Clinical and Economic Review issued its final report on the cost-effectiveness of icosapent ethyl and found that the medication has “high long-term value for money.”
This cost-effectiveness review took into consideration results from the REDUCE-IT trial, according to a press release from the company. As Cardiology Today previously reported, icosapent ethyl (Vascepa) was superior to placebo for reducing risk for ischemic events in patients with elevated triglycerides at high CV risk despite statin therapy.
“Our base-case results suggest that the use of … icosapent ethyl (in patients receiving statins) … provide clinical benefit in terms of gains in quality-adjusted survival and overall survival compared to optimal medical management alone in the adult, established CVD cohort, and in the case of icosapent ethyl also for adults without known CVD but at high risk for cardiovascular events,” according to the Institute for Clinical and Economic Review (ICER) report. “This translated into incremental cost-effectiveness estimates that fell below commonly cited cost-effectiveness thresholds under the assumptions used in this analysis.”
Norman E. Lepor, MD, FACC, FAHA, FSCAI, past president of the California chapter of the American College of Cardiology, clinical professor of medicine at UCLA Geffen School of Medicine, attending cardiologist at Cedars-Sinai Heart Institute, co-director of Cardiovascular Imaging-Westside Medical Center, director of clinical research at Westside Medical Associates of Los Angeles and a principal investigator of the REDUCE-IT trial, told Cardiology Today, “If you have a patient who is REDUCE-IT-trial-like who is pretty well-treated on a statin with an LDL of 78 mg/dL, you have to make a decision in terms of what to do next: add a PCSK9 inhibitor, where there is plenty of solid clinical trial data showing efficacy in secondary prevention but is more expensive; add ezetimibe where there is very little data supporting its use outside of acute coronary syndrome with minimal CV reduction in the IMPROVE-IT trial; or add icosapent ethyl with its significant CV event reduction and meeting or beating the ICER threshold. You can certainly make the case of adding icosapent ethyl and still consider adding a PCSK9 inhibitor based on the ACC/AHA 2018 guidelines in very high-risk patients with LDL > 70 mg/dL on maximally tolerated statin dose or the European Society of Cardiology/European Atherosclerosis Society 2019 lipid guidelines supporting treating high-risk patients to LDL < 55 mg/dL.
Icosapent ethyl is currently approved in the U.S. for use in addition to diet for triglyceride reduction in patients with severe hypertriglyceridemia. Amarin previously submitted a supplemental new drug application to the FDA to expand its use based on results from the REDUCE-IT trial, according to the release. The Prescription Drug User Fee Act target action date is currently set for Dec. 28.
“Amarin has worked for over a decade to develop and test Vascepa to create a new preventive care solution that will potentially help many of our family, friends and neighbors within this population,” Craig Granowitz, MD, PhD, chief medical officer of Amarin, said in the release. “Our goal is to make Vascepa accessible to as many patients as possible who can benefit.”
Another cost-effectiveness analysis of icosapent ethyl will be presented at the American Heart Association Scientific Sessions 2019, according to the release.
Reference:
ICER. Additive Therapies for Cardiovascular Disease: Effectiveness and Value. Final Evidence Report.
For more information:Norman E. Lepor, MD, FACC, FAHA, FSCAI, can be reached at normal.lepor@gmail.com
Disclosures: Granowitz is an employee of Amarin. Lepor reports he was a principal investigator on the REDUCE-IT trial and part of the speaker’s bureau for Amarin.
Perspective
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JoAnn E. Manson, MD, DrPH, FAHA
This report provides further support for the value and cost-effectiveness of icosapent ethyl. Of note, this cost-effectiveness analysis did not take into account the full breadth of vascular outcomes affected, including reductions in coronary revascularization and unstable angina, as well as striking reductions in rates of recurrent events, as reported at the American College of Cardiology Scientific Sessions in March and recently published in the Journal of the American College of Cardiology (Bhatt DL, et al. J Am Coll Cardiol. 2019;doi:10.1016/j.jacc.2019.02.232). Adding these outcomes to this analysis would support even greater cost effectiveness. This is an exciting and promising medication for reducing residual risk.
Our research group recently performed an updated meta-analysis of omega-3 fatty acids in relation to CV events (Hu Y, et al. J Am Heart Assoc. 2019;doi:10.1161/JAHA.119.013543). Icosapent ethyl was clearly an outlier in terms of the magnitude of risk reduction achieved. Interestingly, other trials of omega-3s generally at doses of about 1 g per day tended to show coronary benefits but not reductions in stroke. In contrast, icosapent ethyl markedly reduced both CHD and stroke, leading to substantial reductions in the composite CVD endpoint in REDUCE-IT. Also of note, in the VITAL trial (Manson JE, et al. N Engl J Med. 2018;doi: 10.1056/NEJMoa1811403), omega-3 fatty acids were associated with a 28% reduction in MI but no reduction in stroke, resulting in a small but nonsignificant reduction in overall CV events. Whether the stroke benefit of icosapent ethyl is due to the higher dose or differences in formulation remains unclear. Our recent meta-analysis was the first to do a dose-response analysis of the omega-3 trials and suggested a significant dose-response gradient. For each 1 g increase in omega-3 dose, there was an 8% to 9% reduction in total CV events, without significant heterogeneity across trials.
Although the higher dose is likely playing a role in the efficacy of icosapent ethyl seen in REDUCE-IT, that is probably not the full explanation. Also, the benefits in REDUCE-IT seem to go far beyond what would be projected from triglyceride-lowering alone and were found across a broad range of triglyceride levels at baseline. The STRENGTH trial of omega-3-carboxylic acids (Epanova, AstraZeneca) will provide additional important information about the potential of omega-3s in reducing CV risk.
More research needs to be done on high-dose omega-3s, particularly in high-risk primary prevention populations. REDUCE-IT tested icosapent ethyl in both secondary prevention and a select population of high-risk primary prevention (diabetes, other risk factors, elevated triglycerides and on statin therapy). However, there are other high-risk primary prevention patients who may potentially benefit; additional research in these populations is needed. Given the declining use of aspirin and fewer pharmacologic options in these high-risk primary prevention populations, omega-3s may have a role in filling this void.
I would expect the ICER report to be helpful to the pending application to the FDA to expand the indication for icosapent ethyl to include CV outcomes. The REDUCE-IT trial provided compelling evidence, but this new information adds a piece of the puzzle regarding cost effectiveness and added value. The evidence is falling into place that omega-3s have impressive potential for improving heart health, and more research would be helpful to identify the patient populations that could benefit.
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