ICER Publishes Evidence Report on Additive Cardiovascular Disease Therapies

— Pricing of rivaroxaban and icosapent ethyl aligns well with treatments' benefits for patients; expert roundtable will discuss implications of the potentially large patient population during September 26 public meeting of the Midwest CEPAC —

BOSTON, September 12, 2019 - The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of rivaroxaban (Xarelto®, Janssen Pharmaceuticals) and icosapent ethyl (Vascepa®, Amarin Pharma) as additive cardiovascular disease (CVD) therapies.

"Cardiovascular disease is the leading cause of death in the United States," said David Rind, MD, ICER's Chief Medical Officer. "Tremendous health gains have been achieved with now inexpensive treatments such as aspirin and statins, but high-risk patients have substantial rates of cardiovascular events even on these treatments. Our evidence review suggests that treatments like rivaroxaban and icosapent ethyl can provide additional benefits for such patients, and have prices that reflect those benefits."

This Evidence Report will be reviewed at an upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), in St. Louis, MO on September 26, 2019. The Midwest CEPAC is one of ICER's three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

Register here to attend the Midwest CEPAC meeting in person or to watch by live webcast.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Clinical Findings

The evidence provides high certainty that rivaroxaban provides a small-to-substantial net health benefit in patients with cardiovascular disease, peripheral artery disease, or both conditions. Compared to treatment with aspirin alone, rivaroxaban plus aspirin reduced the composite risk of cardiovascular death, stroke, or myocardial infarction in patients with stable CVD. However, approximately 3% of patients permanently discontinued therapy after experiencing a significant increase in major bleeding events. There remains insufficient evidence at this time to compare rivaroxaban to dual antiplatelet therapy (DAPT).

For adults with established CVD or at high risk of cardiovascular events who are being treated with statins, the evidence provides high certainty that icosapent ethyl delivers a small-to-substantial net health benefit. Compared to optimal medical management alone, icosapent ethyl reduced the risk of a composite outcome of cardiovascular death, stroke, myocardial infarction, coronary revascularization, or unstable angina in patients with established CVD or with diabetes and additional risk factors.

Key Cost-Effectiveness Findings

Both rivaroxaban and icosapent ethyl achieve commonly cited thresholds for cost-effectiveness.

Rivaroxaban's annual Wholesale Acquisition Cost (WAC) of $5,457 falls within ICER's value-based price benchmark range of $5,200-$7,600 per year. Further, rivaroxaban's estimated rebated price of $2,215 per year is significantly lower than ICER's value-based price benchmark. Icosapent ethyl's annual WAC of $3,699 and estimated rebated price of $1,625 are both significantly lower than ICER's value-based price benchmark range of $6,300-$9,200 per year.

ICER's value-based price benchmarks suggest a price range, net of any discounts and rebates, that aligns fairly with a treatment's added benefits for patients over their lifetime. The ranges reflect commonly cited cost-effectiveness thresholds of between $100,000 and $150,000 per Quality-Adjusted Life Year (QALY) gained. To reach alternative thresholds of between $100,000 and $150,000 per Equal Value of Life Year Gained (evLYG), rivaroxaban could be priced between $5,400-$7,800 per year, and icosapent ethyl could be priced between $6,500-$9,400 per year.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER's reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER's reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER's reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER's website.

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