ICER Issues Final Report and Policy Recommendations Regarding Additive Treatments for Cardiovascular Disease

— Independent appraisal committee votes that rivaroxaban and icosapent ethyl improve patient health at prices that achieve good long-term value for money, but the large potential short-term budget impact associated with treating even a small percentage of eligible US patients leads ICER to issue an Access and Affordability Alert —

BOSTON, October 17, 2019 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and long-term value for money of rivaroxaban (Xarelto®, Janssen Pharmaceuticals), and icosapent ethyl (Vascepa®, Amarin Pharma). ICER’s report on these additive treatments for cardiovascular disease (CVD) was reviewed at the September 2019 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees.

“While aspirin and statins have become cornerstone therapies for treating cardiovascular disease, treatments like rivaroxaban and icosapent ethyl appear to provide additional benefits for certain patients who have an elevated risk of major cardiovascular events,” said David Rind, MD, ICER’s Chief Medical Officer. “Input from clinical experts confirmed that the ideal target population for treatment is very large, and therefore, despite being priced in a cost-effective manner, these additive treatments could pose a short-term budgetary challenge for the health system depending on how real-world uptake evolves. In these situations, it is critical for all stakeholders to work together to ensure that pricing and coverage arrangements don’t create barriers to these beneficial therapies, while balancing the need to deliver quality health care for all patients.”

During the meeting, a majority of CEPAC members voted that the evidence suggests that rivaroxaban plus aspirin provides a net health benefit superior to what aspirin alone provides. Likewise, a majority found that the net health benefit from icosapent ethyl added to optimal medical management (including statin therapy) is superior to that provided by optimal medical management alone.

During their deliberation, panel members also weighed the therapies’ other benefits and contextual considerations. Recognizing that CVD is a condition with high severity and burden of illness, the CEPAC noted that both of these therapies offer a new approach that may allow successful treatment of many patients for whom other therapies have failed. On the other hand, the panel also found that both therapies pose significant uncertainty related to their long-term benefit and risks, including the risk of serious side effects for rivaroxaban.

Both rivaroxaban and icosapent ethyl easily meet commonly cited thresholds for cost-effectiveness and therefore represent a high long-term value for money, as established within ICER’s value assessment framework. 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), the results are almost identical: rivaroxaban could be priced between $5,400-$7,800 per year, and icosapent ethyl could be priced between $6,500-$9,400 per year.

Access and Affordability Alert

ICER is issuing an Access and Affordability Alert for both rivaroxaban and icosapent ethyl. While clinical experts at the meeting stated they would consider using rivaroxaban in 30% or more of eligible patients, only 6% of eligible patients in the US could be treated in a given year before crossing ICER’s potential budget impact threshold of $819 million. Likewise, while clinical experts at the meeting stated they believe the majority of eligible patients would want to be on icosapent ethyl, only 4% of eligible patients in the US could be treated in a given year before crossing ICER’s potential budget impact threshold.

The purpose of an ICER Access and Affordability Alert is to signal to stakeholders and policy makers that the amount of added health care costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services or contributing to rapid growth in health care insurance costs that threaten sustainable access to high-value care for all patients.

Key Policy Recommendations  

Following the voting session, a policy roundtable of experts — including clinicians, patient advocates, and representatives from manufacturers and payers — convened to discuss the implications of the evidence for policy and practice. Key recommendations stemming from the roundtable discussion include:

  • Payers should not consider dual-action platelet therapy (DAPT) an appropriate candidate in a step therapy protocol as a first step prior to receiving coverage for rivaroxaban. Clinical experts do not view these two treatment options as interchangeable, given their different mechanisms of action and risk profiles.
  • Clinical and specialty societies should develop a decision algorithm and/or tool for clinicians to use in determining the most appropriate additive therapies to consider for a given patient.
  • Regulators and the research community should align on a common, single definition for key outcomes (such as major bleeding), so clinicians and patients have the information they need to make informed decisions.

ICER’s detailed set of policy recommendations, including considerations for establishing prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

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.