ICER Publishes Final New Evidence Update for Alirocumab, a PCSK9 Inhibitor for Treating High Cholesterol

-Based on new analyses of published results of the ODYSSEY Outcomes trial, alirocumab would meet cost-effectiveness thresholds if priced between $2,300 and $4,000 per year, depending on population-

BOSTON, February 15, 2019 - The Institute for Clinical and Economic Review (ICER) today released a Final New Evidence Update for alirocumab (Praluent®, Regeneron/Sanofi), an injectable PCSK9 inhibitor used for the treatment of high cholesterol in certain patient populations. This New Evidence Update is based on further analysis of results from the ODYSSEY Outcomes trial, which have now undergone peer review and were published in the New England Journal of Medicine on November 7, 2018.

Based on these new analyses, ICER is revising its value-based price benchmark ranges for alirocumab to $2,300-$3,500 per year if used to treat all patients who meet ODYSSEY trial eligibility criteria, and $2,700-$4,000 per year if only used to treat higher-risk patients with LDL cholesterol (LDL-C) ≥ 100 mg/dL despite intensive statin therapy. ICER's value-based price benchmarks suggest a price range, net of any discounts and rebates, that aligns fairly with the treatment's added benefits for patients and the health care system. The ranges reflect commonly cited cost-effectiveness thresholds of between $100,000 and $150,000 per Quality-Adjusted Life Year (QALY) gained.

This Final New Evidence Update is the revised version of ICER's preliminary analysis of the ODYSSEY Outcomes data initially presented at the American College of Cardiology's 2018 Scientific Session. Consistent with the methodology defined on our website, we are now updating that analysis based on the final trial data published in the peer-reviewed manuscript. Of note, Regeneron and Sanofi announced recently that the annual US list price of alirocumab would be reduced to $5,850, down from $14,600 when the drug was first launched in 2015.

"When added to maximally tolerated statin therapy in patients with a recent acute coronary event and an LDL-C of 70 or higher, alirocumab reduced cardiovascular events by 15% and appeared to reduce all-cause mortality by a similar amount," said David Rind, MD, ICER's Chief Medical Officer. "In our preliminary update we had interpreted the evidence as suggesting that the relative reduction in events is greater in patients with an LDL-C above 100 mg/dL. Having reviewed the full published information, however, we now believe it is more likely that the relative benefit of treatment is the same for all patient groups, and thus our updated value-based price benchmark for the high-risk subgroup is lower in this final report than in our preliminary analysis. Some experts, however, continue to believe the evidence supports a higher relative benefit for high-risk patients, and therefore we have included in our final report a supplemental scenario analysis based on this alternative assumption."

ICER's value-based price benchmarks remain lower than even the recently reduced list price of alirocumab. Under the scenario analysis that assumes greater relative benefit in patients with LDL-C above 100 mg/dL, the value-based price benchmark range for the high-risk subgroup would be $4,900-$7,400 per year.

This analysis was conducted in partnership with an independent research group led by Dr. Kirsten Bibbins-Domingo at the University of California, San Francisco and Dr. Dhruv Kazi at the Beth Israel Deaconess Medical Center. The team used the Cardiovascular Disease Policy Model, an established simulation model of cardiovascular disease (CVD) in the US population that systematically combines data from vital statistics, epidemiologic studies, clinical trials, and registries.

ICER's Earlier Assessments of the PCSK9 Inhibitors

ICER first assessed the cost-effectiveness of alirocumab and evolocumab (Repatha®, Amgen) shortly after these drugs were first granted regulatory approval in the US in 2015, and performed a New Evidence Update for evolocumab in September 2017, following the release of outcomes data from the FOURIER trial. This Final New Evidence Update is the revised version of ICER's preliminary analysis of the ODYSSEY Outcomes data initially presented at the American College of Cardiology's 2018 Scientific Session. Today's announcement does not alter ICER's analysis of the FOURIER trial, which concluded that a value-based price benchmark for a year's treatment with evolocumab would be between $1,700 and $2,200.

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, developed in partnership with research groups at academic institutions, 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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