— Currently available evidence is rated as promising but inconclusive to determine whether lecanemab provides a net health benefit over supportive care; the evidence suggests drug would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —

— At the March 17 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate over the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money —

BOSTON, March 1, 2023 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the emerging treatment lecanemab (Leqembi, Eisai Inc.) for Alzheimer’s disease.

On January 19, 2023 Eli Lilly & Co. announced a Complete Response Letter for accelerated approval of donanemab. Therefore, ICER has removed donanemab from this assessment.

“Individuals and families dread Alzheimer’s disease, and the first therapy that effectively halts or reverses dementia will warrant a very high price in the US health system,” said David Rind, MD, ICER’s Chief Medical Officer. “Current evidence strongly suggests that lecanemab mildly slows the loss of cognition in patients with early Alzheimer’s disease. However, given the risks of brain swelling and bleeding, particularly when lecanemab is used outside of clinical trials, we have some uncertainties as to whether the average benefits of lecanemab exceed its risks. At its announced list price, lecanemab exceeds typical thresholds for cost-effectiveness and, given the large number of patients with Alzheimer’s disease, it is particularly important that therapies for Alzheimer’s disease be priced in line with their value to patients.”

This Evidence Report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF) on March 17, 2023. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

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

ICER rated the current evidence to be promising but inconclusive (“P/I”) to determine whether lecanemab provides a net health benefit over supportive care alone in individuals with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.

Key Cost-Effectiveness Findings

Lecanemab has been approved by the FDA and has a list price of $26,500 per year. ICER has calculated a health-benefit price benchmark (HBPB) for lecanemab to be between $8,900 – $21,500 per year.

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

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.