— Independent appraisal committee voted that currently available evidence is not adequate to demonstrate a net health benefit for lecanemab when compared to supportive care —

Using best estimates from current data, ICER analyses suggest lecanemab would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —

— Manufacturers should release all patient-level data to help patients, clinicians, researchers, and regulators understand more about the link between amyloid reduction and cognitive outcomes —

BOSTON, April 17, 2023 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of lecanemab (Leqembi, Eisai Inc.) for the treatment of Alzheimer’s disease.

ICER’s report on these therapies was the subject of the March 2023 public meeting of the of the California Technology Assessment Forum (CTAF) one of ICER’s three independent evidence appraisal committees.

“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, our report concluded that significant uncertainties remain as to whether the average benefits of lecanemab will exceed its risks. A majority of the California Technology Assessment Forum was clearly unconvinced that the current evidence adequately demonstrates that lecanemab provides a net benefit to patients. In addition, using the best current data from the clinical trials, 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.”

ICER’s Virtual Public Meeting: Voting Results on Clinical Effectiveness and Contextual Considerations

For adults with early Alzheimer’s disease (i.e., Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s dementia):

  • A majority of panelists (12-3) found that current evidence is not adequate to demonstrate a net health benefit of lecanemab when compared to supportive care alone.

During their deliberations, panel members also weighed lecanemab’s potential benefits and disadvantages beyond its direct health effects, and broader contextual considerations. Voting highlighted the following as particularly important for payers and other policymakers to note:

  • The acuity of need for treatment of individual patients based on short-term risk of death or progression to permanent disability;
  • The magnitude of the lifetime impact of Alzheimer’s disease on individual patients is substantial;
  • Patients’ ability to achieve major life goals related to education, work, or family life;
  • Caregivers’ quality of life and/or ability to achieve major life goals related to education, work, or family life.

ICER’s Virtual Public Meeting: Voting Results on Long-Term Value for Money

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.

After reviewing the clinical evidence and considering the treatments’ other potential benefits, disadvantages, and contextual considerations noted above, the CTAF evaluated the long-term value of lecanemab at its current pricing:

  • The panelists unanimously (15-0) found that lecanemab at its current pricing represents “low” long-term value for money.  

Access and Affordability Alert

At lecanemab’s current net price, approximately 5% of the 1.4 million US patients eligible for Alzheimer’s disease treatment that targets beta-amyloid could be treated within five years without crossing the ICER potential budget impact threshold of $777 million per year.

ICER is issuing an access and affordability alert for lecanemab in the management of Alzheimer’s disease.  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, creating pressure on payers to sharply restrict access, or causing rapid growth in health care insurance costs that would threaten sustainable access to high-value care for all patients.

Key Policy Recommendations:

ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including the manufacturer, clinical experts, patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access.  Key recommendations stemming from the roundtable discussion include:

  • Manufacturers should release all patient-level data in order to help patients, clinicians,  researchers, and regulators to understand more about the link between amyloid reduction and cognitive outcomes.
  • Patient groups, the manufacturer, clinicians, and clinical specialty societies should accurately describe the clinical benefits of lecanemab as a slowing of decline of cognition and function and avoid over-selling the potential benefit of treatment by using terms such as “improvement” or “return of quality of life” or “game changer” in all personal statements and advertising. Furthermore, there should not be an over-emphasis on the removal of amyloid from the brain, which still has not been conclusively linked to clinical outcomes.
  • Manufacturers of future treatments for Alzheimer’s disease should follow the example set by the manufacturer of lecanemab by sharing a transparent, explicit justification for their pricing.  However, to foster affordability and good access for all patients, manufacturers should align prices with the patient-centered therapeutic value of their treatments as suggested in independent value assessments.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based 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.