Alzheimer’s Association Statement on Lecanemab Phase 3 Full Results

The Alzheimer’s Association welcomes, and is further encouraged by the full Phase 3 data presented by Eisai and Biogen from the CLARITY AD global Phase 3 clinical trial of lecanemab. The data presented today and published in the New England Journal of Medicine confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease. The Alzheimer’s Association calls for the Food and Drug Administration’s (FDA) accelerated approval of lecanemab.

These peer-reviewed, published results show lecanemab will provide patients more time to participate in daily life and live independently. It could mean many months more of recognizing their spouse, children and grandchildren. Treatments that deliver tangible benefits to those living with mild cognitive impairment (MCI) due to Alzheimer’s and early Alzheimer’s dementia are as valuable as treatments that extend the lives of those with other terminal diseases.

However, an unprecedented Centers for Medicare and Medicaid Services (CMS) policy is set to block access to this treatment. The FDA is expected to decide whether to grant accelerated approval to lecanemab by January 6, 2023. Should the FDA do so, the current CMS policy will prevent thousands and thousands of Medicare beneficiaries with a terminal, progressive disease from accessing this treatment within the limited span of time they will have to access it. If a patient decides with their healthcare provider that a treatment is right for them, Medicare must stand behind them as it does for beneficiaries with every other disease.

CMS has pledged to move quickly to modify the NCD if warranted by new evidence. This evidence has now been delivered and CMS can begin its review immediately. The Alzheimer’s Association calls on CMS to revise its policy with the utmost urgency.