One of the latest medical advancements making waves is Eisai and Biogen developed Lecanemab. It was recently presented at the Clinical Trials on Alzheimer’s Disease conference in San Francisco.
There is no debate over Lecanemab’s dramatic effect on amyloid. When measured by PET scan, patients taking the medicine saw their amyloid levels decline by about 70% after 18 months, with 68% of them testing negative for the protein at the end of the study.
But there is a lot of discussion taking center stage over the benefits/risk ratio of the drug in light of death of 2 study participants.
The FDA is expected to decide whether to grant accelerated approval to lecanemab by January 6, 2023. However, even if the FDA does so, the current CMS policy will prevent thousands of Medicare beneficiaries with a terminal, progressive disease from accessing this treatment. CMS indicates to promptly modify the policy if warranted by new evidence, which has now been delivered to CMS.