The U.S. Food and Drug Administration on Friday approved a treatment for Alzheimer’s disease, the second of a new category of medications.
Given the high prevalence of dementia within nursing homes, any new treatments for Alzheimer’s or similar conditions would shape care and services that providers deliver. Nearly 50% of nursing home residents have a dementia diagnosis, according to data shared by the Centers for Disease Control and Prevention (CDC).
However, there are controversies over new drugs, including their efficacy, side effects and cost. These issues have swirled around the drug Aduhelm, and they are again in the discussions related to the newly approved Leqembi.
Generic name lecanemab, the drug targets the fundamental pathophysiology of the disease. Researchers evaluated Lequembi’s efficacy in a study involving 856 patients with Alzheimer’s disease. Patients saw a statistically significant drop in brain amyloid plaque over a year-and-a-half.
Medications like this are an “important advancement” in treating Alzheimer’s disease, the FDA said in a statement.
Leqembi went through the FDA’s Accelerated Approval pathway; the agency approves drugs for serious conditions where there is an unmet medical need and a drug has shown an effect which is “reasonably likely to predict a clinical benefit to patients,” according to the FDA announcement.
The Alzheimer’s Association lauded the FDA for its fast tracking of the drug, while admonishing the Centers for Medicare & Medicare Services (CMS) for denying coverage of the drug months ago.
Joanne Pike, president and CEO of the Alzheimer’s Association, said CMS’ decision is “clearly harmful and unfair” to Alzheimer’s patients.
“Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months — memories, skills and independence. They’re losing time,” Pike said in a statement. “What the FDA did today in granting accelerated approval to Leqembi was the right decision. But what CMS is doing by severely restricting coverage for approved treatments is unprecedented and wrong.”
For its part, CMS is “examining available information and may reconsider its current coverage based on this review,” the agency said in a statement on Friday. CMS would provide broader coverage immediately upon the drug receiving traditional FDA approval.
“At CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” Administrator Chiquita Brooks-LaSure stated.
