Annemarie M. Barnett, executive director of the Greater Cincinnati and Miami Valley Alzheimer’s Association, said the results from lecanemab showed a 27% reduction in cognitive decline for those in the early stages of dementia.
“It’s giving people in the early stages of the disease more time,” Barnett said. “They can make memories with their families … It slows the progression of the disease.”
The Alzheimer’s Association called for the FDA to give accelerated approval of lecanemab, which Barnett said they hope to see in January. The FDA granted a priority review for lecanemab, according to Biogen, and makers of the drug expect to see the FDA’s decision on Jan. 6.
Even if they get FDA accelerated approval, Barnett said Medicare and Medicaid would only cover the drug if the patient was taking part in a clinical study, due to lecanemab being a monoclonal antibody treatment.
“We’re asking them to act swiftly and reverse their (stance),” Barnett said.
The Centers for Medicare and Medicaid Services (CMS) made a decision earlier in the year to cover the type of drug classification lecanemab falls under when the drug is being used in CMS-approved clinical trials.
Lecanemab is a monoclonal antibodies treatment addressing the underlying biology of Alzheimer’s, specifically beta-amyloid protein plaques. When there are abnormal levels of this naturally occurring protein, they can clump together, form plaques in between neurons in the brain, and disrupt cell function, according to the National Institute of Aging.
This most recent clinical trial published in the New England Journal of Medicine found lecanemab resulted in moderately less decline on measures of cognition and function than the participants who had placebo. It was associated with adverse events that were described as mostly mild to moderate.
A CMS spokesperson on Tuesday said the agency is continuing to stay updated on clinical trials like the recent one in the New England Journal of Medicine. The agency has also met with manufacturers to learn about their efforts since the national coverage determination was released on April 7.
CMS is encouraging stakeholders to stay engaged with CMS while the FDA is also reviewing data from their confirmatory trial, which was the clinical trial published in the New England Journal of Medicine.
The Alzheimer’s Association said the Centers for Medicare and Medicaid Services had previously pledged to modify its coverage determination if there was new evidence, so the Alzheimer’s Association is hopeful the centers will revise their policy.
“We feel very confident,” Barnett said.
Barnett also emphasized the importance of individuals taking part in clinical trials, saying the Alzheimer’s Association has a platform called TrialMatch, which can connect individuals living with Alzheimer’s, caregivers, and healthy volunteers to clinical trials that may advance Alzheimer’s research. For more information on TrialMatch, visit www.alz.org/trialmatch.
“We can’t get these drugs to market until we have satisfied clinical trials,” Barnett said.
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