CMS Pressed to Cover Leqembi After FDA Fast-Tracks Approval of Alzheimer's Drug

Without insurance coverage, out-of-pocket costs for the drug will average about $26,500 per patient per year.

With the Food and Drug Administration granting fast-track approval on Friday of Eisai/Biogen's new Alzheimer's drug Leqembi, stakeholders are now urging the Centers for Medicare & Medicaid Services to follow suit and cover the pricey treatment.

The Alzheimer's Association called the FDA approval of the new drug for patients with mild cognitive impairment or in the early stages of Alzheimer's disease "a milestone achievement" for patients and their families. However, they warn that the cost of the drug – about $26,500 annually -- will limit access for many of the 6.5 million people in the United States who suffer from the disease. The advocates are pressing CMS to cover the costs.

"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," Alzheimer's Association CEO/President Joanne Pike, DrPH says.

"The FDA carefully reviewed the evidence for Leqembi before granting approval. CMS, in sharp contrast, denied coverage for Leqembi months ago before it had even reviewed this drug's evidence."

"CMS has never done this before for any drug, and it is clearly harmful and unfair to those with Alzheimer's," Pike says. "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."

CMS Administrator Chiquita Brooks-LaSure says the jury is still out on the efficacy of Leqembi, which has shown moderate success during clinical trials.

"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," Brooks-LaSure says.

FDA Approval

The FDA used its Accelerated Approval pathway to approve Leqembi (lecanemab-irmb) saying the drug, which reduces the beta amyloid clumps linked to Alzheimer's, "represents an important advancement in the ongoing fight to effectively treat Alzheimer's disease."

Billy Dunn, MD, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, called the treatment "the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease."  

The FDA approval follows clinical research that included a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer's disease (three of whom died during the trial, although it's not clear if the drug played a role), and which showed a 27% reduction in cognitive decline over 19 months among patients receiving the 10 milligram/kilogram intravenous dose of the drug every two weeks, when compared with those who received the placebo.

Upon learning Friday that the FDA had fast-tracked Leqembi, Eisai/Biogen immediately submitted a supplemental Biologics License Application to the agency for a traditional approval.

Costs

Leqembi is not cheap, which Tokyo-based Eisai and Cambridge, Mass-based Biogen acknowledge. However, the drugmakers cite an Alzheimer's Association estimate that Medicare, Medicaid, commercial payers and out-of-pocket spending would increase from $267 billion in 2020 to $451 billion in 2030 if no treatments exist to delay the disease.

With effective treatments, however, the drugmakers say they can reduce the average per-person cost of treating Alzheimer's patients from about $37,000 to $26,500 annually, and that the cost could be further reduced to about $15,000 a year for ongoing maintenance once the treatment is underway.