Alzheimer’s disease drug Leqembi gets full FDA approval. Medical coverage should soon follow

The Food and Drug Administration has fully approved the first drug shown to slow Alzheimer’s disease.

This action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults 65 and older. So more people in the early stages of the disease will have access to the drug and be able to afford it.

“It’s not something that’s going to stop the disease or reverse it,” says Dr. sanjeev vaishnavi, director of clinical research at the Penn Memory Center. “But it can slow the progression of the disease and can give people more meaningful time with their families.”

In studies reviewed by the FDA, Leqembi appeared to slow memory and thinking decline by about 27% after 18 months of treatment. It also significantly reduced the sticky beta-amyloid plaques that tend to build up in the brains of people with Alzheimer’s disease.

“It’s very exciting that we are targeting the actual pathology of the disease,” Vaishnavi said.

Just talking about a treatment “is an incredible point for the overall cause of Alzheimer’s disease,” says Joanne PikePresident and CEO of the Alzheimer’s Association.

Leqembi comes from the Japanese pharmaceutical company Eisai and its American partner Biogen. The companies said Leqembi would cost around $26,500 per year.

In January, the drug received what is called expedited approval from the FDA, based on its ability to remove beta-amyloid from the brains of people in the early stages of Alzheimer’s disease. Full or traditional approval reflects the FDA’s assessment that Leqembi also helps preserve memory and thinking.

Also in January, the Centers for Medicare and Medicaid Services announcement this would expand Leqembi’s coverage the same day the drug receives full FDA approval. That should mean the drug will now be covered for most Medicare patients with early signs of cognitive problems and high amyloid levels.

Wider coverage, limited use

Until now, Medicare only paid Leqembi for patients in certain clinical trials.

Under the expanded coverage, one million or more Medicare patients are potential candidates for the drug. But it’s likely that a much smaller number will get it over the next year.

One reason is the drug’s life-threatening side effects, Vaishnavi says.

“I think [patients] are a little suspicious because they hear about bleeding or swelling in the brain,” says Vaishnavi. “They are worried, and I think rightly so.

Another limiting factor is that the US healthcare system is simply not ready to diagnose, treat and monitor large numbers of Alzheimer’s patients, Pike says.

Leqembi requires an initial test to determine amyloid levels in the brain, intravenous infusions every two weeks, and periodic brain scans to detect side effects.

“We don’t have enough specialists who understand how to provide this treatment,” Pike says. “We don’t have enough primary care physicians with the knowledge and confidence to provide a referral.”

But Leqembi has far more support from doctors and payers than an ill-fated predecessor.

In 2021, the FDA granted conditional approval to a drug called Aduhelm. It also removes amyloid from the brain.

But it was unclear whether Aduhelm, also known as aducanumab, slowed memory and thinking loss. So many doctors refused to prescribe it. And Medicare refused to cover the expensive drug except for patients in certain clinical trials.

Leqembi shouldn’t have these problems.

“You really have nothing to lose”

“It seems the scientific and clinical community understands the difference right now between Leqembi and Aduhelm,” Pike said.

Much of what scientists have learned about Leqembi is due to people like Ken and Susan Bell in St. Charles, Missouri.

Susan, who is 70, started showing signs of Alzheimer’s about four years ago. So she enrolled in a clinical trial of Leqembi at Washington University in St. Louis and has been receiving the drug ever since.

The drug did not stop the disease, however.

“There was definitely some degradation in his cognitive powers and so on,” Ken says.

But Susan’s decline has been relatively slow. The couple are still able to travel and play golf, which could indicate the drug is working.

“We don’t have enough experience, like doctors, to know what would have happened” without the drug, Ken says.

Still, Susan thinks other people in the early stages of Alzheimer’s disease should try Leqembi.

“I would tell them, ‘Go for it,'” she said, “because you really have nothing to lose.”

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