National Institute on Aging, National Institutes of Health.
The first drug shown to slow Alzheimer’s is likely to receive full approval from the Food and Drug Administration by July 6.
In theory, the move would make lecanemab (Leqembi) available to more than a million Medicare patients in the early stages of Alzheimer’s. In practice, however, the number is likely to be much smaller.
« I’d be surprised if we saw demand from so many people right away, » he says Dr. David Rind, chief medical officer of the Institute for Clinical and Economic Review. The number could be in the hundreds of thousands, though, he says.
Lecanemab’s rollout could be slowed by factors ranging from extra paperwork required of doctors to a shortage of medical staff trained to diagnose and treat patients, experts say.
The FDA granted lecanemab conditional approval in January, based on the drug’s success in removing a substance called beta-amyloid from the brains of people in the early stages of Alzheimer’s disease. Full approval usually requires proof that a drug also helps patients.
And until the FDA grants full approval, lecanemab isn’t covered for most Medicare patients, who represent the vast majority of people with Alzheimer’s.
That makes the FDA’s impending action a big deal for patients, even if the drug is far from a cure.
« Just the idea that they could buy more time is deeply important and exciting, » she says Robert Egg, chief public policy officer of the Alzheimer’s Association. « That’s why you are patient [and] their families have spoken out loud about the need for Medicare coverage. »
Full FDA approval is all but assured. On June 9, an advisory committee voted unanimously that lecanemab had demonstrated the ability to slow Alzheimer’s, and FDA staff gave the drug a favorable rating.
With full approval, Medicare plans to cover lecanemab treatment in « appropriate settings, » according to a declaration from the centers for Medicare and Medicaid services.
Obstacles after approval
But finding treatment can remain a challenge for many Medicare patients.
One reason is that Medicare will require doctors to participate in aa register designed to monitor drug safety and efficacy.
The extra paperwork could keep some doctors from prescribing the drug, Egge says.
“This is very likely to happen in areas that are already traditionally underserved, where doctors are already stretched out,” he says. « Our biggest concern is that there will be entire communities that will be completely left out. »
Another concern is that payers may not fully cover brain scans and related services associated with lecanemab treatment. And insurers can require doctors and medical facilities to meet certain criteria in order to provide care.
« If that requirement becomes very restrictive, only specialized centers will really be able to do it, » he says Dr. Zaldi Tanmedical director of the Jona Goldrich Center for Alzheimer’s and Memory Disorders at Cedars Sinai Health System in Los Angeles.
Even patients who might be taking the drug might choose not to, Tan says, noting that it takes 18 months of treatment to slow memory and thinking loss by about six months.
« ‘So what did those six months mean to them?’ is my question, » says Tan, « and whether it’s worth showing up for an infusion every two weeks and risking brain bleeding and swelling. »
Even so, Tan supports the expected FDA approval of lecanemab. « It’s a good thing, » she says. While medication isn’t a perfect solution, « we have to start somewhere. »
This view is shared by Dr Mia Yanggeriatrician in Winston-Salem and assistant professor at Wake Forest University School of Medicine.
Lecanemab represents a big improvement over its predecessor, aducanumab, Yang says.
Aducanumab received conditional approval from the FDA in 2021 despite a lack of evidence that it changed the course of the disease. Insurers generally opted not to cover the drug and it only reached a few patients.
« Aducanumab gave the whole class of [amyloid] medicines a bad blow,” Yang says.
Lecanemab appears to work, though the benefit is modest, Yang says. But she fears the United States doesn’t have enough memory specialists or infusion clinics to handle all potential patients.
« I think we’re all flying the plane as we’re building it in terms of healthcare infrastructure, » he says.
It will take a huge effort just to identify the right patients, Yang says. People with advanced Alzheimer’s, for example, are not eligible. And people who take blood thinners may face a higher risk of bleeding into the brain.
« So of the millions of Americans who have Alzheimer’s, » he says, « I definitely don’t think this is a drug that’s applicable to most of them. »
An expensive treatment
Lecanemab’s price can be another barrier, even with insurance coverage.
The drug’s maker, Eisai, expects the drug alone to cost $26,500 a year. Diagnostic and follow-up tests will add to this. And a patient’s fee could run into thousands of dollars.
A analyses of lecanemab’s efficacy and value to patients, he found the price tag too steep, Rind says. « A fair price for this would be about $8,900 up to $21,500 a year, which is a very broad price range, » she says.
Rind favors something towards the lower end of that range.
But at its current price, he says, lecanemab could be very profitable for Eisai and its US partner, Biogen.
« I imagine, however, that there will be a lot of people with early Alzheimer’s who will ask for this drug, » she says. « So it could be a multi-billion dollar drug. »