Alzheimer’s drug Leqembi gets FDA approval: Cost, side effects, access

The U.S. Food and Drug Administration gave full approval earlier this month to Leqembi, the first drug that has been shown to slow the progression of early-stage Alzheimer’s disease and in people who have mild cognitive impairment.

The approval means that for the first time, the treatment — a monoclonal antibody infusion given twice a month — will be available outside of clinical trials and will be covered by Medicare.

“It’s huge for for people living with this disease,” said Karen Schelberg, care consultation director for the Alzheimer’s Association Michigan Chapter. “It gives individuals more time to participate in the activities they love with their grandchildren, driving, traveling, living independently for longer, recognizing their loved ones.”

Although it won’t reverse memory loss or stop it, an 18-month study showed Leqembi slows disease progression by about five to six months, she said.

Obstacles to access

While the approval of Leqembi gives people some hope, getting treatment will require leaping some pretty substantial hurdles.

Patients will need access to specialists who can prescribe testing to confirm that their memory changes are caused by Alzheimer’s disease. They’ll also need access to an infusion center to receive the drug twice each month and regular brain imaging tests to ensure they aren’t having complications, such as bleeding or swelling in the brain. That’s a big challenge for people who live in rural areas a long distance from medical facilities with specialists and equipment to provide those tests.

Additionally, Leqembi isn’t cheap. The annual cost is $26,500. Medicare will cover 80% of that, but unless they have supplemental insurance or also are covered by Medicaid, many patients will have to pick up the copay, plus their share of the costs for the infusions, imaging tests and more.

“There’s a lot of pieces to it,” Schelberg said. “It’s not like doctors can say: ‘Here’s a pill’ and you go on your merry way.”

How does Leqembi work?

Leqembi targets the amyloid protein that builds up in the form of plaques in the brains of people with Alzheimer’s disease, said Dr. Judith Heidebrink, a neurologist at Michigan Medicine and clinical core co-lead of the Michigan Alzheimer’s Disease Center.

“It’s one of several types of drugs that we’ve known have the potential to get into the brain to bind to the amyloid and remove the amyloid, but this is the first one that’s being given full approval,” Heidebrink said. “It’s been approved based on not just a biological effect of removing amyloid, but a clinical effect of slowing the progression of symptoms of people with the early symptoms of Alzheimer’s disease.”

Who is eligible for Leqembi?

The ideal candidate is a person who has what’s called mild cognitive impairment, a stage that’s even earlier than dementia, Heidebrink said, or someone with very mild Alzheimer’s dementia.

“That’s an individual whose … thinking is declining and testing does demonstrate a drop from … what just would be from normal aging,” she said. “So they’ve got confirmed changes in their thinking, but they’re still functioning on their own. Maybe they’re getting by with a lot of good memory aids. They use a lot of calendars, reminder notebooks, things like that.

“They’re still independent, but clearly there’s a detectable memory change.”

The FDA’s labeling of Leqembi requires proof that Alzheimer’s is the cause of early-stage dementia or mild cognitive impairment, and that amyloid plaque is building up in the brain.

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That means physicians are likely to order tests, such as a positron emission tomography (PET) scan or possibly a spinal tap to identify amyloid proteins in cerebrospinal fluid so they have documented evidence of Alzheimer’s brain changes before they can prescribe Leqembi, Heidebrink said.

“We always recommend starting with your primary care physician because not all memory lapses are abnormal or a sign of Alzheimer’s,” Heidebrink said. “Get the initial evaluation. Do we think there is a change that’s beyond just normal aging? Have we looked for easily treatable causes? They may do a series of blood tests, look at brain scans. This is a starting point. … If this person is likely in the early stages of Alzheimer’s, then a referral to a specialist who can help confirm that diagnostic evaluation and specifically determine if the person is an appropriate candidate for this medication.”

How many people have Alzheimer’s disease?

About 6.7 million Americans have Alzheimer’s disease, according to the Alzheimer’s Association.

About 190,000 people older than 65 in Michigan were living with Alzheimer’s disease in 2020, Schelberg said. By 2025, that number is expected to grow to 220,000.

It’s hard to say how many of them have the early-stage disease or mild cognitive impairment that would qualify for Leqembi treatment, Schelberg said. However, the Alzheimer’s Association reports that roughly 8% to 11% of adult Americans 65 and older nationally may fall into that designation.

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How much does Leqembi cost?

“The drug price alone is currently $26,500 a year, but it’s an intravenous drug, and so there are additional costs for delivering the infusion therapies,” Heidebrink said. “There also needs to be testing to determine who is appropriate, both in terms of who clearly has amyloid building up in the brain and whether they are at the right stage to have a potential benefit. And then there also is safety monitoring because we know there are uncommonly serious side effects that can occur with this treatment.”

Medicare will cover 80% of the cost of the drug after a person meets their deductibles, which means, Schelberg said, that “people may be responsible for $5,300 out-of-pocket. If someone has a supplemental plan or Medicare Advantage plan, those plans may pick up more of the cost so it may be less. Also, if someone is dual eligible for Medicare and Medicaid, Medicaid’s role is to cover the 20% coinsurance payment.”

Schelberg said it’s unclear whether Leqembi will be covered by private insurance companies.

“As far as what individual plans/supplemental plans will cover, that’s still being decided,” she said. “The hope is now that Medicare has approved it, third-party payers will also follow their lead.”

What are the side effects of Leqembi?

The FDA says the most common side effects are headache and infusion-related reactions, the agency warns that Leqembi can cause serious bleeding in the brain or brain swelling.

“Everyone needs to have a baseline brain scan,” Heidebrink said. Then, they’ll need several repeated MRI scans during treatment to ensure there is no evidence of bleeding or swelling.

“Typically, it’s going to be three or four (MRI tests) in the first year of treatment … to be able to deliver this treatment safely.”

People who have two copies of the apolipoprotein E gene called APOE4 may be at higher risk for those serious complications, studies have shown.

“It’s long been known that having the APOE4 type increases one’s risk of Alzheimer’s symptoms over your lifetime, and particularly if you have both copies of the E4, but it’s also a risk factor for side effects to this medication, bleeding or swelling,” Heidebrink said.

“Likely that’s because if you’ve got the E4, you may have more amyloid accumulation not just affecting the nerve cells but also around blood vessels in the brain. And so, if this drug is getting in pulling out that amyloid, the blood vessels get leaky and you can get fluid shifts or you can get the bleeding.”

For that reason, Heidebrink said, she recommends that anyone who wants to try Leqembi also have genetic testing to find out what their APOE type is, “so we’ll know whether they’re at higher risk or lower risk and can take that into account in making the decision.”

People who are taking blood thinners, she said, may not be good candidates for Leqembi.

Are there other treatments in the research pipeline?

Yes, including a promising study using the same drug, Heidebrink said.

“This drug has been approved for people with the early symptoms of Alzheimer’s disease, but there are folks who have sort of an asymptomatic buildup of amyloid … a silent phase that occurs when, for example, the amyloid proteins are building up and yet there are no detectable cognitive symptoms,” she said. “That may go on for many years before the earliest symptoms, the early consistent forgetfulness that starts to characterize the symptomatic phase of Alzheimer’s disease.

“There is an ongoing trial with this same exact medication to see if it might be helpful as a prevention and therapy by treating people when that amyloid is accumulating even before symptoms develop.

“If you slow down the brain disease before the symptoms develop, then essentially you have a cure,” Heidebrink said.

Contact Kristen Shamus: khamus@freepress.com. Subscribe to the Free Press.

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