The first drug shown to slow Alzheimer’s disease hit the U.S. market over a year ago, but sales have lagged, major hospital systems have taken months to start using it and some insurers have rejected coverage.
Doctors also expect some patients will hesitate to take Leqembi due to its limited impact and potential side effects. They say it will take years to learn how best to deploy the drug and that work must be done to improve diagnosis.
“This is the start of a very exciting journey,” said Dr. Ambar Kulshreshtha, a suburban Atlanta family physician focused on dementia patients.
More than 6 million Americans, and millions more worldwide, have Alzheimer’s disease, the most common cause of dementia. There’s no cure, but Leqembi clears a sticky brain protein called amyloid that’s a key indicator of Alzheimer’s.
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Studies showed that it can delay the progression of the disease by a few months when given to people with mild symptoms. Some experts say the delay may be too subtle for patients to notice.
Scott Berkheiser, 57, who has Alzheimer's disease, is seen at his home April 5 in Venice, Fla. Insurance denials delayed Berkheiser’s first Leqembi infusion a few months until last December. He said the drugmaker eventually agreed to give it to him for free while he makes co-payments for the infusions. “It was a little crazy,” he said. “It seemed like it was kind of a game that must make sense for some monetary reason.”
The drug also can cause brain swelling and bleeding. Patients need regular brain scans to monitor for that.
The Food and Drug Administration gave Leqembi full approval last summer for patients with early stages of the disease. The federal Medicare program for people ages 65 and over covers Leqembi and the cost of scans needed to diagnose patients.
The drug's maker, Japan's Eisai, initially expected to have 10,000 patients taking the IV drug by the end of March. Company executives have since backed off that projection, though they say sales are growing.
Hospitals and health systems have needed more time than expected to set up their systems for delivering Leqembi, said Alexander Scott, an Eisai executive vice president.
“It’s not like we are adding a drug to an existing system,” he said. “They are building the system for the drug.”
The Cedars-Sinai health system in Los Angeles started administering the drug in early March. Getting there required months of meetings to iron out a plan to coordinate diagnosis, treatment and then monitoring for problems.
“We were very careful about it,” said Dr. Sarah Kremen, a behavioral neurologist.
Banner Health in Arizona also recently started using Leqembi at a couple of specialty clinics in Phoenix, a spokeswoman said.
The first drug shown to slow Alzheimer’s disease, Legembi, hit the U.S. market in 2023, but sales have lagged, major hospital systems have taken months to start using it and some insurers have rejected coverage.
“This is a very phased and staged approach,” said Dr. Alireza Atri, a neurologist who has worked as a paid consultant for Eisai. “As we learn more, we’ll expand and extend it.”
The Mayo Clinic in Rochester, Minnesota, started using Leqembi in October but only for patients who live within a 100-mile radius so it can reach them quickly if they develop side-effect symptoms. Doctors evaluate three to five patients every week for potential treatment, said Alzheimer’s expert Dr. Ron Petersen.
Health systems are still trying to understand how coverage for the drug, its infusions and the needed scans work so patients don’t get stuck with bills. That’s a significant variable for a drug that can cost more than $26,000 a year.
An Eisai spokeswoman said nearly three-quarters of commercial plans in the U.S. cover the drug outside Medicare.
But doctors are concerned that coverage still may be tough for some patients, especially those too young to qualify for Medicare.
Insurance denials delayed Scott Berkheiser’s first Leqembi infusion a few months until last December. The 57-year-old Venice, Florida, resident said the drugmaker eventually agreed to give it to him for free while he makes co-payments for the infusions.
“It was a little crazy,” he said. “It seemed like it was kind of a game that must make sense for some monetary reason.”
Getting treatments started on time remains another challenge.
Texas Neurology had 60 patients screened as possible candidates for Leqembi and on a waitlist when the drug launched last year. Only eight eventually started treatment. The rest either declined to take it or had advanced beyond the mild phase of the disease when they were rescreened, CEO David Evans said.
“That window gets very short very quick,” he said.
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Doctors say more must be done to quickly identify patients and get treatment started before the disease advances. But that’s a murky process.
If people mention memory trouble, doctors must rule out reversible causes like thyroid problems, vitamin deficiencies, medication issues or depression, Kulshreshtha said. Then memory tests for dementia can take a few visits.
Some patients may be ineligible for Leqembi because it would conflict with medication they already take to prevent strokes.
And then getting in to see a neurologist who prescribes the drug can take months.
Those who make it to the first infusion say the treatment process is manageable. Berkheiser says infusions have gone “like clockwork” since his delayed start.
He fits them in between his work as an engineer and training six days a week to compete in an Ironman triathlon.
Charles “Bum” Clegg recently finished his 13th Leqembi infusion. The Salem, Alabama, resident visits a treatment center only 15 minutes from his home.
Clegg and his wife, Carol, say he has had no side effects, and his short-term memory has improved.
“This drug gives you hope,” Carol said.
Seniors in these states have the highest Alzheimer's rates
Seniors in these states have the highest Alzheimer's rates
Alzheimer's disease afflicts an estimated 6.7 million Americans, and that number is only growing. Without a breakthrough in prevention—or a cure—medical professionals believe the volume of diagnoses could double by 2060.
For the first time, the Alzheimer's Association has released estimates on Alzheimer's prevalence in each state and county. Researchers hope the estimates will help regional public health officials better treat Alzheimer's patients, develop localized care plans, and budget for care—particularly as new treatments come at a cost.
Alzheimer's is the most common form of dementia, and among the top 10 causes of death in the U.S. These deaths are increasing as deaths from other health-related causes, including heart disease and stroke, are on the decline. With Alzheimer's, the brain shrinks, brain cells die, and peoples' memory and language centers fail. As the disease advances, the loss of brain function leads to dehydration, malnutrition, infection, and ultimately death.
Progress on finding a cure or effective treatment for Alzheimer's has been slow, as medical professionals still don't know what causes it. But earlier this year, the Food and Drug Administration fully approved the first drug to effectively treat the disease: lecanemab, created by Eisai Inc. and Biogen. Earlier treatments addressed symptoms of Alzheimer's—rather than the disease itself—while lecanemab treats early stages of the disease and slows its progression.
The drug costs $26,500 annually and is partially covered by Medicare if the patient's medical team participates in a registry to track the drug's outcomes. Those high costs could keep the treatment out of reach for low-income Americans, who already have higher odds of developing Alzheimer's, studies have shown.
Nearly all Alzheimer's patients are on government insurance, and estimates show that Medicare could spend $2 billion to $5 billion annually on lecanemab and related care. That's not much compared to the $345 billion that Alzheimer's and other dementias cost in 2023, including nursing home stays, symptom management medications, and other care for those with the disease.
Without medical advancements, the Alzheimer's Association expects those costs could rise to nearly $1 trillion by 2050. If lecanemab and similar drugs can slow progression in even half of mild Alzheimer's patients, Americans would save $212 billion to over $1 trillion in care-related costs over the next decade, one study from the University of Chicago estimates.
Having a treatment to slow the progression of Alzheimer's also creates more urgency to diagnose the disease sooner to retain more brain function. Warning signs for the disease include disruptive memory loss, difficulty with familiar tasks, worsening judgment, and changes in mood and personality, among others.
In the U.S., there is a shortage of specialists in elder and memory-related medicine as well as a shortage of nurses to provide care at nursing homes and assisted-living facilities. In regions with high rates of Alzheimer's, these shortages could be particularly catastrophic within the current models of care.
To see areas most at risk, Stacker mapped states by the share of the 65+ population estimated to have Alzheimer's disease, using data released by the Alzheimer's Association in July 2023.
Alzheimer's rates by state
State and detailed county-level estimates show vast disparities in the prevalence of Alzheimer's disease based on racial and socioeconomic factors. That is by design, as older Americans, women, Black and Hispanic Americans, and those with lower education levels are at higher risk for developing Alzheimer's dementia, according to data from the Chicago Health and Aging Project, which these estimates were based on.
The East and Southeast regions of the U.S. were estimated to have the highest prevalence of Alzheimer's, particularly Maryland, New York, Florida, Mississippi, and Louisiana. In Maryland, nearly 30% of residents are Black and a slightly higher share of the population is 85+ years old compared to national numbers—substantial risk factors that earn it the #1 spot. In addition to a high prevalence of the disease, Mississippi has the highest Alzheimer's mortality rate, largely due to having the worst-quality health care system in the country, Time reported.
Some of the most afflicted counties are home to Black and Hispanic populations in the South, low-income populations in Appalachia, and older adults in Florida, according to Time. Other studies have found that people in rural areas tend to be underdiagnosed or diagnosed in later stages of dementia, delaying or preventing potential treatments.
Alzheimer's Association volunteers have been using the data to advocate for public policy priorities with elected officials, the association's senior director of government affairs in New York, Bill Gustafson, told Stacker via email. Advocates in New York recently utilized the state and county data to advocate for more resources for the Alzheimer's Community Assistance Program and the Special Needs Assisted Living Voucher Demonstration Program for Persons with Dementia. The state of New York budgets $26 million annually for services for Alzheimer's patients and announced new funding in September 2023 to focus on high-risk, rural, and historically underserved communities.
"This data is a tool to help the Alzheimer's Association demonstrate the public health crisis the disease poses for the state and, with that knowledge, urge our elected officials to support dementia-specific policy to address said crisis," Gustafson said.
Beyond medicine, doctors and researchers are evolving patient care for those with Alzheimer's, as well. One French facility creates autonomy for patients in a village-like setting, aiming to create normalcy, improve life quality, and reduce stress and depression. As treatments progress, the U.S. federal government is testing a new payment program for dementia care providers, aiming to delay nursing home stays.
Between advancing medicines, treatments, and databases, as well as shortages of caregivers and medical professionals in the field, change is on the horizon for Alzheimer's care in the U.S. and beyond.
Story editing by Ashleigh Graf. Copy editing by Tim Bruns.
