One year after Leqembi became the first FDA-approved drug shown to slow Alzheimer's disease progression, its adoption has been slower than anticipated, with healthcare systems carefully implementing treatment protocols and patients navigating complex qualification requirements.
Japan's Eisai, the drug's manufacturer, initially projected 10,000 patients would be receiving Leqembi by March 2024 but has since backed away from that estimate. Major hospital systems have taken months to establish treatment protocols, and some insurers have rejected coverage despite the drug's breakthrough status.
Healthcare Systems Building New Infrastructure
"It's not like we are adding a drug to an existing system," explained Alexander Scott, an Eisai executive vice president. "They are building the system for the drug."
The Cedars-Sinai health system in Los Angeles only began administering Leqembi in early March after months of planning to coordinate diagnosis, treatment, and monitoring protocols. Dr. Sarah Kremen, a behavioral neurologist at Cedars-Sinai, emphasized their cautious approach: "We were very careful about it."
Similarly, Banner Health in Arizona has implemented a limited rollout at specialty clinics in Phoenix, while Mayo Clinic restricts treatment to patients living within a 100-mile radius of their Rochester, Minnesota facility to ensure rapid response to potential side effects.
Navigating Coverage and Cost Barriers
With a price tag exceeding $26,000 annually, insurance coverage remains a significant concern. While Medicare covers the drug for patients 65 and older, younger patients face particular challenges. Scott Berkheiser, a 57-year-old Florida resident, experienced months of insurance denials before finally receiving his first infusion in December, with the manufacturer eventually providing the drug for free while he makes co-payments for infusions.
"It was a little crazy," Berkheiser said. "It seemed like it was kind of a game that must make sense for some monetary reason."
According to Eisai, nearly three-quarters of commercial insurance plans in the U.S. now cover the drug outside Medicare, but physicians remain concerned about access barriers.
The Narrow Treatment Window
The drug's effectiveness is limited to patients in early disease stages, creating urgency for timely diagnosis and treatment initiation. Texas Neurology had 60 pre-screened potential candidates on a waitlist when Leqembi launched, but only eight eventually started treatment. The rest either declined therapy or had progressed beyond the mild phase when reassessed.
"That window gets very short very quick," noted David Evans, CEO of Texas Neurology.
The diagnostic process itself presents challenges. Dr. Ambar Kulshreshtha, a suburban Atlanta physician specializing in dementia, explained that when patients mention memory concerns, doctors must first rule out reversible causes like thyroid problems, vitamin deficiencies, medication issues, or depression before conducting memory tests across multiple visits.
Additionally, some patients may be ineligible for Leqembi due to conflicts with medications they take to prevent strokes, and specialist appointments with neurologists who prescribe the drug can have months-long waiting periods.
Patient Experiences and Clinical Reality
For patients who successfully begin treatment, the experience has been manageable. Berkheiser reports that his infusions have gone "like clockwork" since his delayed start, fitting them between his work as an engineer and training for an Ironman triathlon.
Charles "Bum" Clegg, who recently completed his 13th Leqembi infusion at a treatment center near his Alabama home, has experienced no side effects and notes improvements in his short-term memory, according to his wife Carol. "This drug gives you hope," she said.
However, medical experts caution about the drug's limitations. Leqembi clears amyloid, a sticky brain protein associated with Alzheimer's, but its clinical benefit is modest—delaying disease progression by only a few months in studies. Some experts question whether this delay is significant enough for patients to notice.
The drug also carries risks of brain swelling and bleeding, requiring regular brain scans for monitoring. Patients must meet strict eligibility criteria, including being in early disease stages and having confirmed amyloid plaques in their brains. By some estimates, fewer than 20 percent of Alzheimer's patients qualify for treatment.
Looking Toward Future Treatments
Despite these challenges, the medical community sees Leqembi as an important first step. "This is the start of a very exciting journey," said Dr. Kulshreshtha.
Treatment access may improve as new options emerge. The FDA recently approved Eli Lilly's donanemab (brand name Kisunla), another anti-amyloid antibody. Eisai is developing an injectable version of Leqembi that would simplify administration, and blood tests may eventually accelerate amyloid detection.
Researchers emphasize that much remains unknown about Alzheimer's disease, which affects more than 6 million Americans and millions more worldwide. Many believe combination therapies will ultimately be needed.
"We still have a lot to learn about Alzheimer's," said Dr. Eric Widera, a geriatric specialist with the University of California San Francisco. "It's complex, and it's much more than amyloid."
