The FDA has approved Leqembi, the first disease-modifying treatment for early-stage Alzheimer’s and a precursor condition, mild cognitive impairment. Medicare said it will pay for the therapy. Medical centers across the country are scrambling to finalize policies and procedures for providing medications to patients, possibly by the end of summer or early fall.
It’s a tense time, with great hope for families and other promising therapies, like donanemab, on the horizon. Still, medical providers are cautious. This is an important first step in developing treatments for complex neurodegenerative diseases, but it is only a first step, said Ronald Petersen, director of the Alzheimer’s Disease Research Center at Mayo Clinics in Rochester, Minnesota.
Unanswered questions abound as this new era of treatment begins for mild cognitive impairment and early-stage Alzheimer’s. Will the primary benefit of Leqembis, a slight slowing of the decline in cognition and functioning, make a significant difference to patients and families, or will it be difficult to discern? Will its effects accelerate, slow down, or level off over time?
Will demand for Leqembi (brand name for lecanemab), a monoclonal antibody that requires infusions every two weeks, be robust or contained? How many seniors in their 70s and 80s will be able and willing to travel to medical centers for twice-monthly infusions and have regular MRI scans and doctor visits to monitor possible side effects such as brain bleeds or swelling?
Clinics caring for Alzheimer’s patients are deciding who will be treated with the new drug Leqembi. It will not be for everyone with memory loss symptoms. (EISAI CO.)
Even with Medicare coverage, how many people will be able to afford the suite of necessary medical services, including cognitive testing, infusions, doctor visits, MRI scans, genetic testing, and lumbar punctures or PET scans to check for amyloid plaques, a hallmark registered Alzheimer’s disease and a precondition for receiving this therapy?
Will primary care doctors begin routinely screening older adults for mild cognitive impairment, something that does not currently happen?
These questions are not surprising, given that these dementia treatments are opening up uncharted territory. Here are some things people should know:
Leqembi basics. Leqembi is very effective in removing amyloid plaques (a protein that clumps between neurons) from people’s brains. But it does not reverse cognitive decline or prevent future deterioration.
In a briefing paper, Eisai, the company that makes Leqembi, said clinical trials showed a 27% slower rate of decline for people taking the drug. But when raw scores on the cognitive scale used to measure outcomes are considered (4.41 for the Leqembi group at the end of 18 months versus 4.86 for the placebo group), the improvement rate was 9%, from according to Lon Schneider, professor of psychiatry, neurology and gerontology at the Keck School of Medicine at the University of Southern California.
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The benefits can be difficult to detect. Research suggests that patients notice a clinically significant change in cognitive performance, a notable change in their ability to think, remember, and perform daily tasks when scores increase by at least 1 point on an 18-point scale used to measure the impact of Leqembis. . But the change detected after 18 months for patients taking this drug was just 0.45.
That’s a tiny difference, and people are unlikely to notice any real change in cognitive functioning, said Alberto Espay, a professor of neurology at the University of Cincinnati College of Medicine.
Petersen has a different perspective, as many patients have told him they would be happy to delay worsening. If we can keep these patients stable for a little bit longer period of time, that will be significant, he told me.
Side effects are common. The pharmaceutical company reported that 17% of patients who took Leqembi had brain swelling and 13% had brain bleeding. Most of these side effects occurred during the first three months of treatment and resolved without serious consequences four months later.
In just over 1 in 4 cases, there were also infusion-related side effects, chills, pain, nausea, vomiting, a rise or fall in blood pressure, and more.
A little discussed side effect is the reduction in brain volume associated with Leqembi and other anti-amyloid therapies. We don’t know what this will mean for patients long term, and that’s concerning,” Espay said.
Because people with the APOE4 gene variant, which increases Alzheimer’s risk, are also at higher risk of side effects from Leqembi, doctors at major medical centers will recommend genetic testing when evaluating potential patients.
Not all patients will qualify. “I’m very carefully selecting patients who I think are appropriate, focusing on people with mild cognitive symptoms who are otherwise healthy,” said Erik Musiek, associate professor of neurology at Washington University School of Medicine in St. Louis.
He has about 20 patients ready to start treatment once the University of Washington begins offering Leqembi, perhaps in early fall. Applying this therapy will be challenging and I think we need to be cautious, he said.
In Los Angeles, UCLA Health has created a multidisciplinary group of experts similar to a cancer tumor board to perform comprehensive evaluations of patients who want to take Leqembi, said Keith Vossel, director of the Mary S. Easton Center for UCLA Alzheimer’s Research and Care. They will disqualify people with evidence of more than four microbleeds on brain MRIs, those taking blood thinners and those with a history of seizures.
At the Mayo Clinic in Minnesota, a new Alzheimer’s therapy clinic will carefully evaluate potential patients over three to four days and treat only people who live within a 100-mile radius. We will start with reasonably healthy patients and follow them closely, Petersen said.
At Mount Sinai School of Medicine in New York City, Mary Sano, director of Alzheimer’s Disease Research, is concerned about elderly patients with mild cognitive impairment who want to take Leqembi but have no evidence of amyloid plaque buildup in the brain. “We will only treat people who are amyloid positive, and I worry that could make people feel like they are not being taken care of,” she said. About 40% to 60% of patients aged 58 and over with mild cognitive impairment are positive for amyloid, research indicates.
Also of concern are patients who have moderate Alzheimer’s or early-stage cognitive impairment due to vascular dementia or various metabolic causes. They would also not be able to take Leqembi and may be disappointed, Sano noted.
The costs can be considerable. Leqembi’s costs are difficult to calculate, since Medicare officials have not announced how much the government will pay for the services. But the University of Southern California estimates that a year of care, including the $26,500 cost of medication, could total about $90,000, according to Schneider.
A separate analysis by the Institute for Clinical and Economic Review suggests that all medical services needed to administer the drug, monitor patients and perform necessary tests could total an average of $82,500 annually, in addition to the direct cost of Leqembi.
Assuming a 20% copay for the patient, this would mean at least $18,000 in out-of-pocket expenses. Although many seniors have supplemental insurance (a Medigap plan or employer-sponsored retirement coverage) to cover these costs, nearly 1 in 10 Medicare beneficiaries do not have this type of protection. And it remains to be seen what policies private Medicare Advantage plans will implement for this drug.
This article was produced by KFF Health Newsformerly known as Kaiser Health News, a national newsroom that produces in-depth journalism on health issues and is one of the major operating programs of the KFF an independent source of health policy research, surveys and journalism.
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