New Alzheimer’s drug raises hopes along with questions

The FDA has approved Leqembi, the first disease treatment for early-stage Alzheimer’s disease and its precursor condition mild cognitive impairment. Medicare said it would pay for the treatment. Medical centers across the country are working to finalize policies and procedures for providing medications to patients, possibly by late summer or early fall.

It’s a challenging time, with hopes high for families and other promising therapies like donanemab on the horizon. However, medical providers remain cautious. Ronald Petersen, director of the Mayo Clinics Alzheimer’s Disease Research Center in Rochester, Minnesota, said this is an important first step in developing treatments for complex neurodegenerative diseases, but it’s just that. Firstly.

There are many unanswered questions as this new era of treatment begins for mild cognitive impairment and early Alzheimer’s disease. Would Leqembis’s primary benefit of slightly slowing cognitive and functional decline make a significant difference for patients and family members, or would it be difficult to notice? Will its effects accelerate, decelerate, or diminish over time?

Will demand for Leqembi (brand name for lecanemab), a monoclonal antibody that requires biweekly infusions, be strong or limited? How many older adults in their 70s and 80s are able and willing to go to medical centers for twice-monthly infusions and regular MRI scans and doctor visits to monitor potential side effects? like brain bleeding or swelling?

Clinics serving Alzheimer’s patients are learning details about who will be treated with the new drug Leqembi. It will not be for everyone with symptoms of dementia.(EISAI CO.)

Even with Medicare coverage, how many people can afford the necessary package of medical services, including cognitive testing, intravenous fluids, doctor’s appointments, MRI scans, genetic testing and punctures? spinal tap or PET scan to verify the presence of amyloid plaques, signs of Alzheimer’s disease, and prerequisites for receiving this therapy?

Will primary care physicians begin to routinely screen older adults for mild cognitive impairment, which is not currently happening?

These questions are not surprising because these dementia treatments are opening up unexplored areas. Here are some things everyone should know:

Basic Leqembi. Leqembi is very effective in removing amyloid plaques (a protein that clumps between nerve cells) from the human brain. But it does not reverse cognitive decline or prevent future cognitive decline.

In a briefing document, Eisai, the company that makes Leqembi, said clinical trials showed a 27% slower rate of health decline in people taking the drug. But when looking at raw scores on the cognitive scale used to measure outcomes (4.41 for the Leqembi group at the end of 18 months versus 4.86 for the placebo group), the rate of improvement was 9%, according to Lon Schneider, professor of psychiatry, neurology and geriatrics at the Keck School of Medicine at the University of Southern California.

Benefits can be difficult to detect. Research shows that patients notice a clinically meaningful change in cognitive functioning, a noticeable change in the ability to think, remember and perform daily tasks as scores increase At least 1 point on the 18-point scale is used to measure the impact of Leqembis. But the change detected after 18 months for patients taking this drug was only 0.45.

It’s a minimal difference, and people are unlikely to notice any real change in cognitive performance, said Alberto Epay, a professor of neurology at the University of Cincinnati College of Medicine.

Petersen has a different view because many patients have told him they would be happy to delay their condition from getting worse. He told me that if we could keep these patients stable over a longer period of time, it would make sense.

Side effects are common. The drugmaker reports 17% of patients taking Leqembi experienced brain swelling and 13% experienced brain bleeding. Most of these side effects occurred during the first three months of treatment and resolved without serious consequences four months later.

In more than 1 in 4 cases, there are also infusion-related side effects, chills, aches and pains, nausea, vomiting, increased or decreased blood pressure, etc.

A less discussed side effect is brain volume loss associated with Leqembi and other anti-amyloid therapies. We don’t know what this will mean for patients in the long term, and that’s worrying,” Epay said.

Because people with the APOE4 gene variant, which increases the risk of Alzheimer’s disease, are also at higher risk for Leqembi side effects, doctors at major medical centers will recommend genetic testing when they evaluate potential patients.

Not all patients will qualify. Erik Musiek, associate professor of neurology at Washington University School of Medicine in St. Louis, said: “I am very careful in selecting patients who I think will be suitable, focusing on those who have mild cognitive symptoms but are otherwise healthy.”

He has about 20 patients ready to begin treatment when the University of Washington begins offering Leqembi, perhaps in early fall. “Providing this therapy will be challenging and I think we need to be cautious,” he said.

In Los Angeles, UCLA Health has established a multidisciplinary team of experts, similar to a cancer tumor board, to conduct a comprehensive evaluation of patients who want to take Leqembi, said Keith Vossel, director of the Center for Cancer Research. Alzheimer’s Disease Research and Mary S. Easton of UCLA said. Care about. They will exclude people who have evidence of more than four small hemorrhages on brain MRI scans, people who are taking blood thinners, and people with a history of seizures.

At the Mayo Clinic in Minnesota, a new Alzheimer’s therapy clinic carefully evaluates potential patients within three to four days and treats only those who live within a 100-mile radius. Start with fairly healthy patients and monitor them closely, Petersen says.

At Mount Sinai School of Medicine in New York City, Mary Sano, director of Alzheimer’s Disease Research, is concerned about older patients with mild cognitive impairment who want to take Leqembi but have no evidence of plaque buildup amyloid in their brains. “Only treat people who are amyloid positive, and I fear this might make people feel like they’re not taking care of them,” she said. Research shows that about 40% to 60% of patients 58 years of age and older with mild cognitive impairment test positive for amyloid.

Also of concern are patients with moderate Alzheimer’s disease or early cognitive impairment due to vascular dementia or various metabolic causes. Sano noted that they would also not be able to capture Leqembi and would likely be disappointed.

Costs can be significant. Leqembi’s costs are difficult to calculate because Medicare officials have not announced how much the government will pay for the services. But the University of Southern California estimates that a year’s worth of care, including the $26,500 cost of medications, could run about $90,000, according to Schneider.

A separate analysis by the Institute for Clinical and Economic Review found that all the medical services needed to administer medications, monitor patients, and perform necessary tests can have an average total cost. is $82,500 annually over Leqembis’s direct costs.

Assuming the patient has to pay a 20% copay, that would mean an out-of-pocket cost of at least $18,000. While many older adults have supplemental insurance (a Medigap plan or employer-sponsored retiree insurance) to cover these costs, nearly 1 in 10 Medicare beneficiaries lack this type of coverage. this protection. And it remains to be seen what policies private Medicare Advantage plans will adopt 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 core operating programs at KFF an independent source of health policy research, polling and journalism.