New Alzheimer’s drug raises hopes — along with questions

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

This is a difficult moment for the family, with so much hope and other promising treatments on the horizon, including donanemab. Still, medical workers are cautious. “This is an important first step in developing treatments for a complex neurodegenerative disease, but it is just the first step,” said Ronald Petersen, director of the Alzheimer’s Disease Research Center at the Mayo Clinic in Rochester, Minnesota. said.

As this new era of treatment for mild cognitive impairment and early Alzheimer’s disease begins, there are many unanswered questions. Will Rekenbi’s main benefit of slightly slowing cognitive and functional decline make a big difference to patients and families, or is it difficult to tell? Will it accelerate, slow down, or level off?

Will demand for Leqembi (trade name for lecanemab), a monoclonal antibody that requires intravenous infusion every two weeks, be steady or suppressed? The elderly, in their 70s and 80s, go to a medical center twice a month for IV infusions and have regular MRI scans and doctor visits to monitor potential side effects, such as brain bleeding or swelling. How many people can and are willing to do it?

Clinics that treat people with Alzheimer’s disease are working out details of who should be treated with the new drug Requemby. This does not apply to everyone who has symptoms of forgetfulness. (Eisai Co., Ltd.)

Even if Medicare covers you, you can still afford the full range of medical services you need, including cognitive tests, IV fluids, doctor visits, MRI scans, genetic testing, and spinal taps and PET scans to confirm the presence of amyloid plaques. How many people do you know? Is it a feature of Alzheimer’s disease and a prerequisite for receiving this treatment?

Will primary care physicians routinely screen older adults for mild cognitive impairment, which is not currently the case?

These questions are not surprising, given that these dementia treatments are opening up uncharted territory. Some of the things people should know are:

Basics of Rekenbi. Rekenbi is highly effective in removing amyloid plaques (proteins that clump between neurons) from people’s brains. However, it cannot reverse cognitive decline or prevent future cognitive decline.

in Explanatory material, Eisai, which manufactures Rekenbi, announced that clinical trials showed that people who took the drug experienced a 27% slower rate of decline. However, when considering the raw scores on the cognitive scales used to measure outcomes (4.41 for the Rekenbi group and 4.86 for the placebo group at the end of 18 months), the improvement rate was 9%, says Ron Schneider. the professor said. She majored in psychiatry, neurology, and geriatrics at the Keck School of Medicine at the University of Southern California.

The benefits can be difficult to spot. The study found that an increase in score of at least one point on the 18-point scale used to measure Requemby’s effects was associated with a “clinically meaningful” change in cognitive ability, meaning thinking, memory, and daily tasks. They have been shown to notice noticeable changes in their ability to perform. However, the change detected after 18 months in patients taking the drug was only 0.45.

“This is a minimal difference, and it’s unlikely that people will notice any real change in cognitive function,” says Alberto Espey, a professor of neurology at the University of Cincinnati College of Medicine.

Petersen has a different perspective, as many patients have said they want to postpone the disease. “If we can keep these patients stable for some extended period of time, that makes sense,” he told me.

Side effects are common. The drug company reported that 17% of patients taking Requemby experienced brain swelling and 13% experienced cerebral hemorrhage. Most of these side effects occurred during his first 3 months of treatment and resolved after 4 months without serious consequences.

Slightly more than 1 in 4 cases also had infusion-related side effects, including chills, pain, nausea, vomiting, and a spike or drop in blood pressure.

A less-discussed side effect is the reduction in brain volume associated with Requemby and other anti-amyloid therapies. “We don’t know what this means for patients in the long term, but it’s concerning,” Espey said.

People with the APOE4 gene mutation, which increases the risk of Alzheimer’s disease, are also at higher risk for Rekenbi’s side effects, so doctors at major medical centers will likely recommend genetic testing when evaluating potential patients.

Not all patients are eligible. “We’re focusing on people who have mild cognitive symptoms and are otherwise healthy, and we’re carefully selecting patients who we think are appropriate,” said Eric Muzik, an associate professor of neurology at Washington University School of Medicine in St. Louis. Ta.

About 20 patients are poised to begin treatment once the University of Washington begins offering Rekenbi, likely by early fall. Providing this treatment “is going to be difficult, and I think we need to be cautious,” he says.

In Los Angeles, UCLA Health will conduct a comprehensive review of patients who wish to take Requemby by conducting a comprehensive review of patients who wish to take Requemby, according to Keith Vossel, director of the Mary S. Easton Alzheimer’s Disease Research Center at the University of California, Los Angeles. He said he has established an interdisciplinary expert group. Care. Those with evidence of four or more microbleeds on a brain MRI scan, those taking blood thinners, or those with a history of seizures will be disqualified.

A new Alzheimer’s treatment clinic at the Mayo Clinic in Minnesota carefully evaluates potential patients over three to four days and treats only those who live within a 100-mile radius. “We start with fairly healthy patients and follow them closely,” Petersen said.

Mary Sano, director of Alzheimer’s disease research at the Mount Sinai School of Medicine in New York City, said older people with mild cognitive impairment who want to take Requembi but have no evidence of amyloid plaque buildup in their brains. Concerned about the patient. “We only treat people who are positive for amyloid, and I worry that this will make people feel like we don’t value them,” she says. Studies have shown that approximately 40-60% of patients with mild cognitive impairment over the age of 58 are amyloid positive.

Also of concern are patients with vascular dementia and moderate Alzheimer’s disease or early stages of cognitive impairment due to various metabolic causes. Sano pointed out that they too are likely to be disappointed as they will not be able to get Lekembi.

The costs can be significant. Calculating the cost of Requembi is difficult because Medicare officials have not announced how much the government will pay for the service. But Schneider said the University of Southern California estimates that the cost of one year’s treatment, including the $26,500 drug bill, could total about $90,000.

Another analysis According to the Institute for Clinical and Economic Reviews, all the medical services needed to administer the drug, monitor patients, and perform the necessary tests can cost an average of $82,500 per year on top of Requemby’s direct costs. is suggested.

Assuming a patient copayment of 20%, you would incur at least $18,000 in copayments. Many seniors have supplemental insurance (Medigap plans or employer-provided retiree coverage) to cover these costs, but nearly 1 in 10 Medicare beneficiaries does not have this kind of protection. And it remains to be seen what policies private Medicare Advantage plans will have on the drug.

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