Not long ago here on the Blog, we wrote about the FDA approval of a new drug to combat the effects of Alzheimer’s disease. The new compound, called Leqembi, was hailed by some as a breakthrough, the first drug of its kind that showed evidence in clinical trials of slowing the rate of cognitive decline. But others derided the new drug as yet another overpriced treatment producing marginal improvement at best.

Now that Leqembi’s approval is a done deal, the medical community – including Medicare and Medicaid – are starting to grapple with the questions posed by the availability of this controversial drug. To help sort out some of the issues, many of which could very well end up affecting you or someone you love, we turned to a trusted source, Judith Graham, writing for the website KFF Health News.  In Graham’s recent article, she does a good job explaining some of the underlying facts and challenges revolving around Leqembi. Let’s see what the fuss is all about.

Breakthrough Drug – Yet Doctors are Cautious

“The FDA has approved Leqembi, the first disease-modifying treatment for early-stage Alzheimer’s and a precursor condition, mild cognitive impairment,” Graham begins. “Medicare has said it will pay for the therapy. Medical centers across the country are scrambling to finalize policies and procedures for providing the medication to patients, possibly by summer’s end or early autumn.”

There is, as you might imagine, a lot of weight and hope being placed behind this breakthrough, along with promising therapies like donanemab. And yet, medical providers are also urging caution.

“This is an important first step in developing treatments for complex neurodegenerative diseases, but it’s just a first step,” says Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Disease Research Center in Rochester, Minnesota.

Plenty of Unanswered Questions About Leqembi

While certain answers do seem to be falling into place, there are still plenty of unanswered questions around this treatment, which is said to be more effective for mild cognitive impairment and early stages of Alzheimer’s. For example, “Will Leqembi’s primary benefit — a slight slowing of decline in cognition and functioning — make a significant difference to patients and family members or will it be difficult to discern? Will its effects accelerate, decelerate, or flatten out over time?” Graham poses.

 “Will demand for Leqembi (the brand name for lecanemab), a monoclonal antibody that requires infusions every two weeks, be robust or restrained?” she adds. “How many older adults in their 70s and 80s will be able and willing to travel to medical centers for infusions twice a month and have regular MRI scans and physician visits to monitor for potential side effects such as brain bleeds or swelling?”

And the question of cost is still in the air, too. Even with Medicare coverage, how accessible will this treatment be, considering it requires a whole suite of medical services to go along with it, such as cognitive tests, infusions, doctors’ appointments, MRI scans, genetic tests, and spinal taps or PET scans to verify the presence of amyloid plaques, a hallmark of Alzheimer’s and a precondition for receiving this therapy?

And finally: will primary care physicians start routinely screening older adults for mild cognitive impairment, something that doesn’t happen currently? Graham explores the answers to some of these questions in the following paragraphs.

A Basic Look at a Promising Drug

First, expectations should be clear: Leqembi is not designed to reverse cognitive decline or prevent future deterioration. Instead, is it reportedly quite effective at removing amyloid plaques—a protein that clumps between neurons—from people’s brains.

“In a briefing document, Eisai, the company that makes Leqembi, said clinical trials showed a 27 percent slower rate of decline for people taking the drug,” Graham explains. “But when raw scores on the cognitive scale used to measure results are considered (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 percent, according to Lon Schneider, a professor of psychiatry, neurology, and gerontology at the University of Southern California’s Keck School of Medicine.”

Benefits May Be Difficult to Measure

Will patients benefit from a “clinically meaningful” change in their cognitive performance? This degree of benefit would be reflected in a noticeable alteration in their ability to think, remember, and perform daily tasks. With that standard in mind, early results say that the effects would likely be minimal, especially related to how patients perceive their own abilities.

But the Mayo Clinic’s Dr. Petersen has a different perspective on these results. Many of his patients have expressed a desire to simply put off getting worse, and this would likely be accomplished with Leqembi. “If we can keep these patients stable for a somewhat longer period of time, that’s meaningful,” he says.

Leqembi Comes with Worrisome Side Effects

Apart from questionable rates of improvement, doctors also have to consider some troublesome side effects from taking Leqembi. “The drugmaker reported 17 percent of patients taking Leqembi experienced swelling in the brain and 13 percent had brain bleeds,” Graham writes. “Most of these side effects occurred during the first three months of treatment and resolved without serious consequences four months later. In slightly more than 1 in 4 cases, there were also infusion-related side effects — chills, aches, nausea, vomiting, a spike or drop in blood pressure, and more.”

Another little-discussed side effect is a reduction in brain volume, which is often associated with anti-amyloid therapies. Alberto Espay, a professor of neurology at the University of Cincinnati, is one of many experts who is worried by this. “We don’t know what this will mean to patients long term, and that’s concerning,” he says.

Genetic testing will be a major hallmark of evaluations for potential patients to take Leqembi, since people with what’s known as the APOE4 gene variant—which raises the risk of Alzheimer’s—are also at higher risk of side effects.

Biggest Question: Who Qualifies for Care?

“I’m very carefully selecting the patients I think will be appropriate, focusing on people with mild cognitive symptoms who are otherwise healthy,” says Erik Musiek, an associate professor of neurology at the Washington University School of Medicine in St. Louis.

Musiek has about 20 patients ready to start treatment once Washington University starts offering Leqembi, perhaps by early autumn. Delivering this therapy “is going to be challenging, and I think we need to err on the side of caution,” he says.

“In Los Angeles, UCLA Health has set up a multidisciplinary group of specialists, similar to a cancer tumor board, to undertake comprehensive reviews of patients who want to take Leqembi,” says Keith Vossel, director of UCLA’s Mary S. Easton Center for 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, where Petersen practices, a new clinic will assess potential patients over three to four days and will only treat people who live within a 100-mile radius.  “We’ll start with patients who are fairly healthy and follow them very closely,” Petersen says.

Mount Sinai School of Medicine in New York City is also taking things with caution. Mary Sano, director of Alzheimer’s Disease Research there, already feels for the older patients who have mild cognitive impairment but don’t quality for Leqembi based on their lack of amyloid plaque accumulation. “We’ll only treat people who are amyloid-positive, and I’m afraid this could lead to people feeling like we’re not taking care of them,” she says. Patients who are impaired due to vascular dementia or various metabolic causes are also not eligible for Leqembi.

“About 40 percent to 60 percent of patients 58 and older with mild cognitive impairment are amyloid-positive, research indicates,” Graham adds.

Leqembi’s High Cost is a Huge Barrier

We are still waiting on Medicare officials to announce what the government will pay for services, so costs for Leqembi are currently difficult to calculate. “But the University of Southern California estimates that a year’s worth of care, including the $26,500 cost of the medication, could total about $90,000,” Graham writes.

She adds, “A separate analysis by the Institute for Clinical and Economic Review suggests that all the medical services necessary to administer the drug, monitor patients, and undertake needed testing could total an average of $82,500 yearly on top of Leqembi’s direct cost.”

Assuming a patient copayment of 20 percent, this could mean at least $18,000 out-of-pocket. And while many older adults have supplemental insurance, such as a Medigap plan or employer-sponsored coverage, nearly 1 in 10 Medicare beneficiaries lack these protections.

Graham concludes that “it remains to be seen what policies private Medicare Advantage plans will put in place for this medication.”

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(originally reported at www.kffhealthnews.org)