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Neurologist Offers Perspective on Lequembi, Alzheimer’s Drug Newly Approved by FDA

This could be the beginning of a change in Alzheimer’s disease management,” says Dr. Andrea An


The FDA has fully approved Lequembi (lecanemab) for early-stage Alzheimer's treatment.

CHANDLER, Ariz.—Andrea An, M.D., has practiced neurology and treated a range of conditions, including dementias, for more than 20 years. In that time, she considers the U.S. Food & Drug Administration’s recent, final approval of Lequembi (lecanemab) as one of the most “significant” advancements for Alzheimer’s disease.


“This could be the beginning of a change in Alzheimer’s disease management,” says An, medical director of Neurology Associates Neuroscience Center in Arizona.


That’s because Lequembi, from Japan-based Eisai, stands out as the first drug that targets amyloid plaque buildup, the suspected root of Alzheimer’s.


Of note, though, is that Lequembi must be started early in the Alzheimer’s disease cycle to slow the progression. That unfortunately eliminates Lequembi as an option for many of the 6 million-plus Americans living with the most common cause of dementia.

Side Effects a Source of Concern

Dr. Andrea An, medical director at Neurology Associates Neuroscience Center, discusses the FDA's full approval of Lequembi (lecanemab), a drug intended for early-stage Alzheimer's treatment.

And while An sees promise in Lequembi, and a similar pharmaceutical, Eli Lilly’s donanemab, she encourages caution. Both Lequembi and donanemab (which is awaiting its own FDA approval) come with risk, namely brain swelling and bleeding. Donanemab, especially, has led to issues seen in clinical trials that raise some concern, An says.


“Side effects are similar to Leqembi, but Leqembi patients seem to have done better with the potential complications than in the donanemab trial,” she notes.


Furthermore, it’s hard for doctors to weigh the drugs against one another because the clinical trials for each were designed differently.

“Comparisons have to be carefully interpreted,” An says.


As such, An advises patients and their families who may be considering whether either drug might benefit them to consult with their neurologists. It will be vital to seek out expert perspectives on whether the potential benefits outweigh the consequences.


Paying for Lequembi


Importantly, the FDA’s full approval of Lequembi gives Medicare clearance to start covering some or all of the $26,500-per-year cost. Right now, though, what Medicare ultimately will pay for remains unclear. An anticipates the agency to clarify its position soon. In addition, she says, patients not on Medicare may also be affected by the body’s coverage decisions for Leqembi.


“Outside of academic centers or oncology, doctors don’t use medications that are not covered by Medicare, largely due to cost,” An says. “Patients can’t pay for such expensive treatments.”


But when measuring the cost of Alzheimer’s disease itself, early treatment may actually prove the cheaper route, An says.


“The upfront cost of treatment with these new meds may not be all that high if you consider the cost of managing Alzheimer’s later in the disease,” she explains. “These patients require around-the-clock care.”


That means, she adds, that when estimating Lequembi’s price tag against long-term care for an untreated Alzheimer’s patient, drugs such as Lequembi might turn out to be less of a financial burden.

Red Tape Could Hold up Lequembi Access


Keep in mind that money isn’t the only obstacle standing in the way of Lequembi treatment. Bureaucracy and attainability will present more challenges to access, too.


To the first point, uncertainty surrounds the healthcare system’s ability to deliver lecanemab (or even donanemab). There’s a big question mark around whether there are enough doctors comfortable with prescribing Lequembi and enough infusion centers equipped to dispense it (Lequembi is administered intravenously).


To the second point, Eisai, the maker of Lequembi, has said that about 100,000 Americans — far fewer than the number who have Alzheimer’s — could get the diagnosis and eligibility to receive the drug by 2026.

Lequembi Treatment: ’Case-by-Case Assessment’


Right now, experts including An are waiting and watching. There remains a lot to learn about Lequembi and its likely upcoming rival, donanemab. As such, Alzheimer’s patients and their families may not get answers right away, and An knows how frustrating that is.


“Doctors want to do the absolute best for our patients that we can, as soon as we can,” she says. “Sometimes that means we have to recommend holding off on making decisions until we have more information. Depending on the patient, that may apply to whether someone should take Lequembi or donanemab. It’s definitely a case-by-case assessment.”


ABOUT NEUROLOGY ASSOCIATES NEUROSCIENCE CENTER

Neurology Associates Neuroscience Center (NeurologyAssociates.com) specializes in the conditions and disorders linked to brain and spinal abnormalities. Neurology Associates takes patient care beyond typical boundaries, incorporating a truly holistic approach that encompasses imaging, psychiatry, neuropsychology, physical therapy, naturopathic medicine, counseling, cognitive rehabilitation, and more. Neurology Associates is staffed by neurologists with different areas of focus, a psychiatric nurse practitioner, a doctor of physical therapy, naturopathic physicians, clinical psychologists, physician assistants and nurse practitioners. Neurology Associates has two Arizona locations, one in Chandler and one in northeast Mesa.

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