Leqembi and Alzheimer's Disease: Benefits, Side Effects, and What It Costs
6 min read
Ever since Alzheimer’s disease first had a name, researchers have been working diligently to better understand it: what causes it, how to treat it, and whether there’s anything we can do to prevent it.
Now more than ever, this work is critical. By 2050, experts predict that as many as 13 million adults in the United States will be diagnosed with this devastating condition—a rate that’s nearly double what it is today.1 And for the family members and caregivers of loved ones who are affected, more and better Alzheimer’s disease treatments can’t come soon enough. In addition to the economic costs of their unpaid caregiving—nearly $340 billion in 2021—the physical and emotional toll can be substantial.
Yet there’s encouraging news.
“Alzheimer’s is a complex disease to fully understand, and there’s still so much to learn,” said Kathleen Cameron, senior director of NCOA’s Center for Healthy Aging. “Fortunately, the desire to do both is unanimous among scientists, policymakers, funders, and the general public. As a result, there are lots of exciting new therapies are in development right now that hold tremendous potential for changing the course of this disease.”
Researchers hope their discoveries will simultaneously improve patient outcomes while providing additional insight into the benefits of early-stage Alzheimer’s treatment.
What’s new in Alzheimer’s drug research?
In June 2021, we first wrote about Aduhelm™ (generic name aducanumab), a U.S. Food and Drug Administration (FDA) approved drug for Alzheimer’s that works to destroy clumps of protein in the brain, called amyloid plaques, that are a hallmark of the disease. Of the many Alzheimer’s drugs that were undergoing clinical trials at the time, Aduhelm stood out for being the first medication to have received accelerated approval.
“Adulhelm’s significance, then and now, is that it is designed to slow disease progression,” explained Cameron.
Until it came on the market, the other available medications for Alzheimer’s could only treat its symptoms for a short period of time,” Cameron said.
Today, scientists are working to build upon what they’ve learned from Aduhelm thus far and apply it to next-generation Alzheimer’s therapies that similarly target the biological markers of disease (like those amyloid proteins). These therapies, they hope, will delay the onset of cognitive decline—and someday might prevent it altogether.
“The treatments that result from this line of research are the treatments that will potentially help patients maintain their independence and quality of life for much longer,” Cameron said.
Today, there are nearly 200 Alzheimer's drugs in active clinical trials. Most, like Aduhelm, represent disease-modifying agents, while some are designed to address symptoms of cognitive impairments. The rest address behavioral and other symptoms.
Like other Alzheimer’s disease-modifying therapies under evaluation, Aduhelm is biologic—meaning it comes from living organisms—and is administered through an IV. And, similar to other treatments being studied, Aduhelm is a monoclonal antibody.2 (If the term “monoclonal antibodies” rings a bell, there’s good reason: one of the leading treatments for COVID-19 uses them. In the most basic sense, this type of therapy finds a specific protein in the body and then tells the immune system to attack it).
As a result of all this work, “there is a new sense of optimism in the field,” said Suzanne Schindler, MD, a clinical neurologist and dementia specialist at Washington University who spoke at a 2023 Association of Health Care Journalists conference session highlighting ongoing clinical trials and recent advances in drug therapies.3
What is the new treatment for Alzheimer’s?
Leqembi™ (generic name lecanemab) is the latest medication for Alzheimer’s. Like Aduhelm, the FDA also fast-tracked its approval, which happened in January 2023. And in July 2023, the agency granted full approval of the drug, meaning Medicare will provide coverage under certain conditions.
Leqembi is only the second anti-amyloid treatment on the market.4 Already, it shows some promise in reducing cognitive decline—though it’s too soon to know whether the drug will remain effective over time.
“There are millions of people who have Alzheimer's disease, and potentially millions more who will have it in the future,” Juliette Cubanski, deputy director of the program on Medicare policy at the Kaiser Family Foundation, told Reuters. “So it's a much larger potential patient population than for other diseases.”
How does Leqembi work?
Similar to Aduhelm, Leqembi is designed to slow Alzheimer's progression by identifying and attacking beta amyloid proteins in the brain.
This is significant because beta amyloids are the hallmark of Alzheimer’s. These proteins clump together to form plaques that destroy neurons, which are the cells that form the brain’s communication system.5 Leqembi is a monoclonal antibody that binds to these plaques and breaks them apart.6
As of now, patients receive Leqembi through an IV once every two weeks for an indefinite period of time. Each infusion lasts approximately 45-60 minutes.7 Hospitals and specialty infusion centers provide the treatment, which must be prescribed by a physician.
In a clinical trial, an injectable version of Leqembi showed promising initial results, suggesting that a more convenient way of administering the drug may soon be available. A subcutaneous injection would allow people to administer this Alzheimer's treatment at home, eliminating the need to travel to a hospital or other infusion center every two weeks.
Is the Leqembi medication a cure for Alzheimer’s?
Although Leqembi is currently one of the only medications for early-stage Alzheimer’s treatment, it’s important to understand that it does not cure the disease.
According to the FDA’s press release announcing its approval, patients who received the drug during a 79-week clinical trial period did experience a notable reduction of beta amyloid plaques.8 This can slow (but not reverse) progression of the disease and its related declines in memory, cognition, and functioning. Taken together with drugs that ease the symptoms of Alzheimer’s, Leqembi can help patients maintain their independence and ability to participate in daily life for longer. But they will still have Alzheimer’s.
Who qualifies for Leqembi?
The FDA approved Leqembi for patients with early-stage Alzheimer’s disease.
Leqembi’s prescribing information requires that patients undergo diagnostic testing to confirm the presence of beta amyloids before they can begin treatment.7 Generally, doctors accomplish this with a PET scan or by examining cerebrospinal fluid obtained through a lumbar puncture (spinal tap).
During clinical trials, researchers did not study the effectiveness of Leqembi on people living with more advanced Alzheimer’s, or on people who did not show any symptoms. Therefore, these patients will not qualify for treatment.
What are the side effects of Leqembi?
As with all medications, Leqembi does have side effects to be aware of. The most common are swelling and bleeding in the brain that usually goes away over time. Some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea, and seizure that occur with the swelling and bleeding. Other side effects include nausea, vomiting, and changes in blood pressure. If you speak with your health care provider about Leqembi, discussing possible side effects is important.
How much will Leqembi cost? Will Medicare cover it?
Eiasi, Leqembi’s manufacturer, set its list price at $26,500 per year.9 This means that its actual out-of-pocket costs will vary depending on a patient’s insurance coverage.
FDA approval made Leqembi eligible for Medicare coverage—but there are certain conditions that must be met:
- Patients must be enrolled in original Medicare or Medicare Advantage.
- Patients must have a diagnosis of mild Alzheimer’s disease or mild cognitive impairment.
- The patient’s doctor must agree to enter patient data into a CMS-facilitated federal registry, which helps Medicare collect data on the drug's effectiveness. Health care providers must also provide appropriate follow-up care for patients taking Leqembi.
Medicaid also provides coverage of Leqembi—without participation in a registry—depending on the state and other factors. The best way to find out about Medicarid coverage for Leqembi is to contact your state Medicaid office.
What else is on the horizon for Alzheimer’s drug treatments?
Quite a bit, says NCOA's Cameron.
“The research continues to evolve based on what scientists and doctors are learning right now,” she explained. “Here at NCOA, we remain committed to our advocacy on behalf of older adults and their caregivers who are bravely navigating the daily realities of the disease.”
For more information on the latest medications for Alzheimer’s, be sure to visit and bookmark NCOA’s Alzheimer’s disease resource page for older adults.
Sources
1. Alzheimer’s Association. 2023 Alzheimer’s Disease Facts and Figures. Found on the internet at https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf
2. Jeffrey Cummings, et. al. Alzheimer’s disease drug development pipeline: 2022. Translational Research and Clinical Interventions, May 4, 2022. Found on the internet at https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12295
3. Liz Seegert. Alzheimer’s panel at HJ23 will explore unanswered questions.” Covering Health. Feb. 24, 2023. Found on the internet at https://healthjournalism.org/blog/2023/02/alzheimers-panel-at-hj23-will-explore-unanswered-questions/
4. Alzheimer’s Association. Treatments and Research. Found on the internet at https://www.alz.org/help-support/i-have-alz/treatments-research
5. National Institute on Aging. What Happens to the Brain in Alzheimer’s Disease? Found on the internet at https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease
6. Christopher H. van Dyck, et. al. Lecanemab in early Alzheimer’s disease. New England Journal of Medicine. Jan. 5, 2023. Found on the internet at https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
7. Alzheimer’s Association. Lecanemab approved for treatment of early Alzheimer’s Disease. Found on the internet at https://www.alz.org/alzheimers-dementia/treatments/lecanemab-leqembi
8. U.S. Food & Drug Administration. FDA News Release. FDA grants accelerated approval for Alzheimer’s Disease treatment. Found on the internet at https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
9. PR Newswire. Eisai’s approach to U.S. pricing for Leqembi™ (lecanemab), a treatment for early Alzheimer’s disease, sets forth our concept of ‘societal value of medicine’ in relation to ‘price of medicine. Jan. 6, 2023. Found on the internet at https://www.prnewswire.com/news-releases/eisais-approach-to-us-pricing-for-leqembi-lecanemab-a-treatment-for-early-alzheimers-disease-sets-forth-our-concept-of-societal-value-of-medicine-in-relation-to-price-of-medicine-301715694.html
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