The U.S. Food and Drug Administration (FDA) has approved a drug to slow the progression of Alzheimer’s disease, a devastating disease that robs people of their personality, autonomy and ultimately life — and greatly impacts families and caregivers who love them.
An estimated 6.5 million, or one in nine, Americans aged 65 and older were living with some form of Alzheimer’s disease in 2022, and that number is projected to more than double to 13.8 million by 2060.
While other commonly prescribed drugs such as Donepezil (Aricept) and Memantine (Nameda) only target the symptoms of Alzheimer’s, the new drug, lecanemab, sold by its manufacturer Eisai under the brand name Leqembi, gives a degree of hope for people in the disease’s early stages.
Here’s a look at what’s known about Leqembi and what lies ahead in the fight against Alzheimer’s disease.
How does the new Alzheimer’s drug work?
Lecanemab (Leqembi) works by targeting beta-amyloid, a protein that builds up in the brains of those with Alzheimer’s disease. The drug needs to be administered intravenously every two weeks. During the treatment, patients will also have PET and MRI scans of their brain to look for potential side effects and ensure the amyloid plaque has decreased.
For this reason, the FDA prescribing information notes that lecanemab is appropriate for people with early Alzheimer’s with confirmation of elevated beta-amyloid. The treatment was studied in people living with early Alzheimer’s dementia and mild cognitive impairment due to Alzheimer’s who exhibited evidence of a buildup of beta-amyloid plaques in the brain.
Over 18 months, 27% patients who received lecanemab (Leqembi), a monoclonal antibody treatment, in the phase III clinical trial showed slower declines in memory and thinking than those who received the placebo.
Who is — and is not — a candidate for Leqembi?
“This new medication is available only for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease,” explains Ian Kremer, Executive Director of the Leaders Engaged on Alzheimer’s Disease (LEAD) Coalition and a nationally recognized public policy expert in Alzheimer’s disease, who adds that once a person is contending with moderate dementia, they are no longer eligible for the treatment.
It bears noting that women receive two-thirds of all clinically diagnosed cases of dementia and Alzheimer’s disease — in part because they live longer and the risk of developing dementia increases with age.
When reviewing the clinical trial data, Alicia Barber, an Alzheimer’s disease researcher and neuroscience doctoral candidate at Dartmouth, noticed sex differences in the efficacy of the drug. “It appears women experienced more cognitive decline than men following 18 months of Lecanemab treatment,” she points out, recommending that longer-term studies look at the impact of sex and what the benefit of treatment looks like after 18 months.
The FDA approval also comes with a black box label recommending patients are tested for a genetic mutation known as ApoE4 before starting treatment. About 15% of people with Alzheimer’s have ApoE4, according to the National Institute on Aging. “Patients in the trial carrying the genetic mutation ApoE4 experienced more disease progression and adverse events, such as swelling and brain bleeds related to treatment,” points out Barber.
“This new medication is available only for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease.”
— Ian Kremer, Executive Director of The Leaders on Alzheimer’s Disease (LEAD) Coalition
How much does Leqembi cost, and is it covered by Medicare?
Eisai has Leqembi priced at $26,500-a-year, but Medicare announced July 6, 2023, that it will provide coverage providing the following conditions are met:
- Medicare enrollment
- Diagnoses with mild cognitive impairment or mild Alzheimer’s disease with documented evidence (PET scan) of beta-amyloid plaque buildup in their brain
- Healthcare provider participates in a registry or a database (now open) that tracks the drug’s long-term benefits and side effects
According to an analysis from Kaiser Family Foundation, Medicare patients who receive lecanemab (Leqembi) would still be responsible for more than $5,000 out of pocket each year, based on a 20% coinsurance requirement in traditional Medicare. Those with Medicare supplement insurance, such as Medigap or Medicaid, may pay less.
“Even with Medicare coverage, this medication would definitely be out of reach for patients I see,” says Olivia Powell, a nurse practitioner providing geriatric care to homebound Medicare beneficiaries in and around Chicago. “The majority of my patients are on very fixed incomes, most live on $30,000 to $50,000 annually, have very limited health literacy and already have difficulty getting to and from appointments due to coexisting conditions.”
Powell also suspects Medicare’s registry requirement will be a learning curve for providers depending on the complexity and time or cost involved.
“We’ll continue to work closely with Medicare until all the barriers are gone and patients are free to make their own choices in consultation with their own doctors,” says Kremer in reference to the LEAD Coalition’s ongoing advocacy efforts. “Private insurers, including Medicare Advantage plans, should follow Medicare’s lead and do everything in their power to enable patients to receive these important treatments. No delays, no excuses, no complicated prior authorization schemes. People facing Alzheimer’s disease cannot afford for insurance companies to put bureaucratic roadblocks between them and treatments that slow down this devastating disease.”
What are the symptoms of mild cognitive impairment?
Symptoms of mild cognitive impairment, per research in the Archives of Neurology, include:
- Memory loss.
- Language difficulties.
- Impaired decision-making.
“If you are concerned about your own thinking ability or that of a loved one, it is enormously important to talk with your doctor as soon as possible,” Kremer advises. “The diagnostic steps required for Medicare coverage [of lecanemab (Leqembi)] can take a while, and many people experience long wait times before even being able to get an appointment to begin the diagnostic process.”
While not all symptoms of mild cognitive impairment will progress to Alzheimer’s disease, knowing how Alzheimer’s progresses is essential to anticipating your needs or those of a loved one.
Genetics can also increase the risk of developing Alzheimer’s (i.e., if someone in your family has been diagnosed with dementia, you may be more likely to develop it yourself).
Are there any other new Alzheimer’s drugs on the horizon?
Phase III clinical trial results from another promising drug, donanemab, will be presented at the Alzheimer’s Association International Conference in July 2023 and in a forthcoming paper, according to a press release from Eli Lilly and Company.
For people in the earliest stages of Alzheimer’s, preliminary results indicate donanemab — like lecanemab (Leqembi) — gives people more time at or near their full abilities to participate in daily life, remain independent and make future healthcare decisions.
The future of treating Alzheimer’s disease is, according to Barber, developing a personalized medicine approach to care that incorporates factors like sex, genetics and more into one’s treatment regimen. “Anti-amyloid antibody drugs are a start to this future becoming a reality,” she says. “Hopefully, one day we will have a number of different drugs that will work in tandem, in unique combinations, to fight Alzheimer’s disease.”
