A Food and Drug Administration panel has unanimously approved the use of lecanemab to slow the progression of Alzheimer’s disease.
The expert panel described the results of a clinical trial of lecanemab as “robust” and “clear and consistent,” according to Medscape.
Their approval means the medication, which is sold under the brand name Leqembi, should get full FDA approval by July 6, giving hope to the 6.5 million people affected by Alzheimer’s disease, a brain disorder that gets worse over time.
But even though the FDA approved lecanemab through an accelerated approval process, the Centers for Medicare and Medicaid Services — which controls Medicare — will only cover the drug for patients who enroll in a national registry.
That registry does not yet exist, and it’s still unknown when or how patients, their doctors or caregivers would sign up for it.
That roadblock “is an unnecessary and potentially harmful barrier,” according to the Alzheimer’s Association.
“Medicare is supposed to be a rock-solid guarantee for Americans, and it is time for [Centers for Medicare and Medicaid Services] to step up and provide Medicare access on the day of an FDA traditional approval,” the Alzheimer’s Association said in a statement.
“Americans living with Alzheimer’s disease deserve access to FDA-approved therapies without barriers, just like people with cancer, heart disease and HIV/AIDS,” the advocacy group added.
Beyond the human costs, these delays and coverage restrictions are much more expensive in the long run, a research group from the University of Chicago discovered.
Providing coverage for new and effective drugs for Alzheimer’s and other forms of dementia would save taxpayers between $13.1 billion and $545.6 billion in health-care costs over the course of 17 years, the researchers found, according to Fierce Pharma.
The CMS want more information about lecanemab, even though the Department of Veterans Affairs has already decided to use it for patients in the VA system.
In clinical trials, people with mild cognitive impairment or Alzheimer’s dementia who took lecanemab had a 27% slower decline in cognitive abilities compared to those receiving a placebo, according to Time.
The people receiving lecanemab, marketed by drug companies Eisai and Biogen, also improved their ability to perform daily tasks, like getting dressed and feeding themselves, compared to people receiving a placebo.
Despite these benefits, lecanemab — which is given by infusion — has some side effects including infusion site reactions and swelling of the brain, known as amyloid-related imaging abnormalities, or ARIA.
Lecanemab’s label currently includes a warning about the risks of ARIA and the need for doctors to monitor patients for signs of ARIA using MRIs of the brain.
Currently, there is no cure for Alzheimer’s disease, according to the Mayo Clinic.
In the disease’s advanced stages, severe loss of brain function can cause dehydration, malnutrition or infection, which can result in death.