The U.S. Food and Drug Administration (FDA) approved on Thursday (6) the use of the drug Leqembi, the first treatment that has been shown to slow the progression of Alzheimer’s disease.
The drug was approved only for people in the early stages of the disease, those with mild cognitive impairment or mild dementia. It is estimated that this group constitutes about one-sixth of the more than 6 million Americans currently diagnosed with Alzheimer’s.
People in the more advanced stages of the disease may not benefit from the drug and may face greater side effects.
It is important to emphasize that the drug does not cure the disease. During the 18-month clinical trial, people who used Leqembi had a 27% reduction in cognitive ability and function decline.
The Alzheimer’s Association said in a statement on Thursday that it celebrates the FDA’s approval.
“This treatment, while not a cure, can give people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love,” said Dr. Joanne Pike, president and CEO of the group. “This gives people more months of recognition of their spouses, children, and grandchildren. It also means more time for a person to drive safely, accurately, and quickly, manage family finances, and fully engage in hobbies and interests.”
However, the drug also comes with side effects and requires monitoring through regular brain imaging. About 13% of study participants experienced brain swelling or bleeding, and these risks may be greater for certain groups based on their genetics or if they take blood-thinning medications. The FDA states that a warning is included in the prescribing information to alert patients and caregivers about the potential risks associated with the use of this drug.
The drug must be administered via intravenous infusion once every two weeks. Infusion centers are preparing for a possible influx of new patients.
High Cost
Medicare will cover 80% of the costs of about $26,000 for Leqembi. Some patients may not be able to afford the 20% that Medicare does not cover, possibly around $6,600 per year. Including the costs of medical consultations and regular brain scans, some of which will be reimbursed by Medicare, treatment could amount to about $90,000 per year, some experts estimate.
A recent study estimated that covering the drug and necessary services for about 85,000 patients would cost Medicare $2 billion per year and rise to $5.1 billion if the number of patients increased to around 216,000. This could lead to an increase in premiums for all Medicare beneficiaries, not just for those receiving Leqembi, the study said.
Source: CNN and The New York Times