WASHINGTON, DC – July 6, 2023 – On July 6th, the Food and Drug Administration (FDA) fully approved the new Alzheimer’s drug Leqembi (generic name lecanemab) and Medicare responded that it would cover most of its high cost. The drug has been shown to slow cognitive decline in patients with early stages of the disease. However, the medicine is associated with significant health risks. This is the first time in more than 20 years that the FDA has approved a drug for Alzheimer’s disease. It has been estimated that about 1.5 million Americans have early Alzheimer’s disease. About 5 million are more severely affected and are not eligible for treatment with lecanamab. Alzheimer’s disease is a disorder of the brain that usually occurs later in life. Afflicted individuals develop problems with memory and thinking skills, and can lose the ability to perform simple tasks. It is the most common cause of dementia in older persons. Alzheimer’s disease is the 5th leading cause of death for Americans older than 65.
The new Alzheimer’s drug lecanemab significantly slowed the rate of cognitive decline in patients with early-stage disease. The decline was slowed by about 5 months over the 18-month course of the study. Lecanemab is an anti-amyloid antibody that helps remove amyloid plaques. Amyloid is a protein that accumulates in the brain of people afflicted with Alzheimer’s disease. It binds with tau protein to form plaques that are thought to effect brain cell function and cause loss of memory and confusion, the hallmark symptoms of Alzheimer’s disease. Dr. Christopher Van Dyck, the director of the Yale Alzheimer’s Disease Research Center and lead author of the study, said that “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in less decline than placebo on all measures of cognition and function at 18 months.”
Lecanemab is the first anti-amyloid drug to pass the FDA’s full review. It was developed by 2 pharmaceutical companies. Eisai (a Japanese pharmaceutical company) will lead the development. Biogen (an American company) will lead its commercialization and marketing.
Hundreds of anti-amyloid drugs have been trialed or are in the midst of clinical studies, most with discouraging results. Biogen’s drug aducanumab created much noise with a recent controversial study that, nevertheless, won accelerated FDA approval, but not full approval. The drug was not covered by Medicare (except for clinical trials) due to its high price, unwanted complications and a strong belief that there was little evidence that it slowed cognitive impairment in early Alzheimer’s disease.
1,800 people with mild Alzheimer’s disease were enrolled in the lecanemab study. Participants were assigned to either the drug treatment group or the placebo group. Approximately one out of four participants were from minority groups, which was comparable to the Medicare population. The drug was administered intravenously every 2 weeks. The side-effects of treatment with lecanemab included brain swelling or brain bleeding in about 15% of the patients. This was lower than for patients in the aducanumab trials. Most of these cases have been mild or moderate and have resolved. The adverse effects were significantly more than in the placebo group. However, there have been some serious complications in the clinical trial resulting in 3 deaths. The risk of complication is more common in patients taking blood thinners, with a significant history of brain bleeds, and with 2 copies of an Alzheimer’s-linked genetic mutation called APOE4. This mutation is present in about 15% of people with Alzheimer’s. Patient’s will need to take a genetic test prior to starting treatment.
The high cost of the anti-amyloid medicine lecanemab may be a concern for many people. Its cost is $26,500 a year. However, Medicare will cover 80% of the cost. Therefore, a year’s treatment will cost $5,300 for the medicine. Additional costs include medical visits and regular MRIs that may receive some reimbursement from Medicare. Total treatment may run $90 thousand a year. A recent study calculated future Medicare costs of lecanemab treatment to be from about $2 to 5 billion a year depending on the number of patients prescribed the drug. The authors opined that premiums would rise for all Medicare beneficiaries from Medicare’s cost of lecanemab treatment.
Joanne Pike, president and CEO of the Alzheimer’s Association, feels that the FDA endorsement of lecanemab “can give people in the early stages of Alzheimer’s more time to maintain their independence and do the things that they love. This gives people more months of recognizing their spouse, children and grandchildren.”
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