What is the controversy surrounding Leqembi?

Leqembi (lecanemab-irmb), a medication designed to treat Alzheimer's disease, has been a subject of considerable controversy. The primary points of debate revolve around its effectiveness, safety, and cost.

Effectiveness of Leqembi

While Leqembi has shown some promise in slowing cognitive decline, the effect is modest. Critics argue that the benefits may not outweigh the risks for many patients. Leqembi has only been approved for people with mild Alzheimer’s disease, so the benefits in those with moderate or severe disease are not fully known at this time.

The FDA's decision to grant accelerated approval to Leqembi in January 2023 was met with skepticism from some experts. They argued that the evidence supporting the medication’s effectiveness for Alzheimer’s disease was insufficient. The approval was based on the medication showing a decrease in amyloid beta plaques in the brain, which are thought to interfere with normal brain function.

The FDA converted it to traditional approval in July 2023 based on additional data from an 18-month clinical trial. Compared to placebo, participants taking Leqembi had 27% slower cognitive decline at 18 months.

Safety of Leqembi

One of the major concerns with Leqembi is the risk of brain swelling and bleeding. These side effects can be serious, and in some cases, fatal. Leqembi comes with strict monitoring guidelines for patients receiving Leqembi to detect and address potential side effects.

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Cost of Leqembi

Leqembi is expected to be very expensive, raising concerns about accessibility. At $26,500 per year, many patients and healthcare providers may struggle to afford this treatment. Insurance companies have been cautious about covering Leqembi due to its high cost and potential risks. This has led to debates about whether the drug should be covered by government-sponsored healthcare programs.

Medicare beneficiaries may have difficulty affording the out-of-pocket costs, which come down to 20% of the total cost of Leqembi (about $5,300 per year).

While the Leqembi offers hope for some patients, its risks, costs, and limited benefits continue to be debated.

This is not all the information you need to know about Leqembi (lecanemab) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.