Access to Alzheimer’s Drug Lecanemab May Soon Expand with Full FDA Approval: Who Will Benefit?

In patients diagnosed with Alzheimer’s disease, the presence of beta-amyloid, a harmful substance, can form toxic clumps between neurons. To combat this, drugs like lecanemab have been specifically developed to remove amyloid-beta from the brain. According to the National Institute on Aging and the National Institutes of Health, lecanemab is on the cusp of receiving full approval from the Food and Drug Administration (FDA) on July 6, making it available to over a million Medicare patients in the early stages of Alzheimer’s.

However, experts believe that the initial demand for lecanemab may not be as high as anticipated. Dr. David Rind, chief medical officer of the Institute for Clinical and Economic Review, suggests that while it could reach hundreds of thousands of patients, it may not immediately hit the million mark. The slow rollout of lecanemab could be attributed to various factors, such as the additional paperwork burden on doctors and a shortage of medical professionals trained to diagnose and treat Alzheimer’s patients.

The conditional approval granted by the FDA in January was based on lecanemab’s success in removing amyloid-beta from the brains of individuals in the early stages of Alzheimer’s. However, full approval typically requires evidence of the drug’s efficacy in improving patients’ conditions. Until it receives full approval, lecanemab is not covered for most Medicare patients, who make up the majority of Alzheimer’s patients. This impending action by the FDA is of immense significance to patients and their families, despite the drug not being a cure. The potential of gaining more time is incredibly important and exciting for them, states Robert Egge, chief public policy officer of the Alzheimer’s Association.

The likelihood of full FDA approval is high, as an advisory committee unanimously voted in favor of lecanemab’s ability to slow down Alzheimer’s, and FDA staff have given the drug favorable evaluations. Once approved, Medicare plans to cover lecanemab treatment in appropriate settings, as stated by The Centers for Medicare and Medicaid Services.

However, challenges may arise for many Medicare patients seeking treatment. Doctors will be required to participate in a registry designed to monitor the drug’s safety and effectiveness, which could discourage some from prescribing lecanemab. There is concern that underserved areas with already limited access to healthcare will be further excluded from treatment options. Additionally, payers may not fully cover the required brain scans and associated services, making it necessary for doctors and medical facilities to meet specific criteria for treatment provision.

Dr. Zaldy Tan, Medical Director of the Jona Goldrich Center for Alzheimer’s and Memory Disorders, notes that even patients who have access to lecanemab may choose not to undergo treatment due to the extensive duration required (18 months) to slow the loss of memory and cognitive function by approximately six months. The question of whether the potential benefits outweigh the risks and burdens of treatment arises. Nonetheless, Dr. Tan supports the anticipated FDA approval, emphasizing that it is a positive step forward.

Dr. Mia Yang, a geriatrician and assistant professor, believes that lecanemab represents a significant improvement over its predecessor, aducanumab. The conditional approval granted to aducanumab in 2021 did not provide evidence of its effectiveness in altering the course of the disease, leading insurers to decide against coverage. In contrast, lecanemab demonstrates modest benefits. However, Dr. Yang raises concerns about the lack of sufficient memory specialists and infusion clinics to accommodate potential patients, highlighting the need to bolster the healthcare infrastructure.

The price of lecanemab could present an additional obstacle despite insurance coverage. Eisai, the drug’s manufacturer, estimates that the drug alone will cost $26,500 annually, excluding diagnostic and follow-up tests. The patient’s share of the cost could reach thousands of dollars. Dr. Rind, in an analysis of lecanemab’s efficacy and patient value, suggests that the current price is too high. He proposes a fair price range of $8,900 to $21,500 per year, favoring the lower end. Nevertheless, at its current price, lecanemab has the potential to be highly profitable for Eisai and Biogen, its U.S. partner. The demand for the drug may be substantial, leading to a potential multi-billion-dollar revenue.

In summary, the impending FDA approval of lecanemab represents a significant milestone in the treatment of Alzheimer’s disease. However, the challenges surrounding its rollout, accessibility, and affordability are not to be overlooked. While the drug offers potential benefits, its true impact on patients and the healthcare system remains to be seen.

 

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