In a groundbreaking development for Alzheimer’s disease treatment, five prominent U.S. health systems have announced their plans to offer Leqembi, a promising drug co-developed by Eisai and Biogen. The drug recently received full regulatory approval in the United States and is the first treatment proven to slow the progression of Alzheimer’s disease in individuals in its early stages.
The Alzheimer’s disease epidemic has been a pressing concern, affecting an estimated 6.5 million people in the U.S., particularly those aged 65 and older covered by the Medicare plan. With the approval of Leqembi, there is newfound optimism among patients and physicians alike.
Dr. James Galvin, who leads the Alzheimer’s research program at the University of Miami Miller School of Medicine, emphasized the eagerness of patients to receive treatment. However, he also highlighted the importance of a well-considered approach to its rollout, ensuring patient safety and effective administration.
Several distinguished health institutions have outlined their strategies for introducing Leqembi to their patients. Among these institutions are the Mayo Clinic in Rochester, Minnesota; Northwestern Memorial Hospital in Chicago; and Cedars-Sinai Medical Center in Los Angeles. Their plans encompass a comprehensive framework that includes patient assessment, monitoring, and genetic testing to ensure suitability for treatment.
Leqembi’s approval has sparked a pivotal change in Medicare policies as well. The Medicare agency has committed to broad payment coverage for the drug and is even considering relaxing a long-standing restriction on specific brain imaging procedures recommended for eligible candidates. The alignment of regulatory changes and healthcare institutions’ preparations is expected to facilitate smoother access to the drug for those who need it most.
However, challenges remain. Wall Street analysts have expressed concerns about payment logistics and diagnostic testing hurdles that might slow down the launch. To address this, Tokyo-based Eisai has suggested that a more flexible Medicare imaging policy could expedite access to Leqembi. The company envisions reaching a significant number of patients, with projections of up to 100,000 individuals benefitting from the treatment by 2026.
Patient selection for Leqembi treatment involves rigorous cognitive and genetic testing to ensure the disease is in its early stages and to assess the potential risk of side effects. Crucial to the process is the confirmation of amyloid protein presence, which Leqembi targets. Amyloid testing, though, has posed a challenge due to differing preferences between hospitals and patients. While some prefer the less invasive amyloid PET scans, others opt for the spinal fluid test.
Safety is paramount in the administration of Leqembi, as the drug carries risks of brain swelling or bleeding. Patients undergo MRI scans before and during treatment to monitor these potential complications, an approach endorsed by the FDA. Despite the complexities, medical professionals are prepared to handle such challenges, with institutions like the Hospital of the University of Pennsylvania and the University of Miami Health System gearing up for the imminent clinical rollout.
As anticipation grows, the medical community recognizes that the introduction of Leqembi represents a turning point in the battle against Alzheimer’s disease. With innovative treatments and the collaboration of prominent health systems, a brighter future emerges for those affected by this debilitating condition.