Title: FDA Decision Pending for the First Alzheimer’s Drug Shown to Slow Progress
Subtitle: Approval of Alzheimer’s Drug Leqembi Could Expand Coverage and Access
The Food and Drug Administration (FDA) is set to make a pivotal decision on Thursday that could have far-reaching implications in the fight against Alzheimer’s disease. The agency will determine whether to greenlight Leqembi, a groundbreaking drug developed by Eisai and Biogen, which has demonstrated the ability to slow down the progression of this incurable memory-destroying disease.
If Leqembi receives definitive approval, it could lead to a significant change in the coverage offered by Medicare and Medicaid insurance. This move would greatly expand access to the drug for the millions of individuals estimated to be in the early stages of Alzheimer’s, according to CNN.
Patients, families, and medical professionals are eagerly awaiting the FDA’s decision, recognizing the potential impact it could have on their lives. Merit Cudkowicz, a professor at Harvard Medical School, described the approval as a significant change for patients, particularly for a disease where progress has been limited.
The drug, which received expedited approval in January, has shown promise in clearing amyloid plaque buildups in the brain, a key characteristic of Alzheimer’s disease. Final approval would enable health insurance to cover the medication, which is currently priced at $26,500 per year.
For those like Joe Montminy, a patient interviewed by CNN, insurance coverage is pivotal as treatment costs are often unaffordable. The approval of Leqembi would make a meaningful difference, enabling individuals to receive much-needed treatment without the burden of excessive costs.
It is important to note that Leqembi is expected to be approved solely for individuals in the early stages of Alzheimer’s, specifically those with mild cognitive impairment or mild dementia where amyloid plaques have been confirmed in the brain. According to Lawrence Honig, a professor of neurology at Columbia University Irving Medical Center, this group constitutes roughly one-sixth of the over 6 million people diagnosed with Alzheimer’s in the United States.
While the potential benefits of Leqembi are promising, there are side effects and monitoring requirements. Approximately 13% of trial participants experienced brain swelling or bleeding, with potentially higher risks for certain groups based on genetics or the use of blood-thinning medications.
Despite these risks, the FDA acknowledges the importance of considering individual patient assessments. Teresa Buracchio, director of the FDA’s Office of Neuroscience, has stated the agency’s intent to encourage good clinical judgment among doctors, patients, and their families when making treatment decisions.
The healthcare system has been making preparations to accommodate broader access to Leqembi. Administrated through intravenous infusion every two weeks, the drug is expected to generate an increase in referrals of up to 15% to 20%, according to Sue Rottura, chief operating officer of Vivo Infusion.
Cathy McMorris Rodgers, chair of the House Energy and Commerce committee, emphasized the importance of CMS (Centers for Medicare and Medicaid Services) covering key Alzheimer’s treatments approved under the FDA’s expedited process. McMorris Rodgers stressed that if Leqembi receives traditional approval, CMS should provide coverage for all Americans who need it.
In conclusion, Thursday’s FDA decision regarding Leqembi has the potential to revolutionize the treatment landscape for Alzheimer’s disease. Widening access to this groundbreaking drug could bring hope and advancements to millions of individuals and families affected by the debilitating effects of Alzheimer’s.