In a significant development in the field of Alzheimer’s disease treatment, the US Food and Drug Administration (FDA) is poised to make a landmark decision on whether to grant traditional approval to the Alzheimer’s drug, Leqembi. This drug, developed by Eisai and Biogen, is the first medicine to have demonstrated the ability to slow the progression of this memory-robbing disease. The potential approval of Leqembi is expected to bring about a change in how the Centers for Medicare and Medicaid Services (CMS) covers the drug, thereby broadening access for millions of individuals affected by early forms of Alzheimer’s.
Leqembi initially received accelerated approval in January based on evidence suggesting its effectiveness in clearing amyloid plaque buildups in the brain, a hallmark of Alzheimer’s disease. However, due to a coverage decision by CMS, the drug has not been widely accessible to patients. The cost of Leqembi, priced at $26,500 before insurance coverage, has posed a significant financial burden for many. The potential approval by the FDA would not only pave the way for broader access to the drug but also influence the coverage decisions made by CMS, making it more affordable for those in need.
Leqembi is indicated for individuals with early forms of Alzheimer’s, specifically those with mild cognitive impairment or mild dementia who have confirmed amyloid plaques in their brains. It is estimated that this group constitutes approximately one-sixth of the over 6 million Americans currently diagnosed with Alzheimer’s. However, individuals with more advanced stages of the disease may not experience the same benefits and could face increased safety risks. The drug’s efficacy has been demonstrated in an 18-month clinical trial, where it was shown to slow declines in cognitive ability and function by 27%. Although this represents a significant advancement, it is important to note that Leqembi is not a cure for Alzheimer’s.
While Leqembi shows promise in slowing the progression of Alzheimer’s disease, it is not without its risks and side effects. Regular brain imaging is required to monitor patients for potential side effects, such as brain swelling or bleeding. Approximately 13% of participants in the clinical trial experienced these adverse events, and certain patient populations, such as those with specific genetics or taking blood-thinning medications, may be at a higher risk. Healthcare systems have been preparing for the potential broader use of Leqembi, with infusion centers anticipating an increase in patient referrals. However, cautious and thoughtful preparation is necessary to mitigate the complexities associated with the drug’s administration.
For individuals like Joe Montminy, who has been diagnosed with younger-onset Alzheimer’s, the potential accessibility of Leqembi through insurance coverage holds immense significance. The high cost of the drug has been a barrier for many, and the prospect of receiving the treatment gives hope for more time with loved ones and the ability to participate in everyday activities that are often taken for granted. While the number of individuals seeking the drug immediately may be lower than expected, it is anticipated that as therapeutic options become more widely available and testing is reimbursed, more people will opt for treatment in the future.
CMS has outlined its plan to provide broader coverage for Leqembi if the drug receives full FDA approval. However, this coverage comes with certain qualifications. Physicians and clinical teams are required to participate in the collection of evidence through a registry, which will help determine the real-world effectiveness of the medication for Medicare beneficiaries. CMS is working with various organizations to establish these registries, offering clinicians the choice of participation. The data collected will address key questions outlined by CMS, including the drug’s impact on health outcomes, the influence of patient characteristics, and the changes in benefits and harms over time. While some patient groups and the pharmaceutical industry have expressed concerns about using a registry, CMS views it as a means to ensure comprehensive evaluation and informed decision-making.
The potential expansion of Medicare coverage for Leqembi and similar drugs aimed at slowing the progression of Alzheimer’s could have a substantial impact on Medicare spending. If 10% of the estimated 6.7 million older adults affected by Alzheimer’s choose to take Leqembi at its annual list price, it could result in an increase in spending by $17.8 billion. This figure exceeds the total spending on the top 10 Part B drugs administered in doctors’ offices in 2021. The potential rise in spending could lead to higher Medicare Part B premiums for all enrollees, creating a need for careful consideration and planning to balance accessibility and affordability.
The potential FDA approval of Leqembi marks a significant milestone in the treatment of Alzheimer’s disease. While it represents the beginning of a new era in Alzheimer’s treatment, it is crucial to recognize that the current options available are just the tip of the iceberg. Researchers and healthcare professionals continue to work tirelessly to develop more efficacious treatments for this devastating disease. The approval of Leqembi and the potential expansion of Medicare coverage bring hope to individuals and families affected by Alzheimer’s, offering the possibility of improved quality of life and more time spent with loved ones. As the landscape of Alzheimer’s treatment evolves, staying informed about the latest advancements and developments is essential to make informed decisions and advocate for improved care and support for those affected by the disease.
First reported by CNN.
