Revolutionary Alzheimer’s Drug Leqembi Set to Receive Full FDA Approval
Medicare Coverage Expansion Expected to Benefit Millions
In a groundbreaking development, the US Food and Drug Administration (FDA) is poised to grant traditional approval to Leqembi, an Alzheimer’s drug that has demonstrated the ability to slow the progression of the devastating disease.
This historic decision, expected to be announced on Thursday, marks the first time a medication has been proven to have a positive impact on the memory-robbing effects of Alzheimer’s.
A Paradigm Shift: Leqembi’s Potential Impact
Once the FDA grants its approval, the Centers for Medicare and Medicaid Services (CMS) will also revise its coverage policy, expanding access to Leqembi for an estimated one million individuals suffering from early-stage Alzheimer’s.
Developed by Eisai and Biogen, Leqembi received accelerated approval in January based on evidence of its ability to clear amyloid plaque buildups in the brain, which are closely associated with the disease.
However, due to a prior coverage decision by CMS, the drug has been underutilized. With a price tag of $26,500 before insurance coverage, many individuals have been unable to afford it.
Medicare Coverage Expansion Expected to Benefit Millions
Joe Montminy, a 59-year-old diagnosed with younger-onset Alzheimer’s in his early 50s, expressed the frustration of having limited access to the treatment due to insurance coverage issues.
The expansion of coverage is of great significance to him and others in similar situations, as it provides hope for effective treatment options.
A New Era of Treatment
Leqembi’s approval is currently limited to individuals with early forms of Alzheimer’s, specifically those with mild cognitive impairment or mild dementia who have confirmed amyloid plaques in their brains.
Dr. Lawrence Honig, a neurology professor at Columbia University Irving Medical Center, estimates that this group represents about one-sixth of the more than six million Americans currently diagnosed with Alzheimer’s.
However, it’s important to note that individuals with more advanced stages of the disease may not experience the same benefits from the drug and could face increased safety risks.
Dr. Honig emphasizes that while Leqembi represents a significant breakthrough, it is not a cure. In an 18-month clinical trial, the drug showed a 27% reduction in cognitive decline and functional impairment.
Dr. Honig believes that these treatments are just the beginning of a new era in Alzheimer’s research, expressing optimism for the development of more efficacious therapies in the future.
Balancing Potential Benefits and Risks
Leqembi, like any medication, comes with potential side effects and requires regular brain imaging for monitoring purposes.
During the trial, approximately 13% of participants experienced brain swelling or bleeding, and certain groups, such as those with specific genetic factors or individuals on blood-thinning medications, may face higher risks.
Healthcare systems have been preparing for the anticipated increase in Leqembi usage. Dr. Georges Naasan, the medical director of the Division of Behavioral Neurology and Neuropsychology at Mount Sinai, acknowledges the complexities involved in the process but affirms that preparations have been underway to ensure a smooth transition. Infusion centers, such as Vivo Infusion, are gearing up to handle the potential surge of new patients.
Medicare Coverage Expansion and Potential Implications
CMS has announced plans to broaden coverage for Leqembi if it receives traditional FDA approval. However, there are certain qualifications attached to this expanded coverage.
Medicare will cover approved drugs when physicians and clinical teams participate in the collection of real-world evidence through a registry.
This approach aims to assess the effectiveness of the medication in broader community practice. CMS will facilitate a portal where providers can submit the collected evidence free of charge.
While CMS’s approach has been met with some concerns from patient groups and the pharmaceutical industry, who argue that it may create barriers to treatment, the expanded Medicare coverage of Leqembi and similar drugs that slow the progression of Alzheimer’s is expected to have a significant impact on healthcare spending.
An analysis by KFF (formerly the Kaiser Family Foundation) indicates that if 10% of the estimated 6.7 million older adults eligible for the drug opt to take Leqembi, with an annual list price of $26,500, it could result in a spending increase of $17.8 billion.
This figure surpasses the total spending on the top 10 Part B drugs administered in doctors’ offices in 2021. Higher Medicare Part B premiums for all enrollees may be a consequence of the increased spending. Nevertheless,
