The potential approval of Leqembi, an Alzheimer’s drug developed by Eisai and Biogen, is sparking heated debates about its cost and the anticipated broad Medicare coverage. While the drug’s positive effects on slowing cognitive decline in Alzheimer’s patients offer hope, its high annual price tag of $26,500 has triggered criticism and concern, particularly as it looms over the American healthcare system.

Medicare’s Role in Alzheimer’s Treatment

Medicare, the federal health program primarily for seniors, has committed to covering Leqembi on the same day it potentially receives full approval from the FDA, which is expected to happen on July 6, 2023. The program’s decision to provide coverage for Leqembi marks a significant shift in its policy, as it currently limits coverage of Alzheimer’s antibody drugs to only those participating in clinical trials. There are currently no clinical trials underway for Leqembi.

As a result, access to this drug is largely out of reach for most seniors unless they can afford to pay out of pocket. With Medicare’s coverage, the treatment could become available to a wider population.

Concerns about Out-of-Pocket Costs and Impact on Medicare

Despite the promised coverage, the drug’s hefty price is a source of anxiety. Senator Bernie Sanders referred to the cost as “unconscionable,” arguing that even with Medicare coverage, seniors would face substantial out-of-pocket costs. A JAMA Internal Medicine study estimates individual Medicare patients could face annual out-of-pocket costs for the drug of $6,600, depending on their state and their supplemental insurance.

Furthermore, Sanders cautioned that Leqembi’s price could strain Medicare’s finances, raising premiums for all beneficiaries, even those not using the medication. This could affect over 60 million seniors enrolled in Medicare.

FDA Approval and Public Perception

While the pricing and coverage debates intensify, the FDA is gearing up to decide on Leqembi’s approval, which is further complicated by the controversy surrounding the prior approval of another Alzheimer’s drug, Aduhelm, developed by the same companies. Critics, including Sanders, argue that the FDA needs to restore public trust after the problematic Aduhelm approval, which was marked by irregularities and led to several advisors’ resignations.

The FDA’s independent advisory panel, however, unanimously endorsed Leqembi, demonstrating their belief in the drug’s clinical benefits. This endorsement could potentially influence the FDA’s final decision, but the small size of the panel due to conflict of interest issues has raised eyebrows.

Addressing the Disparity and Accessibility Issues

Moreover, concerns about Leqembi extend beyond pricing and Medicare coverage to issues of inclusivity and accessibility. The trial for Leqembi severely underrepresented Black Americans, who are at a higher risk for Alzheimer’s disease, comprising only 2.3% of participants. This has led to calls for more representative studies to ensure equitable treatment options.

As the potential FDA approval looms, healthcare providers, patients, and lawmakers are scrutinizing both the short-term and long-term impacts of Leqembi. The broader implications of the drug’s cost, Medicare’s coverage, and concerns over inclusivity in clinical trials underscore the complexity of treating Alzheimer’s disease and the urgency of finding cost-effective, accessible, and equitable solutions.