FDA grants full approval to Leqembi, a groundbreaking drug slowing disease progression

USA —The U.S. Food and Drug Administration (FDA) has granted traditional full approval to Leqembi, a breakthrough medication for Alzheimer’s disease.

This marks a significant milestone in the fight against a debilitating illness that has long eluded effective treatment.

Clinical trials have demonstrated that Leqembi slows the progression of Alzheimer’s by an impressive 27% in patients at the earliest stages of the disease.

Leqembi, jointly developed by Eisai and Biogen, initially received accelerated approval in January based on evidence of its ability to clear amyloid plaque buildups in the brain, a hallmark of Alzheimer’s.

However, due to previous coverage restrictions imposed by the Centers for Medicare and Medicaid Services (CMS), which provides insurance coverage for many elderly individuals with Alzheimer’s through Medicare, the drug has not been widely accessible.

The annual cost of Leqembi amounts to US$26,500 before insurance coverage.

Functioning as an antibody, Leqembi is specifically designed to remove the sticky amyloid beta protein deposits from the brains of Alzheimer’s patients.

In light of the FDA’s decision, the Centers for Medicare and Medicaid Services has announced the expansion of coverage for the drug, granting broader access to an estimated one million individuals with early-stage Alzheimer’s.

Nevertheless, it is essential to note that Leqembi does come with side effects and requires regular brain imaging monitoring.

Approximately 13% of participants in the clinical trial experienced brain swelling or bleeding, and certain groups may face higher risks based on genetic factors or concurrent use of blood-thinning medications.

To address these concerns, the FDA has included a boxed warning in the prescribing information to ensure patients and caregivers are aware of the potential risks associated with these side effects.

Healthcare systems have been preparing for the anticipated increase in Leqembi’s usage, as the drug is administered through IV infusion once every two weeks.

Infusion centers have geared up to accommodate a potential surge of new patients seeking the treatment.

Eisai, the drug manufacturer, has acknowledged that not everyone estimated to have early-stage Alzheimer’s disease will immediately seek to use the medication.

Recently, a committee of external advisers to the FDA recommended traditional approval of Leqembi, concurring with the agency staff report’s conclusion that the drug provides a meaningful benefit to patients and that safety concerns can be effectively managed.

The Alzheimer’s Association reports that over 6 million Americans currently suffer from Alzheimer’s disease.

Eisai projects that Leqembi and other amyloid-lowering drugs could be used by approximately 100,000 patients in the United States during the drug’s initial three years on the market.

It is worth noting that the first FDA-approved disease-modifying Alzheimer’s drug, Aduhelm, was also developed by Eisai and Biogen. However, the restricted coverage under Medicare has significantly limited its utilization.

In addition to seeking approval in the United States and Japan, Eisai is pursuing regulatory clearance for Leqembi in several other countries, including the European Union, China, Canada, Great Britain, and South Korea.

Both China and Japan have assigned priority review designations to the drug’s application, underscoring the urgent need for effective treatments in these regions.

Expanded Medicare coverage for Leqembi

The recent decision by the Centers for Medicare and Medicaid Services (CMS) to broaden coverage for Leqembi, the FDA-approved drug for Alzheimer’s disease, brings new hope and improved access to innovative treatments for individuals affected by this debilitating condition.

CMS’s commitment to expanding coverage reflects its dedication to facilitating timely access to groundbreaking therapies that may enhance care and outcomes for Alzheimer’s patients.

Administrator Chiquita Brooks-LaSure expressed CMS’s commitment, stating, “CMS today affirms our commitment to help people with Alzheimer’s disease have timely access to innovative treatments that may lead to improved care and better outcomes.

“With FDA’s decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works. This is welcome news for the millions of people in this country and their families who are affected by this debilitating disease.”

While Medicare recipients will likely incur out-of-pocket costs for Leqembi, those with traditional Medicare will be responsible for the 20% coinsurance of the Medicare-approved amount after meeting their Part B deductible.

The out-of-pocket expenses for those enrolled in Medicare Advantage or supplemental plans will vary depending on their specific policy terms.

However, it is important to note that Medicare coverage for Leqembi comes with certain qualifications.

The drug will be covered when physicians and clinical teams participate in evidence collection through a registry to assess the real-world efficacy of these medications.

CMS plans to facilitate a portal for providers to submit evidence, free of charge. This data will play a crucial role in evaluating the drug’s effectiveness for Medicare beneficiaries.

CMS is collaborating with multiple organizations preparing to establish their own registries, allowing clinicians to choose the registry in which they wish to participate.

While broad Medicare coverage of Leqembi and similar medications to slow the progression of Alzheimer’s disease is undoubtedly a positive development, it is expected to have a significant impact on the program’s expenditure.

According to an analysis by KFF (formerly the Kaiser Family Foundation), if 10% of the estimated 6.7 million older adults take Leqembi at its annual list price of US$26,500, it would increase spending by US$17.8 billion.

This figure surpasses the total spending on the top 10 Part B drugs administered in doctors’ offices in 2021.

The anticipated rise in Medicare spending may result in higher premiums for all enrollees in Medicare Part B.

However, the expanded coverage for Leqembi underscores the importance of prioritizing access to innovative therapies for Alzheimer’s patients, providing them with a chance for improved quality of life and enhanced care.

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