The U.S. Food and Drug Administration (FDA) converted the approval of Leqembi (lecanemab) for treating Alzheimer's Disease from accelerated approval to traditional approval. This decision was based on a confirmatory trial that verified the drug's clinical benefit. Leqembi is the first amyloid beta-directed antibody to undergo this conversion for Alzheimer's disease treatment. The medication works by reducing the amyloid plaques in the brain, a characteristic disease feature.
Initially approved in January under the Accelerated Approval pathway, Leqembi received clearance based on its impact on reducing amyloid plaques, which was expected to provide clinical benefits for patients. As a postmarketing requirement, the FDA mandated a confirmatory study to validate the anticipated clinical benefits of Leqembi.
Study 301 (CLARITY AD), a Phase 3 randomized, controlled clinical trial, evaluated the efficacy of Leqembi. The trial enrolled 1,795 patients with Alzheimer's disease and the trial demonstrated statiscally significant improvement in primary and secondary endpoints.
The primary endpoint, the Clinical Dementia Rating Scale Sum of Boxes score, demonstrated a significant reduction with Leqembi compared to the placebo group. Additionally, statistically significant differences were observed between the treatment groups in all secondary endpoints, including the Alzheimer's Disease Assessment Scale Cognitive Subscale 14 and the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment.
The most common side effects of Leqembi include headache, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA).
The labelling specifies that Leqembi should be initiated in mild cognitive impairment or dementia stage of Alzheimer's disease, as studied in clinical trials. There is currently no safety or effectiveness data available for initiating treatment at earlier or later stages of the disease.
Following the traditional approval received by Leqembi, Centers for Medicare & Medicaid Services (CMS) announced that the drug would have broader Medicare coverage. The CMS had previously announced this coverage expansion and has now provided additional details.
With the FDA's approval, clinicians can access a CMS-facilitated registry to facilitate Medicare coverage. Providers can find additional background information, while patients can access relevant information on medicare.gov.
To get enrolled for Medicare coverage, individuals must be enrolled in Medicare, have a diagnosis of mild Alzheimer's disease with documented evidence of beta-amyloid plaque in the brain, and have a physician participating in a qualifying registry with a suitable clinical team and follow-up care. Clinicians participating in the registry must only submit a short and user-friendly data set. Individuals with Medicare should consult their physician to determine if Leqembi is the proper treatment.
For individuals with Original Medicare, the standard 20% coinsurance of the Medicare-approved amount for Leqembi will apply once they meet their Part B deductible. Costs may differ for those with Medicare supplemental coverage (such as a Medigap plan) or other secondary insurance, as well as those enrolled in a Medicare Advantage plan.
Individuals should contact their plan for more specific cost information.
Medicare's coverage of Leqembi aligns with CMS' National Coverage Determination and requires physician and clinical team participation in real-world evidence collection through a registry.
Registries are commonly used in clinical settings and have gathered patient outcome information for many years. The CMS-facilitated registry is designed to be user-friendly and adheres to strict privacy and security protocols.