Medicare Coverage for Alzheimer’s Drugs Brings Hope for Enhanced Care

“Medicare will cover drugs that may slow the progression of Alzheimer’s disease if the FDA grants traditional approval,” announced Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure.

She emphasized the impact of Alzheimer’s on patients, loved ones, and caregivers, stating, “CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease.”

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will review the confirmatory trial results of Eisai’s Leqembi, potentially leading to traditional approval. Broader Medicare coverage would commence upon FDA approval, and other drugs in the same class receiving traditional approval would also be eligible for coverage.

Medicare coverage for approved drugs would require physicians and clinical teams to participate in data collection through a nationwide CMS-facilitated portal. The collected evidence, submitted in an easy-to-use format, will be used for research while adhering to stringent privacy protections.

CMS is collaborating with multiple organizations to establish their registries for this purpose.

The approach aligns with CMS’s National Coverage Determination. To qualify for Medicare coverage, individuals must be enrolled in Medicare Part B, diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s, and have a qualified physician participating in a registry. These criteria supplement the FDA’s label requirements.

Using registries to gather post-approval information is a well-established practice. CMS cited the example of transcatheter aortic valve replacement (TAVR), where participation in a registry was required to track outcomes after the FDA granted traditional approval.

“This development has the potential to greatly benefit long-term care facilities, as it opens doors for improved care and treatment options for individuals with Alzheimer’s disease,” – Hema Shaddarshanam, PIC.