As National Alzheimer’s Awareness Month comes to a close, we mark a year of progress in treatments and improved regulation—though there’s still work to do.
By the numbers: An estimated 6.7 million Americans are living with Alzheimer’s disease in 2023, including 10.7% of people 65 and over, says the Alzheimer’s Association. Almost two-thirds are women, and Black and Hispanic people are disproportionately impacted.
But there are reasons for hope: After 20 years without new Alzheimer’s treatments, promising new drugs target beta-amyloid plaque, a protein abundant in the brains of Alzheimer’s patients. These treatments have been shown to slow cognitive decline in people with early-stage Alzheimer’s.
The drugs: LEQEMBI, developed by Eisai and Biogen, received Food and Drug Administration (FDA) approval in July. Eli Lilly anticipates early 2024 FDA approval of its anti-plaque drug donanemab, which proved effective.
The regulatory obstacles: Patients taking LEQEMBI must join a registry, a potential barrier to access. Determining whether patients can benefit from LEQEMBI involves an amyloid PET scan, a diagnostic formerly restricted by a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD).
The promising regulatory change: In October, CMS announced the removal of the NCD and the end of coverage with evidence development (CED) for amyloid PET scans.
What they’re saying: “Appropriate access to these diagnostics is critical to advancing patient care in Alzheimer’s,” says Aaron Fobes of Eli Lilly, which has urged an end to patient registries and praised the end of the PET scan NCD. “We look forward to working with Medicare contractors to ensure timely and uniform coverage implementation.”
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