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November is National Alzheimer’s Disease Awareness Month—a time to recognize and support patients and their families and put a renewed focus on the need to advance scientific research.
In 2023, we mark a year of progress on both treatments as well as regulation of diagnostics. However, we also recognize the work still needed on both fronts and the role of biotech in ending suffering from Alzheimer’s disease.
Here’s a look at what happened in 2023, and what work is still needed in the years ahead.
The impact of Alzheimer’s disease
An estimated 6.7 million Americans are living with Alzheimer’s disease in 2023, including 10.7% of people 65 and over. “By 2050, this number is projected to rise to nearly 13 million,” says the Alzheimer’s Association.
Almost two-thirds of people with Alzheimer’s are women. Black and Hispanic Americans are disproportionately impacted.
“Today, Alzheimer’s remains a leading cause of death in older adults. It exacts an emotional, physical, and financial toll on the entire family of those who are diagnosed — especially for African Americans and Latinos, who are more likely to develop dementias than any other races or ethnicities, and for individuals with Down syndrome, who are at higher risk for Alzheimer’s,” said President Biden in his proclamation marking Alzheimer’s Disease Awareness Month.
2023 brought progress for Alzheimer’s treatments
After 20 years without new treatments for Alzheimer’s, 2023 brought promising new drugs, bringing hope for patients and their families.
LEQEMBI, developed by Biotechnology Innovation Organization (BIO) members Eisai and Biogen, was approved by the Food and Drug Administration (FDA) in July 2023. The drug is the first in a new class of Alzheimer’s drugs to be granted traditional approval.
LEQEMBI targets beta-amyloid plaque, a protein found in the brains of Alzheimer’s patients. Clinical trials showed LEQEMBI reduced cognitive decline by 27% in patients with early-stage Alzheimer’s disease.
The drug “can alter the course of Alzheimer’s in some people, rather than simply treat symptoms — a sign of hope to so many patients and families affected by this disease,” said President Biden.
Meanwhile, Eli Lilly is developing another plaque-targeting drug, donanemab, which has also shown to reduce cognitive decline by as much as 35%, we reported previously, and as much as 60% in patients in the earliest stages of disease. Eli Lilly anticipates FDA action in early 2024.
This year also brought progress in diagnostics. In October, the Centers for Medicare and Medicaid Services (CMS) announced the removal of the national coverage determination (NCD) and the end of coverage with evidence development (CED) for amyloid PET scans.
“Appropriate access to these diagnostics is critical to advancing patient care in Alzheimer’s,” says Aaron Fobes of Eli Lilly about the scan, which determines whether patients can benefit from drugs like LEQEMBI and donanemab. “We look forward to working with Medicare contractors to ensure timely and uniform coverage implementation.”
Barriers to access remain
Despite the progress in treatments, barriers to access remain. Specifically, as we’ve reported, Medicare will only cover this new class of drugs if they receive traditional approval and if patients participate in a registry. The Alzheimer’s Association called the registry requirement “an unnecessary and potentially harmful barrier.”
While LEQEMBI ultimately received traditional approval, the industry believes drugs with Accelerated Approval should also be accessible to patients.
“The best way to permanently ensure timely and affordable access is for CMS to open a reconsideration of its NCD—as it has promised to do in conjunction with new clinical evidence that is now available—and cover new Alzheimer’s medicines and diagnostics to FDA label,” said a statement from Eli Lilly.
