First-in-Class Alzheimer’s Drug Earns Federal Approval

June 7, 2021

For Alzheimer’s patients, the long wait is over. 

On Monday, the Food and Drug Administration approved aducanumab, the first Alzheimer’s treatment aimed at attacking the disease’s cause and slowing cognitive decline. Existing drugs help only with symptom management, and many are not well tolerated by patients.

Federal approval was anything but certain, but patients’ voices – and the growing unmet need – prevailed.

More than 6 million Americans have Alzheimer’s, a number projected to double by 2050. No new drugs have been approved in almost two decades. 

This week’s approval means physicians will be able to prescribe aducanumab, but the medication may not be a silver bullet. The drug is designed to remove toxic plaque in the brain, called beta-amyloid. Federal regulators are requiring the manufacturer to conduct a large post-approval study, which will verify whether removing that plaque slows cognitive decline. 

The Next Hurdle

Even before aducanumab’s federal approval or price were final, health economists gave the drug low marks. The Boston-based Institute for Clinical and Economic Review deemed the drug wasn’t cost effective, despite flaws in the organization’s model that don’t fully account for the burden of Alzheimer’s and other dementias. 

Insurers have a history of citing ICER’s omission-riddled reports and low valuations when developing formularies.

But ICER’s underwhelming opinion might be just the first is a line of access barriers.

Patients could also encounter barriers to aducanumab just because it’s new. Aptly named “new-to-market exclusions” keep patients from having their medication covered for a period, 30 or 60 days, or even until the next coverage year. Even then, patients’ access may be delayed by an onerous prior authorization process.

But for now, Alzheimer’s patients and advocates are celebrating aducanumab’s approval. After years of dreams dashed by other potential treatments’ failures, this Alzheimer’s & Brain Awareness Month they find hope again. 

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