The FDA on June 7 delivered its much-anticipated approval of Biogen Inc.’s Aduhelm (aducanumab-avwa), immediately stirring up a furor over its high cost, reigniting doubts about its effectiveness, and spurring speculation about how public and private payers will approach coverage for the first novel treatment approved for Alzheimer’s disease since 2003.

Alzheimer’s, which affects more than 6 million Americans and tens of millions of people worldwide, is marked by progressive cognitive and functional decline that eventually results in death. It kills more people than breast and prostate cancers combined and, along with other forms of dementia, is expected to cost the U.S. $355 billion this year alone, according to the Alzheimer’s Association.

Aduhelm stands out from the other drugs currently used to treat Alzheimer’s (see infographic, p. 6) because it aims to slow the progression of the disease rather than just address its symptoms, Douglas Scharre, M.D., tells AIS Health, a division of MMIT. Scharre is a neurologist and director of the division of Cognitive Neurology at Ohio State Wexner Medical Center, and he worked on clinical trials for the drug.

“Aducanumab is the first of a kind in that it is designed to get rid of this protein called amyloid from the brain,” Scharre says.

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