FDA's Approval of Alzheimer's Drug Sets Off Fierce Debate

by Leslie Small

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 payers will approach coverage for the first novel treatment approved for Alzheimer's disease since 2003.

"Aducanumab is the first of a kind in that it is designed to get rid of this protein called amyloid from the brain," says Douglas Scharre, M.D., director of the division of Cognitive Neurology at Ohio State Wexner Medical Center, who was involved with the drug's clinical trials. "No other therapies we've had so far for Alzheimer's [were] able to remove some of these toxic proteins that cause these plaques and lead to a whole cascade of events of cognitive impairments."

Yet controversy has surrounded Aduhelm for some time. The results of two Phase III trials in patients with early-stage and mild Alzheimer's contradicted each other, and the FDA's independent Peripheral and Central Nervous System Drugs Advisory Committee advised against approving the drug. Ultimately, the FDA gave Aduhelm an accelerated approval, which means that it will require Biogen to conduct a post-approval trial to verify the drug's clinical benefit.

The annual wholesale acquisition cost for the average patient taking the full maintenance dose of Aduhelm is $56,000, according to Biogen and Eisai.

David Steinberg, Pharm.D., director of pharmacy insights at Scripta Insights, says he is not convinced that Aduhelm is worth its high cost. "All the independent evaluations that have been done on the medication provide a very clear picture that it is no more effective than what is currently on the market," Steinberg says.

Unlike the other Alzheimer's treatments on the market, which are covered under the pharmacy benefit, Aduhelm will be covered under patients' medical benefit because it has to be infused in a clinical setting. For Medicare patients, that means the drug will be covered under Part B.

Tricia Neuman, senior vice president of the Kaiser Family Foundation and executive director of its Program on Medicare Policy, says that "the largest group of people who would be affected [by Aduhelm's approve] would be all Part B enrollees, who would be responsible for any increase in the Part B premium associated with higher spending for the new drug, because premiums cover 25% of program costs."

From RADAR on Drug Benefits