An experimental Alzheimer’s disease treatment developed by Eisai and Biogen that appears to slow cognitive decline sent shares in both companies soaring, but some analysts are tempering their expectations until they get a better idea if Medicare will pay for the drug. U.S.-listed shares of Eisai
were up 61.9% and Biogen’s
stock gained 35.4% in trading on Wednesday, the day after the companies announced lecanemab reduced cognitive decline by 27% in 18 months compared with placebo. The confirmatory Phase 3 clinical trial also met its secondary endpoints, they said.
Drug companies have long struggled to bring to market effective therapies that can delay or halt the progression of the disease. An estimated 6.5 million people in the U.S. who are 65 years old or older have Alzheimer’s. While the new lecanemab data appears strong enough to support Food and Drug Administration approval, the bigger question is whether the Centers for Medicare and Medicaid Services will reimburse patients who take the therapy if and when it is approved. The CMS issued a national coverage determination in April that put limitations on coverage of anti-amyloid monoclonal antibodies that haven’t shown a clinical benefit. “FDA approval seems likely, but CMS determination [is] another bridge to cross,” Wedbush’s Laura Chico told investors Wednesday morning. “It’s a positive to see the study reach statistical significance, with FDA previously signaling this would be a prerequisite for approval. However, what CMS will see as a clinically meaningful outcome remains to be determined.” The CMS policy essentially shut down broad access to Aduhelm, another Alzheimer’s treatment developed by the same companies with a more complicated back story. Biogen halted the development of the drug back in 2019, saying it wouldn’t meet the primary endpoints in an important clinical trial; then, in 2020, the company announced that a new analysis showed that the drug did …