The U.S. Medicare program’s decision to tightly limit coverage for the first drug meant to slow the course of Alzheimer’s disease has raised the stakes for companies trying to make the next one.
First up are Eisai Co. and Roche Holding AG, which will release data from final-stage trials of their respective lecanemab and gantenerumab treatments later this year. Next will be Eli Lilly & Co., whose donanemab results are expected in the middle of next year. Each of the companies will be trying to reach a bar that has never been met: showing clear evidence that they can alter the course of Alzheimer’s in a way that’s meaningful to patients.
The big studies from the three companies should finally deliver a definitive answer as to whether clearing patients’ brains of amyloid, a protein associated with the disease, helps slow cognitive decline. In its decision on Thursday, the Centers for Medicare and Medicaid Services pledged broad reimbursement for Alzheimer’s medicines that win traditional approval from the Food and Drug Administration. That could mean billions of dollars in sales and a long-awaited treatment option for a disease that affects more than 6 million Americans, many of whom are elderly.
