The only way for Medicare to safely determine if Biogen's controversial Alzheimer's drug, Aduhelm, works is to cover the treatment only for patients who receive it in trials, two physicians wrote in an op-ed published Jan. 3 in Bloomberg.
The article was written by Peter Bach, MD, and Rita Redberg, MD, who have both served as chair of the committee that advises Medicare on which treatments it should cover.
Drs. Bach and Redberg recommend Medicare limit its coverage of Aduhelm, — which costs $28,200 a year for the average patient — to patients who volunteer for clinical trials testing the drug, as they argue there is little evidence of the drug's clinical benefit. They said results from such a trial would allow Medicare to assess if it should cover the drug, the generic name of which is aducanumab, more broadly.
"The best way to help Medicare beneficiaries who develop Alzheimer’s is to make sure the treatments physicians offer are more likely to help than to harm them," the physicians wrote. "But it’s impossible to know whether aducanumab is such a treatment; the data gathered so far don’t indicate that the drug would have any clinically meaningful benefit."
Aduhelm was approved using the FDA’s accelerated approval pathway, which requires Biogen to conduct a post-marketing trial for the drug. However, the FDA gave the drugmaker nine years to complete its research, which Drs. Bach and Redberg argue is too long to know if Aduhelm works. They suggested Medicare conduct its own trial sooner and endeavor to enroll the types of patients Medicare serves.