Mount Sinai Health System and the Cleveland Clinic won't prescribe Biogen's Alzheimer's drug Aduhelm to patients, citing concerns that it doesn't work.
A panel of Cleveland Clinic experts reviewed the evidence of the medicine's safety and efficacy and concluded the health system shouldn't offer Aduhelm, also known as aducanumab, to patients, the company said in a news release.
"However, we support continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients," the health system said.
The Food and Drug Administration approved the drug last month, ignoring the recommendations of FDA advisers that the agency reject Biogen's application. The action provoked protests from physicians and researchers concerned not only about the drug's questionable effectiveness but also about its $56,000 per year price tag. Acting FDA Commissioner Janet Woodcock has promised an internal investigation of her own agency's decision-making, and CMS announced this week that it would begin evaluating whether Medicare will cover the medicine.
UnitedHealth Group is biding its time before it determines whether its health plans will cover Aduhelm, CEO Andrew Witty said in an earnings call Thursday. "It's really about waiting and understanding where CMS sits," he said. "I think we're not the only ones in that regard looking for clear information." At least six Blue Cross and Blue Shield affiliates have decided not to cover Aduhelm.
Most physicians believe the FDA shouldn't have approved Aduhelm and that the drug shouldn't be routinely prescribed, according to a survey by STAT and Medscape.
Mount Sinai won't permit clinicians to administer Aduhelm until the health system collects more evidence and devises plans for how to use the medication, a spokesperson said. Mount Sinai also wants to see the results of an investigation by HHS' inspector general about ties between Biogen and FDA officials. For the time being, Mount Sinai providers will counsel patients who may want to seek Aduhelm from other providers, the spokesperson said.
The FDA declined to comment.
CODE: Nona Tepper contributed to this story.