Major health systems refuse to administer Aduhelm as top FDA leaders meet behind closed doors to talk with payers
Normally when a new drug wins FDA approval, the commercial launch plays out quietly in the background for a few years, with hardly ever any FDA involvement, before there’s some consensus on whether the drug is a commercial or clinical success, failure or somewhere in between.
For Biogen’s new Alzheimer’s drug, however, that launch is kicking off with a deafening bang as two major health systems — the Cleveland Clinic and Mount Sinai — are now refusing to administer the drug. And the FDA is not only leading but funding the discussion over how insurers will deal with Aduhelm — a rarity for an agency that typically steers clear of such contention.
A spokeswoman for the Cleveland Clinic told the New York Times that individual physicians there could prescribe Aduhelm to patients, but those patients would have to receive the drug elsewhere.
New York-based Mount Sinai also said it decided to not administer Aduhelm because of acting FDA commissioner Janet Woodcock’s call for an investigation into the relationships between agency officials and Biogen executives.
“Aduhelm will not be considered for infusion into patients on any of its campuses until and unless” that investigation “affirms the integrity of the F.D.A.-Biogen relationship and goes on to reaffirm” the FDA’s basis for approving the drug, Sam Gandy, director of the Mount Sinai Center for Cognitive Health, told the Times.
Normally when a new drug wins FDA approval, the commercial launch plays out quietly in the background for a few years, with hardly ever any FDA involvement, before there’s some consensus on whether the drug is a commercial or clinical success, failure or somewhere in between.
For Biogen’s new Alzheimer’s drug, however, that launch is kicking off with a deafening bang as two major health systems — the Cleveland Clinic and Mount Sinai — are now refusing to administer the drug. And the FDA is not only leading but funding the discussion over how insurers will deal with Aduhelm — a rarity for an agency that typically steers clear of such contention.
A spokeswoman for the Cleveland Clinic told the New York Times that individual physicians there could prescribe Aduhelm to patients, but those patients would have to receive the drug elsewhere.
New York-based Mount Sinai also said it decided to not administer Aduhelm because of acting FDA commissioner Janet Woodcock’s call for an investigation into the relationships between agency officials and Biogen executives.
“Aduhelm will not be considered for infusion into patients on any of its campuses until and unless” that investigation “affirms the integrity of the F.D.A.-Biogen relationship and goes on to reaffirm” the FDA’s basis for approving the drug, Sam Gandy, director of the Mount Sinai Center for Cognitive Health, told the Times.