Employers are urging Congress to take action on drug prices following the FDA's recent approval of controversial Alzheimer's disease drug Aduhelm.
Aduhelm, or aducanumab, was developed by Biogen and Eisai and was approved by the Food and Drug Administration earlier this month despite pushback from the scientific community about the drug's efficacy.
Following its approval, Biogen said the therapy would be priced at $56,000 per year.
In a letter (PDF) to congressional leaders on both sides of the aisle, several employer groups argue that the approval process and subsequent high price tag should spur legislators to address drug pricing pricing.
"The approval of Aducanumab despite its questionable effectiveness, and its unjustifiable price, demonstrate the profound need for substantial reforms to how the United States approves and prices prescription drugs," the groups wrote.
The Purchaser Business Group on Health, the National Alliance of Healthcare Purchaser Coalitions, the Silicon Valley Employers Forum, the ERISA Industry Committee, the HR Policy Association and the American Benefits Council all signed on to the letter.
The groups warn that approving a drug like Aduhelm with limited scientific evidence could lead to other therapies gaining approval on similarly shaky ground and with similarly high prices.
The FDA did mandate that Biogen conduct further research on the drug and said Aduhelm could be pulled from the market if it is unable to prove its efficacy. However, the company has as long as nine years to conduct this trial, leaving government and private payers to cover it while the research process continues.
The vast majority of people eligible to take Aduhelm are Medicare patients, which could lead to significant cost to taxpayers, the groups said. In addition, Medicare's Part B program incentivizes providers to prescribe high-cost therapies like Aduhelm, they said.
"The unprecedented approval and unjustified pricing of aducanumab provides a cautionary tale of a broken system that is in profound need for reform," the groups wrote. "While there is little Congress can do to put the 'genie back in the bottle' for aducanumab’s approval, policymakers can keep future drugs with little-to-no clinical value off the market and to ensure that the price of all future drugs take into account clinical efficacy and value."