CSRXP: FDA APPROVAL AND SUBSEQUENT BIOGEN PRICING OF ADUCANUMAB DEMAND RETROSPECTION, REFORM

Troubling for Public Health Institution to Depart from Established Norms to Support Drug of Questionable Efficacy with Unjustifiable Price Tag

Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) issued a statement today reflecting on the recent U.S. Food and Drug Administration (FDA) approval of Alzheimer’s treatment aducanumab, brand name Aduhelm.

“Policymakers must carefully and soberly consider the implications of every action at a time when our nation faces historic public health challenges coinciding with an all-time low in public trust of institutions,” said CSRxP executive director Lauren Aronson. “Decision-making that departs from longstanding and well-established norms, like the FDA approval of aducanumab, threatens to undermine public confidence in an agency with a mission critical to the wellbeing of Americans.”

“As a result of the FDA’s approval of aducanumab, and Biogen’s subsequent unjustifiable pricing on the treatment, hopeful patients will pay a punitive price tag for a drug with questionable, or even negligible, efficacy while a Big Pharma company profits,” Aronson continued. “This demands retrospection on the part of regulators — to do their best to ensure decisions going forward follow key principles and are above reproach — and it demands reform from policymakers, who must deliver on repeated promises to hold Big Pharma accountable for the industry’s egregious pricing practices.”

“Every American hopes for true breakthroughs in the treatment of terrible disease,” Aronson added. “But advances will only be true breakthroughs if achieved with trust in our public health institutions intact and if the Americans who need treatments, can afford them.”

In an analysis, The Institute for Clinical and Economic Review (ICER) concluded a fair annual price for aducanumab, barring major new evidence to support the drug’s efficacy, would fall between $2,500 and $8,300. Following FDA approval, Biogen set a list price of $56,000 for annual treatment with the drug. ICER estimates the Big Pharma company will stand to make more than $50 billion in annual profit from the drug that may bring little to no clinical benefit to patients.

In November, the FDA’s advisory committee recommended against approval of aducanumab after reviewing clinical trial data. Ten members of the committee voted against proceeding with approval based on the study evidence available, one member voted “uncertain.” Not a single member voted in favor of advancing approval of the drug.

The FDA’s decision to approve the drug anyway represents the first time the agency has gone against the advisory panel when there was not a single vote in favor. In the days following the FDA approval, three members of the advisory committee resigned, including Mayo Clinic neurologist Dr. David Knopman, Washington University neurologist Dr. Joel Permutter and Aaron Kessleheim, a professor of medicine at Harvard.

Read more from ICER on the FDA’s decision to approve aducanumab and its pricing HERE.

Learn more about market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.