Today, Rep. Frank Pallone, Jr., Chairman of the Committee on Energy and Commerce, and Rep. Carolyn B. Maloney, the Chairwoman of the Committee on Oversight and Reform, sent a letter to Biogen Inc. Chief Executive Officer Michel Vounatsos requesting documents related to the approval process, marketing, and pricing of Biogen’s Alzheimer’s drug, Aduhelm.
“Millions of Americans suffering from Alzheimer’s disease are in need of innovative treatments. While we share in the hope for new advancements to treat this debilitating disease, it is critical that these treatments be safe, effective, and affordable," the Chairs wrote. “We are concerned by reports of an atypical approval process for Aduhelm amid significant questions about the drug’s clinical benefit, and the steep $56,000 annual price tag, which will have serious implications for seniors, federal health care programs, and future Alzheimer’s research."
On June 7, 2021, Biogen was granted accelerated approval from the Food and Drug Administration (FDA) for Aduhelm on the basis that it reduces amyloid beta plaque in the brain. Aduhelm was approved despite the fact that Biogen cancelled clinical trials for Aduhelm in March 2019 due to an independent report indicating the drug was unlikely to benefit people with Alzheimer’s disease and that further clinical study would be futile.
“Recent reporting indicates that in the months following its failed clinical studies, Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm," the Chairs wrote.
As part of this effort, the company reportedly communicated closely with FDA for months as it sought potential paths to regulatory review and approval for Aduhelm. The company announced in October 2019 that “after consulting with" FDA, it would seek approval for Aduhelm.
FDA’s June 7, 2021 approval of Aduhelm was granted despite internal concerns raised by experts in FDA’s Office of Biostatistics about the “inconsistency" of the drug’s supporting clinical data. None of the empaneled members of FDA’s Peripheral and Central Nervous Systems (PCNS) Drugs Advisory Committee recommended approval, and three Advisory Committee members resigned in protest after the drug’s approval.
The Chairs also raised concerns with Biogen’s list price of $56,00 per year for the drug.
“While the company has claimed this price is ‘fair’ and ‘substantiated by the value it is expected to bring,’ an independent analysis determined that a fair price for Aduhelm would be a small fraction of Biogen’s price-between $3,000 and $8,400 per year," the two Chairs continued. “Biogen’s price is also far higher than many investors reportedly expected. Aduhelm’s approval and price will have significant implications for seniors and their families, health care providers, federal health care programs, and taxpayers."
According to conservative estimates, Biogen’s annual list price of $56,000 could result in annual expenditures in excess of $57 billion per year for the Medicare Part B program if one million beneficiaries receive Aduhelm-more than the $37 billion the program spent on all drugs in 2019.
The letter is part of the Committees’ efforts to promote transparency into the process of Aduhelm’s approval; Biogen’s pricing; and the implications for future Alzheimer’s treatments and research, patients, providers, and federal health care programs.
Read the full letter HERE.
