US lawmakers probing the approval of Biogen’s controversial new Alzheimer’s treatment Aduhelm asked the company to turn over years of internal documents about the drug’s development and the company’s dealings with regulators.
The request by Democratic leaders of two House committees investigating the approval adds to the scrutiny of Aduhelm. Last week the acting head of the FDA, Janet Woodcock, asked for an independent government investigation into the approval process from the inspector general that oversees the agency.
Biogen and the US Food and Drug Administration have faced mounting criticism since the early June decision to allow the $56,000-a-year drug on the market over the objection of the agency’s scientific advisers. Rather than being cleared based on its effectiveness, Aduhelm gained approval under an accelerated program by showing it can reduce amyloid in the brain, a physical biomarker long linked to the disease.
Meanwhile, Biogen has nine years to finish a trial on its efficacy.
The lawmakers asked Biogen for all documents from 2018 onward related to the development of the drug, the company’s communications with the FDA, and plans for pricing and commercialization, among other requests. Biogen was asked to respond by July 26.
A spokesperson for Biogen said the company would cooperate with the inquiry.
The request follows a report from STAT on what lawmakers called a “secret campaign” by Biogen, called Project Onyx, to get regulators to approve the drug after two large trials were halted in 2019 when an independent committee deemed them unlikely to succeed. Further analysis of one of the trials later showed a small apparent benefit.
“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,” wrote Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Frank Pallone Jr., chairman of the House Committee on Energy and Commerce.
Meanwhile, the Centers for Medicare & Medicaid Services (CMS) said it plans to review whether Medicare will establish a national policy on drugs targeting amyloid for the treatment of Alzheimer’s. The review is applicable to Aduhelm, and any future monoclonal antibodies that target amyloid, CMS said in a statement.
The review will include a 30-day public comment period starting on Monday and two public listening sessions in July.
“We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,” CMS Administrator Chiquita Brooks-LaSure said in the statement.
Now coverage determinations for the drug are being made at the local level by Medicare administrative contractors who represent 12 jurisdictions across the country, according to the statement. A proposed decision is expected to be posted within six months and a final decision within nine months.
A Biogen spokesperson said in an e-mail that the process “will provide additional clarity on coverage for Medicare beneficiaries and drive consistency of access across the country.” The company added that it expects Medicare contractors and private Medicare Advantage plans will cover Aduhelm while the review is underway.