What’s the Controversy About Aduhelm?

“Behold the deluge,” begins the February 18, 2022 article on the ALZFORUM titled, “On Aduhelm, Medicare Agency Gets Pressure From all Sides”. CMS received 9,956 public comments during its open comment period ending February 10, 2022 to hear from the public about its draft (temporary) decision to approve coverage for Aduhelm for people with Alzheimer’s only if they were enrolled in approved clinical trials. Organizations such as the Alzheimer’s Association and UsAgainstAlzheimer’s, both strongly in support of making Biogen’s drug Aduhelm (also known as aducanumab) widely available with no restrictions, have launched national media campaigns to influence public support for their position.

Because some of the information the public sees and hears about Aduhelm may be inaccurate or misconstrued, DAA is providing a narrative of facts so readers can form their own informed opinions. In disclosure, DAA receives no funding from Biogen.

  • In March 2019, Biogen halted its Phase 3 clinical trials of Aduhelm because the drug showed no efficacy.

  • In October 2019, Biogen reversed its decision saying it had reanalyzed the data and found that there was a small but statistically significant change in the test used to study whether or not it worked.
  • In November 2020, an 11-member independent advisory group at the FDA reviewed all the data and recommended against approval (10-0 with one abstention). There were no votes for approval. Their reason: it was not clear that the drug  had any benefit and it carried serious adverse effects, including headaches, dizziness, falls, and brain bleeds and swelling.
  • On March 31 and April 7, 2021, a 15-member council of senior FDA officials recommended against approval. The evidence did not meet the threshold for “instilling public confidence in the usefulness of the drug,” according to the minutes. Another trial was necessary, the council agreed, but could be “a shorter and more efficient trial.” During the public meeting, the council voted unanimously (15-0) that the evidence was not adequate to demonstrate that aducanumab (Aduhelm) plus supportive care provides a net health benefit  when compared to supportive care alone.
  • On June 7th, 2021, the FDA announced it would approve Aduhelm using an accelerated approval process that does not require the drug developer  to show that the drug actually improves clinical outcomes. That is, the drug does not have to show that it actually benefits the patient, only that it could. Biogen only had to show that its drug affects some part of the disease process and agree to continue studies to show it works. Aduhelm does lower amyloid levels and it was approved by the FDA on that basis.
  • Following the FDA’s June approval, Biogen set the price for Aduhelm at $56,000/year. Biogen lowered the price to $28,200 effective January 1, 2022.
  • On January 11, 2022 the Centers for Medicare and Medicaid Services (CMS) announced in a draft decision it would cover FDA-approved anti-amyloid monoclonal antibody drugs (that includes Aduhelm) for people with Alzheimer’s on Medicare only if they were enrolled in an approved clinical trial in order to better understand the drug’s efficacy and potential for harm.
  • CMS will make a final decision on its coverage for Aduhelm in April 2022.

This last point brings us back to the flurry of comments and current public media attention on the issue. Monied groups are lobbying heavily for CMS’ full, unrestricted approval of the drug. A few more facts to consider –

  • There has been no peer-reviewed publication on the efficacy data of Aduhelm.
  • The American Geriatrics Society, whose membership is comprised of over 6,000 healthcare practitioners, supported CMS’ draft decision because of the drug’s lack of efficacy and serious adverse effects. 
  • In the U.S., after careful review a number of large healthcare organizations decided not to approve Aduhelm for its patients with Alzheimer’s, including the Veterans Administration, the Cleveland Clinic, Mount Sinai, and Massachusetts General Hospital.
  • Globally, Canada, the European Union and Japan have decided not to approve use of the drug.

DAA could not be more strongly in support of a drug that helps ameliorate the effects of Alzheimer’s. Aduhelm has not been shown yet to be beneficial, yet it has been shown to have some serious adverse effects, including brain swelling and bleeds. In our opinion, CMS’ decision only serves to protect people taking the drug by requiring they be enrolled in approved clinical trials so that Aduhelm’s efficacy and safety can be evaluated.

The following is a copy of DAA’s public comments submitted to CMS on February 9, 2022.