Aducanumab was approved for medical use in the United States by the Food and Drug Administration (FDA) in June 2021, in a controversial decision that led to the resignation of three agency advisers who claimed there is no evidence that the drug is effective as a treatment for Alzheimer’s disease but the drug is connected to a Medicare premium increase.
The Centers for Medicare & Medicaid Services announced in November that the standard monthly premium for Medicare Part B would rise to $170.10 in 2022, from $148.50 this year. The 14.5% increase is the largest one-year increase in the program’s history.
Sen. Bernie Sanders asked the White House to delay the Medicare premium increase and tied that insurance price hike to a pricey Alzheimer’s drug whose benefits have been widely questioned
In a letter sent to Biden, Sanders called on him to “prevent the outrageous increase in Medicare Part B premiums associated with the potential approval of the Alzheimer’s drug Aduhelm.”
He said the administration should delay Medicare’s approval for use of Aduhelm until it is deemed safe and effective, and take executive action to reinstate and expand the reasonable pricing clause requiring drug makers that receive federal funding to charge reasonable prices for prescription drugs and treatment.
After Sanders attributed the Medicare premium increase to Aduhelm, the newly approved Alzheimer’s medicine from drugmaker Biogen, the company cut its price from $56,000 a year to $28,200.
The FDA said that its first new treatment since 2003 was approved for Alzheimer’s but aducanumab is controversial due to ambiguous clinical trial results surrounding its efficacy.
Republican Senator Rick Scott of Florida issued a press release blaming President Joe Biden’s “reckless spending and socialist policies” while suggesting that inflation was the cause for the large increase in next year’s standard premiums for Medicare Part B, which covers physicians, some drug costs drug costs and other outpatient services.
Sanders wrote, “In my view, it would be absolutely unacceptable to force 57 million senior citizens to pay $11.50 more a month in Medicare premiums due to Biogen’s greed…” and a search of Federal Election Commission records showed that Scott has received donations from individuals connected to Biogen.
In fact, the FEC showed more than 580 political contributions from people connected with Biogen.
In November 2020, a panel of outside experts for the FDA concluded that a pivotal study of aducanumab failed to show “strong evidence” that the drug worked, citing questionable efficacy and multiple “red flags” found with the data analysis.
“Alzheimer’s treatment is a huge, urgent, unmet need,” said Dr. Joel Perlmutter, of Washington University School of Medicine. “But if we approve something with data that is not strong we have the risk of delaying good, effective treatments.”
Perlmutter was one member of a panel of outside experts who voted against the drug’s evidence; one voted that the drug showed “strong evidence” and two members said they were undecided. The panel also rejected the merits of a second study of the drug.
Ten of the 11 panelists found that there was not enough evidence to show it could slow cognitive decline. The 11th voted “uncertain.”
Nevertheless, the drug was approved under the FDA’s accelerated approval pathway, and the FDA requires Biogen to perform a follow-up study to see if the drug helps treat symptoms of Alzheimer’s
“After a robust and informative discussion, the committee voted, with 10 members against and 1 member uncertain, that it was not reasonable to consider the evidence of clinical benefit from Study 302 as primary evidence of effectiveness of aducanumab for the treatment of Alzheimer’s disease,” wrote Billy Dunn, M.D., the director of the FDA Office of Neuroscience.
“Alzheimer’s treatment is a huge, urgent, unmet need,” said Perlmutter “But if we approve something with data that is not strong we have the risk of delaying good, effective treatments.”
Massachusetts-based Biogen Inc., which is developing with Japan’s Eisai Co. the drug, known as aducanumab, acknowledged that it does not cure or reverse Alzheimer’s; but claims that it modestly slows the rate of decline among patients.
“This is a perfect example of why Medicare should be negotiating drug prices with the pharmaceutical industry,” Sanders wrote in his missive to Biden. “Unless you take action soon, the standard monthly Medicare Part B premium paid by some 57 million beneficiaries will increase by 14.55 percent (from $148.50 to $170.10) beginning next year. This $21.60 a month increase in Medicare premiums would be the largest in the 56-year history of Medicare and it could not come at a worse time for older Americans all over this country who are struggling economically.”