Sept. 28, 2022 – Medicare Part B premiums will dip in 2023 due to a setback for Biogen Inc.’s Alzheimer’s disease medicine, which drew tight payment restrictions because of concerns about its safety and effectiveness.
The standard monthly Part B premium will be $164.90 for 2023, a decrease of $5.20 from the 2022 rate, the Centers for Medicare and Medicaid Services (CMS) said this week.
Medicare officials increased the Part B premium from $148.50 to $170.10 in 2022 due in part to COVID-19 pandemic expenses and the expected sales of Biogen Inc.’s aducanumab (Aduhelm ) drug for Alzheimer’s disease.
Biogen at first priced Aduhelm to cost about $56,000 a year per patient. That’s the price CMS used to calculate the 2022 Part B premium. But as criticism grew over Aduhelm, Massachusetts-based Biogen cut the price to $28,200.
If that had been the initial cost, 2022 Medicare Part B premiums would have been $166.50, CMS said in a May report. And if it had been clear immediately in 2021 that Medicare would limit Aduhelm payment to cases where people were enrolled in clinical trials, the recommended 2021 Part B premium would have been $160.40, CMS said.
“That one drug resulted in an increase in Medicare premiums is a warning that we should pay attention to,” says Adriane Fugh-Berman, MD, director of the PharmedOut project at Georgetown University.
Fugh-Berman, who is an author of a new report, “What Needs to Change at the FDA?”, also says there is added concern about whether Aduhelm’s benefits justify its cost. In a separate interview, David Mitchell, the founder of the advocacy group Patients for Affordable Drugs, made the same point.
The Aduhelm example “shows that if we pay for drugs that don't work or pay a lot for drugs that don't work well, it really does have an impact on people through their premiums,” Mitchell said.
Biogen once sought brisk Aduhelm sales, with promotions including a controversial ad campaign about symptoms of mild cognitive impairment. “Do we all have Alzheimer’s? Drug makers might want you to think so” was the title of a July 2021 Baltimore Sun op-ed Fugh-Berman co-authored that criticized this campaign.
But Aduhelm sales have fallen far short of what was expected, as CMS took a different stance than the FDA.
Medicare usually covers drugs administered in doctors’ offices and clinics, thus covered by Part B, by adding a premium to the reported average sales price. But CMS officials were concerned about what they saw as weak evidence for Aduhelm’s benefit and signals seen in testing of its potential risks. So CMS did its own review of the drug, and ultimately took a cautious stance on Aduhelm.
Citing doubts about the effectiveness of Aduhelm and concerns about side effects, CMS in April announced a Medicare policy for covering the drug only in cases where patients are part of research studies. Biogen has said this policy will reduce future demand for the drug to a “minimal level” and took a write-off of about $275 million this year due to reduced value of Aduhelm inventory.
The FDA took a convoluted approach to clearing Aduhelm through its accelerated approval pathway.
With accelerated approvals, the FDA staff makes a well-educated bet that promising signals suggest a drug’s benefit will be confirmed in future testing.
Accelerated approvals are often used in oncology. Study results from the middle of three stages of testing, phase II, may suggest a drug’s benefit through what’s called a surrogate marker, such as test results showing tumors have not progressed. Accelerated approvals allow companies to sell medicines based on this good data while trying to prove in phase III tests that these drugs help patients live longer or have a better quality of life.
Aduhelm already had shown disappointing phase III results, as Biogen in March 2019 announced it was stopping the major trials of the drug.
Biogen later reversed course and argued that Aduhelm should be approved based on a result seen in certain patients in one trial, those given a high dose of the drug. A panel of FDA advisers heard Biogen’s case but recommended against regular approval of the medicine.
But in June 2021, the FDA opted to grant an accelerated approval for Aduhelm based on a surrogate marker of reduction of amyloid beta plaque in the brain. The hope is that further testing will show clearly that Aduhelm could keep the devastating effect of Alzheimer’s disease at bay for longer.
“The FDA turned around and backed into using an accelerated approval when Aduhelm couldn’t deliver the evidence to warrant a full approval to this day,” said Mitchell, who as a cancer patient himself takes medicines that first won their U.S. clearances on surrogate endpoints. “It seems like a misuse of the accelerated approval to me as a supporter of the accelerated approval pathway.”
That FDA approval of Aduhelm led to the resignation of three members of an advisory committee and an investigation of the agency’s processes by the watchdog unit of the Department of Health and Human Services.