Due to a setback for Biogen Inc.’s Alzheimer’s disease medication, which drew strong payment limits due to concerns about its safety and effectiveness, Medicare Part B premiums will decrease in 2023.
The Centers for Medicare and Medicaid Services (CMS) announced this week that the normal monthly Part B premium will be $164.90 for 2023, a $5.20 decrease from the 2022 rate.
Due in part to costs associated with the COVID-19 pandemic and anticipated sales of Biogen Inc.’s aducanumab (Aduhelm) medicine for Alzheimer’s disease, Medicare officials raised the Part B premium from $148.50 to $170.10 in 2022.
Aduhelm was initially estimated by Biogen to cost each patient roughly $56,000 annually. The Part B premium for 2022 was calculated by CMS using that cost. Aduhelm’s price was reduced to $28,200 by Massachusetts-based Biogen in response to mounting criticism.
According to a May analysis from CMS, 2022 Medicare Part B premiums would have been $166.50 if that had been the starting price. The proposed 2021 Part B premium, according to CMS, would have been $160.40 if it had been known in advance in 2021 that Medicare would restrict Aduhelm payment to cases when patients were engaged in clinical studies.
According to Adriane Fugh-Berman, MD, director of the PharmedOut initiative at Georgetown University, “That one drug led to an increase in Medicare costs is a warning that we should pay attention to.
What Needs to Change at the FDA? study author Fugh-Berman also claims that there is more doubt regarding whether Aduhelm’s advantages outweigh its expense. The same idea was stated in a different interview by Patients for Affordable Drugs founder David Mitchell.
According to Mitchell, the Aduhelm case “shows that if we pay for treatments that don’t work or pay a lot for drugs that don’t work well, it actually does have an impact on individuals through their premiums.”
Unpopular Introduction
Aduhelm was originally promoted aggressively by Biogen, who also ran a contentious marketing campaign about the signs of moderate cognitive impairment. “Does Alzheimer’s affect everyone? A Baltimore Sun opinion piece that Fugh-Berman co-authored in July 2021 with the heading “Drug producers would want you to think so” attacked this approach.
Sales of Aduhelm, however, have fallen significantly short of expectations since CMS disagreed with the FDA in its approach.
Medicare typically adds a premium to the stated average sales price of pharmaceuticals to cover drugs provided in clinics and doctor’s offices, which are therefore covered under Part B. However, the inadequate supporting data for Aduhelm’s benefits and signs of potential hazards in testing alarmed CMS officials. CMS conducted its own evaluation of the medication and eventually adopted a cautious approach about Aduhelm.
Aduhelm is only covered by Medicare when patients are participating in research studies, CMS announced in April, citing questions about the drug’s efficacy and worries about adverse effects. According to Biogen, this approach will lower medicine demand in the future to a “minimum level.” This year, Biogen had to write off nearly $275 million due to the diminished value of its Aduhelm stockpile.
Complicated Method
Through its fast approval procedure, the FDA cleared Aduhelm in a complicated manner.
The FDA staff places a calculated wager that positive signs indicate a drug’s effectiveness will be substantiated in further testing when it grants rapid approvals.
In oncology, accelerated approvals are frequently employed. Phase II study data, the second of three testing phases, may indicate a drug’s usefulness through a phenomenon known as a surrogate marker, such as test results demonstrating that malignancies have not advanced. While attempting to demonstrate in phase III studies that these medications help patients live longer or have a higher quality of life, accelerated approvals allow corporations to market medicines based on this solid data.
Aduhelm had already produced underwhelming phase III results when Biogen announced in March 2019 that it was ending the drug’s major clinical trials.
Later, Biogen changed its position and claimed that Aduhelm should be allowed in light of a result observed in a subset of patients in one experiment who received a high dose of the medication. Despite hearing Biogen’s argument, an FDA advisory panel advised against routinely approving the drug.
However, the FDA decided to expedite the approval of Aduhelm in June 2021 based on a surrogate indicator of a decline in amyloid beta plaque in the brain. It is hoped that additional research will conclusively demonstrate how effective Aduhelm is at delaying the severe effects of Alzheimer’s disease.
Mitchell, a cancer patient himself, uses drugs that were initially approved in the United States based on surrogate endpoints. “The FDA turned around and backed into using an accelerated approval when Aduhelm couldn’t offer the evidence to warrant a complete approval to this day,” Mitchell said. As a proponent of the fast approval method, “it appears like a misuse of the rapid approval.”
Three advisory committee members resigned as a result of the FDA’s approval of Aduhelm, and the Department of Health and Human Services’ watchdog arm launched an investigation of the agency’s procedures.
