Bonnie Salamon has waited for months to learn whether Medicare would cover the hefty price tag for a new and controversial drug that promises to help Alzheimer’s patients like her husband, Steven.
This week, she got an answer that gives her some hope, but for other families, patients and advocates, the news was bittersweet.
In a preliminary decision announced Tuesday, the Centers for Medicare and Medicaid Services said it would cover the cost of the drug, Aduhelm, but there was a catch: the federal agency will only pay for the drug for patients enrolled in clinical trials approved by the agency or supported by the National Institutes of Health.
The unusual decision drastically limits the number of people who could benefit from the drug. Some insurers have already said they won’t cover the cost of the drug.
“It seems cruel when there is something so promising and it’s out of reach,” for most people, Bonnie Salamon said during a telephone interview from her DeKalb County home.
The federal agency’s decision is preliminary and will be followed by a 30-day public comment period. A final determination is due in April.
Linda Davidson, executive director of the Georgia chapter of the Alzheimer’s Association, said she was “concerned and surprised” by the decision “We know there are many people who are underserved and certainly affected by this disease. We know there are people with this disease who don’t trust doctors and are not comfortable with clinical trials. They will be excluded and it’s just very perplexing but hopefully we can respond to this decision.”
The drug’s maker, Biogen, recently announced it was reducing the cost of a year’s worth of the drug to $28,200, roughly half of what it was projected to cost per patient initially.
According to the Chicago-based Alzheimer’s Association, Alzheimer’s is a progressive disease that affects more than 6 million people in the U.S. In Georgia, the number of people 65 and older with Alzheimer’s was 150,000 in 2020 and projected to reach 190,000 in 2025, an increase of 26.7%.
Bonnie Salamon thinks her 76-year-old husband would be willing and eligible to enroll in a study. He’s currently a patient at the Integrated Memory Care Clinic at Emory University and in pretty good health, however it’s not known if Emory will conduct a clinical trial of the drug.
Steven Salamon is in the early stage of the disease, with mild cognitive decline. He received his Alzheimer’s diagnosis around New Year’s Eve. He worked in advertising and public relations before retiring as a kitchen designer. He was highly proficient and productive, but a few years ago his wife noticed he seemed more forgetful. He later began asking the same questions over and over and had difficulty working on his computer. His wife said his physician at the time dismissed it as aging.
“We were optimistic about this drug — then we found out how much it costs,” Bonnie Salamon said. “We’re in our 70s and living on a fixed income. That could be a problem. I was really hopeful that Medicare and Medicaid would wake up and realize that the long-term medical costs of someone with that condition is going to be many multiples the cost of the drug. It can go on for many years. It seems so foolish not to have it covered.”
Approved by the Food and Drug Administration in June, the approval process was criticized from the start with concerns raised about the drug’s efficacy, side effects, the high price tag and the relationship between drugmaker Biogen and the federal agency.
Several members of an advisory committee resigned in protest following the FDA’s decision.
Locally, there are also questions about how many locations in Georgia will conduct studies of the drug and whether they will be in rural areas as well as bigger cities.
Fayron Epps, an assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, said she has mixed emotions about the decision.
She sees it an opportunity to get more individuals involved in clinical trials to prove the benefits of the drug, but she added that at the end of the day “it is about who has access to receive this drug.”
Epps said she worries African Americans, who are twice as likely to get Alzheimer’s as whites, might be left out of trials. “Historically, there are low participation rates in clinical trials among African Americans and I don’t believe this decision will be an influential factor in reversing those statistics.”
Dr. Monica Parker, director of the Minority Engagement Core at Emory University’s Goizueta Alzheimer’s Disease Research Center, agrees that requiring people to be part of a clinical trial is a good thing.
“Clinical research participation ensures an accurate diagnosis, ensures that the proper treatment is administered paid for and that there is close medical follow up,” she said. “Clinical trial research participation and training for same should be accessible and available to all providers and their patients.”
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