- The Food and Drug Administration is limiting the use of the drug Aduhelm to treat Alzheimer’s disease.
- It’s now being recommended only for people in the early stages of the disease.
- Medical professionals and officials at the Alzheimer’s Association say they support the limitations.
Following pushback and resignations over the decision to approve the use of Aduhelm to treat Alzheimer’s disease, officials at the Food and Drug Administration (FDA) have now narrowed their recommendations for the drug to only be used to treat people in the early stages of the disease.
That pullback came just weeks after the approval of the drug, the first approved to treat Alzheimer’s in 18 years.
Medicare has also just launched a review on how — and if — they should cover the cost of the drug.
That review, a seldom-used process called “coverage determination,” will consider Aduhelm’s usefulness along with its price tag, said to be as high as $56,000 a year.
That decision could reduce access to the drug even more.
The revelations prompted officials at the Cleveland Clinic in Ohio and the Mount Sinai medical complex in New York to announce this week that they will not treat people with Aduhelm.
Officials in the Alzheimer’s community have expressed support for the FDA’s latest decision while medical professionals remain careful about whom they suggest the drug could benefit.
“This is not far enough. They really should reconsider their decision and take it off the market,” Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, told Healthline.
Schneider, who worked directly on the trials for the drug, said that the research didn’t include people with diabetes or high blood pressure, or any people taking blood thinners.
Since studies were truncated, he compared any approval of the drug to a baseball game.
“It’s like we’re running two baseball games and in the middle of the fifth inning you just called the winners,” Schneider said. “You don’t know what the actual results might be.”
Dr. Paul E. Schulz, a neurologist with McGovern Medical School at UTHealth in Texas, told Healthline he felt the FDA change was a good one, and that his patients understand that the drug may only help those in the very early stages of the disease.
“The new guidelines say that it should specifically be used in patients with early Alzheimer’s,” he said. “Most people calling us seem to have captured the idea that their loved one needs to be early in the process.”
“Holding the drug from people who are more advanced isn’t done to be cruel to those with that misfortune,” he added. “It doesn’t make sense to give a drug with important side effects to someone that it probably won’t help.”
Schulz said that for healthcare professionals, all eyes are on that Medicare review. He expects that will guide them even further.
“None of us have inside information, but most of us believe that Medicare may decide to cover only those who fit the profile of the patients who were in the aducanumab clinical trials,” he said.
“So, regardless of what the FDA approves, it is CMS [Centers for Medicare & Medicaid Services] that will decide who can actually get it. So, in some senses, this decision by the FDA brings their recommendations closer to what we think that CMS will approve,” Schulz added.
Officials at the Alzheimer’s Association, which advocated for the drug’s approval, say they support the FDA’s change.
“The announcement was consistent with the Alzheimer’s Association’s position, that the treatment should be initiated in patients in the disease stage studied in the clinical trials — people with mild cognitive impairment (MCI) or mild dementia stage of disease,” Kristen Clifford, the association’s chief program officer, told Healthline.
“We encourage people who are interested in learning more about this treatment, for themselves or a loved one, to have a conversation with their healthcare provider,” she said.
And even with the limitations, Clifford said it still brings hope.
“This is the first treatment approved for Alzheimer’s disease since 2003, and the first to address the underlying biology of Alzheimer’s disease. This approval could mean more time for individuals to actively participate in daily life, have sustained independence, and hold on to memories longer,” she said.
“We recognize the drug may work differently for everyone who takes it, and may not work for some individuals,” she added.
Dr. Aaron S. Kesselheim, MPH, one of the FDA advisors who resigned over the initial decision, said he was happy to see the change but still hopes to see more.
“This is a fine and necessary step, but it’s not sufficient, in part because plenty of studies show that prescribers may not read drug labeling in detail,” he told Healthline.
“The FDA needs to do a much better job actively communicating the limitations in the evidence on the benefits of this drug to combat the overly rosy presentations of it that seem to be multiplying online and other places,” Kesselheim added.
Schulz hopes those seeking care stay hopeful despite the limitations.
“Most people calling us seem to have captured the idea that their loved one needs to be early in the process. As with us, they wish that we had good medications to try later in the disease. So, they are disappointed, but many of our good families are very realistic,” he said.
“We haven’t been smart enough yet to find medications that work later in the disease, but hopefully we will have some candidates someday,” Schulz added.