The Food and Drug Administration (FDA) recently approved aducanumab (Aduhelm), the first new drug for Alzheimer’s disease in nearly 20 years, and the first that can slow the progression of this disease.
Some experts consider this to be a big step, but many do not agree with the FDA’s decision, as they say there is little evidence that the drug works and is safe. Several major medical centers, such as the Clinic in Cleveland in Ohio and Mount Sinai Health System in New York, have chosen not to administer Aduhelm to patients at this time .
“It is an incredible achievement for the medical field that we can use a drug to alter the biology of disease,” says Dr. David Wolk, director of the Alzheimer’s Disease Research Center of the University of Pennsylvania Perelman School of Medicine, Philadelphia. But “there is still uncertainty about the clinical benefit of the drug, and it has side effects that, in some cases, can cause serious neurological damage.”
It is possible that the news about Aduhelm will continue to develop for a weather. But for now, here are the answers to the key questions.
How does Aduhelm work?
The drug is delivered via intravenous once a month. It signals the immune system to destroy amyloid plaques, clumps of proteins in the brain that are believed to kill brain cells. In theory, the removal of amyloid could slow the deterioration of the brain , although other experimental treatments targeting amyloid have not alleviated the symptoms of Alzheimer’s disease.
Does it adequately reduce symptoms?
This is uncertain because Aduhelm’s two pivotal clinical trials yielded conflicting results. On average, study participants, people with mild symptoms of Alzheimer’s disease, fared worse on tests of memory, problem-solving ability, and functionality after taking Aduhelm or a placebo for 18 months.
In one of the studies it was found that people who received Aduhelm evolved more slowly than those in the placebo group; in the other it was found that it did not help. “At best, the drug slowed the already slow disease by a quarter to a third,” says Wolk, whose medical center participated in the clinical trials.
Who is Aduhelm for?
It is approved for people in the early stages of Alzheimer’s. The drug’s questionable clinical benefits in people with very mild symptoms suggest that it is highly unlikely to help people with moderate to severe cognitive impairment, says Dr. Constantine Lyketsos, director of the Alzheimer’s and Memory Treatment Center. Johns Hopkins University School of Medicine in Baltimore.
Are there possible side effects?
In studies, close to 40% of patients developed cerebral edema, sometimes along with small cerebral hemorrhages. About one in four people with cerebral edema also experienced headache , confusion, vision changes, or nausea. Other possible side effects are diarrhea and falls, and allergic reactions are possible.
Does insurance cover expenses?
It is not clear. The Centers for Medicare & Medicaid Services (CMS) is conducting a formal review to decide on a national policy. Some Blue Cross Blue Shield plans have already said they won’t cover it, and other insurers are awaiting the CMS decision.
The price is $ 56, 000 per year for the drug, plus services such as security screening and MRIs. “We have calculated that treating a patient with Aduhelm for a year would cost about $ 100, 000 ”, says Lyketsos.
What if you want to take Aduhelm?
Talk to your Alzheimer’s disease specialist to see if it may be appropriate for you. If so, you need to have cognitive tests and probably a lumbar puncture or positron emission tomography (PET) scan to confirm the presence of brain amyloid.
Because the risks of side effects can be greater than the possible clinical benefits, ask your doctor how they will manage those effects and when you should stop taking the medication, says Lyketsos. And keep in mind that you may have to face significant out-of-pocket expenses.
Editor’s note: A version of this article was published in the October issue of 2021 of Consumer Reports On Health .
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Consumer Reports has no financial relationship with the advertisers on this site. Consumer Reports is an independent nonprofit organization that works with consumers to create a just, safe, and healthy world. CR does not endorse products or services and does not accept advertising. Copyright © 2021, Consumer Reports, Inc.