In the weeks since a new Alzheimer’s drug was approved, hopeful patients bombarded Dr. Alireza Atri with calls and emails about a treatment that sparked excitement and skepticism.
They want to know if the drug may be right for them. Like many doctors, Atri does not have easy answers.
“It’s not a simple yes or no,” said the Banner Sun Health Research Institute neurologist in Arizona.
It probably won’t be for a while. Doctors across the country are still trying to figure out who should receive the drug called Aduhelm, which, at best, marginally slows down the deadly disease. Other medications for Alzheimer’s disease only temporarily relieve symptoms such as memory problems, insomnia, and depression.
Although some clinics have already begun administering the drug, many providers say it will take weeks or months to get ready. Insurers, including Medicare, which pays the highest bill for this drug, have yet to determine which patients should cover a treatment that could cost more than $ 50,000 a year. And doctors care that emotions affect the decisions of patients and families when looking for the drug.
“People are desperate. It’s a very horrible disease,” said Dr. Michael Greicius of Stanford University.
Karl Newkirk hopes to start taking Aduhelm if his doctor gives him OK because he doesn’t see any other treatment worth trying.
“She looks like the only star in the sky,” said the 80-year-old Sarasota, Florida resident, who has early-stage Alzheimer’s.
The Newkirk doctor confirms that he is a good candidate for the drug. While the retired tech consultant is still fit enough to ride roller coasters with his grandchildren at nearby Busch Gardens, he struggles with short-term memory loss. He wants to try Aduhelm, even though he is aware of the limits of the drug.
Michele Hall, 54, of Bradenton, Florida, is also eager to talk about the drug at her next appointment with an Alzheimer’s specialist.
A former government lawyer, Hall had to quit her job after struggling with such simple tasks as spelling, public speaking, and remembering deadlines. Doctors at the Mayo Clinic diagnosed him with early Alzheimer’s last November.
Hall tells Aduhelm “the first little light of hope” that she will get more quality time with her husband and three adult children.
“When he gets that diagnosis, he really wakes up every morning and says,‘ Here I am, ticking and just waiting, ’” he said. “Well, now you have something to look forward to.”
Biogen’s Aduhelm is the first drug for Alzheimer’s in nearly 20 years. Its approval by the Food and Drug Administration earlier this month sparked a quick reaction from many experts, including the agency’s own external advisors who had warned that its alleged benefit depended on weak data. Three resigned over the FDA decision.
Aduhelm does not reverse mental decline. It only slowed her down in a study that was affected by difficult-to-interpret results. The data were so murky that the FDA eventually granted conditional approval of the drug based on a different measure: it’s the ability to eliminate harmful plaque groups in the brains of patients with early forms of the disease.
FDA approval is not limited to those early patients. Anyone with Alzheimer’s (at least in theory) could receive the prescription for the drug. But defense groups as the Alzheimer’s Association and many doctors say the focus should be on patients with an early diagnosis, such as those helped in the study.
“I don’t want to see people take their mothers out of nursing homes to receive this treatment,” said Dr. Babak Tousi, a Cleveland Clinic geriatrician who consulted Biogen and helped run one of the places. tests for Aduhelm.
Safety will be a key consideration, according to Dr. Ronald Petersen of the Mayo Clinic, who presents his own guidelines for using the drug.
“We want to be conservative here,” said Petersen, an Alzheimer’s specialist who has consulted most major drug manufacturers in this field, including Biogen.
About 40% of patients who received the full dose of drugs in Biogen studies had tiny swelling or bleeding in the brain. Although side effects used to resolve, in rare cases they caused more severe bleeding that could cause brain damage or other dangerous complications.
Monitoring patients with the drug involves regular brain scans. This adds to a different type of scan to see if patients have the target brain plaque on the drug. Performing all of these tests could approach $ 10,000 in the first year, according to doctors.
Insurers are likely to need prior approval for these scans, which could delay attention. And depending on coverage, patients could be responsible for thousands of dollars a year for scans and treatments due to deductibles and other costs out of pocket.
Biogen claims that about 900 sites in the United States have the equipment and experience to immediately begin administering the drug, which requires monthly IVs.
The Michigan Private Institute of Neurological Disorders has already begun treating early-stage Alzheimer’s patients. The institute said it will charge most of the cost if an insurer finally denies coverage “because it’s a therapy we believe in,” a spokeswoman said.
Meanwhile, Greicius of Stanford, a neurologist and Alzheimer’s specialist, has no plans to prescribe Aduhelm.
“I don’t think there is enough evidence that works and there is a lot of evidence that can harm patients,” he said.
He said he plans to raise a “compelling and compassionate” case as to why he does not want to give patients the drug. But he worries that some patients may simply turn to a doctor who will provide it.
But part of the challenge is that family members often think that a patient is in an earlier stage of the disease than he really is. He said they need to understand that medication will not make someone who they were.
“What we want can’t always be translated into real life,” he said.
A likely consequence of Aduhelm’s approval is the earlier screening and diagnosis of Alzheimer’s, a long-term goal of those studying the disease, as it develops slowly over years or decades.
But a previous diagnosis combined with the incremental benefit of Aduhelm may simply lengthen the difficulties of caring for someone with Alzheimer’s.
“It could turn out that it really increases your caregiver’s burden if you just slow things down a little bit,” said Dr. Suzanne Schindler of the University of Washington in St. Louis. Louis. “I think it’s going to be very disappointing for a lot of people.”
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