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In the weeks since a new Alzheimer’s drug was approved, hopeful patients have asked Dr. Alireza Atri bombarded with phone calls and emails about a treatment that aroused both excitement and skepticism.
They want to know if the drug is right for them. Like many doctors, Atri doesn’t have easy answers.
“It’s not a simple yes or no,” said the neurologist at the Banner Sun Health Research Institute in Arizona.
It will probably take a while. Doctors across the country are still trying to figure out who to get the drug called Aduhelm, which, at best, slows the deadly disease slightly. Other Alzheimer’s disease drugs only provide temporary relief from symptoms such as memory problems, insomnia, and depression.
While some clinics have already started delivering the drug, many providers say it will take weeks or months to be ready. Insurers – including the largest bill payer for this drug, Medicare – have yet to determine which patients will need to cover treatment that could cost more than $ 50,000 a year. And doctors fear that emotions will influence the decisions made by patients and families when looking for the drug.
“People are desperate. It’s a really terrible disease,” said Dr. Michael Greicius from Stanford University.
Karl Newkirk hopes to start taking Aduhelm if his doctor gives the OK as he doesn’t see any other treatments worth trying.
“It looks like the only star in the sky,” said the 80-year-old Sarasota, Florida resident who has early-stage Alzheimer’s disease.
Newkirk’s doctor confirms he is a good candidate for the drug. While the retired technology consultant is still fit enough to ride a roller coaster with his grandchildren in nearby Busch Gardens, he is struggling with short-term memory loss. He wants to try Aduhelm even though he is aware of the drug’s limits.
Michele Hall, 54, from Bradenton, Florida, would also like to discuss the drug with an Alzheimer’s specialist at her next appointment.
Hall, a former prosecutor, was forced to quit her job after struggling with once-simple tasks like spelling, public speaking, and remembering deadlines. Last November, doctors at the Mayo Clinic diagnosed her with early-stage Alzheimer’s.
Hall calls Aduhelm “the first glimmer of hope” that she will have more time with her husband and three grown children.
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“When you get this diagnosis, you really wake up every morning and say, ‘Here I am, it’s ticking and I’m just waiting,'” she said. “Well, now you have something to look forward to.”
Biogen’s Aduhelm is the first Alzheimer’s drug in almost 20 years. The Food and Drug Administration’s approval earlier this month sparked a quick backlash from many experts, including the agency’s own outside consultants, who warned the alleged benefits were based on flimsy data. Three resigned because of the FDA’s decision.
Aduhelm does not reverse the spiritual decline. It only slowed it down in one study clouded by hard-to-interpret results. The data was so grim that the FDA eventually granted the drug conditional approval based on another measure: it’s ability to get rid of harmful clumps of plaque in the brains of patients with early forms of the disease.
FDA approval is not limited to these early patients. Anyone with Alzheimer’s disease – at least in theory – could be prescribed the drug. But stakeholders like the Alzheimer’s Association and many doctors say the focus should be on patients with an early diagnosis, as supported in the study.
“I don’t want people to bring their mothers out of nursing homes to get this treatment,” said Dr. Babak Tousi, a Cleveland Clinic geriatrician, who consulted Biogen and helped run one of the testing centers for Aduhelm.
According to Dr. Ronald Petersen of the Mayo Clinic, which is developing its own application guidelines for the drug, will be an important consideration.
“We want to be conservative here,” said Petersen, an Alzheimer’s specialist who has consulted with most of the major drug companies in the area, including Biogen.
About 40% of patients given the full dose of drug in Biogen’s studies had swelling or tiny bleeding in their brain. While the side effects usually went away, on rare occasions they resulted in heavier bleeding, which could potentially lead to brain injury or other dangerous complications.
Monitoring patients taking the drug includes regular brain scans. This is in addition to another type of scan to see if any patient’s brain plaque is being attacked by the drug. Doctors say doing all of these tests could easily reach $ 10,000 in the first year.
Insurers will likely require prior approval for these scans, which could delay treatment. And depending on insurance coverage, patients can still be held liable for thousands of dollars annually from the scans and treatments due to deductibles and other expenses.
Biogen says approximately 900 locations in the United States have the equipment and expertise to immediately start administering the drug, which requires monthly infusions.
The private Michigan Institute for Neurological Disorders has already begun treating early-stage Alzheimer’s patients. The institute said it would pay most of the cost if an insurer ultimately declines coverage “because it’s a therapy we believe in,” a spokeswoman said.
Meanwhile, Stanford’s Greicius, a neurologist and Alzheimer’s specialist, plans not to prescribe Aduhelm.
“I don’t think there is enough evidence that it works, and there is a lot of evidence that it can harm patients,” he said.
He said he plans to open a “compelling and compassionate” case as to why he does not want to give the medicine to patients. However, he fears that some patients may simply turn to a doctor who will make them available.
Tousi, at the Cleveland Clinic, said talking about expectations, costs, and side effects can help counter some emotional pressure to give the drug to patients who are not suitable.
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Part of the challenge, however, is that family members often think that a patient is in an earlier stage of the disease than they actually are. He said they had to understand that the drugs wouldn’t make anyone who they were again.
“What we want cannot always be translated into real life,” he said.
A likely consequence of Aduhelm’s approval is earlier screening and diagnosis of Alzheimer’s, a long-term goal of those studying the disease as it progresses slowly over years or decades.
But earlier diagnosis combined with the added benefit of Aduhelm can simply prolong the difficulty of caring for an Alzheimer’s patient.
“It might turn out to actually add to the burden on the nursing staff if it just slows things down a little,” said Dr. Suzanne Schindler from Washington University in St. Louis. “I think it’s going to be really disappointing to a lot of people.”