In quiet beginnings, Alzheimer’s drug sparks questions, skepticism
The first new treatment for Alzheimer’s disease in more than 20 years was hailed as a breakthrough when regulators approved it more than four months ago, but its rollout has been slowed by questions about its price and cost. efficiency.
Several major medical centers remain undecided on whether to use Biogen’s Aduhelm, which is recommended for the early stages of the disease. Big names like the Cleveland Clinic and Mass General Brigham in Boston say they’re going to do without it for now.
A neurology firm has even banned the company’s sales representatives from its offices, citing concerns about the drug and its price, which can exceed $ 50,000 a year.
Many doctors say they need to find out more about how Aduhelm works and what will be covered before they decide to offer it. It may take several months to resolve. Even then, questions may persist.
“The drug won’t be for everyone, even with access,” said Salim Syed, analyst who covers Biogen for Mizuho Securities USA.
Syed estimates that only about a tenth of people diagnosed with early-stage Alzheimer’s disease may end up taking Aduhelm chronically, especially if regulators approve similar treatments from Biogen’s competitors.
Biogen, which releases its third quarter financial results on Wednesday, does not say how many people have received the drug since its approval on June 7. 900, the company had said it expected to be ready soon after the drug was approved by regulators.
Aduhelm is the first in a line of new drugs that promise to do what no other treatment for Alzheimer’s disease has succeeded: slow the progression of the deadly brain-destroying disease instead of just managing its symptoms.
“It’s like a breath of fresh air,” said Dr. Stephen Salloway, a Rhode Island neurologist and Biogen consultant who prescribes the drug. People with Alzheimer’s disease “know what’s coming, and they want to do everything in their power to stay at the milder stage.”
The United States Food and Drug Administration has approved Aduhelm over objections from its own independent advisers, several of whom have resigned. The agency later said the drug was appropriate for patients with mild symptoms or early-stage Alzheimer’s disease.
Aduhelm removes plaque from the brain believed to play a role in Alzheimer’s disease, and regulators have launched the call based on the results of a study showing the drug appeared likely to benefit patients.
Biogen, which developed Aduhelm with the Japanese company Eisai Co., had halted two studies of the drug due to disappointing results. He later said that further analysis showed the treatment to be effective at higher doses.
The FDA asks Biogen to conduct a follow-up study.
The research Biogen has submitted so far does not give doctors as much information as they normally would about a drug, said Dr. Brendan Kelley, a neurologist at UT Southwestern Medical Center in Dallas. Its experts are still examining Aduhelm.
“Biogen went to the FDA with preliminary data, so it’s very difficult to know how to navigate,” he said. More comprehensive research would give doctors a better idea of how the drug will work in a larger patient population, Kelley said.
Cost is another concern.
Biogen’s price for Aduhelm is “irresponsible and unreasonable,” according to signs posted on the doors of the offices of the Neurology Center, a Washington, DC area firm. The signs also call Aduhelm a drug of “questionable efficacy” and tell Biogen salespeople that they are no longer welcome in the centre’s offices.
“As doctors, we feel compelled to speak out and protest against BIOGEN’s actions,” read one of the panels.
Neurology centre’s CEO Wendy Van Fossen said signs increased in July, but declined to say why they were displayed.
A spokesperson for Biogen said in an email that it was disappointing that some centers were denying access to the drug.
As to the effectiveness of Aduhelm, company data shows that plaque removal “is reasonably likely to predict clinical benefit,” said Dr. Maha Radhakrishnan, Medical Director of Biogen. She said regulators have looked at data from more than 3,000 patients, including two late stage studies and previous research.
Doctors are also concerned about whether patients taking Aduhelm will be able to get the regular brain scans needed to monitor their progress on the drug.
Problems of access to care have not been explored in clinical research, which also involved patients who were generally younger and healthier than those in the general population, noted Dr Zaldy Tan, director of the memory program. and aging Cedars-Sinai.
The Los Angeles Health System is still evaluating Aduhelm. Its expert committee is looking at things like who will prescribe the drug and how to make sure patients are monitored for problems like dizziness or headaches. Another potential side effect is bleeding in the brain.
“Security and access are real issues that need to be prioritized,” Tan said.
Aduhelm also requires a deeper level of coordination between physicians than other treatments for Alzheimer’s disease, Radhakrishnan noted.
Prescribing physicians must work with neurologists, radiologists and nurse practitioners to diagnose patients, confirm the presence of plaque in the brain, initiate treatment and then monitor them.
“This is all a work in progress,” Radhakrishnan said.
The uncertainty over insurance coverage is another hold-up.
Some insurers have decided not to cover the drug. Others, including leading insurer Medicare Advantage Humana, have yet to make a decision but are reviewing claims on a case-by-case basis in the meantime.
The federal Medicare program is expected to determine national coverage by next spring, which will define how it manages the drug.
Biogen executives recently said they believed most sites that would offer the drug were awaiting clarification on reimbursement, including this move from Medicare.
The determination of Medicare weighs heavily on the experts at Cedars-Sinai. Tan said they knew they would have to make a decision before Medicare’s decision further prompted patients to educate themselves.
He said doctors are also realizing that they’re not just evaluating Aduhelm – they’re also thinking about how to handle similar treatments that might get FDA approval.
“We want to make sure we get it right,” Tan said.
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