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The first new Alzheimer’s treatment in more than 20 years was hailed as a breakthrough when regulators approved it more than four months ago, but its introduction was slowed by questions about its price and effectiveness.
Several large medical centers are still undecided whether to use Biogen’s Aduhelm, which is recommended for early stages of the disease. Big names like the Cleveland Clinic and Mass General Brigham in Boston say they are passing it on for now.
One neurology practice has even banned the company’s sales force from their offices for citing concerns about the drug and its price, which can rise over $ 50,000 annually.
Many doctors say they need to learn more about how Aduhelm works and what is covered before deciding whether to offer it. Clarification can take several months. Even then, questions can remain.
“The drug won’t be for everyone, even with access,” said Salim Syed, an analyst who works for Biogen for Mizuho Securities USA.
Syed estimates that only about a tenth of people diagnosed with early-stage Alzheimer’s disease may take Aduhelm chronically, especially if regulators approve similar treatments from Biogen’s competitors.
Biogen, which released third-quarter financial results on Wednesday, doesn’t say how many people have received the drug since it was approved on June 7, 900 the company said it would be ready soon after the drug was approved by regulators.
Aduhelm is the first in a line of new drugs that promise what no other Alzheimer’s treatment has done: slow the progression of the deadly brain-wrecking disease instead of just treating its symptoms.
“It’s like a breath of fresh air,” said Dr. Stephen Selloway, a Rhode Island neurologist and Biogen consultant who prescribes the drug. People with Alzheimer’s “know what to expect and want to do whatever it takes to stay in the milder stage.”
The U.S. Food and Drug Administration approved Aduhelm despite objections from its own independent advisors, several of whom resigned. The agency later said the drug would be suitable for patients with mild symptoms or early-stage Alzheimer’s.
Aduhelm clears plaques in the brain that are believed to have a role in Alzheimer’s disease, and regulators made the call based on study results showing the drug seemed likely to be useful to patients.
Biogen, which Aduhelm was developing with the Japanese Eisai Co., stopped two studies on the drug due to disappointing results. It was later said that further analysis showed that the treatment was effective at higher doses.
The FDA is asking Biogen to conduct a follow-up study.
The research so far submitted by Biogen doesn’t give doctors as much insight as they would normally have on a drug, said Dr. Brendan Kelley, a neurologist at UT Southwestern Medical Center in Dallas. Aduhelm is still being examined by his experts.
“Biogen went to the FDA with preliminary data, so it’s really difficult to know how to navigate,” he said. More extensive research would give doctors a better idea of how the drug will work in a wider patient population, Kelley said.
The cost is another concern.
Biogen’s pricing for Aduhelm is “irresponsible and unscrupulous,” according to signs on the office doors of the Neurology Center, a Washington, DC practice. The signs also refer to Aduhelm as a drug “of dubious effectiveness” and tell Biogen salespeople that they are no longer welcome in the centre’s offices.
“As doctors, we feel compelled to raise our voices and protest against the actions of BIOGEN,” it says on one of the signs.
Wendy Van Fossen, CEO of the neurology center, said the signs surfaced in July but declined to further explain why they were released.
A Biogen spokeswoman said in an email that it was disappointing that some centers were denying access to the drug.
As for the effectiveness of Aduhelm, company data shows that plaque removal “is fairly likely to predict clinical benefit,” said Dr. Maha Radhakrishnan, Biogen’s Chief Medical Officer. She said regulators had reviewed data from more than 3,000 patients, counting two late-stage studies and earlier research.
Doctors are also concerned about whether patients taking Aduhelm will be able to get the regular brain scans needed to monitor their progress with the drug.
Problems with access to care have not been explored in clinical research, which included patients who were generally younger and healthier than those of the wider population, noted Dr. Zaldy Tan, director of the Cedars Sinai Program on Memory and Aging.
The Los Angeles health system is still under review. His committee of experts examines, among other things, which doctors prescribe the drug and how to ensure that patients are monitored for problems such as dizziness or headaches. Bleeding in the brain is another possible side effect.
“Security and access are real issues that need to be prioritized,” said Tan.
Aduhelm also requires deeper coordination between doctors than other Alzheimer’s treatments, Radhakrishnan noted.
Prescribers must work with neurologists, radiologists, and nurses to diagnose patients, confirm the presence of plaque in the brain, start treatment, and then monitor them.
“All of this is in the works,” said Radhakrishnan.
Uncertainty about insurance coverage is another obstacle.
Some insurers have chosen not to insure the drug. Others, including the large Medicare Advantage insurer Humana, have not yet made a decision but are now reviewing the claims on a case-by-case basis.
The federal Medicare program is expected to make a national coverage decision by next spring that will determine how to handle the drug.
Biogen executives recently said they believe most of the websites offering the drug are waiting for clarity on reimbursement, including Medicare’s decision.
Medicare’s determination matters to the experts at Cedars-Sinai. Tan said they knew they should make a decision before Medicare’s decision sparked more patient inquiries.
He said the doctors also realize that they’re not just evaluating Aduhelm: they’re also thinking about how to deal with similar treatments that might get FDA approval.
“We want to make sure we’re getting it right,” said Tan.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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