The first new Alzheimer’s drug in over 20 years was hailed as a breakthrough when regulators approved it more than four months ago, but adoption has slowed due to questions about its price and how well it works.
Several major medical centers still have not decided whether to use Biogen’s Aduhelm, which is recommended in the early stages of the disease. Big names like the Cleveland Clinic and Mass General Brigham in Boston say they won’t give it up for now.
One neurology department even banned the company’s sales representatives from entering the offices, citing concerns about the drug and its price, which could exceed $ 50,000 a year.
Many doctors say they need to know more about how Aduhelm works and what will be covered before they decide whether to offer it. It can take several months to figure it out. Even then, questions may remain.
“The drug is not for everyone, even if you have access to it,” said Salim Sayed, analyst in charge of Biogen for Mizuho Securities USA.
Syed estimates that only about one-tenth of people diagnosed with early-stage Alzheimer’s may end up taking Aduhelm chronically, especially if regulators approve similar treatments from Biogen’s competitors.
Biogen, which reported third-quarter financial results on Wednesday, did not say how many people have received the drug since it was approved on June 7. Last month, a company executive said Biogen is aware of 50 locations where Aduhelm is being injected, far fewer than 900, the company said it would be ready shortly after regulators approve the drug.
Aduhelm is the first in a line of new drugs that promise to do something that no other Alzheimer’s treatment has done: slow the progression of a fatal brain-damaging disease, rather than simply tackling its symptoms.
“It’s like a breath of fresh air,” said Dr. Stephen Sulloway, a Rhode Island neurologist and prescribing consultant for Biogen. People with Alzheimer’s “know what awaits them and want to do their best to stay in a milder stage.”
The FDA approved Aduhelm, despite objections from his own independent advisers, some of whom resigned. The agency later said the drug was suitable for patients with mild symptoms or early-stage Alzheimer’s disease.
Aduhelm cleanses the brain of plaque believed to play a role in Alzheimer’s disease, and regulators did so based on research results showing the drug is likely to benefit patients.
Biogen, which developed Aduhelm in conjunction with the Japanese company Eisai Co., has halted 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 requires Biogen to conduct additional research.
According to Dr. Brendan Kelly, a neuroscientist at Southwestern University Medical Center at Southwestern University in Dallas, the study presented by Biogen does not provide doctors with the kind of insight they would normally get. His experts are still reviewing Aduhelm.
“Biogen has approached the FDA with preliminary data, so it’s very difficult to figure out how to navigate,” he said. A more complete study would give doctors a better idea of how the drug will work on a wider population of patients, Kelly said.
Cost is another issue.
Biogen’s prices for Aduhelma are “irresponsible and unfair,” according to signs posted on the doors of the Neurological Center’s Washington, DC office. The signs also refer to Aduhelm as a drug of “dubious effectiveness” and tell Biogen sales representatives that they are no longer welcome at the center’s offices.
“As doctors, we feel obligated to speak out and protest against BIOGEN’s actions,” reads one of the captions.
Neuroscience Center CEO Wendy Van Vossen said the signs increased in July but declined to say why they were placed.
A Biogen spokesperson said in an email that it was disappointing that some centers were denying access to the drug.
In terms of Aduhelm’s efficacy, the company’s data shows that plaque removal “is reasonably likely to predict clinical benefit,” said Biogen chief physician Dr. Maha Radhakrishnan. Regulatory agencies have reviewed data from more than 3,000 patients, she said, including two later-stage studies and earlier studies.
Doctors are also concerned about whether patients taking Aduhelm will be able to get regular brain scans to track their progress on the drug.
Problems with access to care were not addressed in clinical trials, which also involved patients who tended to be younger and healthier than the wider population, said Dr. Zaldi Tan, director of the Cedars-Sinai Program on Memory and Aging.
The Los Angeles health care system is still evaluating Aduhelm. Its expert committee considers issues such as who will prescribe the drug and how to ensure that patients are monitored for problems such as dizziness or headaches. Bleeding in the brain is another potential side effect.
“Security and access are real issues that need to be prioritized,” Tan said.
According to Radhakrishnan, Aduhelm also requires deeper coordination between doctors than with other treatments for Alzheimer’s.
Prescribers must work with neurologists, radiologists, and nurse practitioners to diagnose patients, confirm the presence of plaque in the brain, initiate treatment, and then monitor it.
“This is all under development,” said Radhakrishnan.
Uncertainty about coverage is another delay.
Some insurers choose not to cover the drug. Others, including the major insurer Medicare Advantage Humana, have yet to make a decision, but in the meantime they are reviewing claims on a case-by-case basis.
The federal Medicare program is expected to make a national coverage decision by next spring that tells you how to handle the drug.
Biogen executives recently said they believe most sites that will offer the drug are waiting for reimbursement clarity, including Medicare’s decision.
Medicare commitment is very important to Cedars-Sinai experts. Tan said they know they have to make a decision before Medicare’s decision triggers additional patient requests.
He said doctors also understand that they are not just evaluating Aduhelm: they are also thinking about how to handle similar treatments that might get FDA approval.
“We want to make sure we got it right,” Tan said.