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Alzheimer’s drug, Biogen’s Aduhelm, finds questions, skepticism – Riverside, California

Riverside, California 2021-10-17 10:17:38 –

Some neurological practices even prohibit Biogen salespeople from leaving the office over the drug. Doctors say they need to learn more about how aducanumab works.

The new treatment for Alzheimer’s disease, the first in more than 20 years, was welcomed as a breakthrough when regulators approved it more than four months ago, but questions about pricing and its effectiveness led to its rollout. I’m late.

Some major medical centers remain undecided on whether to use the recommended biogen aducanumab in the early stages of the disease. Celebrities like Boston’s Cleveland Clinic and Mass General Brigham have said they will take over for now.

One neurology practice banned the company’s sales representatives from leaving the office, raising concerns about drugs and their prices that could exceed $ 50,000 a year.

Many doctors say that before deciding whether to offer aducanumab, we need to learn more about how aducanumab works and what is covered. It may take months to clean up. Still, questions may remain.

“The drug doesn’t help everyone, even if it’s accessible,” said Salim Syed, an analyst for Biogen at Mizuho Securities USA.

Syed estimates that only about one-tenth of people diagnosed with early-stage Alzheimer’s disease will take Aduhelm chronically, especially if regulators approve similar treatments from Biogen’s competitors. doing.

Biogen, which reports its third-quarter earnings on Wednesday, does not say how many people have received the drug since it was approved on June 7. 900 The company said it expected it to be ready shortly after regulators approved the drug.

Aducanumab is the first product of a new drug that promises to slow the progression of fatal brain-destroying disease, as well as to control symptoms that other treatments for Alzheimer’s disease could not control.

“It’s like a breath of fresh air,” said Dr. Stephen Sarrowway, a Rhode Island neurologist and biogen consultant prescribing medication. “I know what’s coming and I want to do whatever I can to stay calm,” said a person with Alzheimer’s disease.

The US Food and Drug Administration has approved Aduhelm, despite opposition from its own independent advisor. Some of the advisors have resigned. Authorities later stated that the drug was suitable for patients with mild symptoms or early-stage Alzheimer’s disease.

Aducanumab removed brain plaque, which is thought to be involved in Alzheimer’s disease, and regulators called based on research showing that the drug is likely to benefit patients.

Biogen, the developer of aducanumab with Eisai in Japan, has discontinued two studies on the drug due to disappointing results. Later, he said that further analysis showed that the treatment was effective at high doses.

The FDA requires Biogen to conduct a follow-up study.

Dr. Brendan Kerry, a neurologist at the UT Southwestern Medical Center in Dallas, said the studies Biogen has submitted so far do not give as much insight as doctors usually have about drugs. The expert is still reviewing Aduhelm.

“Biogen went to the FDA with preliminary data, so it’s very difficult to know how to navigate,” he said. A more complete study will give doctors a better idea of ​​how the drug works in a wider patient population, Kelly said.

Biogen’s Aducanumab pricing is “irresponsible and rude,” according to a sign on the door of the office of the Neurology Center, a clinic in the Washington, DC area. The label also refers to aducanumab as a “suspiciously effective” drug, telling Biogen sales representatives that it is no longer welcomed in the center’s office.

“As doctors, we feel forced to speak out and protest Biogen’s actions,” reads one of the signs.

Wendy Van Fossen, CEO of the Neurology Center, said signs appeared in July, but she refused to elaborate on why they were posted.

A Biogen spokeswoman said in an email that he was disappointed that some centers were denying access to the drug.

Regarding the effectiveness of Aducanumab, company data show that plaque removal is “quite likely to predict clinical benefits,” said Dr. Maharada Krishnan, Biogen’s Chief Medical Officer. rice field. She said regulators have reviewed data from more than 3,000 patients, counting two late and early studies.

Doctors are also worried about whether patients taking aducanumab will be able to get the regular brain scans needed to monitor the progress of the drug.

Dr. Zardi Tan, director of the Memory and Aging Program at Cedars Sinai, said the issue of access to care was not investigated in clinical studies involving patients who are generally younger and healthier than patients in the wider population. Stated.

The Los Angeles healthcare system is still evaluating Aducanumab. The expert committee is looking at which doctors will prescribe the drug and how to ensure that patients are monitored for problems such as dizziness and the development of headaches. Bleeding in the brain is another potential side effect.

“Safety and access are real issues that need to be prioritized,” says Tan.

Aducanumab also requires a deeper level of coordination between physicians than other treatments for Alzheimer’s disease, Rada Krishnan said.

The prescribing physician should work with a neurologist, radiologist, and nurse practitioner to diagnose the patient, confirm the presence of plaque in the brain, and monitor the patient after starting treatment.

“This is all ongoing work,” said Radhakrishnan.

Uncertainty about insurance coverage is another issue.

Some insurance companies have decided not to cover the drug. Other companies, including Humana, a major Medicare Advantage insurer, haven’t made a decision yet, but are considering billing on a case-by-case basis in the meantime.

The Federal Medicare program will make a national coverage decision by next spring and explain how it handles the drug.

Biogen executives recently said they believe most drug-providing sites are waiting for clarification of reimbursement, including their Medicare decisions.

Medicare’s determination has great implications for Cedars Sinai professionals. Tan said he knew that Medicare decisions should be reached before they prompted more patient inquiries.

He also said he recognizes that doctors are not just evaluating aducanumab. They are also thinking about how to treat similar treatments that can be approved by the FDA.

“We want to make sure it’s done right,” Tan said.

The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

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