© Reuters. File photo: Aduhelm, a controversial early Alzheimer’s disease drug recently approved by Biogen, was seen at Butler Hospital, one of the clinical research centers in Providence, Rhode Island, on June 16, 2021. Jessica Rinaldi/Pool via REUTERS
By Dina Beasley
(Reuters)-Biogen Inc (NASDAQ:)’s Alzheimer’s drug launch has encountered new obstacles because some major hospitals have decided not to use it, and many health insurance companies are waiting for American medical care Insurance (Medicare) insurance clauses, before formulating your own policy.
The Cleveland Clinic, one of the most famous health systems in the United States, and the Mount Sinai Health System in New York confirmed on Thursday that they have decided not to carry the new drug called Aduhelm.
Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health, told Reuters: “When the Inspector General announced the investigation on Friday, the situation changed and there were allegations of possible violations of the FDA-Biogen relationship.”
The FDA last week called for an independent federal investigation of its representatives’ interactions with Biogen.
Biogen shares fell nearly 8% on Thursday, or US$25.21, to US$324.85. Guggenheim analyst Yatin Suneja attributed the plunge in stock prices to the two hospital systems’ decision not to use the drug.
In mid-June, the Center for Neurology in Washington, DC stated that it would not recommend this monthly infusion treatment to any patient due to concerns about efficacy, safety and cost.
Despite mixed results from clinical trials, the US Food and Drug Administration approved the drug, also known as aducanumab, in early June. The agency said it believes that evidence of Aduhelm’s ability to clear amyloid plaques will benefit patients with Alzheimer’s disease.
Biogen said in a statement on Thursday that Aduhelm is priced at $56,000 per year and clinical data supports the approval of the drug. Patients who are denied access should contact the company for help.
Insurance company shelved
The insurance company representing millions of Americans participating in private health insurance plans said that according to data, the drug has not yet reached its coverage standards.
UnitedHealth Group (NYSE:), the largest private insurance company that provides Medicare Advantage insurance to senior citizens, said Thursday that it is still reviewing the drug and awaiting Medicare’s opinion.
“Before we really know it, there is still some way to go. So I won’t lead you to expect very fast decisions on this matter,” said CEO Andrew Witty.
Humana (NYSE:), the second largest provider of Medicare Advantage, also stated that it has not finalized Aduhelm’s coverage due to awaiting guidance from the Centers for Medicare and Medicaid Services (CMS).
Several Blue Cross Blue Shield health insurance plans, including Michigan, North Carolina and Pennsylvania, said that there is insufficient evidence to prove that Aduhelm is good for patients and they will not provide insurance for this drug.
Biogen said in a statement that several Blue Army plans “describe Aduhelm as experimental and research, which is inaccurate and misleading.”
CMS began a national review process on Monday, which reportedly took nine months to complete. Prior to this, the agency stated that the coverage of aducanumab was being made locally by 12 regional contractors.
SVB Leerink said this week that a survey of 57 American neurologists who treat a large number of Alzheimer’s patients found that 44% of them would use Aduhelm in early Alzheimer’s patients, who have amyloid Evidence of plaque.
The Wall Street company estimates that sales of the drug will be $65 million this year, $1.1 billion next year, and $5 billion by 2025.
The Institute of Clinical and Economic Review, an influential pricing organization, held a meeting of doctors, patients, and other stakeholders on Thursday to discuss how the cost of Aduhelm compares with the potential benefits of patients.