Biogen Alzheimer’s drug suffers roadblocks with some hospitals, Reuters insures

Deena by Beasley

(Reuters) – Biogen Inc.’s Alzheimer’s drug, the first new treatment for the disease to steal memory for nearly 20 years, hit new hurdles on Thursday as some hospitals refused to use it and health insurance delayed decision while awaiting Medicare coverage conditions .

A working group of medical experts has also unanimously voted that there is no Aduhelm drug that offers a net health benefit.

A 15-0 vote at a meeting called by the Institute of Clinical and Economic Review (ICER) confirmed that the Cleveland Clinic, one of the most popular health systems in the country, and the Mount Sinai Health System in New York decided. not to take Aduhelm.

“The tide erupted on Friday when the inspector’s general investigation was announced,” said Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health.

The Food and Drug Administration last week called for an independent federal probe with its representatives Biogen (NASDAQ :).

Shares of Biogen were down nearly 7% on Thursday, closing at $ 328.16. Guggenheim analyst Yatin Suneja has blamed the decision on the two hospital systems not to use the drug.

In mid-June, the Center for Neurology in Washington, DC, said it would not recommend treatment, which is given as a monthly infusion, in the case of its patients, because of its effectiveness, safety, and cost.

Although the FDA approved the drug, also known as adducanumab, in early June with mixed results from clinical trials, Aduhelm cited conventional evidence that it could clear amyloid plaques in the brain and benefit Alzheimer’s patients.

But others have raised doubts as to whether there is evidence that it slows down cognitive decline and affects its high cost.

Biogen, who was priced at $ 56,000 a year by Aduhelm, said in a statement Thursday that clinical data supported the drug’s acceptance and that patients denied access should contact the company for help.

ICER said the drug already costs no more than $ 8,400 a year, but Thursday’s vote was not valid because of a unanimous decision on the lack of health benefits.

The review of ICER is closely watched by insurers who negotiate drug prices with developers, although in Aduhelm’s case its role is unclear, especially as it is expected to be paid for by Medicare.

Chris Leibman, Biogen’s chief vice president of values ​​and access, said he expects only a “fraction” of the 1-2 million patients who are eligible for the drug to be a key factor in Biogen’s prices.

“We don’t think there will be a lot of patients,” he said.

INSURANCE INSURANCE

Insurers representing millions of Americans enrolled in private Medicare plans said the drug has not yet been met to get coverage based on its data.

The UnitedHealth Group (NYSE :), the largest private insurance company that offers Medicare Advantage coverage to seniors, said Thursday that it was reviewing the drug and was awaiting Medicare admission.

“This has some avenues ahead of us before we get real clarity. So I wouldn’t guide you to expect decisions to be made very quickly on this piece,” said CEO Andrew Witty.

Humana (NYSE :), the second-largest provider of Medicare Advantage plans, also said it has not completed coverage for Aduhelm, as it is 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, have said there is insufficient evidence of Aduhelm’s benefit to patients and will not provide drug coverage.

Biogen said in a statement that the Blues’ plan to “classify Aduhelm as an experiment and research is inaccurate and misleading.”

On Monday, the CMS said it would take nine months to complete the national review process. Until then, the agency said that decisions about hedging of indiranumab are being made at the local level by 12 contractors in the region.

SVB Leerink said this week that according to a survey of 57 U.S. neurologists treating large volumes of Alzheimer’s patients, 44% of them would use Aduhelm in patients with early Alzheimer’s disease with amyloid plaques.

The Wall Street company estimates sales of $ 65 billion this year, up from $ 1.1 billion next year and $ 2025 billion by 2025.