Biogens Aduhelm’s future depends on US Medicare’s Alzheimer’s coverage – archyde

January 11 (Reuters) – The future of Aduhelm, Biogen Inc. (BIIB.O) controversial and expensive Alzheimer’s drug, could depend on a US Medicare program decision due this week on whether it will pay for the treatment.

The Centers for Medicare and Medicaid Services have been working on a national coverage policy since July for the drug, which was approved by the U.S. Food and Drug Administration last June, despite its questionable efficacy against the brain-destroying disease. Only one of Biogen’s two pivotal studies showed that Aduhelm can slow cognitive decline in Alzheimer’s patients.

Many experts have questioned the FDA’s rationale for approving Aduhelm without definitive evidence of its benefit, and doctors have been reluctant to prescribe it.

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Several key health care providers, including the U.S. Veterans Health Administration, the Cleveland Clinic, and the Mount Sinai Health System, have stated that they would not prescribe Aduhelm to patients.

Sales have been weak so far, and Biogen cut the drug’s list price by about half to $ 28,200 a year last month.

The high price of Aduhelm has raised concerns about the toll it could weigh on the Medicare program, the U.S. government’s health plan for people 65 and older. Since Alzheimer’s is an age-related disease, about 85% of the people who could suffer from it are on the government plan.

Aduhelm, given as a monthly infusion, is a monoclonal antibody designed to clear a type of brain plaque that has been linked to Alzheimer’s disease. Patients should be monitored for possible side effects, including brain swelling.

The agency’s final insurance terms, due by April 12, are expected to apply to all drugs in the class, including experimental drugs under development by Eli Lilly & Co (LLY.N), Roche Holding AG and Biogen – Partner Eisai Co Ltd.

FOUR OPTIONS

Overall, Medicare has four options, according to James Chambers, researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center.

The agency could agree to cover Aduhelm for all patients who meet FDA labeling criteria. But after the backlash from medical professionals, “that seems very unlikely,” Chambers said.

It would also be “politically difficult” for Medicare to deny all coverage and do the likely “something in the middle” option, he said.

Medicare could limit the use of Aduhelm to a small population, although such limits would not reflect the diverse Medicare population.

Medicare will most likely offer insurance coverage through a program that aims to gather evidence of Aduhelm’s impact on patient outcomes, such as a patient registry, Chambers said.

BMO Capital Markets has estimated that full Medicare coverage could sustain a Biogen stock price of $ 468, while a decision not to get access would push Biogen’s stock price to $ 190.

Biogen shares, which surged over $ 400 in June following Aduhelm’s FDA approval, fell around 13% over the past 12 months, closing at $ 235.31 on Monday.

UsAgainstAlzheimer’s patient advocacy on Monday called for a coverage decision “free of restrictions that would restrict access for eligible patients”.

Biogen believes Medicare should cover Aduhelm for the patient population who participated in clinical trials – those diagnosed with early-stage Alzheimer’s disease with amyloid plaques found in the brain.

The FDA initially approved the drug for all Alzheimer’s patients. A few weeks later, criticizing the approval, including from some of its own consultants, the agency narrowed the target group down to people with mild cognitive impairments.

“We believe that the patients who match those we have studied in our clinical trials are the right population,” Chris Leibman, Biogen’s head of Value & Access, told Reuters.

He said that any patient outcomes monitoring requirement would be “double” the effort that Biogen has already endorsed.

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Reporting by Deena Beasley. Editing by Caroline Humer and Bill Berkrot

Our standards: The Thomson Reuters Trust Principles.

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Reference-www.nach-welt.com

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