By Deena Beasley
(Reuters) -Biogen Inc's Alzheimer's drug, the first new treatment for the memory-robbing disease in nearly 20 years, hit new barriers on Thursday with some large hospitals declining to use it and health insurers delaying a decision while awaiting coverage terms from Medicare.
An influential panel of medical experts also voted unanimously that there is no evidence that the drug, Aduhelm, provides a net health benefit to patients.
The 15-0 vote, at a meeting convened by the Institute of Clinical and Economic Review (ICER), followed confirmation from the Cleveland Clinic, one of the country’s best-known health systems, and New York's Mount Sinai Health System that they had decided not to carry Aduhelm.
"The tide turned on Friday when the inspector general investigation was announced," Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health, told Reuters.
The Food and Drug Administration called last week for an independent federal probe into its representatives’ interactions with Biogen.
Biogen shares fell nearly 7% on Thursday, closing at $328.16. Guggenheim analyst Yatin Suneja attributed the drop to the decision by the two hospital systems not to use the drug.
In mid-June, the Washington, D.C., Neurology Center said it would not recommend the treatment, which is given as a monthly infusion, for any of its patients due to concerns about efficacy, safety and cost.
The FDA approved the drug, also known as aducanumab, in early June despite mixed clinical trial results, citing convincing evidence that Aduhelm can clear amyloid brain plaques and benefit Alzheimer's patients.
But others have raised questions about whether there is evidence that it slows cognitive decline and assailed its high cost.
Biogen, which priced Aduhelm at $56,000 a year, said in a statement on Thursday that clinical data supported the drug's approval and patients who are denied access should contact the company for help.
ICER has already said the drug is cost effective at no more than $8,400 per year. The group's review is closely watched by insurers negotiating prices with drugmakers, although its role is not clear in the case of Aduhelm, which is expected to mostly be paid for by Medicare.
Chris Leibman, Biogen senior vice president of value and access, said a key factor in Biogen's pricing was that it expects only a "fraction" of the 1-2 million patients eligible for the drug to eventually be treated with it.
"We do not believe that there is going to be a large number of patients," he said.
INSURERS ON HOLD
Insurers representing millions of American enrolled in private Medicare plans said the drug has yet to meet their bar for coverage based on the data.
UnitedHealth Group, the largest private insurer offering Medicare Advantage coverage to seniors, on Thursday said it was still reviewing the drug and awaiting input from Medicare.
"This has some way to go before we get to real clarity. So I wouldn't guide you to expect a very rapid decision-making on this piece," CEO Andrew Witty said.
Humana, the second largest provider of Medicare Advantage plans, also said it has not finalized coverage for Aduhelm as it awaits guidance from the Centers for Medicare and Medicaid Services (CMS).
Several Blue Cross Blue Shield health insurance plans, including those in Michigan, North Carolina and Pennsylvania, have said there is insufficient evidence of Aduhelm's benefit for patients and they will not provide coverage for the drug.
Biogen said in a statement that the several Blues plans' "characterization of Aduhelm as experimental and investigational is inaccurate and misleading."
CMS on Monday began a national review process it said would take nine months to complete. Until then, the agency said coverage determinations for aducanumab are being made at the local level by 12 regional contractors.
Mark McClellan, director of the Duke-Margolis Center for Health Policy and a former FDA Commissioner and CMS Administrator said during the ICER review that access to Aduhelm will be "pretty limited" at least until CMS finalizes its national coverage terms.
SVB Leerink this week said a survey of 57 U.S. neurologists who treat high volumes of Alzheimer’s patients found that 44% of them would use Aduhelm in patients with early Alzheimer's disease who have evidence of amyloid plaques.
The Wall Street firm estimates sales of the drug at $65 million this year, $1.1 billion next year and $5 billion by 2025.
(Reporting by Deena Beasley; Additional reporting by Manas Mishra in Bangalaru and Julie Steenhuysen in Chicago; Editing by Howard Goller, Daniel Wallis and Ana Nicolaci da Costa)