 U.S.
Veterans Health Administration turns down Biogen Alzheimer's drug
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[August 12, 2021]
(Reuters) - The U.S. Veterans Health
Administration (VHA) will not include Aduhelm, the $56,000-a-year
Alzheimer's drug made by Biogen Inc and Eisai Co Ltd, on its list of
approved drugs due to a lack of evidence that it is effective as well as
safety concerns, the agency said on Wednesday.
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 "It is not being added to the VA National Formulary due to the risk
of significant adverse drug events and to the lack of evidence of a
positive impact on cognition," the agency said in an emailed
statement.
The Department of Veterans Affairs is the largest health system so
far to decline use of the drug, which was approved in June by the
Food and Drug Administration even though one of Biogen's two
large-scale clinical trials failed to show a benefit for patients
diagnosed with the mind-wasting disease.
The FDA itself called last month for an independent federal probe
into its representatives' interactions with Biogen ahead of the
drug's approval.
Biogen had said in a June press release that it was working "to
finalize a multi-year agreement in order to support access for
veterans throughout the VHA system ... with nine million enrolled
veterans, approximately 48 percent of which are over the age of 65."
Still, VA facilities do have the ability to request access to drugs
that are not on the list of approved medications.
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 "Veterans in the VA system have
a pathway to access Aduhelm ... We will continue
to engage closely with the VA as they evaluate
potential updates to their guidance," Biogen
said in an emailed statement on Wednesday.
Several other healthcare providers, including
the Cleveland Clinic and Mount Sinai Health
System, have also said they would not prescribe
Aduhelm for patients.
Some hospitals have begun to use the drug, but
patient numbers have been low as providers await
clarity on whether Medicare, the federal
Medicare health plan for people over the age of
65, will cover the drug's cost.
(Reporting By Deena Beasley; editing by Richard
Pullin)
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