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Florida’s First Choice Neurology has provided Aduhelm to patients through the Biogen access program.
Biogen is providing the controversial Alzheimer’s medication Aduhelm (aducanumab-avwa) free for some patients, amid slow claim reviews by Medicare, sources told Reuters.
In order to expedite treatment, Biogen has begun to provide Aduhelm to Aventura, Fla.-based Florida’s First Choice Neurology free-of-charge, Jeffrey, M.D., Gelblum, a neurologist at the center, told Reuters. "We have been using the Biogen access program,” Gelblum said. “It is almost like a sample program — to get patients started.”
The medication reportedly costs $56,000 per year.
While Biogen has said it has a number of plans in place to support patient access, it did not give further details, Reuters said. Biogen and Florida’s First Choice Neurology did not respond to a request for comment from FormularyWatch®.
Florida’s First Choice has infused more than 30 patients with Aduhelm, according to Reuters. The first doses for two patients were billed to Medicare, while their second doses, along with first doses for the others, were provided at no cost by Biogen, Gelblum said.
The Centers for Medicare and Medicaid Services recently launched a nine-month process to determine standardized national coverage terms for the drug, and is currently processing Aduhelm claims on a case-by-case basis.
Several commercial insurers, including UnitedHealth Group, have said they are waiting for further direction from CMS before covering the drug. Some Blue Cross Blue Shield plans also said they won't cover Aduhelm, noting that Aduhelm is considered investigational due to insufficient evidence of clinical benefit and not applicable for consideration of medical necessity.
And the US Veterans Administration recently said it is declining coverage of Aduhelm on its National Formulary, ”due to the risk of significant adverse drug events and to the lack of evidence of a positive impact on cognition," a VA spokesperson told FormularyWatch®.
While VA’s PBM acknowledges the recent FDA decision on Aduhelm, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal, we recommend against offering this agent to patients with Alzheimer’s dementia (mild or otherwise) or mild cognitive impairment,” the VA said in a notice.
Aduhelm, given as a monthly infusion, was approved by the FDA in June despite one of Biogen's clinical trials failing to show a benefit for patients, Reuters said.