Biogen's $56K price on Aduhelm 'simply unacceptable,' Alzheimer's Association says after vouching for FDA approval

Biogen’s decision to price its historic Alzheimer’s drug Aduhelm at a whopping $56,000 per year unsurprisingly irked lawmakers in Washington D.C., but it’s now drawing criticism from the drugmaker’s own allies as well. 

The Alzheimer’s Association, a leading advocate for Aduhelm’s FDA approval, said in a Saturday statement that the drug’s list price is “simply unacceptable” and will “pose an insurmountable barrier to access.” 

The lofty price tag “complicates and jeopardizes sustainable access to this treatment” and could further deepen health equity issues, the association added. Aduhelm, also known as aducanumab, requires monthly infusions with no clear limit on treatment duration.

“We call on Biogen to change this price,” the association said. Biogen and its Japanese pharma partner Eisai contributed more than $500,000 combined to the non-profit last year. A spokesperson for the company wasn’t immediately available for comment. 

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The advocacy group’s stark rebuke adds to the speculation that Aduhelm will become the newest poster child for drug reform following the FDA’s controversial decision to approve the drug last week. 

The antibody, designed to target amyloid plaques in the brain, is the first Alzheimer’s drug to pass the agency’s finish line in nearly two decades and the only medication to treat the course of the disease, not just its symptoms. 

Shortly following the FDA’s nod, Biogen set Aduhelm’s list price at $4,312 per infusion for a patient of average weight, or $56,000 per year—several times higher than experts had previously estimated. 

It’s well above the recommendation from the drug-cost watchdogs at the Institute for Clinical and Economic Review, which previously said Aduhelm should cost $8,300 per year—at most—given the “insufficient” evidence supporting its benefits in clinical trials. Several analysts had estimated the drug would cost around $10,000 per year.

The drugmaker has defended its pricing strategy, noting that the U.S. dishes out about $600 billion in direct and indirect costs for the disease that affects roughly 6 million Americans. 

For early launch activities, Biogen plans to target between 1 to 2 million patients with early onset symptoms, executives said last week. The company won’t raise the price over the next four years. 

RELATED: Biogen's hefty Aduhelm cost sparks even more talk of a drug pricing crackdown. But will it happen?

Investors are still keeping a close eye on Capitol Hill. In a tweet on Tuesday, Sen. Ron Wyden (D-Ore.), chair of the Senate Finance Committee, called the price “unconscionable” and said that Medicare should have the right to negotiate prices directly with drugmakers.     

Meanwhile, chair of the House Oversight Committee, Rep. Carolyn Maloney (D-N.Y.) told Bloomberg that the price “would cost Medicare billions of dollars.”

The next step toward Aduhelm’s access turns to the Centers for Medicare & Medicaid Services (CMS), which “faces difficult policy decisions” on how to expedite the drug’s availability to qualified Medicare beneficiaries, the Alzheimer’s Association said. 

Maria Carrillo, the chief science officer at the Alzheimer’s Association, told Fierce Pharma in an interview prior to Aduhelm’s approval that the group is focused on ensuring access to the drug, including with payers, clinicians and infusion centers. 

“We will continue to work tirelessly on behalf of people suffering with this disease to ensure that they have access to this drug if they need it,” Carrillo said.