Home Health Group Needs FDA Leaders Ousted Over Alzheimer’s Drug Approval

Group Needs FDA Leaders Ousted Over Alzheimer’s Drug Approval

aducanumab

Advocates Who Backed Approval Decry Price

Aducanumab had a rocky highway to approval however had unwavering backing from the Alzheimer’s Affiliation and a minimum of one different group, UsAgainstAlzheimer’s.

The Alzheimer’s Affiliation was notably outspoken in its help, and, as reported by Medscape in March, was accused of potential battle of curiosity by Public Citizen and several other neurologists as a result of the affiliation had accepted a minimum of $1.4 million from Biogen and its associate Eisai since fiscal 12 months 2018.

The affiliation applauded the FDA approval however, just a few days later, it expressed outrage over the $56,000-a-year price ticket.

“This value is solely unacceptable,” the Alzheimer’s Affiliation mentioned within the assertion. “For a lot of, this value will pose an insurmountable barrier to entry, it complicates and jeopardizes sustainable entry to this therapy, and should additional deepen problems with well being fairness. We name on Biogen to vary this value.”

UsAgainstAlzheimer’s additionally expressed issues about entry, even earlier than it knew aducanumab’s value.

“Shockingly, Medicare doesn’t reimburse sufferers for the costly PET scans vital to find out whether or not somebody is acceptable for this drug,” George Vradenburg, chairman and co-founder of the group, famous in a June 7 statement. “We intend to work with Biogen and Medicare to make entry to this drug inexpensive for each American who wants it.”

Public Citizen’s Carome mentioned the advocates’ complaints had been exhausting to fathom.

“This could not have come as a shock to anybody,” he advised Medscape. “It is primarily the ballpark determine the corporate threw out weeks in the past.”

At $56,000 per 12 months, aducanumab is “egregiously overpriced for a drug that does not work,” Carome mentioned. “If the [Alzheimer’s Association] really finds this objectionable, hopefully they’re going to cease accepting cash from Biogen and its associate Eisai.”

One other advocacy group, Sufferers for Reasonably priced Medicine, counseled the Alzheimer’s Affiliation. Its assertion “was nothing in need of brave, particularly in mild of the Alzheimer’s Affiliation’s reliance on funding from drug firms, together with Biogen,” David Mitchell, a cancer affected person and founding father of Sufferers For Reasonably priced Medicine, mentioned in a statement.

Mitchell mentioned his members “stand with the Alzheimer’s Affiliation in its denunciation of the worth set by Biogen” and referred to as for a brand new regulation that may enable Medicare to barter drug costs.


Alicia Ault is a Lutherville, Maryland-based freelance journalist whose work has appeared in publications together with Smithsonian.com, The New York Occasions, and The Washington Put up. You’ll find her on Twitter @aliciaault.