06.14.2021 / Reporters Note
Reporter’s Note – Approval of Biogen’s Pricey and Unproven aducanumab Drug Signals Win for Big Pharma, Loss for Patients and Families
MEDIA AVAILABILITY – To speak with Sandra Wilkniss, Director of Complex Care Policy and Senior Fellow at Families USA, about aducanumab, contact Lisa Holland, lholland@familiesusa, 202-695-5160 (cell).
Approval of Biogen’s Pricey and Unproven aducanumab Drug Signals Win for Big Pharma, Loss for Patients and Families
The only winner in the Food and Drug Administration’s (FDA) unwarranted approval of aducanumab, Biogen’s treatment for Alzheimer’s disease, is the pharmaceutical industry. Families desperate to find a treatment for this devastating disease sustained a significant loss this week with the approval of this potentially harmful drug that demonstrates no clear clinical benefit. Despite overwhelming rejection by the agency’s expert advisory panel, the drug will hit the market, providing false hope for these families and take a severe financial toll in the process. The move was so contested that three advisory panel members resigned in protest within days of the decision.[i]
Biogen set the price at $56,000, well above stock analysts’ estimates[ii] and exponentially higher than the value assessed by Institute for Clinical and Economic Review, which was in the $2,500 to $8,300 range.[iii] Some estimates show that people who take the drug would have to spend $10,000 or more out of pocket annually.[iv] And it would cost the U.S. government tens of billions per year for the drug alone and exponentially more in ancillary costs, robbing funds that could be spent on effective interventions and research into new treatments that work.
This is just one of the most recent, egregious examples of why Congress needs to act now to finally respond to the 9 out of 10 voters who want lower drug prices. Families USA is calling on them to:
- provide robust oversight and shift incentives to bring safe, effective, and affordable drugs to Americans; and
- untie Medicare’s hands to negotiate prices and level the playing field to protect Americans from price gouging absent real innovation – an abuse that is on full display with this approval and subsequent pricing scheme.
“This is the antithesis of rewarding innovation and a windfall for Biogen,” said Sandra Wilkniss, Director of Complex Care Policy and Senior Fellow. “Accelerated approval of a drug with no clear clinical benefit, potentially serious side effects, and no limits on who is eligible for treatment shows blatant disregard for quality care for families and signals to the pharmaceutical industry that treatments of little to no value will be rewarded in spades.” She added, “The astronomical cost for a drug that doesn’t pass an even reasonable threshold of effectiveness is unconscionable, and elected officials should find it unconscionable that Medicare is powerless to act on behalf of its beneficiaries.”
[i] Steenhuysen, J., O’donnell, C. Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval. Reuters. June 11, 2021. https://www.reuters.com/world/us/third-member-us-fda-advisory-panel-resigns-over-alzheimers-drug-approval-2021-06-10/
[ii] Nathan-Kazis, J. Biogen is charging $56,000 for its Alzheimer’s drug. Why that’s a problem. Barron’s. June 8, 2021. https://www.barrons.com/articles/biogens-alzheimers-drug-price-backfire-51623155998
[iii] Institute for Clinical and Economic Review. ICER Issues statement on the FDA’s approval of aducanumab for Alzheimer’s disease. June 7, 2021. https://icer.org/news-insights/press-releases/icer-issues-statement-on-the-fdas-approval-of-aducanumab-for-alzheimers-disease/
[iv] Walker, J. FDA approves first new Alzheimer’s disease drug in nearly two decades. The Wall Street Journal. June 7, 2021. https://www.wsj.com/articles/first-alzheimers-drug-to-slow-disease-is-approved-by-fda-11623078912?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsmi=132368616&_hsenc=p2ANqtz-8Cn5DnJ3eVvbmHitTDhWkWFFRFz4gRhlVNBANEgnW6GfDTGMxuUEqoHsghp2_qmBNptORGdtrfOVyRjQZP3bs1yMXA0w&utm_content=132368616&utm_source=hs_email