Broad-based Opposition to Egregious Launch Price on Drug With Unproven Clinical Benefit Adds to Momentum to Hold Big Pharma Accountable

Last week, the U.S. Food and Drug Administration (FDA) approved Alzheimer’s treatment aducanumab, brand name Aduhelm, despite serious questions about the medication’s clinical benefit for patients and a unanimous vote against moving forward from the agency’s expert advisory panel. Biogen, the Big Pharma manufacturer of the drug, subsequently set a massive launch price of $56,000 for annual treatment on the drug. Three members of the FDA’s advisory panel have since resigned.

The FDA approval of the drug and subsequent punitive pricing from Biogen highlight the urgency for policymakers in Washington to keep repeated promises to hold Big Pharma accountable and lower prescription drug prices.

Here are what patient advocates, physicians and researchers, clinical experts, drug pricing advocates and even Wall Street analysts have had to say following the FDA approval of aducanumab and Biogen’s subsequent pricing of the product:

The Alzheimer’s Association:

“Following approval, the manufacturer, Biogen, announced their intention to price Aduhelm at $56,000 per year. This price is simply unacceptable. For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity. We call on Biogen to change this price.”

Institute for Clinical and Economic Review (ICER):

“Even in our most optimistic cost-effectiveness scenario — which ignores the contradictions within the two pivotal trials and presumes that only the positive trial captures the true benefits of treatment — aducanumab’s health gains would support an annual price between $11,100-$23,100.”

“The list price of $56,000 per year announced today by the drug maker far exceeds even this optimistic scenario. Our report notes that only a hypothetical drug that halts dementia entirely would merit this pricing level. The evidence on aducanumab suggests that, at best, the drug is not nearly this effective. Nonetheless, even at the lower range of the estimated number of eligible patients, at this price the drug maker would stand to receive well in excess of $50 billion per year even while waiting for evidence to confirm that patients receive actual benefits from treatment.”

Lauren Aronson, Executive Director, Campaign for Sustainable Rx Pricing (CSRxP):

“As a result of the FDA’s approval of aducanumab, and Biogen’s subsequent unjustifiable pricing on the treatment, hopeful patients will pay a punitive price tag for a drug with questionable, or even negligible, efficacy while a Big Pharma company profits. This demands retrospection on the part of regulators — to do their best to ensure decisions going forward follow key principles and are above reproach — and it demands reform from policymakers, who must deliver on repeated promises to hold Big Pharma accountable for the industry’s egregious pricing practices.”

David Mitchell, President and Founder, Patients for Affordable Drugs (P4AD):

“In America, drug corporations have the power to price-set, and Biogen has set a price of $56,000 per year for a drug that has not yet been proven effective… Americans want new treatments for unmet needs, but the price announced today by Biogen lends further urgency for reform of our drug pricing system.”

Dr. Aaron Kesselheim, M.D., Professor of Medicine, Bringham and Women’s Hospital, Harvard Medical School:

“The aducanumab decision by FDA administrators was probably the worst drug approval decision in recent U.S. history… This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system.”

Dr. Peter Bach, M.D., Director, Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center:

“It’s completely unconvincing that we should be using it at all… In reality, we shouldn’t be paying anything. We should be continuing to research until we have drugs that are shown to be effective.”

Karl Herrup, Professor of Neurobiology, University of Pittsburgh School of Medicine, and Jonathan Goulazian:

“Aducanumab is marginally effective at best… Perhaps most important of all, however, aducanumab can never be made widely available. It is far too expensive: the company set a wholesale price of $56,000 per year. Yet, given the fear of Alzheimer’s disease, millions of U.S. residents over age 65 will surely want it. This will only serve to emphasize the disparities in care accessibility that our system is already struggling with. Were Medicare to begin coverage, the projected costs of treating all eligible recipients would quickly overwhelm the resources of the system.”

Ronny Gal, Biopharmaceuticals Senior Research Analyst, Bernstein:

“[The price is] taking advantage of the weak U.S. pricing scheme… Such a high cost will facilitate new management strategies and could be a catalyst for movement on drug price reform… The pricing action of Biogen would likely be very negatively perceived by fiscal conservatives. This may be enough to shift the view within this critical narrow majority. The argument being that the industry can’t be trusted to police itself.”

Mohit Bansal, Director of Biotech Equity Research, Citi:

“The potential impact on Medicare budget can not be ignored… This could potentially spark the drug pricing debate again in the remainder of the year.”

Read CSRxP’s full statement on the FDA approval of aducanumab and Biogen’s subsequent pricing HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable and lower drug prices HERE.

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