The Aducanumab Aftermath
A SPECIAL CONVERSATION SERIES
June 22, 2021
Art by Leslie Walker
About this Special Series
The U.S. Food and Drug Administration (FDA) recently approved the costly new Alzheimer’s drug aducanumab (now known by the brand name Aduhelm) despite doubts about its safety and efficacy. Priced at $56,000 by drugmaker Biogen, aducanumab could have such a significant impact on so many facets of the U.S. health care system that we are dedicating a four-part series to it.
Each of the four episodes is a one-on-one conversation between host Dan Gorenstein and one person who’s grappling with the fallout from this FDA approval. Together, the episodes will explore some of the difficult questions facing important stakeholder groups: doctors, patients, payers and the pharmaceutical industry.
Scroll down for the full episodes, transcript links and more information.
The Basics: Alzheimer's and Aducanumab
Alzheimer’s disease largely affects older adults and worsens with time, eventually leaving people unable to complete basic daily activities like eating or bathing. Older Black and Hispanic adults are disproportionately vulnerable to Alzheimer’s, largely due to socioeconomic disparities that increase the prevalence of chronic conditions (such as hypertension) that exacerbate dementia risk. In addition to costing the health care system more than $300 billion annually, Alzheimer’s and related dementia care also takes a huge financial, physical and emotional toll on caregivers.
There is currently no cure for Alzheimer’s and there are only a few treatments with limited efficacy available. It has been 18 years since the last new Alzheimer’s treatment was approved by the FDA, so aducanumab offered new hope as the first treatment to target a suspected underlying cause of the disease.
However, most experts believed the clinical data underlying the drug painted a much more pessimistic picture. The FDA’s own panel of expert advisers found the drug’s evidence insufficient for approval by a vote of 10-0 last fall. But on June 7, 2021, the FDA went against its advisers and made what many saw as a shocking decision to approve aducanumab.
While some patients and advocacy groups rejoiced, three of the FDA’s expert advisors resigned in protest. Others recoiled at the $56,000 price tag drugmaker Biogen put on a product that neither cures nor halts Alzheimer’s disease. The hefty price could squeeze seniors with large out-of-pocket costs and swamp the already fiscally precarious Medicare program with billions in new spending.
Part 1: The Doctor
In this first conversation, neurologist Winston Chiong, MD, PhD told us he would not proactively recommend aducanumab to any of his patients. However, for patients with mild and early Alzheimer’s — the type of patients the drug was tested on — he would engage in a conversation about their values and the drug’s risks and benefits if they were interested.
Three big questions he’s grappling with are:
- “‘I’m just winging it’: Faced with confusing data on the new Alzheimer’s drug, doctors scramble to advise their patients” (Elizabeth Cooney, STAT, 6/14/2021)
- “Ready, set, prescribe? Doctors detail why they’ll deploy Biogen’s new Alzheimer’s drug—or not” (Beth Snyder Bulik, FiercePharma, 6/8/2021)
- “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it” (Jason Karlawish, STAT, 5/30/2021)
Part 2: The Patient
In this second conversation, Alzheimer’s patient and Alzheimer’s Association board member Arthena Caston told us she’s more scared of losing her cognitive abilities and independence than she is of aducanumab’s risks. Her biggest concern is her ability to access and afford the treatment, which also goes by the brand name Aduhelm.
Three big questions she’s grappling with are:
What other patients are saying:
- “Patient receives first infusion of Biogen’s controversial Alzheimer’s drug” (Berkeley Lovelace Jr., CNBC, 6/16/2021)
- “Elation, pride, and a slew of questions: Clinical trial participants reflect on their own complicated reactions to Aduhelm approval” (Andrew Joseph, STAT, 6/8/2021)
- “Patient Support May Have Helped Push Aduhelm Toward Approval” (Derrick Gingery, PharmaIntelligence, 6/7/2021)
Part 3: The Payer
In this third conversation, we spoke with Mark Miller, PhD, who advised Congress on Medicare policy for 15 years as a member of the Medicare Payment Advisory Commission (MedPAC). He is now Executive Vice President for Health Care at Arnold Ventures, which also supports Tradeoffs.
Miller outlined how aducanumab could saddle seniors with thousands of dollars in out-of-pocket costs and push Medicare further into fiscal trouble. While there are ways the federal policymakers could rein in spending on this drug, Miller expressed doubts they will take meaningful action any time soon.
Three big questions on his mind are:
What other payers and Medicare experts are saying:
- “Health insurers leery of Aduhelm, but don’t know how to cover it yet” (Bob Herman, Axios, 6/23/2021)
- “New Drug Could Cost the Government as Much as It Spends on NASA” (Josh Katz, Sarah Kliff and Margot Sanger-Katz; New York Times; 6/22/2021)
- “Medicare Must Study Unproven, Expensive Alzheimer’s Drug” (Peter Bach and Craig Garthwaite, Bloomberg, 6/15/2021)
- “New Alzheimer’s Drug is Projected to Increase National Health Expenditures by More Than One Percent” (George Miller, Ani Turner and Corwin Rhyan; Altarum; 6/16/2021)
- “The Drug That Could Break American Health Care” (Nicholas Bagley and Rachel Sachs, The Atlantic, 6/11/2021)
- “FDA’s Approval of Biogen’s New Alzheimer’s Drug Has Huge Cost Implications for Medicare and Beneficiaries” (Juliette Cubanski and Tricia Neuman, Kaiser Family Foundation, 6/10/2021)
Part 4: The Pharmaceutical Industry
In this final installment of our four-part series, we spoke with longtime biotech journalist Luke Timmerman, who founded and runs Timmerman Report, an independent industry newsletter. Timmerman described industry insiders feeling both confused by the FDA’s approval decision and outraged at drugmaker Biogen’s move to price Aduhelm at $56,000 despite serious questions about its efficacy.
Three major questions on his mind:
What other industry insiders and reporters are saying:
- “FDA’s Woodcock is just ‘not that concerned’ about the criticism over Biogen’s Alzheimer’s drug, Aduhelm” (Nicholas Florko, STAT, 6/24/2021)
- “The new Alzheimer’s drug is the first of its kind. Will it be the last?” (Dylan Scott, Vox, 6/24/2021)
- “Eli Lilly to Seek FDA Approval for Alzheimer’s Drug” (Laura Cooper, Wall Street Journal, 6/24/2021)
- “Biogen Expects Slow Alzheimer’s Drug Uptake, May Reset Price” (John Tozzi, Bloomberg, 6/23/2021)
- “Biogen isn’t worried about backlash to ‘bewildering’ price of Alzheimer’s drug” (Damian Garde, STAT, 6/8/2021)
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Special thanks to...
Mike Lynch, Tricia Neuman, Juliette Cubanski, Rachel Sachs, Sean Dickson, the Tradeoffs Advisory Board and our stellar staff!
The Tradeoffs theme song was composed by Ty Citerman. Additional music provided by Blue Dot Sessions.
This series was reported and produced by Leslie Walker and mixed by Andrew Parrella.