The Aducanumab Aftermath


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. 

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The Basics: Alzheimer's and Aducanumab

0 million
people affected by Alzheimer's disease in the U.S. — a number expected to more than double by 2060¹
deaths from Alzheimer's disease in 2019¹

¹2021 Alzheimer’s Disease Facts and Figures, Alzheimer’s Association.

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:

Winston Chiong, MD, PhD

Neurologist and Associate Professor, University of California, San Francisco

Will my patients have side effects?

About 40% of people in the the drug's Phase 3 trials had brain swelling or bleeding. While the symptoms went away for most, about 1 in 14 had to stop the drug. "I wouldn't consider these risks unacceptable if there was a big benefit on the other side," said Chiong.

Is this better than the drugs we have?

"Even in the [one study] for aducanumab that seemed to show a positive benefit, the benefit was smaller than we see with old drugs we've been using for 20 years, and those drugs have much fewer risks," said Chiong.

Can I still trust the FDA?

"Has this lowered the bar for the next set of treatments?" asked Chiong. He also worries about the difficult decision-making burden the FDA's approval has placed on patients and providers.

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:

Arthena Caston headshot
Arthena Caston, Alzheimer's patient and advocate (Credit: Robert Johnson)

Can I afford Aduhelm?

Caston called the drug's $56,000 price "just plain ridiculous." Her private insurance company told her they are still deciding if or how to cover the treatment. Kaiser Family Foundation found that patients on Medicare could face out-of-pocket costs as high as $11,000.

Will I be able to access it?

Caston's doctor has so far refused to prescribe aducanumab due to reservations about its safety and efficacy. The New York Times also reported experts are expecting a shortage in the number of providers and places equipped to administer the infused drug.

Will it work?

"I don't want to have the side effects, but I want to have a little more time," said Caston. "Each day is a long time. Each minute is a long time ... for a person living with this disease."

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:

Mark Miller, PhD, Executive Vice President, Arnold Ventures

Will Medicare restrict the use of this drug?

Using a national coverage determination, the Centers for Medicare and Medicaid Services (CMS) could deny reimbursement or restrict it to patients with certain clinical indications, but Miller noted the politics of refusing Alzheimer's patients treatment are hard.

How much will this drive up spending?

Depending on how many patients take aducanumab, new spending could soar into the tens of billions. "Everybody is going to carry this cost — all the Medicare beneficiaries, all the taxpayers," said Miller. Patients taking the drug will also face out-of-pocket costs as high as $11,000.

Will this spur federal drug pricing reforms?

Miller said aducanumab is a "case study" in why Medicare needs more power to control drug prices. Although influential Sen. Ron Wyden recently criticized Aduhelm's price, Miller is pessimistic this moment will catalyze change. "It should, but it probably won't."

What other payers and Medicare experts are saying:

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:

Luke Timmerman, journalist and founder, Timmerman Report

Will this help or hurt Alzheimer's drug development?

"It could spark something of a rebirth of Alzheimer's R&D," said Timmerman. He also warned, however, that the approval could inspire drugmakers to simply copy Aduhelm's therapeutic approach, the efficacy of which scientists have questioned.

Will the industry see a backlash to the drug's price?

Timmerman said industry leaders are deeply concerned the drug's high price could backfire. Two senators have already called for a hearing on the drug's price, and Health and Human Services Secretary Xavier Becerra suggested his agency is scrutinizing it too.

Will this undermine confidence in the FDA?

"People in the biotech industry want the FDA to be the guardian of safe and effective drugs," said Timmerman. He added that executives worry this decision could shake the faith of physicians and payers in the value of an FDA approval.

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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.