Aduhelm Saga Continues as Lawmakers Plan to Investigate Approval, Pricing

Biogen_John Tlumacki/The Boston Globe via Getty

John Tlumacki/The Boston Globe via Getty Images

The U.S. Food and Drug Administration (FDA) approved Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease on June 7, but the fallout continues. 

The controversial drug was granted approval despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and assured that the agency was not considering an accelerated approval. But the agency did approve it via an accelerated approval pathway, which used surrogate endpoints, in the case of Aduhelm, removal of amyloid plaques, instead of clinical evidence of improvement in cognition and memory. It also requires post-marketing studies with a nine-year timeline.

On Friday, June 25, the House Committee on Oversight and Reform announced plans to investigate the approval and pricing of the drug. The drug has a list price of $56,000 per year.

In their statement, the House Committee said, “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit.” The investigation was announced by Rep. Carolyn Maloney (D-NY), chair of the committee and Rep. Frank Pallone, Jr. (D-NJ), chair of the Committee on Energy and Commerce.

Biogen, on its part, has defended the price of the drug, noting that Merck’s checkpoint inhibitor Keytruda (pembrolizumab) for certain types of cancer can run up to $150,000 per year and AbbVie’s Humira for inflammatory conditions like psoriasis and rheumatoid arthritis, can cost more than $70,000 per year.

“There is no perfect analog in this space,” Biogen’s spokeswoman Allison Parks told the Boston Globe, “but we have priced Aduhelm at roughly 1/3 the level of cancer immunotherapies and roughly 25% below the average level of psoriasis biologics,” such as Humira.

Critics of the drug pushed back hard.

Brian Skorney, an analyst at Baird, who doesn’t think the FDA should have approved Aduhelm, said, “Keytruda is an expensive drug, but for patients with non-small cell lung cancer, you have clinical data showing it improves survival. The concern here with Aduhelm’s price is there’s no argument that it does for Alzheimer’s patients what Keytruda does for cancer patients.”

Parks indicated that Biogen believes the $56,000 price tag “reflects the overall value this treatment brings to patients, caregivers and society.”

Prior to the approval, the Institute for Clinical and Economic Review (ICER), a drug-pricing watchdog, issued a preliminary report attacking the drug’s clinical trial data over insufficient efficacy and recommended a price, if approved, of $2500 to $8300 per patient per year. ICER does not have official standing with drug pricing, although they are influential in bringing attention to drug-pricing issues.

In a recent statement, Steven Pearson, president of ICER, said, “Based on the evidence we have today, this drug is nowhere near to being that effective, if it’s effective at all.”

The Kaiser Family Foundation has made projections that at $56,000 a year, Medicare might spend $57 billion or more annually on Aduhelm, which is more than Medicare Part B spends on all other drugs combined. 

Pearson’s organization recently attempted to calculate a reasonable price for a hypothetical therapeutic that didn’t cure Alzheimer’s but stopped it from progressing in early-stage patients. They estimated it would be a breakthrough, and a reasonable price would be $50,000 to $70,000 per year and based on that $500 billion in annual costs to the U.S. health care system.

Drug pricing is an enormously controversial subject. For example, Novartis’ one-time gene therapy, Zolgensma, for spinal muscular atrophy (SMA), has a price tag of $2.1 million. That therapy, however, is essentially a cure, and the disease, which kills very young children, is sporadic. So the criticism of Aduhelm, per se, isn’t over the price itself, but over the accumulative price given the large population of potential patients and on the ambiguity over its efficacy.

Other politicians, including Senator Elizabeth Warren (D-Mass.) and Bill Cassidy (R-Louisiana) called on Congress to study the effect Aduhelm would have on the federal budget. Biogen and Eisai have indicated they expected to market the drug to the 1 to 2 million people in the U.S. with mild cognitive impairment. However, it’s not clear yet if or how much insurance companies will be willing to pay or place limitations on the patients who can receive it.

Biogen has indicated it is negotiating with Connecticut-based CIGNA and the Veterans Health Administration on “innovative access agreements.” Michael Sherman, chief medical officer of Point32Health, the second-largest health insurer in Massachusetts, told the Boston Globe they were studying whether to cover the drug, not only because of the price, but because the experts they have consulted over it have “uniformly … been negative about their belief in the efficacy of the drug.”

Even the Alzheimer’s Association, which supported the approval, is critical of the price. Joanne Pike, the organization’s chief strategy officer, said, “The association does not determine drug costs, but we’re adamant that the treatment be affordable and accessible. The price as it is today is unacceptable.”

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