Biogen Alzheimer’s Approval Prompts Backlash, Could Bring Investigation

Aduhelm (aducanumab), the Biogen Inc. Alzheimer’s drug recently approved by the FDA, seems less and less likely to be dispensed to patients, as prominent providers, practitioner groups and experts have all publicly argued against doing so. Several health insurers have said they will not pay for the drug unless patients pass strict prior authorization standards — and the FDA approval itself could be in jeopardy as the agency’s acting commissioner has called for the HHS Office of Inspector General (OIG) to investigate the process that led to the approval.

FDA Acting Commissioner Janet Woodcock, M.D., on July 9 asked the OIG to investigate the approval process for Aduhelm. (Woodcock was not involved in the decision to approve the drug.)

In a letter to OIG that Woodcock published on Twitter, she wrote that she had “tremendous confidence” in the agency staff who made the decision, but that “there continue to be concerns raised…regarding contacts between representatives from Biogen and FDA during the review process.”

Raja Sekaran, a partner of Nossaman LLP and former senior council at HHS OIG, says he expects OIG will take a look at the Aduhelm process.

“I would expect that OIG will follow her request and do an investigation. The head of the agency itself is asking for the investigation, which to me seems like a responsible step to take on her part,” Sekaran tells AIS Health, a division of MMIT.

Tesia Williams, OIG’s director of communications, tells AIS Health via email: “We are aware of concerns regarding FDA’s handling of the Aducanumab approval process and have received Dr. Woodcock’s letter requesting a review. We are now determining the most appropriate course of action to address the issue. If we decide to launch a review into this matter, our organization will announce it on our website and provide a statement for use.”

Request for Investigation Is Unusual

Sekaran says Woodcock’s request will make the investigation urgent if OIG does proceed.

“This is unusual, because it’s responding to certain events and accusations,” Sekaran explains. “I would think that the pressure is really on to make it clear where this is headed in the short term. Congress is watching, as well as the public and the press, so I cannot imagine that they have a long window of time to sort through everything. I think they really have to get on it right away.”

As to what the investigation will entail, Sekaran expects that OIG will “take a look at the details of the communications between the Biogen representative and anyone and everyone involved on the FDA side of the approval process. I think they’ll want to look at emails, correspondence and documents. And I think they’ll do some interviews.”

Sekaran says OIG has subpoena power that does not require signoff from a judge.

“Those can be issued quite quickly, actually,” Sekaran says. “And in a situation like this, I imagine that if the investigation is opened, [subpoenas] will be issued to the drug company itself. Within the FDA, I will be interested to see whether they think in a subpoena is required. I would suspect that, because it’s a government agency, and it’s overseen by OIG, that an intra-department request would suffice.”

If OIG does find any wrongdoing in the Aduhelm approval process, Sekaran says that FDA employees could be “subject to internal discipline or termination.”

“As far as the drug itself — does it go back to square one?” Sekaran asks. “That I don’t know.”

Meanwhile, some clinicians say administering Aduhelm to patients isn’t worth it. Aaron Kesselheim, M.D., a member of an FDA expert panel that reviewed Aduhelm, resigned from that panel on June 10 over the FDA approval.

In an open letter to Woodcock, Kesselheim wrote that “the aducanumab decision by FDA administrators was probably the worst drug approval decision in recent U.S. history.” In the same letter, he added that Aduhelm is “highly problematic” and “offer[s] little evidence that [it] would meaningfully benefit patients.”

Ten of the 11 members of the committee Kesselheim served on, the Peripheral and Central Nervous System Drugs Advisory Committee, voted against approval. The remaining member voted “not sure.” In addition to Kesselheim, two other members of the committee resigned over the Aduhelm approval.

Meanwhile, the executive committee of the American Neurological Association advised its members in a July 14 post that “based on the clinical evidence, ADUHELM should not have been approved at this time.” In that post, the executive committee emphasized the poor results that Aduhelm delivered in clinical trials.

Leading providers have also said they will not prescribe Aduhelm. The Cleveland Clinic tasked a multidisciplinary panel with reviewing the drug and decided that “based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time.”

Leading Hospitals Won’t Dispense Drug

Sam Gandy, M.D., Ph.D., director of the Mount Sinai Center for Cognitive Health, told the New York Times that “Aduhelm will not be considered for infusion into patients on any of [Mount Sinai’s] campuses until and unless” the OIG investigation “affirms the integrity of the FDA-Biogen relationship” and the basis for the drug’s approval.

On the back of the practitioner backlash, insurance carriers have also indicated they will apply stringent standards before authorizing Aduhelm — if they even reimburse it at all. James Chambers, Ph.D., MPharm., an associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, says that Blue Cross Blue Shield of North Carolina, Florida Blue, Independence Blue Cross, Blue Cross Blue Shield of Michigan, Blue Cross Blue Shield of New York and Highmark Blue Cross Blue Shield have all designated the drug as investigational. Chambers leads the Tufts Specialty Drug Evidence and Coverage Database.

“That’s certainly unprecedented,” Chambers tells AIS Health. But it’s “not particularly surprising, I think, given the clinical evidence.”

Plans Intend to Restrict Access

Chambers says it’s unusual for plans to make public their reasoning in making coverage decisions for new drugs.

“Typically — and some of these health plans have done so — they’ll cite different clinical studies, guidelines which they use to support that decision. But very rarely do they provide a critique of the evidence and really explain because of the limitations and weaknesses of certain studies,” Chambers explains. That’s not the case with Aduhelm, he says, since payers specifically cited the dearth of clinical evidence.

Still, Chambers adds that plans may reverse their positions if evidence of Aduhelm’s efficacy becomes available.

“To be sure, these health plans will revisit these decisions,” Chambers says. “That’s part of why we have the database we have, to track these decisions as they change. So whenever new evidence becomes available, or Medicare and CMS issues their [national coverage determination], we can expect the health plans to revisit their positions on this. Maybe, potentially, they would change how they cover the product.”

Aduhelm’s rollout could have profound cost implications for public health insurance as well. The Kaiser Family Foundation estimated in June that spending on Aduhelm could easily be the highest of any drug covered by Medicare. A July 13 analysis by KFF found that “Medicaid will see increased costs through direct payment of Aduhelm for individuals who receive their drug coverage through Medicaid, as well as through potentially higher Medicare premium payments and cost-sharing for dual eligible beneficiaries.”

State Medicaid programs have more limited control over what they can dispense in comparison to commercial plans, says Rachel Dolan, a senior policy analyst at KFF and one of the authors of the report.

“States do have the ability to use certain utilization controls,” Dolan tells AIS Health. But “they cannot exclude drugs from the formulary at this point. …They do use prior authorization and clinical criteria.”

Dolan compares Aduhelm to hepatitis C therapies, which were also very expensive — Aduhelm costs $56,000 per year for a maintenance course.

“There were some issues around states using too strict clinical criteria, and people were not able to access the hepatitis C medications,” Dolan explains. “But there can be a line, particularly for the hepatitis C [drugs], which were curative therapies. If you’re restricting access to something like that, CMS may be more willing to step in. For this drug, that’s less certain.”

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Peter Johnson

Peter Johnson

Peter has worked as a journalist since 2011 and has covered health care since 2020. At AIS Health, Peter covers trends in finance, business and policy that affect the health insurance and pharma sectors. For Health Plan Weekly, he covers all aspects of the U.S. health insurance sector, including employer-sponsored insurance, Medicaid managed care, Medicare Advantage and the Affordable Care Act individual marketplaces. In Radar on Drug Benefits, Peter covers the operations of (and conflicts between) pharmacy benefit managers and pharmaceutical manufacturers, with a particular focus on pricing dynamics and market access. Before joining AIS Health, Peter covered transportation, public safety and local government for various outlets in Seattle, his hometown and current place of residence. He graduated with a B.A. from Colby College.

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