Our Take: Health systems, insurers take a ‘wait and see; stance on Aduhelm

At least three large health systems and several major insurers have said they will wait for more information before making any final decisions about Biogen’s recently approved Alzheimer’s drug, Aduhelm (aducanumab).

The FDA granted accelerated approval of Aduhelm in early June for patients with Alzheimer’s disease, even though the agency’s panel of expert advisors had voted against recommending approval. The fallout was swift, with the FDA receiving criticism for approving a drug that failed to clearly demonstrate its benefits in clinical testing. Biogen subsequently invited additional controversy by pricing the drug at $56,000 per year — far more than industry analysts anticipated.

Earlier this month, two House committees announced an investigation into the drug’s approval and pricing, and Dr. Janet Woodcock, acting commissioner of the FDA, asked the Office of Inspector General (OIG) at the Department of Health and Human Services to conduct its own investigation into the FDA’s approval process — presumably to show that Biogen had not unduly influenced the FDA.

CMS also initiated a national coverage determination analysis a couple of weeks ago and is seeking input it can use in deciding whether Medicare will adopt a universal coverage strategy for the drug.

In light of these developments, Cleveland Clinic, New York’s Mount Sinai Health System, and Renton, Wash.-based Providence all said last week that they will not administer Aduhelm — at least not for the time being.

Cleveland Clinic said it based its decision on the available clinical evidence and that physicians at the health system could prescribe the drug, but patients would need to go somewhere else to receive their infusions. Mount Sinai is waiting for the OIG to complete its investigation. Providence is holding off until the House investigation has been concluded and more clinical data becomes available.

In the meantime, Anthem and UnitedHealthcare said during their earnings calls this month that they are holding off on deciding whether to cover Aduhelm for their members until they have more data. Earlier, half a dozen Blue Cross and Blue Shield affiliates said they would not cover the drug or would do so only with prior approval. And Point32Health, the entity formed when Tufts Health Plan merged with Harvard Pilgrim Health Care, indicated that it may not cover Aduhelm unless Biogen drastically reduces its price.

Experts at the Institute for Clinical and Economic Reviews (ICER) shared their views after meeting a week and a half ago to discuss the drug. They voted unanimously, 15-0, that Aduhelm does not provide additional benefits when compared with routine care for Alzheimer’s disease. ICER also addressed Biogen’s pricing of Aduhelm, stating that the organization’s revised Evidence Report “finds the price range needed to reach standard cost-effectiveness thresholds for Aduhelm is $3,000–$8,400, representing an 85%–95% discount from the announced list price.”

Our Take: Anyone who has ever been a caregiver for someone with Alzheimer’s disease, or has had a family member with it, knows what a horrible disease it is. Even learning that you’re genetically predisposed to developing Alzheimer’s disease can be terrifying.

It’s understandable, then, that millions of patients and their families are desperate for a treatment that can at least delay progression of the disease. So many Alzheimer’s drug candidates have failed in clinical trials — and not too long ago, it looked as if aducanumab was one of them.

Like everyone else who is following the Aduhelm saga, we’re eager to see what the investigations turn up. Until the reports are released, and probably even afterward, the controversy surrounding the drug will surely continue to swirl.

We wonder, though, would there be as much scrutiny if the drug were priced at $8,000 a year instead of $56,000?

Biogen’s CEO, Michel Vounatsos, reportedly berated critics and the media during an earnings call last week for fomenting the controversy, and the company’s chief of research and development, Dr. Alfred Sandrock, said in “an open letter to the Alzheimer’s disease community” that “Aduhelm’s approval has been the subject of “extensive misinformation and misunderstanding.”

We’ll do as Cleveland Clinic et al. are doing: wait and see.

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“What’s Going On Over at Health Systems?” Stacey Richter asks Darwin Research Group CEO John Marchica this week on Relentless Health Value — the longest running business-focused health care podcast. In this episode, John reviews top-line results from Darwin’s latest quarterly survey of integrated health systems, and they discuss some of the challenges health systems are facing in the wake of the pandemic. Find it here or wherever you get your podcasts.

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