Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab) is facing yet another obstacle as at least six affiliates of Blue Cross Blue Shield likely won’t cover the drug.
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Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab) is facing yet another obstacle as at least six affiliates of Blue Cross Blue Shield likely won’t cover the drug. The affiliates are in Florida, New York, Michigan, North Carolina and Pennsylvania. They have indicated in postings online that they will not cover the drug because they consider it “investigational” or “experimental” or because “a clinical benefit has not been established.” The price of the drug is $56,000 per patient per year.
Aduhelm was approved on June 7 by the U.S. Food and Drug Administration despite its own Peripheral and Central Nervous System Drugs Advisory Committee voting strongly against it. The primary criticism is that the drug hasn’t demonstrated clear clinical benefit. The agency also shifted its approval from a clinical benefit endpoint to a surrogate biomarker endpoint, utilizing an accelerated approval process. This resulted in three of the adcom members resigning in protest.
In addition, the agency’s acting commissioner, Janet Woodcock, has requested the independent Office of the Inspector General to investigate how the FDA and Biogen representatives interacted before the approval. Also, the House Committee on Oversight and Reform announced plans to investigate the approval and pricing of Aduhelm. There are concerns that with the $56,000 price tag, and most of the millions of potential patients for the drug on Medicare, it could bankrupt the program. Even if about a third of the three to six million potential patients in the U.S. were given the drug, it would require spending more on Aduhelm alone than on all Medicare Part B drugs combined in a single year. It also prompted Biogen to change the label on the drug to define a narrower patient population.
Of the insurers declining to cover the drug, James Chambers, an associate professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, told The Boston Globe that although insurance companies sometimes refused to pay for an expensive approved drug for a rare disease, it was very unusual for a drug likely to be prescribed for millions of people.
“This is unprecedented,” Chambers said. “Maybe it’s not entirely surprising given the controversy surrounding the drug’s approval, but it’s not something I’ve seen before.”
Helen Stojic, spokeswoman for Blue Cross Blue Shield of Michigan, did note that the company’s website indicated Aduhelm was “considered investigational/experimental” because of “insufficient evidence of a clinical benefit.” But she said the company had not decided yet if it would cover it.
Blue Cross Blue Shield of Massachusetts said it is still working to have a decision, which it expects by the end of July. Other insurers, such as Point32Health, are also studying the drug and working to make a decision. Point32Health’s chief medical officer, Dr. Michael Sherman, accused Biogen in June of putting “excessive corporate profits” ahead of patients in the pricing of Aduhelm. He said he thought the cost should be $5,400, based on its questionable benefits and possible risks. That is more in line with what the Institute for Clinical and Economic Review (ICER), a drug-price watchdog, projected in May before the drug was approved. ICER didn’t think the drug should be approved based on flimsy clinical benefit, but said if it did, it should be priced between $2,500 and $8,300 per patient per year.
The Centers for Medicare and Medicaid Services (CMS) indicated this week they have begun reviewing Medicare coverage for the drug and expects a final ruling within nine months. Because Alzheimer’s tends to affect the elderly, and the elderly are primarily insured by Medicare, the program is expected to handle the brunt of the expense. Usually, private insurers wait until CMS decides on coverage before making a final decision.
Chambers, from Tufts, thinks they are “drawing a line in the sand and making a point about a very expensive drug.”
In addition, The New York Times has reported that the Cleveland Clinic and Mount Sinai do not plan to treat patients with Aduhelm. The Cleveland Clinic stated, “A multidisciplinary panel of Cleveland Clinic experts have reviewed all available scientific evidence on this medication. Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab at this time. However, we support continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients.”
Biogen spokeswoman Allison Parks said the company was “disappointed” by the insurers’ decisions and that they were mischaracterizing Aduhelm. “Typically, an experimental drug is one that has not yet entered clinical trials, whereas an investigational drug is one that is being studied in trials but has not yet received marketing approval from the FDA. Aduhelm is approved by the FDA and is neither experimental nor investigational.”
Woodcock is also facing tough questions over the agency’s decision. In an interview with STAT on Wednesday, July 14, she admitted the agency may have mis-stepped in how it handled the approval but defended the decision. She stated, “It’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved. Was the process done exactly the best that it could be? Possibly not.”
However, she went on to say, “The accelerated approval was based on very solid grounds. I do believe that will play out over time, as people see that was a very appropriate use of that authority and the right thing to do for patients.”
But she refused to discuss whether she was aware of a May 2019 off-the-record discussion between an FDA regulator, Billy Dunn, and Biogen executives. She told STAT, “I was working in Operation Warp Speed all of last year, all right, as the therapeutic lead. And I’m not going to comment on my awareness or elsewise.” After a follow-up question, she said, “I think we ought to move on” and eventually adding, “This is an interrogation right now.”
