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2021-07-18| Trials & Approvals

Aftermath of Biogen’s Alzheimer’s Drug Approval Continues as Some Hospitals, Insurers Refuse Administration

by Daniel Ojeda
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July 17th, 2021 – Biogen and Eisai Co.’s Alzheimer’s drug, Aduhelm (aducanumab), suffered two more blowbacks this week. First, a panel of experts convened by the Institute of Clinical and Economic Review (ICER) voted unanimously that there is no evidence to say the drug offers significant health benefits. Then, two major health systems announced they would not carry Aduhelm. At the end of the week, the news pushed Biogen’s stock down more than 8%.

Aduhelm became the first drug approved to treat Alzheimer’s disease (AD) in nearly 20 years. However, the approval has faced a lot of criticism for two main reasons: 

  • Experts are not convinced it offers significant health benefits. An FDA advisory panel voted 7 against, 4 uncertain, and 0 in favor that the Phase 3 clinical trial demonstrated its efficacy.
  • Its exorbitant price tag of $56,000 could make it inaccessible for uninsured people and even those insured if insurers do not cover the cost.

Following the pushback from various quarters, on July 8th, the FDA updated Aduhelm’s label, narrowing its administration to only patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia.

Additionally, Dr. Janet Woodcock, the Acting Commissioner of the FDA, asked the Inspector General last week to investigate interactions between Biogen and FDA review staff to ensure they were consistent with FDA’s policies and procedures.

 

Roadblocks with Experts and Insurers

With the possible lack of health benefits and the high price, the Cleveland Clinic and New York’s Mount Sinai Health System announced they would not carry Aduhelm. The news sent Biogen’s stock price crashing almost 7% on Thursday.

Later that day, a panel of experts voted 15-0 during a meeting organized by the ICER that there is no evidence Aduhelm provides net health benefits. Additionally, the ICER said the drug is cost-effective at no more than $8,400. That is 15% of the current price listed by Biogen.

Another roadblock on Aduhelm’s way is coverage by insurers. Blue Cross Blue Shield health insurance plans from Michigan, North Carolina, and Pennsylvania already announced they will not cover the drug due to insufficient evidence regarding benefits to the patients. 

Similarly, UnitedHealth, and Humana, the first- and second-largest providers of Medicare Advantage, respectively, announced they were awaiting input from Centers for Medicare and Medicaid Services (CMS) before finalizing coverage.

For their part, CMS began a 9-month long national review process on Monday to determine the nationwide conditions for coverage. Until then, approval determinations will be made by 12 regional contractors at the local level.

Andrew Witty, CEO of UnitedHealth, said to Reuters, “This has some way to go before we get to real clarity. So I wouldn’t guide you to expect a very rapid decision-making on this piece,” 

Biogen’s stocks were down more than 8% by the end of the week, and Eisai Co.’s stock decreased by almost 13%. Friday’s closing price of Biogen’s stock was $324.64, which is 25% lower than the peak price it reached after Aduhelm’s FDA approval.

Related Article: FDA Grants Breakthrough Status to Two Experimental Alzheimer’s Drugs While Pushback Over Aduhelm’s Approval Still Rages On

 

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