Biogen Stock Dives After Cleveland Clinic, Mount Sinai Ban Alzheimer’s Drug Aduhelm
[Biogen Stock Dives After Cleveland Clinic, Mount Sinai Ban Alzheimer’s Drug Aduhelm | Investor’s Business Daily (investors.com)](https://www.investors.com/news/technology/biogen-stock-dives-after-cleveland-clinic-mount-sinai-ban-alzheimers-drug-aduhelm/)
[**ALLISON GATLIN**](https://www.investors.com/author/gatlina/) 4:21 PM 07/15/2021
Biogen stock tumbled Thursday after the Cleveland Clinic and Mount Sinai said they won’t administer the company’s controversial Alzheimer’s drug, Aduhelm.
Remember, chart patterns don’t mark the end of the run, they mark the beginningVolume 0%
In a statement emailed to Investor’s Business Daily, the Ohio-based Cleveland Clinic said a panel of experts reviewed the scientific data associated with **Biogen**’s ([**BIIB**](https://research.investors.com/quote.aspx?symbol=BIIB)) aducanumab, the test name for Aduhelm.
“Based on the current data regarding its safety and (effectiveness), we have decided not to carry aducanumab at this time,” the clinic said. “However, we support continued research in this area and, when additional data become available, we will then re-evaluate this medication for use in our patients.”
New York-based Mount Sinai said its group of Alzheimer’s experts is writing out best practices for Aduhelm while another group is putting together formulary addition protocols. The clinic also awaits the outcome of an Office of Inspector General investigation into Aduhelm’s approval.
“The FDA’s approval of Aduhelm has raised serious concerns and questions by clinicians, patients and caregivers and a cautious approach is required,” Mount Sinai said in a statement emailed to IBD. “Mount Sinai Health System will not administer Aduhelm until the outcome of the FDA Inspector General’s Investigation of Biogen is complete. Depending on this outcome, if appropriate, our experts will follow formulary addition protocols and consider best practices for Aduhelm to inform clinical practice.”
On the [**stock market today**](https://www.investors.com/market-trend/stock-market-today/stock-market-today-market-trends-best-stocks-buy-watch/), Biogen stock skidded 6.8% to 328.16.
**Biogen Stock Dives On Coverage Issues**
The fact two notable medical centers won’t administer Aduhelm doesn’t bode well for adoption. Mizuho Securities analyst Salim Syed questioned whether others might follow suit. This could put expectations for $9 billion in peak Aduhelm sales at risk, he said in a note to clients.
It’s also another move pressuring Biogen stock this week.
Biogen said it remains committed to helping appropriate patients access Aduhelm.
“Medical decisions should be based on science and data, so it is disappointing that patients living with Alzheimer’s Disease may reportedly not be able to access Aduhelm at some facilities,” the company said in a statement emailed to IBD. “Biogen continues to stand 100% behind Aduhelm and the clinical data that supported approval.”
The company also referenced comments from Janet Woodcock, acting Food and Drug Administration commissioner, during Stat’s Breakthrough Science Summit on Wednesday. She said the approval was “based on very solid grounds” and “the right thing to do for patients.”
But, according to Stat News, Woodcock also acknowledged the FDA could have handled the approval process differently to minimize the controversy. The FDA approved Aduhelm using an accelerated pathway that gives Biogen nine years to run a study confirming the drug’s benefit on cognition. An advisory committee earlier voted against recommending the approval.
**Medicare Decision Expected In 2022**
Also this week, the Centers for Medicare and Medicaid Services began the process to determine if it will cover Aduhelm. This process, called a national coverage determination, could limit the number of patients eligible to receive Medicare reimbursement for Aduhelm.
Medicare expects to have a final decision within nine months. In the meantime, local contractors in 12 regions will determine [**coverage for their areas**](https://www.wsj.com/articles/medicare-to-review-coverage-for-new-alzheimers-drug-aduhelm-11626130325), according to The Wall Street Journal.
Medicare reimbursement will be key. Without it, many patients will be responsible for the drug’s $56,000 annual price tag. It’s still unclear who will foot the bill for the costly scans to check for beta amyloid in patients’ brains. Aduhelm removes the “sticky” plaque associated with Alzheimer’s.
But the Cleveland Clinic’s decision wasn’t based on the price tag, Mizuho’s Syed said. He reiterated his neutral rating and 244 price target on Biogen stock.
“It’s based on the data, not even financials, which I thought was interesting,” he said.
*Follow Allison Gatlin on Twitter at* [***@IBD\_AGatlin***](https://twitter.com/IBD_AGatlin)*.*
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