Proposal to limit Biogen's Alzheimer's drug followed evidence-based process - Medicare chief
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The head of the body charged with administering Medicare said Wednesday that a proposed rule limiting access to Biogen's (NASDAQ:BIIB) controversial Alzheimer's drug followed an "evidence-based process" meant to ensure the product is "appropriate for a Medicare population."
Speaking to CNBC, Chiquita Brooks-LaSure, director of the Centers for Medicare and Medicaid Services, noted that the decision followed "a lot of stakeholder discussion" about how best to treat this "heartbreaking disease."
Biogen (BIIB) dropped in Wednesday's intraday trading on news that CMS plans to restrict access to its Alzheimer's drug, Aduhelm, to patients enrolled in clinical trials.
Last June, BIIB received approval from the U.S. Food and Drug Administration to begin selling Aduhelm, the first new Alzheimer's drug to hit the market since 2003. However, the process that led to the FDA's approval raised eyebrows, as the product has yet to establish its efficacy in slowing the disease progression.
In clinical trials, Aduhelm has reduced Alzheimer's-causing plaque in the brain, a fact that suggests it could provide a benefit to patients. However, not enough evidence exists to prove that this translates into improved longevity or quality of life.

The company has promised to gather long-term data on the drug to demonstrate its efficacy definitively.
Meanwhile, the company's pricing for the Alzheimer's drug has elicited criticism as well. BIIB initially announced a price of $56K a year. At that level, analysts estimated peak revenue from the drug of about $12B-$13B.
That bill would largely be picked up by CMS, as the patients covered by Medicare include a large chunk of the country's older population. One analyst predicted that more than 80% of Aduhelm sales in the U.S. would be paid for by Medicare -- an "existential question" for an insurance program that had a total drug budget of $37B in 2019.
BIIB has responded to these criticisms by slashing its prices for the drug, cutting them in half to $28.2K a year. This, in turn, sparked HHS Secretary Xavier Becerra to order a re-evaluation of Medicare premium increase that was largely inspired by the introduction of Aduhelm.
BIIB spiked in June in response to the Aduhelm approval, as investors saw blockbuster potential in the drug. Shares jumped from a level below $275 to a 52-week high of $468.55 in the span of a week.
However, since then, the controversy over the drug has ground the stock down. Shares now sit well below their levels prior to the FDA approval. On Wednesday, the stock has slipped $15.32 to $226.20 at around 1:45 p.m. ET.
During the session, BIIB also reached a 52-week low of $217.10. Overall, the stock has fallen about 42% since its post-Aduhelm peak. Over the same period, the S&P 500 has climbed about 12%, as you can see in this chart.