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The Food and Drug Administration’s approval on Monday of an Alzheimer’s drug developed by Biogen (BIIB) is raising fresh questions about the financial implications for millions of families, insurers, and American taxpayers. But the drug maker is already scrambling to mitigate the fallout.

At a wholesale price of $56,000 per year, the company exceeded some Wall Street expectations, and greatly surpassed the $8,300 threshold that a nonprofit determined was the price at which the medication could be considered cost-effective. That assessment reflected intense controversy over study data that prompted numerous experts to question the extent to which the drug actually helps patients.

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And because the FDA issued a broad label that places few restrictions placed on usage, the drug could be prescribed to potentially millions of patients, regardless of the extent of their disease. There are an estimated 5.3 million people 65 years and older in the U.S. with Alzheimer’s and another 200,000 younger patients with a milder form of the disease.

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