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One of the nation’s largest health insurers has decided not to cover a controversial Duchenne muscular dystrophy drug after raising doubts about clinical trial data that regulators relied on to approve the medicine last month.

In a bulletin issued to clients on Friday, Anthem reviewed the results from various studies and concluded that Exondys 51, which is sold by Sarepta Therapeutics, is “not medically necessary” and that “the clinical benefit … has not been demonstrated.” Duchenne is a rare disease that confines boys to wheelchairs and condemns them to an early death.

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The Anthem decision is significant because the insurer is one of the largest in the country, covering nearly 38 million lives. Not only does Anthem have a significant presence serving individuals and small employers, the insurer is also a major player serving large employers that operate in different states.

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