Anthem Declines to Cover Sarepta Drug for Duchenne, Citing Doubts over Data

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.

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. […]

The decision is not only a setback for Sarepta, but also amounts to a rebuke of the US Food and Drug Administration, which approved the drug last month after unusually protracted bickering among high-ranking agency staff.

For months, FDA officials quarreled behind the scenes over study results. […] Consequently, Anthem pointed to the uncertainty over these findings to justify its decision. […]

To some, the Anthem decision is not a surprise.

“The FDA is not doing patients any favors when they approve a drug or device that is not proven to work,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. “In order to keep health insurance affordable, companies need to ensure that they are paying for safe and effective treatments. When FDA fails to ensure those standards, then FDA approval is no longer a gold standard that insurance companies can rely on.” […]

Read the full article here.

To see the NCHR president’s official statement, click here.