In a setback for Sarepta Therapeutics, a New York panel has voted unanimously to recommend the state Medicaid program should pause coverage of a treatment for Duchenne muscular dystrophy in response to a high-profile safety controversy this past summer.
The Drug Utilization Review Board late last week suggested the state should wait for the Food and Drug Administration to add safety and clinical trial data to the product labeling for the therapy, Elevidys. The board also recommended the state should first evaluate a forthcoming regimen that the company is developing to mitigate the risk of liver failure in patients who are treated.
However, the state will cover some patients under a Medicaid benefit known as the Early and Periodic Screening, Diagnostic and Treatment, which provides health care for children under 21 years old. The state will do so on a case-by-case basis after determining medical necessity, a New York Department of Health spokeswoman wrote us.
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