Anthem said on Friday that it has decided not to cover a new drug aimed at treating Duchenne muscular dystrophy, citing concerns about a lack of data regarding how the treatment would improve health outcomes.
The insurer, one of the largest in the country, said it won’t cover Exondys 51, a drug manufactured by Sarepta Therapeutics to treat the genetic disorder, which affects about one out of every 3,600 male infants. The treatment was approved by the Food and Drug Administration last month under an accelerated approval pathway, but Sarepta must complete a clinical trial to confirm the drug’s benefits.
Anthem said it would await those results, and others, to re-evaluate whether it would cover the treatment. There currently isn’t enough scientific evidence available to show the drug would be effective, the company said.
“In reviewing new drug treatments, technologies and devices, we rely on scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community,” Anthem said in a statement Friday. “In reviewing the medical literature, Anthem’s Medical Policy & Technology Assessment Committee, a majority of whom are external physicians, determined that Exondys 51 failed to show it improves health outcomes, and therefore it is not a covered benefit for our members.”