Viltolarsen (Viltepso®)

Viltepso (viltolarsen) is FDA‑approved under accelerated approval for Duchenne muscular dystrophy with a confirmed DMD gene mutation amenable to exon 53 skipping but eviCore does not recommend approval because clinical benefit has not been established and continued approval is contingent on verification in confirmatory trials. Coverage requires documentation of the DMD diagnosis, genetic confirmation of an exon‑53‑amenable mutation, and adherence to the policy’s specified coverage and safety criteria.

"Viltepso is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping."

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