Viltepso® (viltolarsen)

Viltepso is FDA‑approved for Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation amenable to exon 53 skipping, but this policy does not recommend approval because clinical benefit has not been established. Coverage would require documentation of the confirmed exon‑53‑skippable mutation, meeting the policy’s specific coverage and safety criteria, and recognition that continued approval may depend on confirmatory trial verification.

"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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