Viltolarsen (Viltepso®)

Viltepso (viltolarsen) is FDA‑approved only for DMD 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. If considered, coverage would be limited to patients with documented exon‑53‑amenable mutations and clinical DMD diagnosis with submission of genetic test results and compliance with the referenced specific coverage guidelines 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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