Viltepso® (viltolarsen)

EviCore does not recommend approval/coverage of Viltepso (viltolarsen) despite its FDA accelerated approval for DMD patients with confirmed DMD gene mutations amenable to exon 53 skipping, because clinical benefit has not been established. Coverage would require documented confirmation of an exon 53–amenable DMD mutation and adherence to the policy’s referenced coverage and safety criteria, and continued FDA approval is contingent on confirmatory trial verification of clinical benefit.

"Viltepso (viltolarsen) 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. (FDA-appro..."

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