Vyondys 53 (golodirsen)

Vyondys 53 (golodirsen) is indicated for Duchenne muscular dystrophy patients with a confirmed DMD mutation amenable to exon 53 skipping, but EviCore does not recommend approval because clinical benefit has not been established. Approval requests must include documentation of the DMD diagnosis, genetic test confirming an exon 53‑amenable mutation, and meet specific coverage and safety criteria, with FDA continued approval contingent on confirmatory trials.

"When requesting Vyondys 53 (golodirsen), the individual requiring treatment must be diagnosed with FDA-approved indication and meet the specific coverage guidelines and applicable safety criteria f..."

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