Casimersen Intravenous Infusion (Amondys 45®)

Amondys 45 (casimersen IV) is not recommended for approval due to insufficient clinical efficacy data despite FDA accelerated approval for DMD patients with a confirmed DMD gene mutation amenable to exon 45 skipping and an unestablished clinical benefit. Coverage, if considered, requires documentation of the exon‑45–amenable DMD mutation and that the request meets the policy’s specific coverage guidelines and applicable safety criteria (with continued approval contingent on confirmatory trial results).

"Amondys 45 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 45 skipping. (FDA-approved indicati..."

Sign up to see full coverage criteria, indications, and limitations.