Casimersen Intravenous Infusion (Amondys 45®)

Amondys 45 (casimersen) is FDA‑approved under accelerated approval for Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation amenable to exon 45 skipping, but this policy does not recommend approval because clinical benefit has not been established and continued approval is contingent on confirmatory trials. Coverage is limited to patients with documented genetic test results showing an exon‑45‑amenable mutation and to requests that meet the plan’s specific coverage guidelines and applicable safety criteria; patients without such a confirmed mutation are not indicated.

"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."

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