Amondys 45® (casimersen)

Evicore does not recommend approval/coverage of Amondys 45 (casimersen) — FDA‑approved under accelerated approval for DMD patients with a DMD gene mutation amenable to exon 45 skipping — because clinical benefit has not been established. Continued FDA approval is contingent on verification of clinical benefit in confirmatory trials.

"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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