Amondys 45® (casimersen intravenous infusion)

Amondys 45 (casimersen) is not recommended for approval/coverage by this policy due to insufficient clinical efficacy data despite FDA accelerated approval for DMD with a DMD gene mutation amenable to exon 45 skipping. The only required documentation for requests is a confirmed DMD diagnosis with an exon-45-amenable mutation; no other coverage, safety, or efficacy criteria are specified.

"The prescribing information for Amondys 45 states that a clinical benefit has not been established."

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