Elevidys (delandistrogene moxeparvovec-rokl)

Elevidys is not recommended for coverage/approval by this policy because clinical benefit has not been established despite FDA accelerated approval for ambulatory pediatric patients aged 4–5 years with a confirmed DMD gene mutation. If authorization is considered, required documentation includes DMD diagnosis, genetic confirmation of a pathogenic DMD mutation, proof the patient is 4–5 years old and ambulatory, and compliance with specified safety and coverage criteria (not detailed here).

"Implied age restriction: only patients aged 4 through 5 years are within the FDA-approved indication."

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