Elevidys™ (Delandistrogene Moxparvovec-Rokl) – Commercial Medical Benefit Drug Policyopen_in_new

Covered only for ambulatory Duchenne muscular dystrophy patients aged 4–5 with a confirmed DMD mutation that is NOT a deletion in exon 8 or 9; excluded for Becker MD, non‑ambulatory patients, ambulatory patients <4 or ≥6 years, patients with exon 8/9 deletions, anti‑AAVrh74 titer ≥1:400, preexisting hepatic impairment or elevated GGT, LVEF <40%, prior gene therapy, or concomitant/subsequent exon‑skipping therapy. Key requirements include one lifetime treatment per FDA labeling prescribed by/with a pediatric neuromuscular specialist, documentation of age/ambulatory status/genetics/antibody titer/liver tests and LVEF, corticosteroid regimen per label, weekly liver monitoring for 3 months and weekly troponin‑I for 1 month post‑dose, and authorization limited to one treatment and no longer than 45 days from approval or until age 6, whichever is first.

"Patient must be ambulatory without an assistive device (use in patients requiring assistive devices is excluded)"