Duvyzat (givinostat) oral suspension — United Healthcare

Duchenne muscular dystrophy (DMD)

Initial criteria

Diagnosis of Duchenne muscular dystrophy (DMD)
Diagnosis confirmed by the presence of a mutation in the DMD gene
age ≥ 6 years
Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
Patient has been or will be established on a stable corticosteroid regimen
Prescribed by, or in consultation with, a pediatric neuromuscular specialist with expertise in the treatment of DMD
Patient has not received gene therapy for DMD [e.g., Elevidys (delandistrogene moxparvovec-rokl)]
Patient will not receive Duvyzat in combination with exon-skipping therapies for DMD [e.g., Amondys (casimersen), Exondys 51 (eteplirsen), Viltepso (viltolarsen), Vyondys 53 (golodirsen)]

Physician attestation that patient would benefit from continued administration
Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
Patient continues to receive concomitant corticosteroid regimen
Prescribed by, or in consultation with, a pediatric neuromuscular specialist with expertise in the treatment of DMD
Patient has not received gene therapy for DMD [e.g., Elevidys (delandistrogene moxparvovec-rokl)]
Patient will not receive Duvyzat in combination with exon-skipping therapies for DMD [e.g., Amondys (casimersen), Exondys 51 (eteplirsen), Viltepso (viltolarsen), Vyondys 53 (golodirsen)]

12 months