Duvyzat (givinostat oral suspension) — Medica

Duchenne muscular dystrophy

Initial criteria

Patient is age ≥ 6 years
Diagnosis of Duchenne muscular dystrophy is confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene [documentation required]
Patient is ambulatory
Patient is on a stable systemic corticosteroid therapy for at least 6 months
Medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders

Patient is age ≥ 6 years
Patient is ambulatory
Patient is continuing to receive stable systemic corticosteroid therapy
According to the prescriber, the patient continues to benefit from therapy, as demonstrated by a stabilization or slowed decline on timed function tests (e.g., 4-stair climb, 6-minute walk test, time-to-rise) or in the North Star Ambulatory Assessment (NSAA) score
Medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders

1 year