Duvyzat (givinostat oral suspension – ITF Therapeutics) — Cigna
Duchenne muscular dystrophy (DMD)
Initial criteria
- Patient is age ≥ 6 years; AND
- Patient’s diagnosis of Duchenne Muscular Dystrophy is confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene [documentation required]; AND
- Patient is ambulatory; AND
- Patient is on a stable systemic corticosteroid therapy for at least 6 months; AND
- Medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders
Reauthorization criteria
- Patient is age ≥ 6 years; AND
- Patient is ambulatory; AND
- Patient is continuing to receive stable systemic corticosteroid therapy; AND
- 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; AND
- Medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders
Approval duration
1 year