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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