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Emflaza (deflazacort) — Highmark

Duchenne muscular dystrophy (DMD)

Preferred products

  • plan‑preferred prednisone
  • generic deflazacort tablets
  • generic deflazacort suspension

Initial criteria

  • age ≥ 2 years if request is for brand Emflaza
  • age ≥ 5 years if request is for generic deflazacort
  • confirmed diagnosis of Duchenne muscular dystrophy (ICD-10: G71.01) with documented mutation of the dystrophin gene
  • prescribed by or in consultation with a physician who specializes in treating neuromuscular disorders (e.g., neurologist)
  • onset of weakness prior to age 5 or documented history of the disease starting before age 5
  • member meets one of the following: (1) intolerable adverse events from trial of plan‑preferred prednisone for a duration of at least 6 months defined by ≥1 of: diabetes or hypertension difficult to manage; Cushingoid appearance; central (truncal) obesity; undesirable ≥10% weight increase over 6 months OR (2) severe behavioral adverse event while on plan‑preferred prednisone therapy warranting dose reduction impacting efficacy, defined by ≥1 of: abnormal behavior; aggression; irritability; disturbance in mood
  • if age ≥ 5 years and request is for brand Emflaza tablets: experienced therapeutic failure or intolerance to generic deflazacort tablets
  • if age ≥ 5 years and request is for brand Emflaza suspension: experienced therapeutic failure or intolerance to both plan‑preferred generic deflazacort tablets and generic deflazacort suspension
  • if age ≥ 5 years and request is for generic deflazacort suspension: experienced therapeutic failure or intolerance to generic deflazacort tablets

Reauthorization criteria

  • prescriber attests to positive clinical response to therapy
  • if age ≥ 5 years and request is for brand Emflaza tablets: experienced therapeutic failure or intolerance to generic deflazacort tablets
  • if age ≥ 5 years and request is for brand Emflaza suspension: experienced therapeutic failure or intolerance to both plan‑preferred generic deflazacort tablets and generic deflazacort suspension
  • if age ≥ 5 years and request is for generic deflazacort suspension: experienced therapeutic failure or intolerance to generic deflazacort tablets

Approval duration

12 months