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Emflaza™

Drug  - Emflaza™ (deflazacort) [Marathon]

October 2017

Therapeutic area - Duchene Muscular Distrophy (DMD)

Initial approval criteria

  • Patient must be 5 years of age or older AND
  • Must be prescribed by a provider specializing in neurology AND
  • Prescriber’s specialty must be provided at time of request AND
  • Patient must have documentation of a confirmed diagnosis of Duchenne muscular dystrophy (DMD) AND
  • Patient retains meaningful voluntary motor function (e.g., patient is able to speak, manipulate objects using upper extremities, ambulate, etc.) AND
  • Patient should be receiving physical therapy AND
  • Patient has tried and failed prednisone, having experienced 1 of the following unacceptable adverse reactions directly attributable to previous therapy with prednisone:
    • Patient has manifested significant behavioral changes negatively impacting function at school, day care, etc. OR
    • Patient has experienced significant weight gain (e.g., crossing 2 percentiles and/or reaching 98th percentile for age and sex)

Renewal criteria

  • Patient retains meaningful voluntary motor function (e.g., patient is able to speak, manipulate objects using upper extremities, ambulate, etc.) AND
  • Patient continues to receive physical therapy AND
  • Patient has received benefit from therapy, which may include 1 or more of the following:
    • Stability or slowing of decline in motor function
    • Stability or slowing of decline in respiratory function
    • Stability or slowing of decline in sequelae related to diminished strength of stabilizing musculature (e.g., scoliosis, etc.)

Quantity limits

  • Dosing is based on 0.9 mg/kg/day
  • Patient’s most up to date weight (in kg) must be submitted at time of request
  • If tablets are requested, round up to the nearest possible dose.
  • If oral suspension is requested, round up to the nearest tenth of a milliliter (mL)

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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