Emflaza™

Drug  - Emflaza™ (deflazacort) [Marathon]

June 2022

Therapeutic area - Duchene Muscular Distrophy (DMD)

Initial approval criteria

• Patient must be at least 2 years of age or must meet the age limit in the FDA-approved label 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 (for example, patient is able to speak, manipulate objects using upper extremities, ambulate, and so forth) AND
• Prescriber attests that multidisciplinary rehabilitation assessments are conducted every 6-12 months AND
• Patient has tried and failed prednisone, having experienced one 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 (for example, crossing two  percentiles reaching 98th percentile for age and sex, or both)

Renewal criteria

• Patient retains meaningful voluntary motor function (for example, patient is able to speak, manipulate objects using upper extremities, ambulate, and so forth) AND
• Prescriber attests that multidisciplinary rehabilitation assessments are conducted every 6-12 months AND
• Patient has received benefit from therapy, which may include one 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 (for example, scoliosis, etc.)

Quantity limits

• Daily quantity limit must not exceed those established in the FDA-approved label.
• Dosing frequency must reflect those established in the FDA-approved label.
• Patient’s most up-to-date weight (in kilograms [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?

Contact the MHCP Provider Resource Center at 651-431-2700 or 800-366-5411 with any questions.