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