Emflaza — Medical Mutual

Initial criteria

• Patient is age ≥ 2 years; AND
• Diagnosis of Duchenne Muscular Dystrophy is confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene OR muscle biopsy showing absence or marked decrease in dystrophin protein [documentation required]; AND
• Patient meets ONE of the following conditions: (a) Patient has tried prednisone or prednisolone for ≥ 6 months [documentation required] AND has had at least one of the following intolerable adverse effects: Cushingoid appearance, central obesity, undesirable weight gain defined as > 10% increase over a 6‑month period, diabetes and/or hypertension difficult to manage; OR (b) Patient has experienced a severe behavioral adverse effect on prednisone or prednisolone that has or would require dose reduction [documentation required]; AND
• Medication is prescribed by or in consultation with a physician who specializes in Duchenne Muscular Dystrophy and/or neuromuscular disorders; AND
• If brand Emflaza is prescribed, patient has tried generic deflazacort tablets [documentation required] AND cannot take deflazacort tablets due to a formulation difference in inactive ingredient(s) that would result in significant allergy or serious adverse reaction [documentation required]

Reauthorization criteria

• Patient is age ≥ 2 years; AND
• Patient has tried prednisone or prednisolone [documentation required]; AND
• According to the prescriber, patient has responded to or continues to receive improvement or benefit from Emflaza therapy (e.g., improvements in motor function, muscle strength, pulmonary function) [documentation required]; AND
• Medication is prescribed by or in consultation with a physician who specializes in Duchenne Muscular Dystrophy and/or neuromuscular disorders; AND
• If brand Emflaza is prescribed, patient has tried generic deflazacort tablets [documentation required] AND cannot take deflazacort tablets due to a formulation difference in inactive ingredient(s) that would result in significant allergy or serious adverse reaction [documentation required]

Approval duration

1 year initial, 1 year reauth