Emflaza (deflazacort) — Blue Cross Blue Shield of New Mexico

Preferred products

• generic prednisone
• prednisolone
• deflazacort (generic)

Initial criteria

• 1. Diagnosis criteria: ONE of the following: A. Patient has Duchenne Muscular Dystrophy confirmed by genetic analysis [genetic test required] OR B. Patient has another FDA labeled indication for the requested agent and route of administration
• 2. Age requirement: ONE of the following: A. Patient’s age is within FDA labeling for requested indication and agent OR B. There is support for use of requested agent for patient’s age for the requested indication
• 3. Treatment/plan requirement: ONE of the following: A. The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non‑ERISA ASO/Self‑insured Municipalities/Counties member OR B. Patient is currently being treated with and stable on requested agent [chart notes required] OR C. Patient has tried and had an inadequate response after 6 months of therapy with generic prednisone (or prednisolone) [chart notes required] OR D. Generic prednisone (or prednisolone) was discontinued due to lack of efficacy or adverse event [chart notes required] OR E. Patient has an intolerance or hypersensitivity to generic prednisone (or prednisolone) [chart notes required] OR F. Patient has an FDA labeled contraindication to generic prednisone (or prednisolone) [chart notes required] OR G. Generic prednisone (or prednisolone) is expected to be ineffective or inappropriate for patient due to known characteristics or would cause adherence barrier, worsen comorbidity, reduce functional ability, or cause harm [chart notes required] OR H. Generic prednisone (or prednisolone) is NOT in best medical interest [chart notes required] OR I. Patient tried another drug in same class/mechanism as prednisone (or prednisolone) and discontinued due to lack of efficacy or adverse event [chart notes required]
• 4. If request is for brand Emflaza (deflazacort) with available generic equivalent, ONE of the following: A. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non‑ERISA ASO/Self‑insured Municipalities/Counties member OR B. Patient is stable on requested brand [chart notes required] OR C. Patient had inadequate response to generic equivalent [chart notes required] OR D. Generic equivalent discontinued due to inefficacy or adverse event [chart notes required] OR E. Patient has intolerance or hypersensitivity to generic not expected with brand [chart notes required] OR F. Patient has FDA labeled contraindication to generic not expected to occur with brand [chart notes required] OR G. Generic expected to be ineffective or cause barrier/adverse reaction/functional harm [chart notes required] OR H. Generic not in best interest of patient [chart notes required] OR I. Patient tried another drug in same class/mechanism as generic and discontinued due to inefficacy/adverse event [chart notes required] OR J. There is support for use of brand over generic
• 5. Prescriber requirement: Prescriber is a specialist in the area of the patient’s diagnosis (e.g., pediatric neurologist) or has consulted with a specialist
• 6. Patient does NOT have any FDA labeled contraindications to requested agent
• 7. Requested quantity (dose) does NOT exceed maximum FDA labeled dose based on patient weight
• 8. For Ohio members: member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND patient meets one of the following: A. Patient has another FDA labeled indication for requested agent and route of administration OR B. Patient has compendia-supported indication OR C. Prescriber provides TWO peer‑reviewed journal articles supporting efficacy/safety per accepted criteria

Reauthorization criteria

• 1. Patient has been previously approved for requested agent through plan’s Prior Authorization process
• 2. Patient has had improvements or stabilization (e.g., improved strength, timed motor or pulmonary function, reduced need for scoliosis surgery)
• 3. If request is for brand Emflaza (deflazacort) with available generic equivalent, ONE of the following applies (same as initial criteria for brand/generic substitution: stable on brand, inadequate response to generic, intolerance, etc.)

Approval duration

Agamree: 6 months (all other plans), BCBSOK: 36 months; Emflaza: 12 months (BCBSIL/BCBSMT 12 months, BCBSOK 36 months)