vamorolone — CareFirst (Caremark)

Initial criteria

• Diagnosis of Duchenne muscular dystrophy confirmed by either genetic testing documenting a mutation in the DMD gene OR muscle biopsy documenting absent dystrophin
• Member age ≥ 2 years
• Member meets one of the following criteria:
• — Experienced unmanageable and/or clinically significant weight gain/obesity as evidenced by body mass index in the overweight or obese category while receiving treatment with prednisone or prednisolone
• — Experienced unmanageable and/or clinically significant psychiatric/behavioral issues (e.g., abnormal behavior, aggression, irritability) with prednisone or prednisolone
• — Experienced clinically significant growth stunting while receiving treatment with prednisone, prednisolone, or deflazacort as evidenced by any of the following: decline in mean height percentile for age from baseline; decrease in growth trajectory and/or growth velocity; reduction in serum biomarkers of bone formation and/or bone turnover

Reauthorization criteria

• Member meets all requirements in the coverage criteria section
• Member is receiving a clinical benefit from therapy with the requested medication (e.g., improvement or stabilization in muscle strength and/or motor function)

Approval duration

Initial: 6 months; Continuation: 12 months