givinostat — CareFirst (Caremark)

Initial criteria

• Member is age ≥ 6 years
• Diagnosis of DMD confirmed by genetic testing documenting a mutation in the DMD gene OR by muscle biopsy documenting absent dystrophin
• Member has clinical signs and symptoms of DMD (e.g., proximal muscle weakness, Gower’s maneuver, elevated serum creatine kinase level)
• Member is ambulant
• Medication will be used in combination with a corticosteroid (e.g., prednisone) unless contraindicated or not tolerated
• Prescribed by or in consultation with a physician who specializes in the treatment of DMD

Reauthorization criteria

• Member has demonstrated a response to therapy as evidenced by remaining ambulatory (e.g., able to walk with or without assistance, not wheelchair dependent)

Approval duration

Initial: 6 months; Reauthorization: 12 months