Carbaglu (carglumic acid) — Highmark

Preferred products

• Generic carglumic acid

Initial criteria

• The member is using Carbaglu as adjunctive therapy to standard of care for acute hyperammonemia (ICD-10: E72.20) due to hepatic enzyme N-acetylglutamate synthase (NAGS) deficiency
• The member is using Carbaglu as maintenance therapy for chronic hyperammonemia due to hepatic enzyme NAGS deficiency
• The member is using Carbaglu as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)
• If the request is for brand Carbaglu, the member has experienced therapeutic failure or intolerance to generic carglumic acid

Reauthorization criteria

• The prescriber attests that the member has experienced positive clinical response to therapy (e.g., reduction in blood ammonia levels)
• If Carbaglu is being used for the treatment of acute hyperammonemia due to NAGS deficiency or treatment of acute hyperammonemia due to PA or MMA, the member is continuing use of requested drug with standard of care (e.g., dietary protein restriction and/or amino acid supplementation)

Approval duration

12 months