Carbaglu (carglumic acid) — Medica

Initial criteria

• Diagnosis is supported by ONE of the following (A or B):
• A) Genetic testing confirmed a mutation leading to N-acetylglutamate synthase deficiency; OR
• B) The patient has hyperammonemia diagnosed with an ammonia level above the upper limit of the normal reference range for the reporting laboratory
• The medication is prescribed in conjunction with a protein-restricted diet
• The medication is prescribed by or in consultation with a metabolic disease specialist (or specialist who focuses in the treatment of metabolic diseases)

Approval duration

1 year if confirmed by genetic testing; 3 months if based on ammonia level only