Aralast™ NP, Glassia™, Prolastin-C® , and Zemaira® (alpha1- proteinase inhibitor [human])

Covered: intravenous alpha1‑proteinase inhibitor products (Aralast NP, Glassia, Prolastin‑C, Zemaira) for adults with clinically evident emphysema from severe hereditary AAT deficiency (FDA‑approved) and for AAT‑deficiency panniculitis (compendial); other non‑FDA/non‑compendial uses are excluded. Key requirements: age ≥18, pretreatment AAT <11 μmol/L (or <80 mg/dL by radial immunodiffusion or <57 mg/dL by nephelometry), nonsmoker status for emphysema, documented diagnosis and labs, approval limited to 12 months with recommended dosing 60 mg/kg IV weekly.

"Chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of alpha1-antitrypsin (AAT) (FDA‑approved indication)."

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