Initial Evaluation
Prolastin-C will be approved when ALL of the following are met:
- The patient has a diagnosis of alpha-1 antitrypsin deficiency (AATD) with clinically evident emphysema AND
- The patient has a pre-treatment serum alpha-1 antitrypsin (AAT) level less than 11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL using nephelometry) AND
- The patient does NOT have any FDA labeled contraindications to the requested medication AND
- The requested dose is within FDA labeled dosing for the requested indication
Length of Approval: 12 months
Renewal Evaluation
Prolastin-C will be approved when ALL of the following are met:
- The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria AND
- The patient has a diagnosis of alpha-1 antitrypsin deficiency (AATD) with clinically evident emphysema AND
- The patient has had clinical benefit with the requested medication AND
- The patient does NOT have any FDA labeled contraindications to the requested medication AND
- The requested dose is within FDA labeled dosing for the requested indication
Length of Approval: 12 months
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