Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Alpha-1 proteinase inhibitors (Aralast NP, Glassia, Prolastin-C, or Zemaira) administered intravenously may be considered medically necessary in individuals 18 years of age and older when ALL the following criteria are met:
- Individual diagnosed with emphysema due to alpha-1 antitrypsin deficiency; and
- There is a documented high risk phenotype** resulting in a low serum concentration of alpha-1 antitrypsin (AAT), as evidenced by less than 80 mg per deciliter (mg/dL) (0.8 g/L) by radial immunodiffusion (or less than 50 mg/dL (0.5 g/L) if measured by nephelometry) or less than 11 µM/L (35 % of normal); and
- ONE of the following is present:
- Presence of airflow obstruction is evidenced by forced expiratory volume (FEV1) less than or equal to 80% of predicted value, prior to initiation of therapy; or
- Individual has a rapid decline in lung function as measured by a change in FEV1 greater than 120 ml/year; and
- The individual is a non-smoker or is a smoker undergoing active smoking cessation therapy; and
- Must be on standard therapy for chronic obstructive pulmonary disease (COPD) (i.e., inhaled bronchodilators, inhaled steroids) as defined by current clinical guidelines (i.e., the Global Initiative COPD- GOLD guidelines); or
- The individual has necrotizing panniculitis.
** PiZZ, PiZ, or Pi phenotype (homozygous) or other phenotypes, (PiSZ or PiMS) when associated with serum AAT concentrations of less than 80 mg/dL.
Reauthorization Criteria
- Continuation of therapy for AAT inhibitor therapy with Aralast NP, Glassia, Prolastin-C, or Zemaira may be considered medically necessary when ALL the following criteria are met:
- Individual is currently receiving AAT inhibitor therapy; and
- Provider attestation of positive clinical response.
AAT inhibitor therapy (i.e., Aralast NP, Glassia, Prolastin-C, or Zemaira) is considered experimental/investigational and therefore non-covered for any other indication. The safety and/or effectiveness of the treatment cannot be established by review of the available published peer-reviewed literature.
Procedure Codes
