Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
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:
- Moderate airflow obstruction is evidenced by forced expiratory volume (FEV1) of 30-65% 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); and
- The individual is likely to be compliant with the prescribed protocol.
** PiZZ, PiZ, or Pi phenotype (homozygous) or other phenotypes, (PiSZ or PiMS) when associated with serum AAT concentrations of less than 80 mg/dL.
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.