Criteria
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.
Benralizumab (Fasenra) may be considered medically necessary as an add-on maintenance treatment when the following criteria are met:
- Individual is 12 years of age or older; and
- Individual diagnosed with severe asthma with an eosinophilic phenotype; and
- A documented history of two (2) or more exacerbations (requiring oral or systemic corticosteroid treatment) in the previous year despite regular treatment with medium or high dose ICS plus a long-acting beta agonist (LABA) with or without oral corticosteroids and additional asthma controller medications; and
- A documented reduced lung function [pre-bronchodilator forced expiratory volume (FEV1) below 80% in adults, and below 90% in adolescents]; and
- The individual has ONE of the following blood eosinophil count (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection):
- Greater than or equal to 150 cells/microliter within six (6) weeks of initiation of therapy; or
- Greater than or equal to 300 cells/microliter within twelve (12) months of initiation of therapy; and
- Individual is not receiving benralizumab (Fasenra) in combination with mepolizumab (Nucala), omalizumab (Xolair) or reslizumab (Cinqair).
Continuation of therapy with benralizumab (Fasenra) after twelve (12) months may be considered medically necessary for the treatment of an individual with documented severe eosinophilic asthma when the following criteria are met:
- Treatment with benralizumab (Fasenra) has resulted in clinical improvement as documented by ONE or more of the following:
- Decreased utilization of rescue medications; or
- Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in ICS dose or treatment with systemic corticosteroids); or
- Increase in predicted forced expiratory volume in one second (FEV1) from pretreatment baseline; or
- Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing; and
- Individual is not receiving benralizumab (Fasenra) in combination with mepolizumab (Nucala), omalizumab (Xolair) or reslizumab (Cinqair).
Benralizumab (Fasenra) is considered experimental/investigational for any other indication not listed above. Scientific evidence does not support its use for any other indications.
Procedure Codes