This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Benralizumab (Fasenra) may be considered medically necessary as an add-on maintenance treatment for individuals with severe asthma 12 years of age and older with an eosinophilic phenotype when the following criteria are met:

• The individual meets ALL of the following:
  • A history of 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 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 6 weeks 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.

Mepolizumab (Nucala) may be considered medically necessary as an add-on maintenance treatment for individuals with severe asthma aged 12 years and older with an eosinophilic phenotype when the following criteria are met:

• The individual meets ONE of the following:
  • A history of two (2) or more exacerbations in the previous year despite at least twelve (12) months of high-dose ICS given in combination with at least three (3) months of controller medication (either a LABA, or LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to all of these agents; or
  • Symptoms are inadequately controlled with use of six (6) months of ICS with daily oral glucocorticoids given in combination with a minimum of three (3) months of controller medication (either a LABA, or LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; and
• The individual has ONE of the following blood eosinophil counts (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.

• Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair).

Continuation of therapy with mepolizumab (Nucala) 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 mepolizumab (Nucala) 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; or
  • Patient is not receiving mepolizumab in combination with omalizumab or reslizumab; and

•  Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair).

Mepolizumab (Nucala) may be considered medically necessary for the treatment of individuals 18 years of age or older with eosinophilic granulomatosis with polyangiitis (EGPA) and if ALL of the following are met:

• Documented history of relapsing disease; and
• Individual is on a stable dosage of oral prednisolone or prednisone for four (4) weeks; and
• Individual will be receiving standard of care while on therapy (glucocorticoid treatment (prednisone or prednisolone), with or without immunosuppressive therapy (cyclosporine, leflunomide, azathioprine etc.)

Mepolizumab (Nucala) is considered experimental/investigational for any other indication not listed above. Scientific evidence does not support its use for any other indications.

Reslizumab (Cinqair) may be considered medically necessary as an add-on maintenance treatment for a period of up to twelve (12) months for individuals with severe eosinophilic asthma when ALL of the following criteria are met:

• Individual is 18 years of age or older; and
• Is currently being treated with high-dose ICS (with or without oral corticosteroids) plus an additional controller (e.g., LABA, LTRA, or theophylline) medication, unless contraindicated; and 
• Has a history of 2 or more exacerbations requiring systemic glucocorticoids while being treated with fluticasone propionate at doses of 880 μg or more or its equivalent in the last year; and
• Has eosinophilic phenotype (blood eosinophils of 400 cells/μL or higher within four (4) weeks of initiation of therapy); and
• Individual is not receiving Reslizumab (Cinqair) in combination with benralizumab (Fasenra), omalizumab (Xolair) or mepolizumab (Nucala).

Continuation of therapy with Reslizumab (Cinqair) 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 Reslizumab (Cinqair) 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 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 Reslizumab (Cinqair) in combination with benralizumab (Fasenra), omalizumab (Xolair) or mepolizumab (Nucala).  

Reslizumab (Cinqair) for the treatment of any other indication not listed above is considered experimental/investigational; there is a lack of scientific documentation supporting its use for any other indication.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Benralizumab (Fasenra), Mepolizumab (Nucala) or Reslizumab (Cinqair) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

01/2017, Criteria Established for Reslizumab (CINQAIR®)
05/2018, Updated Coverage Guidelines for Monoclonal Antibodies for the Treatment of Eosinophilic Conditions

• Link to Diagnosis Codes

• Link to References