Severe Asthma
Mepolizumab (Nucala) may be considered medically necessary when the following criteria are met:
- Individual aged six (6) years or older; and
- Individual diagnosed with severe asthma with an eosinophilic phenotype; and
- Mepolizumab (Nucala) will be used as an add-on maintenance treatment; and
- Individual is currently being treated with high dose ICS plus at least three (3) months of treatment with a controller medication (either a LABA, LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to all of these agents; and
- Asthma is classified as uncontrolled or inadequately controlled as defined as ONE of the following:
- Poor symptom control (e.g., ACQ score consistently greater than 1.5 or ACT consistently less than 20); or
- A history of two (2) or more exacerbations in the last 12 months requiring oral or systemic corticosteroid treatment; or
- 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 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; and
- Initial authorization will be for no longer than 12 months; and
- Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair).
Reauthorization Criteria
Continuation of therapy with mepolizumab (Nucala) 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; 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
- Reauthorization will be for 12 months; and
- Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair).
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Mepolizumab (Nucala) may be considered medically necessary when the following criteria are met:
- Individual 18 years of age or older; and
- Individual diagnosed with eosinophilic granulomatosis with polyangiitis (EGPA); and
- 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.); and
- Initial authorization will be for a 12 month period.
Reauthorization Criteria
Continuation of therapy with mepolizumab (Nucala) may be considered medically necessary for the treatment of an individual with documented EGPA when the following criteria are met:
- Treatment with mepolizumab (Nucala) resulted in an improvement of individuals condition; and
- Reauthorization will be for 12 months.
Hypereosinophilic Syndrome (HES)
Mepolizumab (Nucala) may be considered medically necessary when ALL of the following criteria are met:
- Individual 12 years of age or older; and
- Individual diagnosed with HES for greater than or equal to six (6) months; and
- There is no identifiable non-hematologic secondary cause of HES (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy); and
- Individual does not have FIP1L1-PDGFRα kinase-positive HES; and
- Individual has experienced at least two (2) HES flares (defined as HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy) within the past 12 months; and
- Individual has a blood eosinophil count of 1,000 cells/mcL or higher prior to starting mepolizumab (Nucala); and
- Individual is on stable HES therapy (chronic or episodic oral corticosteroids, immunosuppressive, or cytotoxic therapy) for at least four (4) weeks prior to initiation of mepolizumab (Nucala); and
- Initial authorization will be for a 12 month period.
Reauthorization Criteria for HES
Continuation of therapy with mepolizumab (Nucala) may be considered medically necessary for the treatment of an individual with documented HES when the following criteria are met:
- Treatment with mepolizumab (Nucala) resulted in a decrease in HES flares; and
- Reauthorization will be for 12 months.
Mepolizumab (Nucala) is considered experimental/investigational for any other indication not listed above. Scientific evidence does not support its use for any other indications.
Procedure Codes