Mepolizumab (Nucala) vial may be considered medically necessary when the following criteria are met:
Eosinophilic Asthma
- The individual must meet label recommendations for indication and age; and
- Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
- The individual must have had at least one exacerbation despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
- The individual has eosinophilic phenotype with eosinophil count ≥ 150 cells/mcL within the past 90 days; and
- The individual must have had a 3-month trial of one (1) preferred Eosinophilic Asthma agent (Fasenra, Dupixent or Xolair), as evidenced by paid claims or pharmacy printouts; and
- The individual will only be on one strength of mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Initial Authorization: 3 months
Reauthorization Criteria
Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:
- The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma exacerbations and utilization of rescue medications since treatment initiation; and
- The individual will only be on one strength mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Continuation Authorization: 12 months
Eosinophilic granulomatosis with polyangiitis (EGPA)
- The individual must be 18 years of age or older; and
- The prescription must be written by, or in consultation with, a hematologist, pulmonologist, or allergy/immunology specialist; and
- The individual must have a diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) characterized by:
- The individual has asthma poorly controlled on moderate doses of inhaled glucocorticoids; and
- The individual has a greater than blood eosinophilia > 1000 cells/mcL or 10% eosinophils on the differential leukocyte count, as evidenced by laboratory documentation attached to the request; and
- Two of more of the following:
- Mononeuropathy (including multiplex) or polyneuropathy; or
- Pulmonary infiltrates; or
- Paranasal sinus abnormality; or
- Eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation; or
- Glomerulonephritis; or
- Alveolar hemorrhage; or
- Palpable purpura; or
- Myocardial infarction due to coronaritis; or
- Anti-neutrophil cytoplasmic antibody (ANCA) positivity; and
- The individual must have had relapsing or recurring disease requiring systemic corticosteroids in previous year despite a 3-month trial with good compliance of one (1) of the following medication, as evidenced by paid claims or pharmacy printouts:
- Cyclophosphamide; or
- Azathioprine; or
- Methotrexate; or
- Leflunomide; and
- The individual will only be on one strength of mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Initial Authorization: 6 months
Reauthorization Criteria
Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:
- The individual must have experienced and maintained clinical benefit since starting treatment with mepolizumab (Nucala), as evidenced by medical documentation (e.g. chart notes) attached to the request (subject to clinical review); and
- The individual will only be on one strength mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Continuation Authorization: 12 months
Hypereosinophilic Syndrome
- The individual must be 12 years of age or older; and
- The prescription must be written by, or in consultation with, a hematologist, or allergy/immunology specialist; and
- The individual must have a diagnosis of hypereosinophilic syndrome (HES) characterized by the following:
- The individual must have experienced hypereosinophilic syndrome for ≥6 months; and
- The provider must attest that there is no identifiable nonhematologic secondary cause; and
- The individual must have experienced at least 2 HES flares within the past 12 months despite continued compliant use of oral corticosteroids and/or steroid sparing therapy (e.g. hydroxyurea); and
- The individual must have a blood eosinophil count of 1,000 cells/mcL or higher, as evidenced by laboratory documentation attached to the request; and
- The individual will only be on one strength of mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Initial Authorization: 6 months
Reauthorization Criteria
Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:
- The individual must have experienced and maintained clinical benefit since starting treatment with mepolizumab (Nucala), as evidenced by medical documentation (e.g. chart notes) attached to the request (subject to clinical review); and
- The individual will only be on one strength mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Continuation Authorization: 12 months
Nasal Polyps
- The individual must meet label recommendations for indication and age; and
- Must be prescribed by, or in consult with, an ear/nose/throat specialist or allergist/immunologist; and
- The individual must have had a 12-week trial of intranasal or oral corticosteroid; and
- The individual must have bilateral polyps confirmed by sinus CT, sinus MRI, or nasal endoscopy; and
- The individual must have documentation of at least two (2) of the following symptoms:
- Nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); or
- Facial pain/pressure; or
- Reduction or loss of smell; and
- The individual must have had a 90-day trial with a preferred agent (Dupixent or Xolair), as evidenced by paid claims or pharmacy printouts; and
- The individual will only be on one strength of mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Initial Authorization: 3 months
Reauthorization Criteria
Continuation of therapy with mepolizumab (Nucala) vial may be considered medically necessary when ALL of the following are met:
- The prescriber must provide documentation showing that the individual has achieved a significant reduction in nasal
polyp size and symptoms since treatment initiation; and
- The individual must be receiving intranasal steroids; and
- The individual will only be on one strength of mepolizumab (Nucala) at a time; and
- The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].
Continuation Authorization: 12 months
Mepolizumab (Nucala) 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.
Procedure Codes