Mepolizumab (Nucala) vial may be considered medically necessary when the following criteria are met:
Eosinophilic Asthma
- The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
- Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
- If the individual is a current tobacco user, the individual must have received tobacco cessation counseling in the past year; and
- The individual must have had at least one exacerbation requiring use of oral corticosteroids in the past year despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) for at least 3 months prior to the exacerbation, as evidenced by paid claims or pharmacy printouts; and
- The individual has an eosinophil count greater than or equal to 150 cells/mcL within the past year; and
- The individual must have had at least one exacerbation requiring use of oral corticosteroids in the past year despite continued compliant use of a triple therapy regimen (high dose inhaled steroid + long-acting beta agonist (LABA) + long-acting muscarinic antagonist (LAMA)) in combination with each of the following for at least four months, as evidenced by paid claims or pharmacy printouts: Dupixent, Fasenra, and Tezspire; 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, Cinqair, Nucala, Dupixent or Tezspire).
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 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, Cinqair, Nucala, Dupixent or Tezspire).
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
- The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
- Must be prescribed by, or in consult with, a pulmonologist, rheumatologist or allergy/immunology specialist; and
- The individual must not have severe disease defined as vasculitis with life- or organ-threatening manifestations (e.g., alveolar hemorrhage, glomerulonephritis, central nervous system vasculitis, mononeuritis multiplex, cardiac involvement, mesenteric ischemia, limb/digit ischemia); and
- The individual must have received at least 4 weeks of an oral corticosteroid dose greater than or equal to 7.5 mg/day to control relapsing or refractory disease; and
- The individual must have asthmatic manifestations on a combination of high doses of inhaled glucocorticoids and long acting β2-agonist; and
- The individual must have blood eosinophil count of greater than or equal to 1000 cells/mcL and/or greater than or equal to 10 percent of leukocytes within the previous six (6) weeks; and
- The individual must have failed a 3-month trial of Fasenra, 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, Cinqair, Fasenra, Dupixent or Tezspire).
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 a decrease in relapses* and corticosteroid dose, and an increase of time of remission since starting treatment with the requested medication, 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, Cinqair, Fasenra, Dupixent or Tezspire).
*Relapse is defined as active vasculitis, active asthma symptoms, active nasal or sinus disease requiring the use of glucocorticoids or immunosuppressants.
Hypereosinophilic Syndrome (HES)
- The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
- Must be prescribed by, or in consult with, a hematologist, or allergy/immunology specialist; and
- The individual must not be FIP1L1-PDGFRα kinase-positive; and
- The individual must have experienced at least two (2) HES flares within the past 12 months despite a (3)-month trial with each of the following:
- Oral corticosteroids; and
- Steroid sparing therapy (e.g., hydroxyurea); and
- The individual must have a blood eosinophil count of 1,000 cells/mcL or higher; 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, Cinqair, Fasenra, Dupixent or Tezspire).
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 (e.g., reduction in flares, decreased blood eosinophilic count, reduction in corticosteroid dose or steroid sparing therapy) since starting treatment with the requested medication, 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, Cinqair, Fasenra, Dupixent or Tezspire).
*HES flares are defined as worsening of clinical signs and symptoms of HES or increasing eosinophils, resulting in the need to increase OCS or increase/add cytotoxic or immunosuppressive HES therapy.
Chronic Rhinosinusitis with Nasal Polyps
- The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); 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 corticosteroid; and
- The individual must have trialed at least two (2) courses of a 10-day trial of oral glucocorticoids in the past year; and
- The individual must have bilateral polyps confirmed by sinus CT, anterior rhinoscopy, or nasal endoscopy; 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, Cinqair, Fasenra, Dupixent or Tezspire).
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 with mepolizumab (Nucala); 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, Cinqair, Fasenra, Dupixent or Tezspire).
The use of mepolizumab (Nucala) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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