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Nucala (mepolizumab) — Blue Cross Blue Shield of New Mexico

hypereosinophilic syndrome (HES)

Initial criteria

  • For continuation of therapy: prescriber states patient has been treated with the requested agent within the past 90 days (starting on samples not approvable) and is at risk if therapy is changed.
  • OR For new starts: ONE of the following diagnoses must apply:
  • A. Severe eosinophilic asthma AND BOTH of the following:
  • 1. Diagnosis confirmed by ONE of:
  • - Baseline blood eosinophil count ≥150 cells/microliter while on high-dose inhaled corticosteroids or daily oral corticosteroids OR
  • - Fraction of exhaled nitric oxide (FeNO) ≥20 ppb while on high-dose inhaled corticosteroids or daily oral corticosteroids OR
  • - Sputum eosinophils ≥2% while on high-dose inhaled corticosteroids or daily oral corticosteroids
  • 2. History of uncontrolled asthma on control therapy, demonstrated by ONE of:
  • - ≥2 courses of systemic corticosteroids in past 12 months OR
  • - Hospitalization, mechanical ventilation, or ER/urgent care visit for asthma in past 12 months OR
  • - Controlled asthma that worsens when inhaled/systemic corticosteroids are tapered OR
  • - Baseline FEV1 <80% predicted
  • B. Eosinophilic granulomatosis with polyangiitis (EGPA) AND ALL of the following:
  • - Baseline eosinophilia ≥1000 cells/microliter OR ≥10% eosinophils on WBC differential
  • - History or presence of asthma
  • - No severe organ- or life-threatening manifestations (e.g., alveolar hemorrhage, glomerulonephritis, CNS vasculitis, mononeuritis multiplex, cardiac involvement, mesenteric ischemia, limb/digit ischemia)
  • - ONE of: (a) currently on OCS therapy ≥4 weeks in past 90 days and will continue OCS with requested agent OR (b) intolerance/hypersensitivity to OCS OR (c) FDA labeled contraindication to all OCS
  • - Will use agent for ONE of: relapsing or refractory disease OR maintenance of remission
  • C. Hypereosinophilic syndrome (HES) AND ALL of following:
  • - Requested agent FDA labeled or compendia supported for HES
  • - Diagnosis of HES ≥6 months
  • - Diagnosis confirmed by BOTH: (a) ONE of: peripheral blood eosinophil count ≥1000/microliter OR bone marrow eosinophils >20% OR marked deposition of eosinophil granule proteins OR extensive tissue infiltration by eosinophils; AND (b) evaluation of organ involvement related to hypereosinophilia
  • - No identifiable nonhematologic secondary cause (e.g., infection, allergy, drug hypersensitivity, collagen vascular disease, metabolic, or malignancy)
  • - No FIP1L1-PDGFRA-positive disease
  • - ≥2 HES flares within past 12 months requiring therapy escalation
  • - ONE of: (a) inadequate response to OCS, hydroxyurea, interferon-α, or another immunosuppressive agent OR (b) intolerance/hypersensitivity to such therapies OR (c) FDA labeled contraindication to hydroxyurea, interferon-α, all OCS, and immunosuppressive agents (e.g., cyclosporine, methotrexate)
  • D. Chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:
  • - Requested agent FDA labeled or compendia supported for CRSwNP
  • - At least TWO of: nasal discharge, nasal obstruction/congestion, loss/decreased sense of smell, facial pressure/pain
  • - Symptoms for ≥12 consecutive weeks