Nucala — Blue Cross Blue Shield of Alabama

Initial criteria

• - ONE of the following:
• • Continuation of therapy: patient has been treated with the requested agent within past 90 days (not including sample use) OR prescriber attests to such treatment and risk if changed.
• - OR new start criteria depending on diagnosis:
• • Severe eosinophilic asthma: baseline blood eosinophil ≥150 cells/microliter, history of uncontrolled asthma on control therapy shown by ≥2 exacerbations per year AND ≥3 days of daily oral corticosteroid use, severe disease per guideline (daytime symptoms, frequent awakenings, FEV1 <60%, etc.), and agent not for acute bronchospasm/status asthmaticus.
• • EGPA: eosinophils >10% or >1000 cells/microliter, confirmed EGPA with asthma history and ≥2 features (histopathologic eosinophilic vasculitis/perivascular infiltration, neuropathy, pulmonary infiltrates, sinonasal abnormalities, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positivity) AND one of: currently or recently on oral corticosteroids ≥4 weeks and will continue OCS with agent OR OCS intolerance/hypersensitivity OR contraindication to all OCS.
• • HES: FDA labeled or supported for HES, diagnosis ≥6 months, eosinophils ≥1000/microliter, no reactive secondary cause, FIP1L1-PDGFRA negative, ≥2 flares in past 12 months requiring therapy escalation, AND one of: prior inadequate response to oral corticosteroid, hydroxyurea, interferon‑α, or another immunosuppressive (cyclosporine, methotrexate) OR intolerance/hypersensitivity OR contraindication to all said agents.
• • CRSwNP: FDA labeled or supported for CRSwNP, ≥2 symptoms (nasal discharge, obstruction, smell loss, pain/pressure) for ≥12 weeks, ≥3 indicators for biologic therapy (type 2 inflammation marker, frequent corticosteroid courses, QoL impairment, smell loss, comorbid asthma), tried and had inadequate response/intolerance/contraindication to ≥1 intranasal corticosteroid (fluticasone, mometasone, Sinuva) ≥4 weeks, absence of exclusions (antrochoanal polyps, nasal septal deviation occluding nostril, lack of type 2 inflammation, cystic fibrosis, mucoceles), other causes ruled out, prescriber assessed baseline severity objectively.
• - For all FDA-labeled indications, patient age must be within labeling or supported in compendia.
• - If severe eosinophilic asthma, must be on maximally tolerated inhaled corticosteroid ≥3 months with adherence 90/120 days (or same standard if continuation therapy).