Nucala — Blue Cross Blue Shield of Montana

Initial criteria

• Continuation of therapy: Prescriber states patient has been treated with requested agent within past 90 days and is at risk if therapy is changed.
• For severe eosinophilic asthma: BOTH of the following: (1) Diagnosis confirmed by ONE of the following: (A) baseline blood eosinophil count ≥150 cells/microliter while on high-dose inhaled or daily oral corticosteroids OR (B) fraction of exhaled nitric oxide (FeNO) ≥20 parts per billion while on high-dose inhaled or daily oral corticosteroids OR (C) sputum eosinophils ≥2% while on high-dose inhaled or daily oral corticosteroids; AND (2) History of uncontrolled asthma on asthma control therapy demonstrated by ONE of the following: (A) ≥2 courses of systemic corticosteroids within past 12 months OR (B) hospitalization, mechanical ventilation, or ER/urgent care visit within past 12 months OR (C) controlled asthma that worsens with corticosteroid taper OR (D) baseline FEV1 <80% predicted.
• For eosinophilic granulomatosis with polyangiitis (EGPA): ALL of the following: (1) ONE of [baseline blood eosinophilia ≥1000 cells/microliter OR ≥10% eosinophils on differential]; (2) History or presence of asthma; (3) No severe organ- or life-threatening manifestations (e.g., alveolar hemorrhage, glomerulonephritis, CNS vasculitis, mononeuritis multiplex, cardiac, mesenteric, or digital ischemia); (4) ONE of [patient currently treated within past 90 days with oral corticosteroid ≥4 weeks and will use OCS with requested agent OR intolerance/hypersensitivity to OCS OR FDA-labeled contraindication to all OCS]; (5) Requested agent used for [relapsing or refractory disease OR maintenance of remission].
• For hypereosinophilic syndrome (HES): ALL of the following: (1) Requested agent FDA-labeled or compendia supported; (2) Diagnosis duration ≥6 months; (3) Diagnosis confirmed by BOTH: (A) ONE of [peripheral blood eosinophils ≥1000 cells/microliter OR bone marrow eosinophils >20% OR marked eosinophil granule deposition OR extensive tissue eosinophil infiltration]; AND (B) evaluation of organ involvement (e.g., lung, heart, digestive tract, skin, etc.); (4) No secondary (reactive) cause of HES; (5) FIP1L1-PDGFRA-negative; (6) ≥2 HES flares in past 12 months; (7) ONE of [trial and inadequate response to OCS, hydroxyurea, interferon-α, or immunosuppressant (e.g., cyclosporine, methotrexate) OR intolerance/hypersensitivity to these OR FDA-labeled contraindication to these agents].
• For chronic rhinosinusitis with nasal polyps (CRSwNP): ALL of the following: (1) Requested agent FDA-labeled or compendia supported; (2) At least TWO symptoms of CRS [nasal discharge, obstruction/congestion, loss/decreased smell, facial pain/pressure]; (3) Symptoms ≥12 consecutive weeks.