Fasenra pen — Blue Cross Blue Shield of Oklahoma

Initial criteria

• The requested agent will be approved when ALL of the following are met:
• 1. ONE of the following:
• A. The requested agent is eligible for continuation of therapy AND:
• • All target agents are eligible for continuation of therapy.
• • The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed.
• OR
• B. BOTH of the following:
• 1. ONE of the following diagnoses:
• A. Severe eosinophilic asthma AND BOTH of the following:
• • 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 parts per billion while on high-dose inhaled corticosteroids or daily oral corticosteroids OR
• – Sputum eosinophils ≥2% while on high-dose inhaled corticosteroids or daily oral corticosteroids
• • History of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of:
• – ≥2 courses of systemic corticosteroids within past 12 months OR
• – Serious exacerbations requiring hospitalization, mechanical ventilation, or ER/urgent care visit within past 12 months OR
• – Controlled asthma worsens when inhaled/systemic corticosteroid doses are tapered OR
• – Baseline FEV1 <80% predicted.
• B. Eosinophilic granulomatosis with polyangiitis (EGPA) AND ALL of the following:
• • ONE of:
• – Baseline blood eosinophilia ≥1000 cells/microliter OR
• – Baseline eosinophil level ≥10% 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 or limb ischemia).
• • ONE of:
• – Currently treated within past 90 days with oral corticosteroid therapy ≥4 weeks AND will continue with oral corticosteroid therapy in combination with the requested agent OR
• – Intolerance or hypersensitivity to oral corticosteroid therapy OR
• – FDA-labeled contraindication to all oral corticosteroids.
• • Will use requested agent for ONE of:
• – Relapsing or refractory disease OR
• – Maintenance of disease remission.
• C. Hypereosinophilic syndrome (HES) AND ALL of the following:
• • Requested agent is FDA labeled or compendia supported for HES.
• • Diagnosis of HES for ≥6 months.
• • Diagnosis confirmed by BOTH:
• – ONE of:
• ∙ Peripheral blood eosinophil count ≥1000 cells/microliter OR
• ∙ ≥20% eosinophils in bone marrow section OR
• ∙ Marked deposition of eosinophil granule proteins OR
• ∙ Tissue infiltration by eosinophils extensive per pathologist.
• – Evaluation of hypereosinophilia-related organ involvement (e.g., lung, heart, gut, skin, thrombosis, neuropathy, or other organ involvement).
• • No identifiable secondary (reactive) cause of HES (e.g., infection, allergy/atopy, medications, collagen vascular disease, metabolic, solid tumor/lymphoma).
• • FIP1L1-PDGFRA–positive disease excluded.
• • History of ≥2 HES flares within past 12 months requiring escalation in therapy.
• • ONE of:
• – Tried and had inadequate response to at least ONE of: oral corticosteroid, hydroxyurea, interferon-α, or other immunosuppressive agent (e.g., cyclosporine, methotrexate) OR
• – Intolerance or hypersensitivity to therapy with oral corticosteroid, hydroxyurea, interferon-α, or immunosuppressive agent OR
• – FDA-labeled contraindication to hydroxyurea, interferon-α, and all oral corticosteroids/immunosuppressive agents used in treatment of HES.
• D. Chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:
• • Requested agent is FDA labeled or compendia supported for CRSwNP.
• • Patient has ≥2 of the following symptoms: nasal discharge, nasal obstruction/congestion, loss or decreased sense of smell, facial pressure or pain.
• • Symptoms present for ≥12 consecutive weeks.