dupilumab — Blue Cross Blue Shield of Texas

Initial criteria

• For continuation of therapy: patient has been treated with the requested agent within the past 90 days (starting on samples is not approvable) and is at risk if therapy is changed.
• For moderate-to-severe atopic dermatitis (AD):
• • Patient has ≥10% body surface area involvement OR involvement of areas difficult to treat with prolonged topical corticosteroids (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR EASI score ≥16 OR IGA score ≥3, AND
• • Patient has tried and had inadequate response to at least a medium-potency topical corticosteroid after ≥4 weeks OR has intolerance/hypersensitivity OR an FDA-labeled contraindication to all medium, high, and super-potency topical corticosteroids, AND
• • Patient has tried and had inadequate response to a topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) after ≥6 weeks OR has intolerance/hypersensitivity OR an FDA-labeled contraindication to all topical calcineurin inhibitors, OR medication history indicates use of another biologic immunomodulator labeled or supported for AD.
• For moderate-to-severe asthma:
• • Patient has eosinophilic-type asthma (baseline eosinophils ≥150 cells/μL, FeNO ≥20 ppb, or sputum eosinophils ≥2%) OR oral corticosteroid-dependent asthma, AND
• • Patient has history of uncontrolled asthma despite therapy as shown by ≥2 courses systemic corticosteroids in past 12 months, serious exacerbation requiring hospitalization or emergency care in past 12 months, controlled asthma worsening when corticosteroids tapered, OR FEV1 <80% predicted.
• For COPD:
• • Diagnosis confirmed by spirometry with post-bronchodilator FEV1/FVC <0.7 AND FEV1 30–70% predicted, eosinophilic phenotype (baseline eosinophils ≥300 cells/μL), symptoms of chronic bronchitis ≥3 months in last year, AND inadequately controlled COPD on maintenance therapy shown by ≥2 moderate exacerbations requiring systemic corticosteroids or 1 severe exacerbation requiring hospitalization or emergency care in past 12 months.
• For chronic rhinosinusitis with nasal polyps (CRSwNP):
• • ≥2 symptoms (nasal discharge, nasal congestion, loss/decreased smell, facial pressure/pain), symptoms ≥12 consecutive weeks, diagnosis confirmed by endoscopy or CT, AND inadequate response/intolerance/contraindication to ≥1 intranasal corticosteroid after ≥4 weeks.
• For chronic spontaneous urticaria (CSU):
• • Hives and itching >6 weeks, AND if treated with medications known to cause or worsen urticaria, resolution considered or excluded.