dupilumab — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following:
• The requested agent is eligible for continuation of therapy AND ONE of the following:
• - The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
• - 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 BOTH of the following:
• ONE of the following:
• - The patient has a diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following:
• • ONE of the following:
• - The patient has at least 10% body surface area involvement OR
• - The patient has involvement of body sites that are difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds) OR
• - The patient has an Eczema Area and Severity Index (EASI) score ≥ 16 OR
• - The patient has an Investigator Global Assessment (IGA) score ≥ 3
• AND ONE of the following:
• - The patient has tried and had an inadequate response to at least a medium-potency topical corticosteroid used in AD after at least a 4-week duration of therapy OR
• - Has intolerance or hypersensitivity to a medium-potency topical corticosteroid OR
• - Has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in AD
• AND ONE of the following:
• - The patient has tried and had an inadequate response to a topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in AD after at least a 6-week duration of therapy OR
• - Has intolerance or hypersensitivity to a topical calcineurin inhibitor OR
• - Has an FDA labeled contraindication to ALL topical calcineurin inhibitors used in AD
• OR
• - The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of AD
• OR The patient has a diagnosis of moderate-to-severe asthma AND BOTH of the following:
• • ONE of the following:
• - The patient has eosinophilic type asthma AND ONE of the following:
• ▪ Baseline blood eosinophil count ≥150 cells/µL 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
• - The patient has oral corticosteroid dependent type asthma
• AND The patient has a history of uncontrolled asthma while on control therapy as demonstrated by ONE of the following:
• - ≥2 courses of systemic corticosteroids within 12 months OR
• - Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or ER/urgent care visit within 12 months OR
• - Controlled asthma worsening when corticosteroids are tapered OR
• - Baseline FEV1 <80% predicted
• OR
• The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) AND ALL of the following:
• • Diagnosis confirmed by spirometry with post-bronchodilator FEV1/FVC <0.7 AND
• • Airflow obstruction defined by post-bronchodilator FEV1 30%-70% of predicted normal value