Nucala (mepolizumab) — Point32Health

Initial criteria

• Documented diagnosis of severe asthma of eosinophilic phenotype as determined by one of the following: an eosinophilic phenotype confirmed by a blood eosinophil level of at least 150 cells/mcL within the past 6 weeks OR an eosinophilic phenotype confirmed by a blood eosinophil level of at least 300 cells/mcL within the past 12 months OR current treatment with an alternative biologic indicated for moderate to severe allergic or eosinophilic asthma
• Patient age ≥ 6 years
• Prescribed by or in consultation with an allergist, immunologist, or pulmonologist
• Documentation that the patient is currently maintained on a maximally tolerated inhaled corticosteroid plus at least one other asthma maintenance medication (e.g., long-acting inhaled beta2-agonist, long-acting muscarinic antagonist, leukotriene receptor antagonist)
• The patient will not be concurrently treated with an alternative biologic for asthma

Reauthorization criteria

• Documented diagnosis of severe asthma of eosinophilic phenotype
• Patient age ≥ 6 years
• Prescribed by or in consultation with an allergist, immunologist, or pulmonologist
• Documentation the patient has experienced a therapeutic response as defined by one of the following: increase in percent predicted FEV1 from pretreatment baseline OR reduction in the dose of inhaled corticosteroids required to control asthma OR reduction in asthma exacerbations (e.g., decreased frequency of use of unscheduled emergency department/urgent care visits) OR reduction in asthma symptoms (e.g., chest tightness, coughing, shortness of breath, or nocturnal awakenings) OR reduction in the use of oral corticosteroids to treat and/or prevent asthma exacerbations
• The patient will not be concurrently treated with an alternative biologic for asthma

Approval duration

initial 6 months; reauth 12 months