Nucala (mepolizumab) — United Healthcare
Severe asthma with an eosinophilic phenotype
Initial criteria
- EITHER:
- (1) ALL of the following:
- • Patient has been established on therapy with Nucala under an active UnitedHealthcare medical prior authorization for severe asthma
- AND • Documentation of positive clinical response as shown by ≥1 of: reduction in exacerbations; decreased rescue medication use; increased % predicted FEV1; reduction in asthma symptoms; reduction in oral corticosteroid requirements
- AND • Nucala used with an inhaled corticosteroid (ICS)-containing maintenance medication [e.g., Advair/AirDuo, Breo Ellipta, Symbicort, Trelegy Ellipta]
- AND • Patient not receiving Nucala with: Anti-interleukin-5 therapy [Cinqair, Fasenra], Anti-IgE therapy [Xolair], Anti-interleukin-4 therapy [Dupixent], or TSLP inhibitor [Tezspire]
- AND • Prescribed by pulmonologist OR allergist OR immunologist
- OR (2) ALL of the following:
- • Diagnosis of severe asthma
- AND • Asthma is uncontrolled/inadequately controlled (≥1 of: poor symptom control [ACQ>1.5 or ACT<20]; ≥2 corticosteroid bursts ≥3 days in prior 12 months; asthma-related ER/hospital/urgent visit; FEV1<80% predicted; or oral corticosteroid dependence)
- AND • Asthma confirmed eosinophilic phenotype by baseline blood eosinophil ≥150 cells/μL
- AND • Nucala used in combination with (i) one maximally dosed ICS/LABA or (ii) both a maximally dosed ICS and an additional controller [LABA, leukotriene receptor antagonist, or theophylline]
- AND • Patient not on Nucala with any of: Anti-IL5, Anti-IgE, Anti-IL4, TSLP inhibitor therapies
- AND • Prescribed by allergist OR immunologist OR pulmonologist
Reauthorization criteria
- • Documentation of positive clinical response to Nucala as shown by ≥1 of: reduction in exacerbations; decreased rescue medication use; increased % predicted FEV1; reduction in asthma symptoms; reduction in oral corticosteroid requirements
- AND • Continued use with an ICS-containing maintenance medication [Advair/AirDuo, Breo Ellipta, Symbicort, Trelegy Ellipta]
- AND • Patient not receiving Nucala with: Anti-interleukin-5 therapy [Cinqair, Fasenra], Anti-IgE therapy [Xolair], Anti-interleukin-4 therapy [Dupixent], or TSLP inhibitor [Tezspire]
Approval duration
12 months