Nucala — United Healthcare

Chronic Obstructive Pulmonary Disease (COPD)

Initial criteria

One of the following: (1) Established on therapy with Nucala under an active UnitedHealthcare medical benefit prior authorization for COPD, documentation of positive clinical response, continued use as add-on maintenance therapy, and not used in combination with anti-interleukin-5, anti-IgE, anti-interleukin-4, or TSLP inhibitors
OR (2) Diagnosis of COPD with all of the following: (a) post-bronchodilator FEV1/FVC ratio <0.7; (b) post-bronchodilator FEV1 % predicted ≥30% and ≤70%; (c) baseline eosinophil level ≥300 cells/µL; (d) uncontrolled or inadequately controlled COPD demonstrated by ≥2 exacerbations requiring systemic corticosteroids/antibiotics OR ≥1 hospitalization/observation for >24 hours in the past year; (e) exacerbations occurred while on either triple therapy (LAMA + LABA + ICS) OR dual therapy (LAMA + LABA) with failure/contraindication/intolerance to ICS; (f) symptoms of chronic productive cough for ≥3 months in the past year; (g) Nucala will be used as add-on maintenance therapy with triple therapy (LAMA+LABA+ICS) or dual therapy (LAMA+LABA) with ICS failure; (h) not used concomitantly with anti-interleukin-5, anti-IgE, anti-interleukin-4, or TSLP inhibitors; (i) prescribed by Allergist, Immunologist, or Pulmonologist

Documentation of positive clinical response to Nucala therapy as demonstrated by ≥1 of: reduction in COPD exacerbation frequency, increase in percent predicted FEV1, reduction in severity/frequency of COPD symptoms (e.g., dyspnea, wheezing, cough, sputum volume/purulence), or reduction in oral corticosteroid requirements
Nucala used as add-on maintenance therapy with triple therapy (LAMA+LABA+ICS) or dual therapy (LAMA+LABA) with ICS failure/contraindication/intolerance
Patient is not receiving Nucala in combination with anti-interleukin-5 therapy [e.g., Cinqair (resilizumab), Fasenra (benralizumab)], anti-IgE therapy [e.g., Xolair (omalizumab)], anti-interleukin-4 therapy [e.g., Dupixent (dupilumab)], or thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]
Prescribed by Allergist, Immunologist, or Pulmonologist

12 months