Dupixent (dupilumab) — United Healthcare

Initial criteria

• Diagnosis of COPD
• Submission of medical records documenting all of the following: (a) Post-bronchodilator FEV1/FVC ratio < 0.7 (b) Post-bronchodilator FEV1 % predicted ≥ 30% and ≤ 70% (c) Baseline (pre-dupilumab treatment) peripheral blood eosinophil level ≥ 300 cells/μL
• Uncontrolled or inadequately controlled COPD demonstrated by BOTH of the following: (a) One of: i. ≥ 2 COPD exacerbations in previous year requiring systemic corticosteroids and/or antibiotics OR ii. ≥ 1 COPD exacerbation resulting in hospitalization or observation > 24 hours in the past year (b) COPD exacerbation(s) occurred while receiving maintenance therapy with one of: i. Triple therapy with LAMA + LABA + ICS (e.g., Breztri Aerosphere, Trelegy Ellipta) OR ii. Dual therapy with LAMA + LABA (e.g., Anoro Ellipta, Bevespi Aerosphere, Stiolto Respimat) and a failure, contraindication, or intolerance to an inhaled corticosteroid (ICS)
• Symptoms of chronic productive cough for at least 3 months in the past year
• Dupixent will be used as add-on maintenance therapy in combination with one of: (a) Triple therapy with LAMA + LABA + ICS (e.g., Breztri Aerosphere, Trelegy Ellipta) OR (b) Dual therapy with LAMA + LABA and failure, contraindication, or intolerance to ICS
• Patient is not receiving Dupixent in combination with any of the following for the same indication: (a) Anti–interleukin-5 therapy [e.g., Nucala (mepolizumab), Cinqair (resilizumab), Fasenra (benralizumab)] (b) Anti-IgE therapy [e.g., Xolair (omalizumab)] (c) Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]
• Prescribed by allergist OR immunologist OR pulmonologist

Reauthorization criteria

• Documentation of a positive clinical response to Dupixent therapy as demonstrated by at least one of: (a) Reduction in COPD exacerbation frequency (b) Increase in percent predicted FEV1 from baseline (c) Reduction in severity or frequency of COPD-related symptoms (e.g., dyspnea, wheezing, cough, sputum volume, purulence) (d) Reduction in oral corticosteroid requirements
• Dupixent is used as add-on maintenance therapy in combination with one of: (a) Triple therapy with LAMA + LABA + ICS (e.g., Breztri Aerosphere, Trelegy Ellipta) OR (b) Dual therapy with LAMA + LABA (e.g., Anoro Ellipta, Bevespi Aerosphere, Stiolto Respimat) and failure, contraindication, or intolerance to ICS
• Patient is not receiving Dupixent in combination with any of the following for the same indication: (a) Anti–interleukin-5 therapy [e.g., Nucala (mepolizumab), Cinqair (resilizumab), Fasenra (benralizumab)] (b) Anti-IgE therapy [e.g., Xolair (omalizumab)] (c) Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]
• Prescribed by allergist OR immunologist OR pulmonologist

Approval duration

12 months