Xolair (omalizumab) — United Healthcare

Initial criteria

• EITHER (a) Patient established on Xolair with positive clinical response (reduction in exacerbations, decreased rescue med use, increased FEV1, improved symptoms) AND used concurrently with an ICS-containing maintenance medication AND not used with any anti-IL4, anti-IL5, or TSLP inhibitor agents
• OR (b) Diagnosis of moderate to severe asthma AND uncontrolled or inadequately controlled asthma (poor symptom control or >=2 steroid bursts in 12 months or ER/hospital/urgent visit or FEV1<80% predicted or oral corticosteroid dependent) AND baseline serum total IgE ≥30 IU/mL and ≤1300 IU/mL AND positive skin test or in vitro reactivity to perennial aeroallergen AND used with maximally dosed ICS/LABA or ICS + additional controller AND not used with anti-IL4/5/TSLP inhibitor AND prescribed by allergist, immunologist, or pulmonologist

Reauthorization criteria

• Positive clinical response (reduction in exacerbations, decreased rescue medication use, increased FEV1, improved symptoms) AND continued combination with ICS-containing maintenance medication AND not used with anti-IL4, anti-IL5, or TSLP inhibitor therapy

Approval duration

12 months