Xolair (omalizumab) — United Healthcare

Initial criteria

• ONE of the following:
• 1) ALL of the following:
• • Patient has been established on therapy with Xolair for IgE-mediated food allergy under an active UnitedHealthcare medical benefit prior authorization AND
• • Documentation of positive clinical response to Xolair therapy (e.g., reduction in type I allergic reactions) AND
• • Xolair will be used in conjunction with food allergen avoidance AND
• • Patient has access to epinephrine AND
• • Patient is not receiving Xolair in combination with any of the following: Anti-interleukin-4 therapy [e.g., Dupixent (dupilumab)]; Anti-interleukin-5 therapy [e.g., Nucala (mepolizumab), Cinqair (resilizumab), Fasenra (benralizumab)]; Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)] AND
• • Prescribed by an allergist or immunologist
• OR
• 2) ALL of the following:
• • Diagnosis of IgE-mediated food allergy to one or more foods AND
• • age ≥ 1 year AND
• • IgE-mediated food allergy to specific food(s) has been confirmed by BOTH of the following: History of type I allergic reactions (e.g., nausea, vomiting, cramping, diarrhea, flushing, pruritus, urticaria, swelling of the lips, face or throat, wheezing, lightheadedness, syncope) AND ONE of the following: Food specific skin prick testing (SPT); IgE antibody in vitro testing; Oral food challenge (OFC) AND
• • Xolair will be used in conjunction with food allergen avoidance AND
• • Patient has access to epinephrine AND
• • Patient is not receiving Xolair in combination with any of the following: Anti-interleukin-4 therapy [e.g., Dupixent (dupilumab)]; Anti-interleukin-5 therapy [e.g., Nucala (mepolizumab), Cinqair (resilizumab), Fasenra (benralizumab)]; Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)] AND
• • Prescribed by an allergist or immunologist

Reauthorization criteria

• ALL of the following:
• • Documentation of positive clinical response to Xolair therapy (e.g., reduction in type I allergic reactions) AND
• • Xolair will be used in conjunction with food allergen avoidance AND
• • Patient has access to epinephrine AND
• • Patient is not receiving Xolair in combination with any of the following: Anti-interleukin-4 therapy [e.g., Dupixent (dupilumab)]; Anti-interleukin-5 therapy [e.g., Nucala (mepolizumab), Cinqair (resilizumab), Fasenra (benralizumab)]; Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)] AND
• • Prescribed by an allergist or immunologist

Approval duration

12 months