Xolair (omalizumab) pre-filled syringe for self-administration — Point32Health

Initial criteria

• Diagnosis of moderate to severe persistent asthma OR current treatment with an alternative biologic indicated for moderate to severe asthma
• Pre-treatment serum IgE level ≥ 30 IU/mL
• Positive skin test or in vitro reactivity to ≥ 1 perennial allergen
• Patient age ≥ 6 years
• Prescribed by or in consultation with an allergist, immunologist, or pulmonologist
• Patient currently maintained on a maximally tolerated inhaled corticosteroid plus ≥ 1 other asthma maintenance medication (e.g., long-acting inhaled beta2-agonist, long-acting muscarinic antagonist, leukotriene receptor antagonist)
• Patient will not be concurrently treated with an alternative biologic for asthma

Reauthorization criteria

• Documented diagnosis of moderate to severe persistent asthma
• Patient age ≥ 6 years
• Prescribed by or in consultation with an allergist, immunologist, or pulmonologist
• Therapeutic response demonstrated by ≥ 1 of the following: increase in FEV1, reduction in inhaled corticosteroid dose, reduction in asthma exacerbations or emergency visits, reduction in asthma symptoms, or reduction in oral corticosteroid use
• Patient will not be concurrently treated with an alternative biologic for asthma

Approval duration

initial 6 months; reauth 12 months