Xolair (omalizumab) prefilled syringe — Highmark
Moderate to severe persistent asthma
Initial criteria
- age ≥ 6 years if prefilled syringe OR age ≥ 12 years if autoinjector
- diagnosis of moderate to severe persistent asthma (ICD-10: J45.40, J45.50)
- positive skin test or in vitro reactivity to a perennial aeroallergen
- baseline IgE ≥ 30 IU/mL
- history of ≥ 2 asthma exacerbations requiring oral/injectable corticosteroids in past 12 months OR ≥ 1 asthma exacerbation requiring hospitalization in past 12 months
- inadequate symptom control despite regular treatment with medium- or high-dose inhaled corticosteroids and at least one additional asthma controller (LABA, LTRA, or theophylline), with or without oral corticosteroids, unless intolerant or contraindicated
- will continue treatment with medium- or high-dose inhaled corticosteroids and at least one additional asthma controller while using Xolair
- prescriber attests the member is appropriate for self-administration: no history of anaphylaxis AND at least 3 doses administered under healthcare provider guidance with no hypersensitivity reactions
- prescriber provides documentation: current weight AND pretreatment serum IgE
Reauthorization criteria
- age ≥ 6 years if prefilled syringe OR age ≥ 12 years if autoinjector
- prescriber provides documentation: current weight AND pretreatment serum IgE
- prescriber attests to improvement meeting one of the following: decreased rescue or oral corticosteroid use OR decreased frequency of severe asthma exacerbations OR increased pulmonary function from baseline (e.g., FEV1) OR reduction in asthma-related symptoms (e.g., coughing, fatigue, shortness of breath, sleep disturbance, wheezing)