omalizumab — Highmark
chronic spontaneous urticaria (CSU)
Initial criteria
- age ≥ 12 years
- diagnosis of urticaria (ICD-10 L50.0, L50.1, L50.8, L50.9) classified as chronic spontaneous urticaria
- therapeutic failure, contraindication, or intolerance to a second-generation non-sedating H1 antihistamine at the maximum recommended doses (e.g., cetirizine, desloratadine, levocetirizine)
- prescriber attests member is appropriate candidate for self-administration, meeting ALL: (a) no history of anaphylaxis AND (b) will receive at least 3 doses of Xolair (syringe or vial) under guidance of a healthcare provider with no hypersensitivity reactions
Reauthorization criteria
- member has improved CSU symptoms
- prescriber assessed for dose de-escalation AND one of the following: (a) Xolair requested at dose of 150 mg every 4 weeks OR (b) prescriber attests member had ≥1 CSU attack in last 6 months and de-escalation inappropriate OR (c) prescriber attests 150 mg every 4 weeks would not be appropriate (e.g., history of CSU-induced potential or actual airway compromise)