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AetnaCommercial · Prior Auth · Medical Policy · Allergy & Immunology, Pulmonology, ENT (Ear, Nose & Throat) +3 moreMedium impact

Omalizumab (CPB 0670, reviewed 2026-08-21)

Effective date
Not stated in the notice
Identified
Sep 29, 2026

Summary

Aetna Clinical Policy Bulletin 0670 sets the coverage criteria for omalizumab (Xolair) and its biosimilar omalizumab-igec (Omlyclo) under commercial medical plans. Covered indications are asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, IgE-mediated food allergy, refractory immune checkpoint inhibitor-related pruritus, and systemic mastocytosis, each with listed criteria such as diagnosis, pre-treatment IgE level, prior therapy and continued positive clinical response. Precertification is required in applicable plan designs and the Site of Care Utilization Management Policy applies, and Aetna considers all other indications, including allergic rhinitis, atopic dermatitis and eosinophilic esophagitis, experimental, investigational or unproven.

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What to do

Action · 8 steps
01REQUIREMENTS: Billing team and providers: Before scheduling omalizumab for Aetna commercial members, obtain precertification, which is required of all Aetna participating providers and members in applicable plan designs.
02Call (1) 752-7021 or fax (2) 267-3277 for omalizumab precertification, and use the Statement of Medical Necessity precertification forms where required.
03Confirm that the drug is prescribed by or in consultation with an allergist/immunologist, pulmonologist, otolaryngologist, dermatologist, hematologist or oncologist, depending on the indication.
04Apply the Site of Care Utilization Management Policy to omalizumab products.
05For asthma, obtain a baseline total serum IgE level, which the policy states is medically necessary before treatment, and document a positive skin test or in vitro reactivity to a perennial aeroallergen.
06Continued asthma treatment with inhaled corticosteroids and an additional controller must be documented alongside the requested medication.
07For CRSwNP, document continued daily intranasal corticosteroid use unless contraindicated or not tolerated.
08Confirm the member is not using omalizumab concomitantly with another biologic or targeted synthetic drug for the same indication.

Codes mentioned

J2357Q515495012D47.02L50.8J33.0J33.9J45.40J45.52

Original notice

Omalizumab (CPB 0670, reviewed 2026-08-21)
aetna.com · Always check the source before changing claims.
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