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Omalizumab (CPB 0670, reviewed 2026-06-05)
Effective date
Not stated in the notice
Identified
Aug 12, 2026
Summary
Aetna Clinical Policy Bulletin 0670 covers omalizumab (Xolair) and omalizumab-igec (Omlyclo) for commercial medical plans, and precertification is required for these products in applicable plan designs. Aetna considers omalizumab medically necessary for asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria, IgE-mediated food allergy, immune checkpoint inhibitor-related toxicity and systemic mastocytosis when the listed criteria are met. Aetna considers all other indications experimental, investigational or unproven, and the Site of Care Utilization Management Policy applies to these products.
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What to do
Action · 10 steps
01Precertification is required for omalizumab products in applicable plan designs, so obtain it before scheduling by calling (1) 752-7021 or faxing (2) 267-3277, using the Statement of Medical Necessity forms listed under Specialty Pharmacy Precertification.
02Claims need documentation that the medication was prescribed by or in consultation with the specialist listed for the indication.
03For asthma, claims need documentation of age 6 or older, a positive skin test or in vitro reactivity to a perennial aeroallergen, pretreatment total IgE of 30 IU/mL or greater, uncontrolled asthma as the policy defines it, inadequate control on medium-to-high-dose inhaled corticosteroids plus an additional controller, and continued maintenance asthma treatment alongside the drug.
04For CRSwNP, claims need documentation of age 18 or older, bilateral nasal polyposis with chronic sinusitis symptoms despite intranasal corticosteroids for at least 4 weeks, pretreatment IgE of 30 IU/mL or greater, polyps reaching below the lower border of the middle turbinate on endoscopy, anterior rhinoscopy or CT, or a Meltzer score of 2 or higher in both nostrils, or a total endoscopic nasal polyp score of at least 5 with at least 2 in each nostril, plus nasal blockage or congestion with one additional listed symptom, and continued daily intranasal corticosteroid.
05For chronic spontaneous urticaria, claims need documentation of symptoms despite up-dosed second-generation H1 antihistamine for at least 2 weeks, evaluation for other causes of wheals or angioedema, and spontaneous onset of wheals, angioedema or both for at least 6 weeks.
06For IgE-mediated food allergy, claims need documentation of confirmed allergy by food-specific IgE or skin-prick test, a positive physician-controlled oral food challenge or a history of a systemic reaction to a food, pretreatment IgE of 30 IU/mL or greater, and continued food-allergen avoidance.
07Baseline total serum IgE is considered medically necessary for asthma, while monitoring total IgE during therapy is not considered medically necessary.
08Members cannot use this drug with any other biologic or targeted synthetic drug for the same indication.
09Omalizumab is billed under HCPCS J2357 and omalizumab-igec under Q5154.
10Nitric oxide expired gas determination (CPT 95012) is not covered for the listed indications, and FeNO measurement to predict response to omalizumab in asthma is experimental, investigational or unproven.
Codes mentioned
J2357Q515495012D47.02L50.8L25.4L27.2D47.01D84.1K20.0K52.81U07.1Z88.6Z51.89Z91.040J2182J2786312313123331235704867048770488860038600586008
Original notice
Omalizumab (CPB 0670, reviewed 2026-06-05)
aetna.com · Always check the source before changing claims.
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Related policy hubs
Aetna policiesAllergy & ImmunologyPulmonologyENT (Ear, Nose & Throat)DermatologyHematologyOncologyCode J2357Code Q5154Code 95012Code D47.02Code L50.8Code L25.4Code L27.2Code D47.01Code D84.1Code K20.0Code K52.81Code U07.1Code Z88.6Code Z51.89Code Z91.040Code J2182Code J2786Code 31231Code 31233Code 31235Code 70486Code 70487Code 70488Code 86003Code 86005Code 86008