CurrentUnitedHealthcarePolicy IEXD0033.14

Xolair® (Omalizumab) – Individual Exchange Medical Benefit Drug Policy

UnitedHealthcare Individual Exchange medical benefit drug policy for provider-administered Xolair (omalizumab) applying to Individual Exchange plans in all states except Massachusetts, Nevada, and New York; defines indications covered, clinical criteria for initiation and reauthorization, exclusions (unproven uses), prescribing providers, dosing alignment with FDA labeling, and applicable procedure and diagnosis codes (part 1 of 2).

Policy Summary

PayerUnitedHealthcare

PolicyXolair® (Omalizumab) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0033.14

Change TypeNo material change

Effective DateOct 1, 2025

Next Review Date

Key ActionDocument required clinical criteria and baseline/response measures for initial and reauthorization approvals; authorizations limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy remains current with no substantive updates reported.

5Indications addressed (asthma, chronic urticaria, nasal polyps, IgE-mediated food allergy, unproven uses listed)

1HCPCS drug code listed

>=30–<=1300 IU/mLIgE threshold range

Coverage Summary

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This UnitedHealthcare Individual Exchange medical benefit drug policy applies to provider-administered Xolair (omalizumab) for Individual Exchange plans in all states except Massachusetts, Nevada, and New York. The policy addresses coverage for the following indications: moderate to severe persistent allergic asthma, chronic spontaneous/idiopathic urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy. The policy states Xolair is covered with criteria and specifies clinical initiation and reauthorization criteria for each indication, concurrent biologic therapy exclusions, prescriber specialty requirements, and that dosing must be in accordance with FDA-approved labeling. Initial and reauthorization authorizations are limited to no more than 12 months. The policy also lists unproven/not medically necessary uses and provides applicable procedure and diagnosis codes (e.g., HCPCS J2357 and listed ICD-10 codes).

Key thresholds and policy parameters

Total serum IgE threshold>= 30 IU/mL and <= 1300 IU/mL

Age - allergic asthma>= 6 years

Age - chronic urticaria>= 12 years

Age - nasal polyps>= 18 years

Age - IgE-mediated food allergy>= 1 year

HCPCS drug codeJ2357

Policy effective date2025-10-01

Policy statusCURRENT

Initial Therapy Criteria — By Indication

Moderate to Severe Persistent Asthma — Initial Therapy (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Asthma classified as uncontrolled or inadequately controlled defined by at least one of:
- Diagnosis of moderate or severe asthma
- Poor symptom control (e.g., ACQ > 1.5 consistently or ACT < 20 consistently)
- Two or more bursts of systemic corticosteroids for at least 3 days each in the previous 12 months
- Asthma-related emergency treatment (e.g., ER visit, hospital admission, or unscheduled physician office visit for nebulizer or other urgent treatment)
- Airflow limitation (e.g., after bronchodilator withholding FEV1 < 80% predicted with reduced FEV1/FVC < lower limit of normal)
- Patient is currently dependent on maintenance oral corticosteroids for treatment of asthma
IgE and allergy requirements
- Baseline (pre-omalizumab) serum total IgE ≥ 30 IU/mL and ≤ 1300 IU/mL>=30 IU/mL and <=1300 IU/mL
- Positive skin test or in vitro reactivity to a perennial aeroallergen
Used in combination with ONE of the following:
- One maximally-dosed (age-appropriate) combination ICS/LABA product (e.g., fluticasone/salmeterol, budesonide/formoterol, fluticasone furoate/vilanterol)
- OR combination therapy including BOTH:
  - One maximally-dosed (age-appropriate) ICS product (e.g., ciclesonide, mometasone furoate, beclomethasone dipropionate)
  - One additional asthma controller medication (e.g., LABA, leukotriene receptor antagonist, theophylline)
Concurrent therapy exclusions
- Anti-IL-4 therapy (e.g., dupilumab)
- Anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab)
- TSLP inhibitor (e.g., tezepelumab)
Dosing is in accordance with FDA-approved labeling
Prescribed by an allergist/immunologist or pulmonologist
Initial authorization will be for no more than 12 months

Chronic Urticaria — Initial Therapy (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of chronic urticaria
One of the following antihistamine trial criteria:
- Patient remains symptomatic despite at least a 2-week trial of, or history of contraindication or intolerance to, two H1-antihistamines (e.g., fexofenadine, diphenhydramine, loratadine)
- OR remains symptomatic despite at least a 2-week trial of, or intolerance/contraindication to, BOTH:
  - A second-generation H1-antihistamine (e.g., fexofenadine, loratadine, cetirizine)
  - AND one of:

Reauthorization / Continuation Criteria — By Indication

Moderate to Severe Persistent Asthma — Reauthorization/Continuation

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response demonstrated by at least one:
- Reduction in the frequency of exacerbations
- Decreased utilization of rescue medications
- Increase in percent predicted FEV1 from pretreatment baseline
- Reduction in severity or frequency of asthma-related symptoms (e.g., wheezing, shortness of breath, coughing)
Used in combination with an ICS-containing maintenance medication
Concurrent therapy exclusions (same as initial)
- Anti-IL-4 therapy (e.g., dupilumab)
- Anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab)
- TSLP inhibitor (e.g., tezepelumab)
Dosing is in accordance with FDA-approved labeling
Reauthorization will be for no more than 12 months

Chronic Urticaria — Reauthorization/Continuation

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response (e.g., reduction in exacerbations, itch severity, hives)
Concurrent therapy exclusions
- Anti-IL-5 therapy (e.g., reslizumab, benralizumab)
- Anti-IL-4 therapy (e.g., dupilumab)
- TSLP inhibitor (e.g., tezepelumab)
Dosing is in accordance with FDA-approved labeling

Nasal Polyps — Reauthorization/Continuation

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response
Patient will continue to receive Xolair as add-on maintenance therapy in combination with intranasal corticosteroids
Concurrent therapy exclusions
- Anti-IL-5 therapy (e.g., reslizumab, benralizumab, mepolizumab)
- Anti-IL-4 therapy (e.g., dupilumab)
- TSLP inhibitor (e.g., tezepelumab)

IgE-Mediated Food Allergy — Reauthorization/Continuation

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Xolair therapy (e.g., reduction in type I allergic reactions)
Xolair will be used in conjunction with food allergen avoidance
Patient has access to epinephrine
Concurrent therapy exclusions
- Anti-IL-4 therapy (e.g., dupilumab)
- Anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab)

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Authorization required for provider-administered Xolair

Initial and reauthorization approvals require documentation meeting the specified clinical criteria, and initial and reauthorization authorizations are limited to no more than 12 months.

J2357

Documentation Required

Documentation of baseline and response measures

Document baseline serum total IgE for asthma (30–1300 IU/mL), positive skin test or in vitro reactivity (as applicable), prior medication trials and evidence of uncontrolled disease. For reauthorization, document positive clinical response (examples per indication include reduction in exacerbations, decreased rescue medication use, increased percent predicted FEV1, reduction in symptom severity/frequency, or decreases in itch/hives depending on indication).

Documentation Required

Concurrent biologic therapy exclusion

Do not use or document concomitant use of Xolair with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies for the same indication — the presence of such therapy precludes coverage under these criteria.

Documentation Required

Prescriber specialty requirement

Prescriptions must be from the specified specialists depending on the indication.

Asthma: allergist/immunologist or pulmonologist
Chronic urticaria: allergist/immunologist or dermatologist
Nasal polyps: allergist/immunologist, otolaryngologist, or pulmonologist
Food allergy: allergist/immunologist

Clinical Evidence

68%Xolair response rate vs placebo for peanut ≥600 mg: 68% vs 5% (treatment difference 63%, 95% CI 50–73)

300 mg q4wChronic urticaria: significant reductions in itch severity and UAS7; higher proportion with UAS7 ≤6 and UAS7 =0 vs placebo (300 mg every 4 weeks)

24.5%Allergic asthma (ICATA): reduced symptom days by 24.5% and lower exacerbation rates vs placebo; improvements despite reductions in ICS/LABA use

Omalizumab is a monoclonal anti-IgE antibody that binds circulating IgE and prevents IgE from engaging high-affinity receptors on effector cells, thereby reducing degranulation and inflammatory mediator release; trials have shown reductions in free serum IgE, sputum eosinophils, and attenuation of early and late allergic responses. Clinical trials across indications demonstrate efficacy: in allergic asthma (e.g., ICATA and other randomized trials) omalizumab reduced asthma symptom days and exacerbations and improved FEV1; in chronic spontaneous urticaria randomized trials (e.g., ASTERIA I) omalizumab 300 mg q4w significantly reduced itch severity and UAS7 and increased rates of well-controlled or complete response; in nasal polyps trials omalizumab produced greater improvements in nasal polyp score and nasal congestion versus placebo; and in IgE-mediated food allergy trials Xolair increased the proportion of patients tolerating predefined oral food challenge thresholds (for peanut ≥ 600 mg, response rate 68% vs 5% for placebo). Safety and tolerability across trials were generally consistent with the established profile: common adverse events included nasopharyngitis and upper respiratory infections, overall adverse event rates were similar to placebo in many studies, serious adverse events were infrequent, and no new safety concerns were identified in trial program analyses.

Definitions & Background

Positive clinical response: Examples include reduction in exacerbations, decreased rescue medication use, increased percent predicted FEV1, reduction in symptom severity/frequency, or decreases in itch/hives depending on indication.

Maximally-dosed: Dose of ICS or ICS/LABA adjusted appropriately for age as per product labeling.

Background: Omalizumab is a monoclonal antibody that targets IgE and is indicated for allergic asthma (age ≥ 6 years), chronic spontaneous urticaria (age ≥ 12 years), nasal polyps (age ≥ 18 years), and IgE-mediated food allergy (age ≥ 1 year) as specified in the policy.

Policy Summary

PayerUnitedHealthcare

PolicyXolair® (Omalizumab) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0033.14

Change TypeNo material change

Effective DateOct 1, 2025

Next Review Date

Key ActionDocument required clinical criteria and baseline/response measures for initial and reauthorization approvals; authorizations limited to no more than 12 months.

SourceLink

On This Page

J33.0	Polyp of the nasal cavity
J33.1	Polypoid sinus degeneration
J33.8	Other polyp of sinus
J33.9	Nasal polyp, unspecified
J44.1	Chronic obstructive pulmonary disease with (acute) exacerbation
J44.9	Chronic obstructive pulmonary disease, unspecified
J45.40	Moderate persistent asthma, uncomplicated
J45.41	Moderate persistent asthma with (acute) exacerbation
J45.50	Severe persistent asthma, uncomplicated
J45.51	Severe persistent asthma with (acute) exacerbation

OpenPayer

Xolair® (Omalizumab) – Individual Exchange Medical Benefit Drug Policy

Coverage Summary

Initial Therapy Criteria — By Indication

Reauthorization / Continuation Criteria — By Indication

Unproven / Not Medically Necessary

Applicable Codes

Provider Actions / Prior Authorization & Documentation

Clinical Evidence

Definitions & Background

Revision History