CurrentUnitedHealthcarePolicy IEXD0033.14

Xolair (Omalizumab) provider-administered subcutaneous injection

UnitedHealthcare Individual Exchange medical benefit drug policy (IEXD0033.14) governing provider-administered Xolair (omalizumab) for multiple indications (moderate-to-severe persistent asthma, chronic urticaria, nasal polyps, IgE-mediated food allergy) including initial and reauthorization criteria, excluded/unproven indications, and applicable procedure/diagnosis codes. Applies to Individual Exchange plans in all states except MA, NV, and NY.

Policy Summary

PayerUnitedHealthcare

PolicyIEXD0033.14

Policy CodePolicy IEXD0033.14

Change TypeCriteria revision and ICD-10 code updates

Effective DateOct 1, 2025

Next Review Date

Key ActionInitial authorization requires documentation that all specified clinical criteria are met and that the prescriber is an appropriate specialist; initial auth limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

Replaced criterion requiring 'the patient is not receiving any of [the listed therapies] in combination with Xolair' with 'the patient is not receiving any of [the listed therapies] in combination with Xolair for treatment of the same indication'.

Updated list of applicable ICD-10 diagnosis codes to reflect annual edits including addition of Z91.0110, Z91.0111, Z91.0112, Z91.0120, Z91.0121, and Z91.0122.

Updated Clinical Evidence, FDA, and References sections to reflect the most current information.

4Approved Indications (provider-administered)

5Unproven / Not Medically Necessary Indications Listed

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HCPCS Drug Code Listed

5Covered Indications referenced (as discussed)

1Policy version (current)

2025-10-01Effective date of latest revision

Coverage Summary

UnitedHealthcare Individual Exchange medical benefit drug policy IEXD0033.14 (effective October 1, 2025) governs provider‑administered Xolair (omalizumab) for moderate-to-severe persistent asthma, chronic urticaria, nasal polyps, and IgE-mediated food allergy for Individual Exchange plans in all states except MA, NV, and NY.

Policy thresholds and cut‑points

Total serum IgE (baseline pre-omalizumab)>= 30 IU/mL and <= 1300 IU/mL

Age for IgE‑mediated food allergy indication>= 1 year

Asthma symptom control scores (examples)ACQ > 1.5 or ACT < 20

Nasal polyps symptom duration> 12 weeks

GINA/ERS‑ATS threshold — frequent exacerbations>= 2/year requiring oral corticosteroids (OCS)

GINA/ERS‑ATS threshold — serious exacerbations>= 1/year requiring hospitalization

ERS/ATS biomarker cut‑points related to biologic selectionBlood eosinophils >= 150 μL^-1; cut‑offs identifying likely anti‑IgE responders: eosinophils >= 260 μL^-1 and FENO >= 19.5 ppb

Initial Therapy Criteria

Moderate to Severe Persistent Asthma - Initial Therapy

Xolair for provider administration is proven and medically necessary when ALL of the following criteria are met:

ALL of the following

ONE of
- Poor symptom control (e.g., ACQ > 1.5 or ACT < 20)
- 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's office visit for nebulizer or other urgent treatment)
- Airflow limitation (e.g., after appropriate bronchodilator withhold FEV1 < 80% predicted with reduced FEV1/FVC defined as < lower limit of normal)

Continuation / Reauthorization Criteria

Moderate to Severe Persistent Asthma - Reauthorization/Continuation

Authorization for continued use will be approved based on ALL of the following:

ALL of the following

ANY of the following
- 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)

Unproven / Not Medically Necessary

Xolair for provider administration is unproven and not medically necessary in the following:

ANY of the following

Seasonal allergic rhinitis
Perennial allergic rhinitis
Atopic dermatitis
Acute bronchospasm or status asthmaticus
Emergency treatment of allergic reactions, including anaphylaxis

Applicable Codes

HCPCS - DrugHCPCSCovered

J2357

Injection, omalizumab, 5 mg

ICD-10 - Diagnoses referenced in policyICD-10

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

1–10 of 24

1/3

Updated ICD-10 diagnosis codes (annual edits)ICD-10

Z91.0110
Z91.0111
Z91.0112
Z91.0120
Z91.0121
Z91.0122

Provider Actions / Prior Authorization

Prior Authorization

Initial prior authorization required with specialty prescriber

Initial prior authorization required with specialty prescriber. Initial authorization requires documentation that all specified clinical criteria are met and that prescriber is an appropriate specialist. Initial authorization will be for no more than 12 months. HCPCS code J2357 applies (Injection, omalizumab, 5 mg).

Specialist prescriber (allergist/immunologist, pulmonologist, dermatologist, otolaryngologist as indicated)
Initial authorization limited to no more than 12 months
Drug HCPCS code: J2357 (injection, omalizumab, 5 mg)

Documentation Required

Document baseline laboratory and testing

Document baseline laboratory and testing. For asthma, baseline (pre-omalizumab) serum total IgE must be documented as greater than or equal to 30 IU/mL and less than or equal to 1300 IU/mL, and a positive skin test or in vitro reactivity to a perennial aeroallergen must be documented.

Clinical Evidence

68%Peanut ≥600 mg DBPCFC response (Xolair) vs placebo 5% — treatment difference 63% (95% CI 50–73)

65%Peanut ≥1000 mg response (Xolair) vs placebo 0% — difference 65% (95% CI 56–74)

24.5%ICATA: symptom days reduced by 24.5% (1.96→1.48 days per 2 weeks); exacerbations 30.3% vs 48.8%

300mgCIU/CSU: Omalizumab 300 mg reduced weekly itch severity score and met multiple secondary endpoints (significant vs placebo)

A systematic review and meta-analysis of randomized trials in seasonal (and perennial) allergic rhinitis (11 RCTs, 2,870 patients) found a reduction in daily nasal symptom severity score (SMD -0.67, 95% CI -1.3 to -0.31) and a reduction in daily nasal rescue medication score (SMD -0.22, 95% CI -0.39 to -0.05), with no significant difference in occurrence of any adverse event (RR 1.06, 95% CI 0.94–1.19).

Open-label studies in perennial allergic rhinitis (Corren et al.) using IV dosing 0.015–0.03 mg/kg/IgE reported decreases in free IgE up to 99% and reduced nasal allergen challenge symptom scores; a randomized trial (Chervinsky) of subcutaneous dosing ≥ 0.016 mg/kg/IgE every 4 weeks over 16 weeks reduced daily nasal severity score by 69% vs 49% for placebo (p=0.001) and achieved symptom control (<0.75) in 28% vs 10%.

Background

Omalizumab is a monoclonal antibody that binds to IgE's high‑affinity Fc receptor, preventing IgE binding to effector cells and reducing allergic mediator release; clinical trials have shown reductions in free serum IgE (> 90%) and effects on eosinophils and allergic responses.

Omalizumab is approved by the U.S. Food and Drug Administration for allergic asthma (adults and adolescents ≥ 6 years with positive perennial aeroallergen reactivity), chronic idiopathic urticaria (≥ 12 years), chronic rhinosinusitis with nasal polyps (≥ 18 years), and IgE‑mediated food allergy (≥ 1 year, as adjunct to allergen avoidance); it is not indicated for acute bronchospasm or status asthmaticus.

This policy summarizes efficacy and safety evidence from randomized clinical trials and observational studies across these indications (including asthma, chronic urticaria, nasal polyps, and IgE‑mediated food allergy) and provides patient selection criteria for provider‑administered Xolair.

Guideline organizations (e.g., GINA, ERS/ATS) provide recommendations and phenotype/biomarker considerations to guide biologic use in severe asthma, which are referenced in the policy.

Key definitions

Positive clinical responseReduction in exacerbations, decreased rescue medication use, increase in percent predicted FEV1 from pretreatment baseline, or reduction in severity/frequency of disease‑specific symptoms (examples listed per indication)

Provider administration

Revision History

10/01/2025policy_revision (material)Latest

Revised combination therapy exclusion: replaced prior requirement that the patient not be receiving any of the listed therapies in combination with Xolair with language specifying the patient is not receiving those therapies in combination with Xolair for treatment of the same indication; effective 10/01/2025.

10/01/2025code_update (material)Latest

Updated applicable ICD-10 diagnosis codes to reflect annual edits: added Z91.0110, Z91.0111, Z91.0112, Z91.0120, Z91.0121, and Z91.0122 and removed Z91.011 and Z91.012.

Policy Summary

PayerUnitedHealthcare

PolicyIEXD0033.14

Policy CodePolicy IEXD0033.14

Change TypeCriteria revision and ICD-10 code updates

Effective DateOct 1, 2025

Next Review Date

SourceLink

On This Page

Patient is currently dependent on maintenance therapy with oral corticosteroids for the treatment of asthma

Baseline (pre-omalizumab) serum total IgE level ≥ 30 IU/mL and ≤ 1300 IU/mL>= 30 and <= 1300 IU/mL

Positive skin test or in vitro reactivity to a perennial aeroallergen

ANY of the following

One maximally-dosed (age-appropriate) combination ICS/LABA product (e.g., fluticasone/salmeterol, budesonide/formoterol, fluticasone furoate/vilanterol)
ALL of the following
- 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)

ALL of the following

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

Nasal Polyps - Initial Therapy

Xolair for provider administration is proven and medically necessary when ALL of the following criteria are met:

ALL of the following

Diagnosis of nasal polyps
ALL of the following
- Nasal mucopurulent discharge
- Nasal obstruction, blockage, or congestion
- Facial pain, pressure, and/or fullness
- Reduction or loss of sense of smell
One of the following findings:
- Purulent mucus or edema in the middle meatus or ethmoid regions
- Polyps in the nasal cavity or the middle meatus
- Radiographic imaging demonstrating mucosal thickening or partial or complete opacification of paranasal sinuses
One of the following:
- Patient has required prior sinus surgery
- Patient has required systemic corticosteroids for nasal polyps in the previous 2 years
- Patient has been unable to obtain symptom relief after trial of both intranasal corticosteroids AND one other therapy used in management of nasal polyps (e.g., nasal saline irrigations, antileukotriene agents)
Patient will receive Xolair as add-on maintenance therapy in combination with intranasal corticosteroids
ALL of the following
- Anti-IL-5 therapy (e.g., reslizumab, benralizumab, mepolizumab)
- Anti-IL-4 therapy (e.g., dupilumab)
- TSLP inhibitor (e.g., tezepelumab)
Dosing is in accordance with FDA approved labeling
Prescribed by an allergist/immunologist/otolaryngologist/pulmonologist
Initial authorization will be for no more than 12 months

IgE-Mediated Food Allergy - Initial Therapy

Xolair for provider administration is proven and medically necessary when ALL of the following criteria are met:

ALL of the following

Diagnosis of IgE-mediated food allergy to one or more foods
Patient is aged ≥ 1 year>= 1 year
ALL of the following
- History of type I allergic reactions (e.g., nausea, vomiting, cramping, diarrhea, flushing, pruritus, urticaria, swelling of lips/face/throat, wheezing, lightheadedness, syncope)
- One of the following diagnostic tests:
  - Food specific skin prick testing (SPT)
  - IgE antibody in vitro testing
  - Oral food challenge (OFC)
Xolair will be used in conjunction with food allergen avoidance
Patient has access to epinephrine
ALL of the following
- 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 or immunologist
Initial authorization will be for no more than 12 months

Used in combination with an ICS-containing maintenance medication (examples provided)

Patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor for the same indication

Dosing is in accordance with FDA approved labeling

Reauthorization will be for no more than 12 months

Chronic Urticaria - Reauthorization/Continuation

Authorization for continued use will be approved based on ALL of the following:

ALL of the following

Documentation of positive clinical response (e.g., reduction in exacerbations, itch severity, hives)
Patient is not receiving Xolair in combination with anti-IL-5, anti-IL-4, or TSLP inhibitor for the same indication
Dosing is in accordance with FDA approved labeling
Reauthorization will be for no more than 12 months

Nasal Polyps - Reauthorization/Continuation

Authorization for continued use will be approved based on ALL of the following:

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
Patient is not receiving Xolair in combination with anti-IL-5, anti-IL-4, or TSLP inhibitor for the same indication
Dosing is in accordance with FDA approved labeling
Reauthorization will be for no more than 12 months

IgE-Mediated Food Allergy - Reauthorization/Continuation

Authorization for continued use will be approved based on ALL of the following:

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
Patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor for the same indication
Dosing is in accordance with FDA approved labeling
Prescribed by an allergist or immunologist
Reauthorization will be for no more than 12 months

Coverage Rationale (revision note)

Revised coverage criteria language as of 10/01/2025:

Patient is not receiving any of the listed therapies in combination with Xolair for treatment of the same indication

Replaces prior broader prohibition language

Baseline total serum IgE ≥ 30 IU/mL and ≤ 1300 IU/mL
Positive skin test or in vitro reactivity to a perennial aeroallergen

Documentation Required

Document trial and response to prior therapies

Document trial and response to prior therapies. For each indication providers must document prior therapy trials and lack of adequate response or contraindication/intolerance as specified (examples: for asthma — prior use of maximally dosed ICS/LABA or maximally dosed ICS plus an additional controller; for chronic urticaria — trial of two H1-antihistamines or combination antihistamine therapy; for nasal polyps — trial of intranasal corticosteroids and one other therapy such as saline irrigation or antileukotriene; for food allergy — allergen avoidance and access to epinephrine).

Asthma: maximally-dosed ICS/LABA or maximally-dosed ICS plus an additional controller medication
Chronic urticaria: trial of two H1-antihistamines or combination antihistamine regimens
Nasal polyps: trial of intranasal corticosteroids and one other therapy (e.g., saline irrigation, antileukotriene)
Food allergy: allergen avoidance and documentation of access to epinephrine

Denial Risk

Concurrent biologic therapy exclusion

Concurrent biologic therapy exclusion. Claims may be denied if the patient is receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies for treatment of the same indication.

Anti-IL-4 example: dupilumab
Anti-IL-5 examples: mepolizumab, reslizumab, benralizumab
TSLP inhibitor example: tezepelumab
Applies when used in combination for the same indication

Prior Authorization

Reauthorization requirements

Reauthorization requirements. Reauthorization requires documentation of positive clinical response (examples provided per indication) and reauthorization will be for no more than 12 months.

Document positive clinical response (e.g., reduced exacerbations, decreased rescue medication use, improved FEV1, reduced symptom severity)
Reauthorization limited to no more than 12 months

Documentation Required

Reference member-specific benefits

Reference member-specific benefits. When deciding coverage, reference the member specific benefit plan document; in the event of a conflict, the member-specific benefit plan governs.

Member specific benefit plan may differ from policy and governs if conflict exists

Documentation Required

Use of external criteria tools

Use of external criteria tools. UnitedHealthcare may use third-party tools, such as InterQual, to assist in administering benefits; providers should anticipate requests consistent with those tools.

Third-party example: InterQual

Prior Authorization

Revised combination therapy exclusion qualifier

Revised combination therapy exclusion qualifier. Coverage criteria were revised effective 2025-10-01 to specify that the patient must not be receiving listed therapies in combination with Xolair for treatment of the same indication; prior authorization decisions should apply this updated language.

Effective date: October 1, 2025
Qualifier: 'for treatment of the same indication'

A 16‑week randomized, placebo‑controlled pilot trial in atopic dermatitis (n=20) showed reductions in free IgE with omalizumab but did not demonstrate significant improvement in clinical disease activity.

FDA informational labeling notes approvals for moderate to severe persistent allergic asthma (≥ 6 years), chronic idiopathic urticaria (≥ 12 years), chronic rhinosinusitis with nasal polyps (≥ 18 years), and IgE‑mediated food allergy (≥ 1 year) as adjunct to avoidance, and states that Xolair is not indicated for acute bronchospasm or status asthmaticus.

Clinical guideline recommendations include GINA (2024) supporting add‑on omalizumab for severe allergic asthma (aged ≥ 6 years, Evidence A) and ERS/ATS guidance providing phenotype and biomarker cut-offs (e.g., eosinophil and FENO thresholds) to help guide biologic selection.

Randomized trial data in IgE‑mediated food allergy (peanut and other foods) demonstrated clinically meaningful increases in tolerance (e.g., peanut ≥ 600 mg response: 68% vs 5%, treatment difference 63%, 95% CI 50–73; peanut ≥ 1000 mg response: 65% vs 0%, treatment difference 65%, 95% CI 56–74).

Xolair administered by a healthcare professional (self‑administered formulation is covered under pharmacy benefit and not included in this provider‑administered policy)

Uncontrolled asthmaPoor symptom control and/or frequent exacerbations (>= 2/year requiring OCS) or serious exacerbations (>= 1/year requiring hospitalization)

Difficult‑to‑treat asthmaAsthma uncontrolled despite medium/high‑dose ICS with a second controller or maintenance OCS, or requires high‑dose treatment to maintain control

Severe asthmaAsthma uncontrolled despite adherence with optimized high‑dose ICS‑LABA and management of contributory factors, or worsens when high‑dose treatment is decreased

10/01/2025content_updateLatest

Updated Clinical Evidence, FDA, and References sections to reflect the most current information.

10/01/2025archived_prior_versionLatest

Archived previous policy version IEXD0033.13.