ModifiedUnitedHealthcarePolicy CS2025D0033AD

Xolair (omalizumab) — Provider-Administered: Coverage Criteria

Defines UnitedHealthcare medical benefit drug policy coverage criteria for provider-administered Xolair (omalizumab) across multiple indications (asthma, chronic urticaria, nasal polyps, IgE-mediated food allergy) and who may prescribe/administer it.

Policy Summary

PayerUnitedHealthcare

PolicyXolair (omalizumab) — Provider-Administered: Coverage Criteria

Policy CodePolicy CS2025D0033AD

Change TypeCoverage criteria revisedICD-10 updatesreferences updated

Effective Date10/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and document indication, prior therapies, and that any concurrent biologic use is for a different indication.

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: added several Z91.01x codes and removed others.

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

4Indications with detailed criteria

12 monthsMax initial/reauthorization period

30–1300 IU/mLBaseline IgE range (asthma)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Min age for food allergy

10/01/2025Policy effective date

Coverage Criteria for Provider-Administered Xolair (omalizumab)

Moderate to Severe Persistent Asthma — Initial Therapy

Covered when ALL of the following are met

Asthma diagnosis and control: Diagnosis of moderate or severe asthma AND classification of asthma as uncontrolled or inadequately controlled (e.g., ACQ >1.5 or ACT <20; asthma-related emergency treatment such as ER visit, hospitalization, or unscheduled urgent visit; two or more systemic corticosteroid bursts of ≥3 days in the prior 12 months; or airflow limitation with post-bronchodilator FEV1 <80% predicted)

Maintenance OCS dependence and IgE: Patient is currently dependent on maintenance oral corticosteroids for asthma treatment AND positive skin test or in vitro reactivity to a perennial aeroallergen AND baseline (pre-treatment) serum total IgE ≥30 IU/mL and ≤1300 IU/mLIgE 30-1300 IU/mL

Concomitant controller therapy: Omalizumab will be used in combination with either (a) a maximally-dosed age-appropriate ICS/LABA product or (b) a maximally-dosed age-appropriate ICS product plus one additional asthma controller medication

Examples of controller medications listed in policy

Prescriber and dosing: Prescribed by an allergist/immunologist or pulmonologist AND dosing in accordance with FDA-approved labeling AND initial authorization will be for no more than 12 months<=12 months

Chronic Urticaria — Initial Therapy

Covered when ALL of the following are met

Diagnosis of chronic urticaria (chronic spontaneous/idiopathic urticaria)

Antihistamine trial: Patient remains symptomatic despite at least a 2-week trial of a second-generation H1-antihistamine OR remains symptomatic despite a 2‑week trial of combination therapies (e.g., second-generation H1-antihistamine plus a different second-generation H1-antihistamine or hydroxyzine) or a leukotriene modifier, or has contraindication/intolerance to these agents

Prescriber, dosing, and combination biologics: Prescribed by an allergist/immunologist or dermatologist AND dosing in accordance with FDA-approved labeling AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitors for treatment of the same indication

Self-administration attestation: Physician attestation that self-administration of the Xolair prefilled syringe by the patient or caregiver is not appropriate with documentation supporting one of the specified reasons (e.g., new to therapy requiring initial provider doses, history of anaphylaxis, prior therapy interrupted ≥6 months, inability to perform injections or recognize/treat anaphylaxis, or inadequate location for self-administration)

Nasal Polyps — Initial Therapy

Covered when ALL of the following are met

Diagnosis and symptom duration: Diagnosis of nasal polyps AND at least two symptoms for longer than 12 weeks (nasal obstruction/ congestion, mucopurulent discharge, facial pain/pressure/fullness, or reduction/loss of smell)>12 weeks

Objective findings: Findings of purulent mucus or edema in the middle meatus/ethmoid OR nasal endoscopy demonstrating polyps OR CT imaging showing mucosal thickening or sinus opacification

Prior therapy or surgical history: Patient has required systemic corticosteroids for nasal polyps in the previous 2 years OR has prior sinus surgery OR has failed trials of other therapies (intranasal corticosteroid plus another management therapy)

Concomitant therapy, exclusions, prescriber, and dosing:

IgE-Mediated Food Allergy — Initial Therapy

Covered when ALL of the following are met

Diagnosis of IgE-mediated food allergy to one or more foods

Age: Patient is aged ≥2 years>=2 years

Clinical history of type I reactions: History of type I allergic reactions (examples include nausea, vomiting, cramping, diarrhea, flushing, pruritus, urticaria, lip/face/throat swelling, wheezing, lightheadedness, syncope)

Diagnostic confirmation: IgE-mediated food allergy confirmed by at least one of: IgE antibody in vitro testing, food-specific skin prick testing, or oral food challenge

Initial Authorization — IgE-mediated Food Allergy

Covered when ALL of the following are met for provider-administered Xolair for IgE-mediated food allergy:

Patient-level requirements: Diagnosis of IgE-mediated food allergy to one or more foods; patient aged ≥2 years; history of type I allergic reactions (e.g., gastrointestinal, cutaneous, respiratory, or cardiovascular manifestations); confirmation of IgE-mediated food allergy by at least one of: in vitro IgE antibody testing, food-specific skin prick testing, or oral food challenge.

Concomitant management and safety: Xolair will be used in conjunction with food allergen avoidance; patient has access to epinephrine; and physician attestation that self-administration by patient/caregiver is not appropriate with documentation supporting one of the specified reasons (inability to recognize/treat anaphylaxis, prior anaphylaxis, inability to perform injections or adhere to regimen, or inadequate location for self-administration).

Prescriber, dosing, exclusions, and duration: Prescribed by an allergist or immunologist; dosing in accordance with FDA-approved labeling; patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitors for the same indication; initial authorization will be for no more than 12 months.<=12 months

Reauthorization/Continuation — IgE-mediated Food Allergy

Reauthorization covered when ALL of the following are met:

Clinical response: Documentation of positive clinical response to Xolair therapy (for example, reduction in type I allergic reactions),

Ongoing safety and concomitant therapy: Continued use in conjunction with food allergen avoidance; continued physician attestation that self-administration is not appropriate with supporting documentation as for initial authorization; patient not receiving Xolair in combination with excluded biologics for the same indication; dosing per FDA labeling; reauthorization will be for no more than 12 months.<=12 months

Prescriber requirement: Prescribed by an allergist or immunologist for continuation of care where specified.

Severe Allergic Asthma

Covered when ALL of the following indication-based trial or guideline-aligned conditions are met (per supporting text in these sections):

Severe allergic asthma (trial/guideline context)

Evidence of uncontrolled status: Uncontrolled symptoms or frequent exacerbations requiring systemic corticosteroids or hospitalization, or persistent poor control despite high-dose ICS+LABA

Chronic Idiopathic/Spontaneous Urticaria

Covered when ALL of the following are met:

Chronic spontaneous/idiopathic urticaria: Patient aged ≥12 years with chronic spontaneous/idiopathic urticaria who remains symptomatic despite approved doses of H1 antihistamines; clinical trial evidence (ASTERIA I) demonstrates efficacy of omalizumab 300 mg every 4 weeks for this population.Age ≥12 years; prior H1 antihistamine therapy failed

Nasal Polyps (Adults)

Covered when ALL of the following are met:

Chronic rhinosinusitis with nasal polyps (adult): Adult patient (≥18 years) with bilateral nasal polyps with total Nasal Polyp Score (NPS) ≥5 and ≥2 in each nostril AND persistent symptoms (for example, weekly average nasal congestion score above trial threshold) despite intranasal corticosteroid therapy (mometasone) during run-in; omalizumab demonstrated improvement in NPS and nasal congestion score in randomized trials. Prior INCS trial of at least 4 weeks and higher disease burden or comorbid asthma support biologic use per guidelines.NPS ≥5 total; NPS ≥2 per nostril; INCS trial ≥4 weeks

IgE-mediated Food Allergy

Considered investigational/conditionally supported when ALL of the following trial-aligned conditions are met:

IgE-mediated food allergy (trial evidence context): Pediatric patients allergic to peanut and at least two other foods demonstrated higher rates of passing DBPCFC after 16–20 weeks of Xolair versus placebo (primary endpoint: ability to consume a single dose of 2600 mg peanut protein without dose-limiting symptoms); extrapolation to adults based on disease and pharmacokinetic similarity. Trial primary and secondary endpoints showed significantly higher response rates with Xolair versus placebo for multiple foods.Primary endpoint: ability to consume ≥2600 mg peanut protein without dose-limiting symptoms

Indication-specific coverage criteria

Covered when criteria follow specialty guidelines and FDA labeling for respective indications

Asthma indication: Patients with moderate-to-severe persistent allergic asthma with positive perennial aeroallergen reactivity and inadequate control on inhaled corticosteroids; consider biomarker cutoffs to predict response (blood eosinophils approximately 150–260 cells/µL and FeNO ≈19.5 ppb).eosinophils ~150–260 cells/µL; FeNO ~19.5 ppb

Chronic rhinosinusitis with nasal polyps (CRSwNP): Patients with inadequate response to intranasal corticosteroids after at least 4 weeks and with higher disease burden or comorbid indications (e.g., asthma) — guidelines may prefer biologics such as omalizumab in selected patients.INCS trial >=4 weeks

Chronic spontaneous urticaria (CSU): Patients remaining symptomatic despite escalation of H1-antihistamine therapy (including higher-dose second-generation H1s and adjuncts); step-care guidance supports use of omalizumab or cyclosporine as next steps.

This policy applies to provider‑administered Xolair (omalizumab) given by subcutaneous injection. Self‑administered Xolair (prefilled syringe) is obtained under the pharmacy benefit and is therefore not governed by this provider‑administration policy.

Provider‑administered Xolair is unproven and not medically necessary for several conditions where evidence or labeling do not support its use. These include seasonal allergic rhinitis, perennial allergic rhinitis, acute bronchospasm or status asthmaticus, atopic dermatitis, and emergency treatment of allergic reactions including anaphylaxis.

Per the U.S. Food and Drug Administration labeling, Xolair (omalizumab) cannot be used to treat acute bronchospasm or status asthmaticus. Requests for use in those acute settings are inconsistent with the FDA label and the policy.

Xolair is not indicated for emergent treatment of allergic reactions, including anaphylaxis. Although FDA approval includes reduction of allergic reactions in food allergy when used as adjunctive therapy with avoidance, Xolair is not an appropriate agent for emergency management of acute allergic events.

For provider‑administered use, Xolair is considered unproven and not medically necessary for the listed non‑covered conditions. Specifically, coverage is not supported for seasonal or perennial allergic rhinitis, atopic dermatitis, acute bronchospasm or status asthmaticus, and for emergency treatment of allergic reactions including anaphylaxis. These exclusions reflect the policy’s interpretation of available evidence and FDA indications.

Use of Xolair outside FDA‑approved or guideline‑supported indications

Coding and Diagnostic Requirements

Applicable HCPCSHCPCS

J2357

Injection, omalizumab, 5 mg

Applicable ICD-like and other diagnosis codesmixed

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.

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Applicable ICD-10 diagnosis codes — updatedICD-10

Z91.0110	added ICD-10 code
Z91.0111	added ICD-10 code
Z91.0112	added ICD-10 code
Z91.0120	added ICD-10 code
Z91.0121	added ICD-10 code
Z91.0122	added ICD-10 code
Z91.011	removed ICD-10 code
Z91.012	removed ICD-10 code

Baseline serum total IgE — numeric range requirement for certain asthma indication

Baseline total serum IgE requirement>= 30 IU/mL and <= 1,300 IU/mL

ContextRequired as pre-omalizumab (baseline) measurement for asthma patients dependent on maintenance oral corticosteroids

Supporting eligibility notePositive perennial aeroallergen skin test or in vitro reactivity also required per asthma criteria

FEV1 percent predicted — criterion (asthma) < 80% predicted after bronchodilator

FEV1 threshold< 80% predicted after bronchodilator

Context

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization
Prior Authorization Required for Provider Administration
Provider-administered Xolair (omalizumab) requires prior authorization. Initial authorization for provider administration will be for no more than 12 months and dosing must follow FDA-approved labeling. Requests that exceed 12 months or that propose dosing outside FDA labeling may be denied.
Initial authorization: ≤ 12 months
Dosing must follow FDA labeling
Requests > 12 months may be denied

Documentation Required
Document Diagnosis-Specific Trial-Based Eligibility
Prior authorization requests must document diagnosis-specific trial-based eligibility consistent with the clinical criteria for each indication (e.g., asthma, chronic urticaria, nasal polyps, IgE-mediated food allergy). Documentation should include prior therapies tried, duration of trials, reasons for intolerance or contraindication (if applicable), and objective measures when required by the indication (e.g., ACT/ACQ scores or FEV1 for asthma).

Background and Clinical Context

Omalizumab (Xolair) is a monoclonal antibody that binds circulating immunoglobulin E (IgE), preventing IgE from binding to effector cells and thereby reducing mediator release. It is administered by subcutaneous injection and is indicated for several IgE‑mediated allergic conditions when used according to FDA labeling and specialty guidance.

Definitions and Clinical Thresholds

Uncontrolled or inadequately controlled asthma — definition and examples (ACQ/ACT thresholds, exacerbation history)

Definition of uncontrolled/inadequately controlled asthmaAsthma with poor symptom control (e.g., ACQ >1.5 or ACT <20), asthma-related emergency treatment, or >=2 systemic corticosteroid bursts of >=3 days in prior 12 months, or airflow limitation with post-bronchodilator FEV1 <80% predicted

Examples/measurement toolsACQ, ACT, documented ER visits/hospital admissions, unscheduled urgent visits, and spirometry (post-bronchodilator FEV1)

Implication for coverageThese elements are used to determine eligibility for omalizumab in moderate-to-severe persistent asthma

Baseline total serum IgE requirement (asthma maintenance OCS) — Pre-treatment total serum IgE >=30 IU/mL and <=1300 IU/mL

Baseline total serum IgE requirement (OCS-dependent asthma)>=30 IU/mL and <=1300 IU/mL

Policy Summary

PayerUnitedHealthcare

PolicyXolair (omalizumab) — Provider-Administered: Coverage Criteria

Policy CodePolicy CS2025D0033AD

Change TypeCoverage criteria revisedICD-10 updatesreferences updated

Effective Date10/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and document indication, prior therapies, and that any concurrent biologic use is for a different indication.

SourceLink

On This Page

Initial authorization duration: Initial authorization will be for no more than 12 months<=12 months

Patient will receive Xolair as add-on maintenance therapy in combination with intranasal corticosteroids AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitors for the same indication AND dosing per FDA label AND prescribed by an allergist/immunologist, otolaryngologist, or pulmonologist AND initial authorization ≤12 months

Self-administration attestation: Physician attestation that self-administration is not appropriate with required supporting documentation (reasons as specified, including new to therapy, prior interruption ≥6 months, inability to perform injections or manage anaphylaxis, or inadequate self-administration setting)

trial of antihistamine escalation

Food allergy indication (adjunct): Omalizumab may be used as an adjunct to reduce allergic reactions to accidental food exposures in certain patients as described in FDA labeling; must be used with allergen avoidance and is not for emergent treatment of anaphylaxis.age >=1 year per FDA labeling

Measured post-bronchodilator as evidence of airflow limitation for uncontrolled asthma

Role in criteriaOne of several indicators (with symptom scores, exacerbation history) defining uncontrolled or inadequately controlled asthma

Total serum IgE eligible range in key trials — 30 to 1,300 IU/mL

Trial-eligible IgE range30 to 1,300 IU/mL

Trial contextPatients with allergic asthma enrolled in key trials had total serum IgE between 30 and 1,300 IU/mL

ImplicationThis range informed pivotal study inclusion and subsequent labeling considerations

High IgE study range — >700 up to 2,000 IU/mL

High-IgE study range>700 up to 2,000 IU/mL

Study detailsRandomized study evaluated high-dose omalizumab in patients with IgE grouped as 700–2,000 IU/mL

Outcomes measuredEAR and suppression of FENO and serum free IgE were assessed in this high-IgE cohort

blood eosinophil threshold referenced for anti-IL-5 initiation — >=150 cells/µL

Anti-IL-5 initiation eosinophil threshold>=150 cells/µL

Source guidanceERS/ATS guideline cites a blood eosinophil cut-point of approximately 150 cells/µL to guide anti-IL-5 initiation

Role in phenotype selectionUsed to identify eosinophilic phenotype for anti-IL-5 therapy consideration

eosinophil and FeNO cut-offs to identify likelihood of response to anti-IgE — eosinophils >=260 cells/µL and FeNO >=19.5 ppb

Eosinophil and FeNO cut-offs for anti-IgE response likelihoodEosinophils >=260 cells/µL and FeNO >=19.5 ppb

Guideline contextERS/ATS summarized specific cut-offs to identify adolescents or adults with greatest likelihood of response to anti-IgE therapy

Use caseThese thresholds are guidance to predict higher probability of benefit from anti-IgE therapy, not absolute eligibility limits

Blood eosinophils — guidance cites ~150 to 260 cells/µL as cut points for predicting response

Blood eosinophil guidance range~150 to 260 cells/µL cited as cut points for predicting response

ContextGuidelines reference these approximate cut points when considering biologic selection for asthma phenotypes

InterpretationRanges are presented as guides to likelihood of response rather than strict coverage thresholds

Fractional exhaled nitric oxide (FeNO) — guidance cites ~19.5 ppb as a predictive cut-off

FeNO predictive cut-off~19.5 ppb

Guideline sourceERS/ATS identifies exhaled nitric oxide fraction (~19.5 ppb) as a cut-off to predict likelihood of response to anti-IgE

Clinical roleFeNO used alongside eosinophil counts and clinical features to inform biologic selection

Document prior therapies and trial durations
Provide objective measures where indicated (e.g., ACT, ACQ, FEV1, NPS, NCS)
State reasons for intolerance/contraindication if a standard therapy was not tried

Billing Rule
Prior Authorization and Code Updates
Providers must confirm the indication for use and include any applicable coding updates on the prior authorization request. The policy was updated effective 2025-10-01 to revise coverage language about combination therapy for the same indication and to update the list of applicable ICD-10 diagnosis codes.
Verify and submit the correct ICD-10 code(s) related to the treated indication
Policy number: CS2025D0033AD; Effective date: 2025-10-01

Prior Authorization
Duration and Combination Therapy Limits
Requests exceeding 12 months, or requests where the member is receiving Xolair in combination with another biologic for the same indication (anti-IL-4, anti-IL-5/5R, or TSLP inhibitors), may be denied. Concurrent use of Xolair with those agents for the same indication is not permitted under this policy. Ensure the submission clearly states whether concomitant biologic therapy is being used and the indication for each agent.
Maximum authorization duration: 12 months (initial and reauthorization limits)
Combination therapy exclusion: no concurrent anti-IL-4, anti-IL-5/5R, or anti-TSLP for the same indication
Requests showing combination biologic use for the same indication may be denied

Denial Risk
Acute Bronchospasm/Status Asthmaticus Exclusion
Per FDA labeling, Xolair is not indicated for the treatment of acute bronchospasm or status asthmaticus. Authorization for claims where Xolair is being used to treat an acute asthma exacerbation or status asthmaticus should be denied.
Do not use Xolair to treat acute bronchospasm/status asthmaticus
Authorization requests for emergent treatment of asthma exacerbations should be denied

Documentation Required
Nasal Polyps Documentation Requirements
For nasal polyps, prior authorization must document required trial elements used in the pivotal trials and labeling: total Nasal Polyp Score (NPS) ≥ 5 with ≥ 2 in each nostril (endoscopic assessment), and a baseline nasal congestion score above trial thresholds despite intranasal corticosteroid therapy. Also document prior systemic corticosteroid use in the past 2 years, prior sinus surgery, or failure of other therapies per policy. The request must indicate that Xolair will be used as add-on maintenance therapy in combination with intranasal corticosteroids.
Total NPS ≥ 5 with ≥ 2 per nostril (endoscopy)
Document average nasal congestion score consistent with trial inclusion despite intranasal corticosteroids
Document prior systemic corticosteroid use in past 2 years, prior sinus surgery, or failure of specified therapies
Confirm Xolair as add-on to intranasal corticosteroids

Step Therapy
Guideline-Based Step Placement
Professional society guidance supports placing biologic therapy as add-on treatment after standard stepped care for the relevant condition. For example, GINA and specialty guidelines recommend biologics for uncontrolled severe asthma despite optimized high-dose ICS-LABA and management of contributory factors; JTFPP and other societies recommend biologics (including omalizumab) for chronic rhinosinusitis with nasal polyposis when disease burden remains high despite intranasal corticosteroids. Submit documentation showing guideline-based step placement when applicable.
For asthma: document optimization of high-dose ICS-LABA and management of contributory factors prior to biologic
For nasal polyps: INCS trial ≥ 4 weeks and high disease burden before biologic
For chronic urticaria: demonstrate escalation of antihistamine therapy per guidelines

Step Therapy
Stepwise Therapy Expectations per Specialty Guidelines
The policy aligns with specialty stepwise therapy expectations: e.g., for chronic urticaria demonstrate antihistamine dose escalation (and trials of additional antihistamines, H2 agents, leukotriene modifiers or potent antihistamines) before biologic therapy; for asthma document failure on optimized controller therapy; for nasal polyps document INCS trial and prior systemics/surgery or failure of other therapies. Lack of documented stepwise care consistent with specialty guidelines is a common reason for denial.
Chronic urticaria: document antihistamine escalation and other stepwise trials per guideline
Asthma: document optimization of controller therapy and objective evidence of uncontrolled disease
Nasal polyps: document INCS trial and prior systemic steroid use or surgery or failure of specified therapies

Must be pre-omalizumab (baseline) measurement

Concurrent requirementPositive perennial aeroallergen skin test or in vitro reactivity required in asthma criteria

Omalizumab (omalizumab/ Xolair) — mechanism of action definition

Mechanism of actionMonoclonal antibody that binds to human IgE, preventing IgE from binding to effector cells and reducing mediator release

Pharmacologic effectReduces free serum IgE concentrations by >90% and suppresses eosinophils in induced sputum in clinical studies

Clinical implicationPrevents IgE-mediated cell activation and mediator release underlying allergic diseases treated with omalizumab

Uncontrolled asthma — operational definition (symptom control, exacerbations)

Operational definition of uncontrolled asthmaPoor symptom control (frequent symptoms or reliever use, activity limitation, night waking) and/or frequent exacerbations requiring OCS or hospitalization; not controlled despite optimized therapy

Relation to treatment stepsDifficult-to-treat and severe asthma defined by GINA as uncontrolled despite medium/high-dose ICS + second controller or maintenance OCS; biologics recommended for uncontrolled severe asthma

Use in policyThis operational definition informs eligibility for biologic add-on therapy including omalizumab

Nasal Polyp Score (NPS) — endoscopic scoring 0-4 per nostril (total 0-8) with study inclusion requiring total NPS >=5 and >=2 per nostril

Nasal Polyp Score (NPS) scaleEndoscopic scoring 0-4 per nostril (total 0-8)

Trial inclusion requirementStudy enrollment required total NPS >=5 and >=2 per nostril

Scoring details0 = no polyps; 1 = small polyps not reaching below middle turbinate inferior border; 2 = polyps reaching below lower border of middle turbinate; 3 = large polyps reaching lower border of inferior turbinate; 4 = large polyps causing complete obstruction

Xolair / omalizumab — anti-IgE therapy identifier

Therapy identifierXolair (omalizumab) — anti-IgE monoclonal antibody

Indications notedIndicated for moderate-to-severe persistent asthma, chronic idiopathic urticaria (>=12 years), nasal polyps (>=18 years), and IgE-mediated food allergy (>=1 year) per FDA

AdministrationGiven by subcutaneous injection; provider-administered vs self-administered pathways distinguished in policy

Biomarker thresholds (as discussed in guidelines) — blood eosinophil and FeNO cutoffs referenced as guides

Biomarker thresholds referencedBlood eosinophil and FeNO cutoffs cited as guides: eosinophils ~150–260 cells/µL; FeNO ~19.5 ppb

Guideline originDerived from ERS/ATS and summarized guideline recommendations for phenotype-directed biologic selection

Intended useThresholds serve as predictive guides for likelihood of response rather than absolute coverage exclusions