ModifiedUnitedHealthcarePolicy 2025D0033AC

Xolair (omalizumab) — provider‑administered therapy

Governs medical-benefit coverage, medical necessity criteria, and reauthorization requirements for provider‑administered subcutaneous Xolair (omalizumab) for UnitedHealthcare members (provider‑administered; self‑administered covered under pharmacy benefit unless specified).

Policy Summary

PayerUnitedHealthcare

PolicyXolair (omalizumab) — provider‑administered therapy

Policy CodePolicy 2025D0033AC

Change TypeMaterial updates to benefit routing, concomitant therapy language, and ICD-10 code list

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for provider‑administered Xolair with approvals limited to a maximum of 12 months and confirm benefit routing (pharmacy vs medical) per the member's plan.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that self-administered subcutaneous Xolair may be obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise; and a special note for UnitedHealthcare of California delegated provider groups.

Replaced criterion requiring the patient not receive any of the listed therapies in combination with Xolair with the more specific requirement that the patient is not receiving those therapies in combination with Xolair for treatment of the same indication.

Updated list of applicable ICD-10 diagnosis codes (annual edits): added several Z91.* codes and removed prior Z91.011 and Z91.012 codes.

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

4Covered indications listed

12 monthsMax authorization

30–1300 IU/mLIgE eligibility range

up to 2000Efficacy noted at high IgE

Coverage Criteria for Provider‑Administered Xolair (omalizumab)

Moderate to Severe Persistent Asthma — Initial Therapy

Covered when ALL of the following are met:

Asthma severity and control: Diagnosis of moderate or severe persistent asthma that is uncontrolled or inadequately controlled as defined by at least one of: poor symptom control (e.g., ACQ >1.5 or ACT <20), asthma-related emergency treatment (ER visit, hospitalization, or unscheduled urgent visit requiring nebulizer/urgent treatment), two or more systemic corticosteroid bursts (>=3 days each) in the prior 12 months, or airflow limitation (post-bronchodilator FEV1 <80% predicted with reduced FEV1/FVC)

IgE and allergen evidence: Baseline (pre-omalizumab) serum total IgE >= 30 IU/mL and <= 1300 IU/mL AND positive skin test or in vitro reactivity to a perennial aeroallergenIgE 30–1300 IU/mL

Documentation of baseline total serum IgE and perennial aeroallergen sensitization required

Maintenance therapy optimization: Symptoms inadequately controlled despite maintenance therapy with inhaled corticosteroids and use in combination with a maximally dosed age-appropriate ICS–LABA product or a maximally dosed ICS plus at least one additional controller medication

Document trials of maximal appropriate controller therapy (ICS–LABA or high‑dose ICS plus additional controller)

Concomitant biologic exclusion: Patient is not receiving Xolair in combination with anti‑IL‑5 agents, anti‑IL‑4 therapy, or TSLP inhibitors for treatment of the same indication

Concurrent use of listed biologics for the same indication is not allowed

Dosing and prescriber: Dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months; prescribed by an allergist/immunologist or pulmonologist<=12 months

Prescriber specialty and FDA-concordant dosing required

Chronic Urticaria — Initial Therapy

Covered when ALL of the following are met:

Diagnosis and symptomatic status: Diagnosis of chronic urticaria (chronic spontaneous/idiopathic urticaria) with ongoing symptoms despite antihistamine therapy

Chronic urticaria defined as recurrent urticaria/angioedema for ≥6 weeks

Prior therapy requirement: Patient remains symptomatic despite at least a 2‑week trial of, or has contraindication/intolerance to, antihistamine regimens: either two different second‑generation H1 antihistamines OR combination regimens (e.g., second‑generation H1 agents plus H2 antagonist, first‑generation H1, or leukotriene modifier)

Follow JTFPP step-care: consider dose escalation of second‑generation H1 agents before biologic

Concomitant biologic exclusion and prescriber: Patient is not receiving Xolair in combination with anti‑IL‑4, anti‑IL‑5, or TSLP inhibitors for treatment of the same indication; dosing per FDA labeling; prescribed by an allergist/immunologist or dermatologist; initial authorization up to 12 months<=12 months

Nasal Polyps (CRSwNP) — Initial Therapy

Covered when ALL of the following are met:

Diagnosis and symptom duration: Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) with two or more specified symptoms for longer than 12 weeks (e.g., nasal mucopurulent discharge; facial pain/pressure/fullness; nasal obstruction/congestion; reduction or loss of sense of smell)>12 weeks

Objective findings: Either purulent mucus or edema in the middle meatus/ethmoid regions OR endoscopic or CT evidence of mucosal thickening or sinus opacification

Endoscopic/CT findings or exam evidence support diagnosis

Prior treatment or severity: Inadequate response to intranasal corticosteroids AND at least one of: failure of other medical therapies (e.g., saline irrigations, antileukotrienes), prior sinus surgery, or requirement for systemic corticosteroids for CRSwNP in the previous 2 years

Documentation of ongoing intranasal corticosteroid use required when omalizumab used as add-on maintenance

IgE‑Mediated Food Allergy — Initial Therapy

Covered when ALL of the following are met:

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

Diagnosis confirmation: Diagnosis of IgE‑mediated food allergy confirmed by history of type I allergic reactions PLUS food‑specific testing (skin prick testing or oral food challenge)

Document clinical history and confirmatory testing

Concomitant management and access: Xolair will be used in conjunction with food allergen avoidance and the patient has access to epinephrine

Allergen avoidance and epinephrine availability required

Concomitant biologic exclusion and prescriber:

Initial Authorization — IgE-mediated food allergy (provider administration)

Covered when ALL of the following are met

Initial authorization criteria: Xolair will be used in conjunction with food allergen avoidance; patient has access to epinephrine; dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months; prescribed by an allergist or immunologist; patient is not receiving Xolair in combination with specified biologics for the same indication.<=12 months

Excluded concurrent biologics listed include anti-IL-4 (dupilumab), anti-IL-5 agents, and TSLP inhibitors (tezepelumab)

Reauthorization/Continuation — IgE-mediated food allergy (provider administration)

Reauthorization approved when ALL of the following are met

Reauthorization criteria: Xolair will be used in conjunction with food allergen avoidance; documentation of positive clinical response to Xolair therapy (e.g., reduction in type I allergic reactions); patient has access to epinephrine; dosing is in accordance with FDA-approved labeling; reauthorization will be for no more than 12 months; prescribed by an allergist or immunologist; patient is not receiving Xolair in combination with specified biologics for the same indication.<=12 months

Excluded concurrent biologics include anti-IL-4, anti-IL-5 agents, and TSLP inhibitors

Unproven / Not Medically Necessary indications

The following uses are considered unproven and not medically necessary

Unproven indications: Seasonal allergic rhinitis; perennial allergic rhinitis; acute bronchospasm or status asthmaticus; atopic dermatitis; emergency treatment of allergic reactions, including anaphylaxis.

These indications are listed as unproven/not medically necessary per policy

Covered indications per evidence and FDA labeling

Covered when criteria specific to the FDA indications and professional-society-recommended stepwise therapy are met

Asthma (FDA indication): Patient is ≥6 years old AND has moderate to severe persistent allergic asthma with positive skin test or in vitro reactivity to a perennial aeroallergen AND symptoms inadequately controlled with inhaled corticosteroidsage >=6

FDA indication; professional guidance defines uncontrolled asthma and supports add-on anti-IgE for severe allergic asthma

Chronic idiopathic/spontaneous urticaria (CIU/CSU): Patient is ≥12 years old AND remains symptomatic despite H1-antihistamine treatment including dose escalation or combination regimensage >=12

Omalizumab demonstrated efficacy (300 mg q4w) in antihistamine-refractory CIU/CSU per JTFPP guidance

Chronic rhinosinusitis with nasal polyps (CRSwNP):

Covered Indications and Context

Covered when used for FDA‑approved indications and consistent with policy criteria and benefit routing.

FDA Indication Context: Use aligns with FDA‑approved indications described: allergic asthma (≥6 years) with perennial aeroallergen sensitivity inadequately controlled on inhaled corticosteroids; chronic idiopathic urticaria (≥12 years) refractory to H1 antihistamines; CRSwNP (≥18 years) with inadequate response to nasal corticosteroids; IgE‑mediated food allergy (≥1 year) to reduce reactions with accidental exposure.

FDA informational section is for context; coverage requires meeting policy criteria

Chronic Urticaria Treatment Pathway: Per 2014 JTFPP step-care, escalate H1-antihistamine dose and consider combination/additional agents before omalizumab; omalizumab and cyclosporine have greatest published experience for antihistamine-refractory CU

Reflects professional-society recommended stepwise approach

Concomitant Therapy Restriction: Patient must not be receiving the listed biologic therapies in combination with Xolair for treatment of the same indication (policy language revised to specify 'for the same indication').

Self‑administered subcutaneous Xolair (omalizumab) obtained under the pharmacy benefit is not governed by this provider‑administered medical‑benefit policy except where a member's benefit plan specifies otherwise. For members enrolled in UnitedHealthcare of California plans with delegated provider groups conducting authorization review, self‑administered Xolair may be obtained under the medical benefit per plan direction. Confirm benefit routing with the member's plan documents before submitting a medical‑benefit prior authorization request.

The following indications are considered unproven and are listed as not medically necessary for provider‑administered Xolair: seasonal allergic rhinitis and perennial allergic rhinitis. Evidence is limited and inconsistent despite some small trials and meta‑analyses suggesting symptomatic benefit; larger, definitive trials and economic analyses are lacking. Also considered unproven/not medically necessary are atopic dermatitis and use for the emergent treatment of allergic reactions, including anaphylaxis.

Xolair is not indicated for the treatment of acute bronchospasm or status asthmaticus. The FDA label requires that Xolair not be used for these acute, emergent conditions; use for acute bronchospasm/status asthmaticus is therefore excluded from coverage under this policy and would be a denial trigger if billed as treatment for those conditions.

Additional exclusions include use of Xolair for conditions not supported by FDA labeling or insufficient evidence. Specifically, Xolair is not indicated for other forms of urticaria beyond chronic idiopathic/spontaneous urticaria, for rhinosinusitis without nasal polyps, or for emergent/anaphylactic treatment. These emergent uses and non‑FDA indications are considered unproven and not medically necessary.

Concurrent administration of Xolair with other biologic agents for the same indication is not permitted. Patients must not be receiving Xolair in combination with anti‑IL‑5 agents (e.g., mepolizumab, reslizumab, benralizumab), anti‑IL‑4 therapy (e.g., dupilumab), or TSLP inhibitors (e.g., tezepelumab) for treatment of the same condition.

Uses that are unproven, lack sufficient evidence, or fall outside FDA‑approved indications — such as allergic rhinitis, atopic dermatitis, emergent treatment of anaphylaxis, and acute bronchospasm/status asthmaticus — are considered not medically necessary and are excluded from coverage under this policy.

Omalizumab (Xolair) is approved for several IgE‑mediated or type‑2 inflammatory indications but many proposed uses remain off‑label. The policy reflects the evidence base: randomized trials and systematic reviews support efficacy for select indications (e.g., allergic asthma, chronic idiopathic urticaria, CRSwNP, and reduction of reactions in IgE‑mediated food allergy), while studies in other conditions are small, open‑label, or inconsistent. Coverage is therefore limited to FDA‑listed indications and situations meeting the policy's documented clinical criteria.

This policy does not support use of Xolair for forms of urticaria other than chronic idiopathic/spontaneous urticaria. Likewise, Xolair is not supported for emergent management of allergic reactions or anaphylaxis; it is intended as a long‑term, preventive biologic rather than an emergency therapy and patients treated with Xolair must still have access to epinephrine and appropriate acute care.

For indications that require baseline testing, eligibility includes a documented pre‑treatment total serum IgE within the policy range and evidence of perennial sensitization where specified. For example, patients with moderate‑to‑severe persistent allergic asthma must have baseline total serum IgE ≥30 IU/mL and ≤1300 IU/mL and demonstrate positive skin prick testing or in‑vitro reactivity to a perennial aeroallergen prior to initiation of provider‑administered Xolair.

Coding and Diagnostic Criteria

Applicable HCPCSHCPCS

J2357

Injection, omalizumab, 5 mg

Applicable ICD-10 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.

1–10 of 24

1/3

Covered codesmixed

No codes listed

Applicable ICD-10 diagnosis codes (edits noted)ICD-10

Z91.0110	added (as per policy changes)
Z91.0111	added (as per policy changes)
Z91.0112	added (as per policy changes)
Z91.0120	added (as per policy changes)
Z91.0121	added (as per policy changes)
Z91.0122	added (as per policy changes)
Z91.011	removed (prior code)
Z91.012	removed (prior code)

inv-22: Baseline total serum IgE

Baseline total serum IgE (as eligibility range)≥ 30 IU/mL and ≤ 1300 IU/mL

PurposeRequired baseline (pre-omalizumab) total IgE for moderate-to-severe persistent allergic asthma eligibility

Source contextSpecified in asthma coverage criteria and initial authorization requirements

inv-23: IgE level (study eligibility/dosing table constraints)

Common trial enrollment IgE range30 to 1300 IU/mL used in major asthma trials (e.g., ICATA)

Evidence for higher IgE

Provider Actions, Prior Authorization & Denial Triggers

Prior Authorization

Prior Authorization Required — Initial Approvals

Prior authorization is required for initial requests. Initial approvals will be for up to 12 months; confirm dosing is consistent with FDA‑approved labeling and prescriber specialty requirements.

Initial authorizations ≤ 12 months
Prescribed by appropriate specialist (e.g., allergist/immunologist, pulmonologist, dermatologist, otolaryngologist depending on indication)

Documentation Required

Indication and Age Confirmation Required

Requests for Xolair administered by the provider require documentation of the indication and the member's age consistent with FDA labeling or the policy's age criteria.

Background and Definitions

Omalizumab (Xolair) is a monoclonal anti‑IgE antibody that binds circulating IgE and prevents IgE from interacting with effector cells, thereby reducing allergic inflammatory responses. It is administered subcutaneously by a healthcare professional for FDA‑listed IgE‑mediated and type‑2 inflammatory indications and is used as add‑on maintenance therapy in those settings.

inv-48: Uncontrolled or inadequately controlled asthma

Definition (policy)Asthma classified as uncontrolled or inadequately controlled by at least one of: poor symptom control (e.g., ACQ > 1.5 or ACT < 20), asthma-related emergency care, ≥2 systemic corticosteroid bursts in prior 12 months, or airflow limitation (post-bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC)

Examples of uncontrolled featuresEmergency room visit, hospital admission, unscheduled office visit for urgent treatment, or frequent reliever use/activity limitation/night waking

Measurement instrumentsACQ and ACT thresholds explicitly cited (ACQ >1.5; ACT <20) as examples of poor symptom control

inv-49: Baseline total serum IgE eligibility

Policy Summary

PayerUnitedHealthcare

PolicyXolair (omalizumab) — provider‑administered therapy

Policy CodePolicy 2025D0033AC

Change TypeMaterial updates to benefit routing, concomitant therapy language, and ICD-10 code list

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for provider‑administered Xolair with approvals limited to a maximum of 12 months and confirm benefit routing (pharmacy vs medical) per the member's plan.

SourceLink

On This Page

Concurrent biologic therapy for the same indication is excluded

Combination therapy and exclusions: Xolair to be used as add-on maintenance with intranasal corticosteroids; patient is not receiving Xolair in combination with anti‑IL‑5, anti‑IL‑4, or TSLP inhibitors for the same indication; dosing per FDA labeling; prescribed by an allergist/immunologist, otolaryngologist, or pulmonologist; initial authorization up to 12 months<=12 months

Baseline bilateral NPS (e.g., per-trial NPS >=2 per nostril and total NPS >=5) supports severity

Patient is not receiving Xolair in combination with anti‑IL‑4, anti‑IL‑5, or TSLP inhibitors for treatment of the same indication; dosing per FDA labeling; initial authorization up to 12 months; prescribed by an allergist or immunologist

Concurrent biologic therapy for same indication excluded

Patient is ≥18 years old AND has inadequate response to intranasal corticosteroids AND bilateral nasal polyps with trial entry severity (e.g., per-nostril NPS >=2 and total NPS >=5) and persistent symptoms

Trials required background nasal corticosteroid (mometasone) and specific NPS/NCS entry criteria

IgE-mediated food allergy: Patient (pediatric or adult) with documented IgE-mediated food allergy at risk for accidental exposure used in conjunction with allergen avoidance with intent to reduce allergic reactions including anaphylaxisnone

Evidence showed increased tolerance to target protein doses (e.g., peanut) in trials

Clarifies permissible concomitant therapies across indications

Retrospective and other evidence presented showing clinical response in patients with IgE >700 IU/mL and efficacy data discussed up to 2000 IU/mL

Implication for dosing/eligibilityPolicy retains 30–1300 IU/mL eligibility but cites evidence for benefit above trial ranges

inv-24: Exhaled nitric oxide fraction (FeNO)

FeNO suggested cut-off≥ 19.5 ppb

Use in phenotype assessmentFeNO recommended by professional societies as a biomarker to guide Type 2/eosinophilic phenotype assessment

ContextReferenced alongside other biomarkers when considering add-on biologic therapy

inv-25: Blood eosinophil suggested cut-off

Blood eosinophil suggested cut-off≥ 150 cells/µL (referenced as a threshold to guide anti-IL‑5 therapy selection)

RoleUsed to phenotype eosinophilic asthma and guide biologic selection in professional society guidance

Policy noteThreshold cited in context of phenotype selection; omalizumab eligibility uses IgE and allergen sensitization rather than eosinophil count

Confirm age per indication (e.g., asthma ≥6 years, chronic urticaria ≥12 years, nasal polyps ≥18 years, IgE‑mediated food allergy ≥1 or per policy sections)

Document primary diagnosis supporting use

Billing Rule

Benefit Routing for Self‑Administered Xolair — Verify Benefit

Self-administered Xolair is generally obtained under the pharmacy benefit unless the member's benefit plan specifies medical benefit routing. Exception: certain UnitedHealthcare of California delegated-review plans may authorize self‑administered Xolair under the medical benefit. Always verify member‑specific benefit plan for benefit routing before submitting requests.

Pharmacy benefit routing is default for self-administered Xolair
Check member-specific plan and state/federal plan applicability
UnitedHealthcare of California delegated provider groups may route to medical benefit

Denial Risk

Requests for Self‑Administered Xolair — Routing Risk

Requests for self-administered Xolair may be routed incorrectly between pharmacy and medical benefits. Confirm routing before authorization to avoid delays or denials.

If plan documents are ambiguous, contact the payer to confirm benefit routing
Requests from delegated-review plans may follow alternate routing rules

Prior Authorization

Concurrent Biologic Therapy Restriction

Do not combine Xolair with certain biologics for treatment of the same indication. Concurrent use with anti‑IL‑5/5R agents, anti‑IL‑4 agents, or anti‑TSLP therapies for the same indication is not allowed.

Examples: mepolizumab, reslizumab, benralizumab (anti‑IL‑5); dupilumab (anti‑IL‑4); tezepelumab (anti‑TSLP)
Concurrent biologic use for different indications may require separate review/documentation

Step Therapy

Documented Prior Therapy Trials Required — Chronic Urticaria Step‑Care

For chronic urticaria, document trials of step‑care therapy per guideline recommendations before initiating Xolair. Include evidence of trials or contraindications to at least two second‑generation H1 antihistamines and escalation steps per the JTFPP (e.g., dose up‑titration, addition of H2 antagonist or leukotriene modifier) where applicable.

Document at least 2‑week trials of second‑generation H1 antihistamines unless contraindicated
If used, document trials of higher‑dose second‑generation antihistamine, H2 antagonists, leukotriene modifiers, or rationale for intolerance/contraindication

Documentation Required

Baseline Serum Total IgE and Allergen Sensitization Required

Obtain a baseline (pre‑treatment) serum total IgE value and documentation of perennial aeroallergen sensitization when required by the indication (e.g., allergic asthma). Baseline total IgE must be ≥ 30 IU/mL and ≤ 1300 IU/mL where specified.

Report baseline serum total IgE (value and date)
Provide positive skin test or in vitro reactivity to a perennial aeroallergen when required

Documentation Required

Nasal Polyps — Baseline Severity and Prior Therapy Documentation

For nasal polyps, include documentation of inadequate response to nasal corticosteroids, baseline nasal polyp score (NPS) or other objective severity assessments, symptom duration (>12 weeks), and prior medical or surgical therapies (e.g., prior sinus surgery or systemic corticosteroid use within 2 years) as applicable.

Document failure of adequate nasal corticosteroid therapy
Provide NPS or endoscopic/CT findings when available (e.g., total NPS ≥4 with ≥2 in each nostril per trial inclusion criteria)
Document prior sinus surgery or systemic corticosteroid use for CRSwNP when applicable

Documentation Required

IgE‑Mediated Food Allergy — Initial Requirements

For IgE‑mediated food allergy, document patient age per policy (generally ≥1 or as specified), confirmation of IgE‑mediated allergy (history of type I reactions and confirmatory testing such as skin prick testing, specific IgE, or oral food challenge), evidence of food allergen avoidance counseling, and access to epinephrine.

Confirm patient age meets policy criteria (e.g., pediatric age thresholds)
Provide documentation of allergic history and confirmatory testing (SPT, specific IgE, or OFC)
Document food avoidance counseling and that the patient has access to epinephrine

Documentation Required

Initial Authorization — Required Documentation

Initial authorization requests must include documentation of avoidance measures (for food allergy), access to epinephrine (when applicable), confirmatory testing, indication‑consistent dosing, and any other policy‑specified baseline data.

Include dosing consistent with FDA labeling
Provide evidence of avoidance measures and epinephrine access for food allergy indications
Attach baseline labs and diagnostic test results required by the specific indication

Documentation Required

Reauthorization — Documentation of Clinical Response Required

Reauthorization requests must document continued clinical benefit (e.g., reduction in allergic reactions, improved urticaria control, reduced exacerbations or corticosteroid bursts, or objective improvement in nasal polyp scores), adherence to therapy, and ongoing access to required supports (e.g., epinephrine). Reauthorizations are for no more than 12 months.

Document measurable clinical response to Xolair since initiation
Confirm continued access to epinephrine where applicable
Reauthorization approvals ≤ 12 months

Denial Risk

Acute Bronchospasm / Status Asthmaticus Exclusion

Xolair is not indicated for acute bronchospasm or status asthmaticus. Use in these emergent settings is contraindicated and will not be covered.

Requests for use during acute exacerbations or status asthmaticus will be denied

Denial Risk

Denial Triggers — What May Cause a Denial

Denial triggers include non‑FDA dosing, missing required documentation (e.g., baseline IgE, confirmatory testing, prior therapy trials), prescriber specialty not aligned with indication, or concurrent biologic therapy for the same indication without justification.

Non‑FDA dosing or dosing documentation absent
Missing baseline labs or confirmatory tests
Prescriber specialty not consistent with policy requirements
Concurrent use with disallowed biologics for the same indication

Note

Verify Member‑Specific Benefit Plan Before Deciding Coverage

Always verify the member‑specific benefit plan and applicable federal/state plan applicability before making coverage decisions. In case of conflict, the member's benefit plan governs.

Member specific plan documents and state/federal mandates may override standard policy language
Contact payer for clarifications when plan documents are unclear

Eligibility numeric range (asthma)Baseline (pre-omalizumab) total serum IgE ≥ 30 IU/mL and ≤ 1300 IU/mL

Applies toModerate-to-severe persistent allergic asthma with perennial aeroallergen sensitization

Documentation requirementBaseline serum total IgE must be documented for authorization

inv-50: Omalizumab

Agent descriptionOmalizumab is a monoclonal anti‑IgE antibody that binds circulating IgE and prevents IgE binding to effector cells, reducing allergic inflammatory responses

AdministrationSubcutaneous injection administered by a healthcare professional (provider‑administered policy applies)

Indications overviewUsed as add-on therapy for several IgE-mediated and Type 2 inflammatory conditions per FDA labeling

inv-51: Chronic spontaneous urticaria (CSU)

DefinitionChronic spontaneous urticaria (CSU) is recurrent urticaria and/or angioedema for ≥6 weeks without an apparent external trigger

Clinical courseSymptoms persist long-term and may include hives, wheals, and angioedema; estimated ~1% lifetime adult prevalence

Treatment contextFirst-line therapy is H1-antihistamines with stepwise dose escalation per JTFPP; omalizumab considered for antihistamine-refractory CSU

inv-52: Uncontrolled asthma

Symptom-based definitionUncontrolled asthma includes frequent symptoms or reliever use, activity limitation, night waking, and/or frequent exacerbations requiring oral corticosteroids or hospitalization

Objective criteriaAlso includes airflow limitation (post-bronchodilator FEV1 <80% predicted with reduced FEV1/FVC) and recent systemic steroid bursts

Clinical measurement examplesACQ >1.5 or ACT <20 cited as examples of poor symptom control

inv-53: Nasal Polyp Score (NPS)

NPS definition and scaleEndoscopic nasal polyp score (NPS) graded 0–4 per nostril (total 0–8)

Trial entry thresholdsTrials commonly required total NPS ≥5 and per‑nostril NPS ≥2 despite intranasal corticosteroid use

Scoring description0 = no polyps; 1 = small polyps not reaching below middle turbinate; 2 = polyps reaching below lower border of middle turbinate; 3 = large polyps reaching lower border of inferior turbinate; 4 = complete obstruction

inv-54: Chronic Idiopathic (Spontaneous) Urticaria

DefinitionChronic idiopathic (spontaneous) urticaria is urticaria persisting ≥6 weeks where H1-antihistamines are first-line therapy

When to consider omalizumabPatients remaining symptomatic despite antihistamine treatment (including dose escalation) may be candidates for omalizumab or cyclosporine per JTFPP step-care

Guideline reference2014 JTFPP practice parameter recommends stepwise antihistamine escalation before biologic therapy

inv-55: Indications (FDA-described in fragment)

FDA-described indications (summary)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) — per FDA informational section

Coverage caveatFDA approvals are informational; policy ties coverage to specified clinical criteria and documentation

Safety noteXolair is not indicated for acute bronchospasm or status asthmaticus and is not for emergent treatment of allergic reactions/anaphylaxis