UnitedHealthcare Xolair Prior Auth Policy Update

Coverage and Medical Necessity Criteria

Initial Authorization — Moderate to severe persistent asthma

Covered when ALL of the following are met (pathway 1) OR when ALL of the alternative pathway criteria are met (pathway 2).

Asthma authorization pathways: Pathway A: Patient has been established on therapy with Xolair for moderate to severe persistent asthma under an active UnitedHealthcare medical benefit prior authorization AND documentation of positive clinical response to Xolair therapy AND Xolair is being used in combination with an ICS-containing maintenance medication AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies AND prescribed by an allergist, immunologist, or pulmonologist.

Pathway B: New start: Diagnosis of moderate to severe asthma AND classification of asthma as uncontrolled or inadequately controlled as defined by at least one of: poor symptom control (e.g., ACQ >1.5 or ACT <20), two or more systemic corticosteroid bursts (≥3 days each) in prior 12 months, asthma-related emergency treatment (ER/hospital/unscheduled urgent visit), airflow limitation (post-bronchodilator FEV1 <80% predicted with reduced FEV1/FVC), or current dependence on oral corticosteroids; AND submission of medical records documenting baseline (pre-omalizumab) serum total IgE ≥30 IU/mL and ≤1300 IU/mL AND positive skin test or in vitro reactivity to a perennial aeroallergen AND Xolair will be used in combination with a maximally dosed ICS/LABA or other specified controller regimens (plus one additional controller) AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies AND prescribed by an allergist, immunologist, or pulmonologist.

Reauthorization — Moderate to severe persistent asthma

Reauthorization covered when ALL of the following are met:

Asthma reauthorization: Documentation of positive clinical response to Xolair therapy (e.g., reduction in exacerbation frequency, decreased rescue medication use, increase in percent predicted FEV1 from pretreatment baseline, or reduction in severity/frequency of asthma symptoms) AND Xolair is being used in combination with an ICS-containing maintenance medication AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies.

Initial Authorization and Reauthorization — Chronic spontaneous urticaria

Covered when ALL of the following are met (pathway 1) OR when ALL of the alternative pathway criteria are met (pathway 2).

CSU authorization pathways: Pathway A: Patient has been established on therapy with Xolair for chronic urticaria under an active UnitedHealthcare medical benefit prior authorization AND documentation of positive clinical response to Xolair therapy AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies AND prescribed by an allergist, dermatologist, or immunologist.

Pathway B: New start: Diagnosis of chronic urticaria AND one of the following: patient remains symptomatic despite at least a 2-week trial of, or has contraindication/intolerance to, two H1-antihistamines OR patient remains symptomatic despite at least a 2-week trial of, or has contraindication/intolerance to, combination therapy with a second-generation H1-antihistamine plus an additional agent; AND trial of an additional agent from a different second-generation H1-antihistamine, a first-generation H1-antihistamine, an H2-antihistamine, or a leukotriene modifier AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies AND prescribed by an allergist, dermatologist, or immunologist.

CSU reauthorization: Documentation of positive clinical response to Xolair therapy AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies.

Initial Authorization — Chronic rhinosinusitis with nasal polyps (CRSwNP)

Covered when ALL of the following are met:

CRSwNP initial authorization (established therapy): Patient has been established on therapy with Xolair for nasal polyps under an active UnitedHealthcare medical benefit prior authorization AND documentation of positive clinical response to Xolair therapy AND patient will continue to 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 inhibitor therapies AND prescribed by an allergist, immunologist, otolaryngologist, or pulmonologist.

Initial Therapy - Nasal Polyps

Covered when ONE of the following initial authorization pathways is met:

Pathway A: Patient has been established on Xolair for nasal polyps under an active UnitedHealthcare medical benefit prior authorization. (Requires documentation of positive clinical response and continued use as add-on maintenance with intranasal corticosteroids; patient must not be receiving specified biologics concurrently and prescriber specialties are specified.)

Pathway B (new start): Diagnosis of nasal polyps with two or more symptoms for longer than 12 weeks (e.g., nasal mucopurulent discharge; nasal obstruction/blockage/congestion; facial pain/pressure/fullness; reduction or loss of sense of smell) AND objective findings on nasal endoscopy or sinus CT (e.g., purulent mucus/edema in middle meatus/ethmoid, polyps in nasal cavity/middle meatus, or radiographic mucosal thickening or opacification) AND one of: failure of intranasal corticosteroids plus one other therapy (e.g., nasal saline irrigation or antileukotriene) OR required systemic corticosteroids for nasal polyps in previous 2 years OR prior sinus surgery; AND 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 inhibitor therapies AND prescribed by an allergist, immunologist, otolaryngologist, or pulmonologist.symptoms >12 weeks

Reauthorization - Nasal Polyps

Reauthorization requires all of the following:

Reauth Nasal Polyps: Documentation of positive clinical response to Xolair therapy AND patient will continue to 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 inhibitor therapies.

Initial Therapy - IgE-Mediated Food Allergy

Covered when ONE of the following initial authorization pathways is met:

Pathway A - Established therapy: Patient has been established on therapy with Xolair for IgE-mediated food allergy under an active UnitedHealthcare medical benefit prior authorization AND documentation of positive clinical response to Xolair therapy; 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 therapies; prescribed by an allergist or immunologist.

Pathway B - New start: Diagnosis of IgE-mediated food allergy to one or more foods AND confirmation by history of type I allergic reaction AND one confirmatory test (food-specific skin prick testing, IgE antibody in vitro testing, or oral food challenge) AND Xolair will be used in conjunction with food allergen avoidance AND patient has access to epinephrine AND patient is aged ≥ 1 year AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies AND prescribed by an allergist or immunologist.

Reauthorization - IgE-Mediated Food Allergy

Reauthorization requires ALL of the following:

Reauth Food Allergy: Documentation of positive clinical response to Xolair therapy (e.g., reduction in type I allergic reactions) AND continued use in conjunction with food allergen avoidance AND patient has access to epinephrine AND patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitor therapies AND prescribed by an allergist or immunologist.

Use of Xolair for acute bronchospasm, status asthmaticus, the emergency treatment of allergic reactions (including anaphylaxis), or for other forms of urticaria not specified in the indications is outside the labeled indications and is a limitation of use. Requests for coverage for these acute or emergency indications may be denied as they are not supported by the policy's approved indications.

Xolair must not be used concurrently with specified biologic therapies. Patients who are receiving Xolair in combination with an anti‑interleukin‑4 agent (e.g., dupilumab), an anti‑interleukin‑5 agent (e.g., mepolizumab, reslizumab, benralizumab), or a thymic stromal lymphopoietin (TSLP) inhibitor (e.g., tezepelumab) are ineligible for approval across the indicated conditions. Concomitant administration with these classes of biologics will preclude coverage.

Use of Xolair outside the specific, FDA‑labeled and policy‑listed indications (for example, for acute or emergency allergic reactions, acute bronchospasm/status asthmaticus, or for forms of urticaria not included in the chronic spontaneous urticaria indication) is not supported by the indications and is considered not medically necessary under this policy.

Drug Formulations, Codes, and Key Clinical Values

Covered NDC/formulationsNDCCovered

NDC	Prefilled syringe and prefilled autoinjector formulations of Xolair (omalizumab) — self-administered subcutaneous use

Baseline serum total IgE — Asthma threshold

Baseline serum total IgE (as required for asthma pathway)>= 30 IU/mL and <= 1300 IU/mL

Documentation timingBaseline (pre-omalizumab) serum total IgE must be submitted with medical records

Measurement unitsIU/mL

PurposeUsed to determine eligibility for initial authorization in moderate to severe persistent asthma pathway

Provider Requirements, Documentation, and Exclusions

Prior Authorization

Prior Authorization Required / Safety Exclusions

Prior authorization is required and will be granted when indication-specific clinical criteria are met. Xolair is not indicated for acute bronchospasm, status asthmaticus, or emergency treatment of allergic reactions (including anaphylaxis); these uses should not be submitted for authorization.

Do not submit for acute bronchospasm or status asthmaticus.
Do not submit for emergency treatment of allergic reactions or anaphylaxis.

Prior Authorization

Initial Authorization — Established on Therapy Allowed

Initial authorization requires meeting indication-specific criteria OR documentation that the patient was already established on Xolair under an active UnitedHealthcare medical benefit prior authorization for the same indication.

Established-on-therapy pathway: documentation that the member was receiving Xolair under an active UnitedHealthcare medical benefit prior authorization for the specific indication (asthma, chronic urticaria, nasal polyps, IgE-mediated food allergy) is acceptable in lieu of meeting all new-start criteria.

Key Definitions

Chronic spontaneous urticaria (CSU)

DefinitionChronic spontaneous urticaria (CSU): persistent hives/itching despite H1 antihistamine treatment

Minimum age for indication12 years of age and older

Typical prescribersAllergist, dermatologist, or immunologist (per coverage criteria)

CRSwNP (Chronic rhinosinusitis with nasal polyps)

DefinitionChronic rhinosinusitis with nasal polyps (CRSwNP): nasal polyps in adult patients with inadequate response to nasal corticosteroids, considered for add-on maintenance treatment

Minimum age for indication18 years of age and older

Clinical Background

Omalizumab (Xolair) is an anti‑IgE monoclonal antibody indicated as add‑on therapy for multiple IgE‑mediated and type‑2 inflammatory conditions in age‑appropriate patients, including moderate to severe persistent asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE‑mediated food allergy. The policy specifies clinical criteria, required concomitant controller therapies, and documentation (for example, baseline serum total IgE thresholds for asthma) to establish medical necessity. Importantly, Xolair is not indicated for acute bronchospasm, status asthmaticus, or emergency treatment of allergic reactions such as anaphylaxis.

Policy Revision History

2025-04annual_reviewLatest

Annual review completed with no changes to coverage criteria.

2024-06criteria_expansion

Expanded coverage of Xolair for IgE-mediated food allergy to include all foods.

2024-05criteria_update

OpenPayer

Xolair (omalizumab) prior authorization and medical necessity