CurrentUnitedHealthcarePolicy N/A

Xolair (omalizumab) prior authorization and medical necessity

Defines UnitedHealthcare's prior authorization and medical necessity criteria for Xolair (omalizumab) subcutaneous prefilled syringe and autoinjector formulations for self-administration, covering indications including asthma, chronic urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy for affected members and prescribing providers.

Policy Summary

PayerUnitedHealthcare

PolicyXolair (omalizumab) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeAdded and expanded coverage for IgE-mediated food allergyrevised biologic exclusion list

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of indication-specific criteria and baseline total IgE when required.

SourceLink

POLICY UPDATE CHANGES

Added criteria for new indication, IgE-mediated food allergy.

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

Added Tezspire to list of agents not to be used in combination with Xolair for all indications.

4primary indications

>=30–<=1300IgE requirement (asthma)

6+min age (asthma)

≥1

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min age (food allergy)

12 moreauthorization duration

Coverage and Medical Necessity Criteria

COVERAGE CRITERIA — Moderate to severe persistent asthma

Covered when ONE of the following alternative sets of criteria is met for moderate to severe persistent asthma:

ANY of the following

Pathway 1
- Patient has been established on therapy with Xolair for moderate to severe persistent asthma under an active UnitedHealthcare medical benefit prior authorization.
Pathway 2
- Diagnosis of moderate to severe asthma.
- Classification of asthma as uncontrolled or inadequately controlled as defined by at least one of the following: Poor symptom control (e.g., ACQ > 1.5 or ACT < 20); two or more bursts of systemic corticosteroids (≥3 days each) in the previous 12 months; asthma-related emergency treatment (ER visit, hospitalization, or unscheduled urgent visit); airflow limitation (post-bronchodilator FEV1 < 80% predicted in the context of reduced FEV1/FVC); or current dependence on oral corticosteroids for asthma.
- Submission of medical records documenting a baseline (pre-omalizumab) serum total IgE level ≥ 30 IU/mL and ≤ 1300 IU/mL.
- Positive skin test or in vitro reactivity to a perennial aeroallergen.
- Xolair will be used in combination with one maximally dosed (age-appropriate) ICS/LABA inhaled combination (e.g., fluticasone/salmeterol, budesonide/formoterol, fluticasone furoate/vilanterol) AND one additional asthma controller (e.g., leukotriene receptor antagonist montelukast, theophylline, or an additional LABA where applicable).
- Patient is not receiving Xolair in combination with any of the following: anti-IL-4 therapy (e.g., dupilumab); anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab); or a TSLP inhibitor (e.g., tezepelumab).
- Prescribed by an allergist, immunologist, or pulmonologist.

COVERAGE CRITERIA — Chronic spontaneous urticaria

Covered when ONE of the following alternative sets of criteria is met for chronic spontaneous urticaria:

ANY of the following

Pathway 1
- Patient has been established on therapy with Xolair for chronic urticaria under an active UnitedHealthcare medical benefit prior authorization.
Pathway 2
- Diagnosis of chronic urticaria.
- Patient remains symptomatic despite at least a 2-week trial of, or has contraindication or intolerance to, two H1-antihistamines.
- Trial of additional therapies as appropriate (e.g., different second-generation H1-antihistamine, first-generation H1-antihistamine, H2-antihistamine, or leukotriene modifier) unless contraindicated or not tolerated.

COVERAGE CRITERIA — Reauthorization

Reauthorization covered when ALL of the following are met for the respective indications:

ALL of the following

Documentation of positive clinical response to Xolair therapy (examples include reduction in frequency or severity of exacerbations, decreased rescue medication use, improved FEV1, reduction in asthma symptoms, or reduction in itch severity and hives for urticaria).
Xolair is being used in combination with maintenance therapy appropriate to the indication (e.g., for asthma: an ICS-containing maintenance medication; for chronic rhinosinusitis with nasal polyps: intranasal corticosteroids; for food allergy: continued food allergen avoidance).
Patient is not receiving Xolair in combination with any of the following: anti-IL-4 therapy (e.g., dupilumab); anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab); or a TSLP inhibitor (e.g., tezepelumab).
Prescribed by an appropriate specialist for the indication (e.g., allergist, immunologist, pulmonologist, dermatologist, otolaryngologist as applicable).

Initial Therapy (CRSwNP)

Initial Therapy (CRSwNP) — criteria for patients established on therapy under active UnitedHealthcare medical benefit:

ALL of the following

Patient has been established on therapy with Xolair for nasal polyps under an active UnitedHealthcare medical benefit prior authorization.

Initial Authorization - Chronic rhinosinusitis with nasal polyps

Initial Authorization - Chronic rhinosinusitis with nasal polyps — Covered when ONE of the following pathways is met:

ANY of the following

Pathway 1 (Established on therapy)
- Patient has been established on therapy with Xolair for nasal polyps under an active UnitedHealthcare medical benefit prior authorization.
- Documentation of positive clinical response to Xolair therapy.
- Patient will continue to receive Xolair as add-on maintenance therapy in combination with intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone).
- Patient is not receiving Xolair in combination with anti-IL-5, anti-IL-4, or TSLP inhibitors.

Reauthorization - Chronic rhinosinusitis with nasal polyps

Reauthorization - Chronic rhinosinusitis with nasal polyps — Covered when ALL of the following are met for reauthorization:

ALL of the following

Documentation of positive clinical response to Xolair therapy.
Patient will continue to receive Xolair as add-on maintenance therapy in combination with intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone).
Patient is not receiving Xolair in combination with anti-IL-5, anti-IL-4, or TSLP inhibitors.

Initial Authorization - IgE-mediated food allergy

Initial Authorization - IgE-mediated food allergy — Covered when ONE of the following pathways is met:

ANY of the following

Pathway 1 (Established on therapy)
- Patient has been established on therapy with Xolair for IgE-mediated food allergy under an active UnitedHealthcare medical benefit prior authorization.
- 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; and prescribed by an allergist or immunologist.
- Patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitors.

Reauthorization - IgE-mediated food allergy

Reauthorization - IgE-mediated food allergy — Covered when ALL of the following are met for reauthorization:

ALL of the following

Documentation of positive clinical response to Xolair therapy (e.g., reduction in type I allergic reactions).
Xolair is being used in conjunction with continued food allergen avoidance and the patient has access to epinephrine.
Patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitors.
Prescribed by an allergist or immunologist.

COVERAGE CRITERIA — Limitations of use (not indicated for acute bronchospasm, status asthmaticus, emergency treatment of allergic reactions including anaphylaxis, etc.)

Limitations of use:

ALL of the following

Xolair is not indicated for acute bronchospasm or status asthmaticus.
Xolair is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Xolair is not indicated for other forms of urticaria (beyond chronic spontaneous urticaria as specified).

Laboratory and Coding Requirements

Baseline total IgE — numeric eligibility requirement

Baseline total IgE range>= 30 IU/mL and <= 1300 IU/mL

When requiredSubmission of baseline (pre-omalizumab) serum total IgE is required for asthma initial authorization

Measurement timingBaseline IgE must be documented prior to initiation of omalizumab therapy

Limitations of use — key-value summary of uses not indicated

Not for acute treatment of asthmaXolair is not indicated for acute bronchospasm or status asthmaticus

Not for emergency allergic reactionsNot indicated for the emergency treatment of allergic reactions, including anaphylaxis

What Prescribers and Providers Must Submit

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xolair. Approval is contingent on meeting indication‑specific initial authorization criteria (e.g., asthma, chronic urticaria, CRSwNP, IgE‑mediated food allergy) or documentation that the member was established on Xolair under an active UnitedHealthcare medical benefit prior authorization.

Applies to all labeled indications in the policy

Denial Risk

Denial Risk — Established on Therapy Required

Requests may be denied if the patient is not already established on Xolair therapy under an active UnitedHealthcare medical benefit prior authorization when that is a condition of approval for the specific indication.

Clinical Background and Rationale

Omalizumab is a monoclonal antibody that targets immunoglobulin E (IgE) and is used as add‑on therapy for several allergic and atopic conditions. The policy lists approved indications including moderate to severe persistent asthma (pediatric and adult), chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE‑mediated food allergy. For covered indications, Xolair is typically used as maintenance therapy (often as add‑on to inhaled or intranasal corticosteroids where applicable) and coverage decisions require documentation of diagnosis and clinical response.

Definitions and Key Terms

Limitations of use — key definitions (for Definitions section)

Acute/emergency exclusionsXolair is not indicated for acute bronchospasm, status asthmaticus, or emergency treatment of allergic reactions (including anaphylaxis)

Urticaria scopeNot indicated for forms of urticaria other than chronic spontaneous urticaria (CSU)

Concurrent biologic useUse in combination with anti‑IL‑4, anti‑IL‑5, or TSLP inhibitors is not permitted for covered indications

Positive clinical response — definition/examples of response attributable to Xolair

Definition — attributable improvementDocumented improvement in the patient’s condition attributable to Xolair therapy (required for initial authorization if established on therapy and for reauthorization)

Food allergy example

Policy Revision History

2024-04addition

Added criteria for a new indication: IgE-mediated food allergy.

2024-06expansion

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

2022-02addition

Added Tezspire to the list of agents not to be used in combination with Xolair for all indications.

Policy Summary

PayerUnitedHealthcare

PolicyXolair (omalizumab) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeAdded and expanded coverage for IgE-mediated food allergyrevised biologic exclusion list

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of indication-specific criteria and baseline total IgE when required.

SourceLink

On This Page

Patient is not receiving Xolair in combination with any of the following: anti-IL-4 therapy (e.g., dupilumab); anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab); or a TSLP inhibitor (e.g., tezepelumab).

Prescribed by an allergist, dermatologist, or immunologist.

Pathway 2 (New initiation)

Diagnosis of nasal polyps with at least two of the following symptoms for >12 weeks: nasal mucopurulent discharge; nasal obstruction/blockage/congestion; facial pain/pressure/fullness; reduction or loss of sense of smell.
One of the following findings on nasal endoscopy and/or sinus CT: purulent mucus or edema in the middle meatus/ethmoid, polyps in the nasal cavity or middle meatus, or radiographic mucosal thickening/partial or complete sinus opacification.
AND one of the following: failure 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 such as montelukast, zafirlukast, zileuton); OR requirement for systemic corticosteroids for nasal polyps in the previous 2 years; OR prior sinus surgery.
Patient will 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 inhibitors.
Prescribed by an allergist, immunologist, otolaryngologist, or pulmonologist.

Pathway 2 (New initiation)

Diagnosis of IgE-mediated food allergy to one or more foods.
IgE-mediated food allergy confirmed by history of type I allergic reactions (e.g., nausea, vomiting, cramping, diarrhea, flushing, pruritus, urticaria, lip/face/throat swelling, wheezing, lightheadedness, syncope) AND one of: food-specific skin prick testing, in vitro IgE antibody testing, or oral food challenge.
Xolair will be used in conjunction with food allergen avoidance; patient has access to epinephrine; patient is aged ≥ 1 year; and prescribed by an allergist or immunologist.
Patient is not receiving Xolair in combination with anti-IL-4, anti-IL-5, or TSLP inhibitors.

Not for other urticaria types

Not indicated for forms of urticaria other than chronic spontaneous urticaria (CSU)

Avoid combination biologicsNot to be used in combination with anti‑IL‑4, anti‑IL‑5, or TSLP inhibitors for covered indications

Positive clinical response — examples of documented response required for continuation/reauthorization

Required for continuation/reauthorizationDocumentation of a positive clinical response to Xolair therapy is required for reauthorization

Examples — asthmaReduction in exacerbations; decreased rescue medication use; increase in % predicted FEV1 from pretreatment baseline; reduction in severity or frequency of asthma symptoms

Examples — CSUReduction in itch severity and/or reduction in number or severity of hives

Examples — food allergy/CRSwNPReduction in type I allergic reactions for food allergy; symptom improvement for nasal polyps when used as add‑on maintenance with intranasal corticosteroids

Documentation Required

Provider Actions — Chronic Urticaria Antihistamine Trial Requirement

For chronic spontaneous urticaria, document a trial of, or contraindication/intolerance to, antihistamine therapy: either two H1‑antihistamines (2‑week trials) or combination therapy with a second‑generation H1 plus one additional agent (e.g., different second‑generation H1, first‑generation H1, H2‑antagonist, or leukotriene modifier). Also document prescribing clinician specialty (allergist, dermatologist, or immunologist) and that the patient is not receiving Xolair with anti‑IL‑4, anti‑IL‑5, or TSLP inhibitors.

Documentation Required

Provider Actions — CRSwNP Failure of Intranasal Corticosteroids Plus Additional Therapy

For chronic rhinosinusitis with nasal polyps (CRSwNP), document failed therapy with intranasal corticosteroids and one other therapy used for nasal polyps (e.g., nasal saline irrigation or an antileukotriene). Also document positive clinical response if patient is already established on Xolair, continued use as add‑on maintenance with intranasal corticosteroids, appropriate prescriber specialty (allergist, immunologist, otolaryngologist, or pulmonologist), and that Xolair is not being used concurrently with anti‑IL‑4, anti‑IL‑5, or TSLP inhibitors.

Documentation Required

Provider Actions — IgE‑Mediated Food Allergy Diagnostic Confirmation

For IgE‑mediated food allergy, confirm diagnosis with (1) history consistent with type I allergic reactions and (2) supportive testing such as food‑specific skin prick test, serum food‑specific IgE, or oral food challenge. Also document patient access to epinephrine, use of food allergen avoidance, positive clinical response for established patients, age ≥1 year, prescribing specialty (allergist or immunologist), and that Xolair is not being used concurrently with anti‑IL‑4, anti‑IL‑5, or TSLP inhibitors.

Documentation Required

Provider Actions — Baseline Serum Total IgE Requirement

Submit baseline (pre‑omalizumab) serum total IgE level when required by the indication (e.g., asthma: ≥30 IU/mL and ≤1300 IU/mL).

Documentation Required

Provider Actions — Document Positive Clinical Response for Established Patients and Reauthorization

Documentation of positive clinical response to Xolair therapy is required for initial authorization when the member is already established on therapy and for reauthorization/continuation of therapy.

Denial Risk

Denial Risk — Concurrent Use with Other Biologic Immunomodulators

Denial risk if Xolair is being used in combination with anti‑IL‑4 (e.g., dupilumab), anti‑IL‑5 (e.g., mepolizumab, reslizumab, benralizumab), or TSLP inhibitors (e.g., tezepelumab). Ensure charting confirms Xolair is not being used concurrently with these agents.

Reduction in type I allergic reactions (e.g., decreased frequency/severity of allergic reactions with accidental exposure)

Nasal polyps exampleSymptom improvement when used as add‑on maintenance with intranasal corticosteroids (e.g., decreased nasal obstruction, discharge, or improved sense of smell)

Asthma exampleReduction in exacerbations, decreased rescue medication use, or increased % predicted FEV1 from pretreatment baseline

2023-10revision

Annual review with removal of prescriber requirement for initial authorizations for patients established on therapy under UHC prior authorization and added requirement that patient is not receiving Xolair with other similar treatments for chronic urticaria reauthorization.

2025-04reviewLatest

Annual review; no changes to coverage criteria noted.