CurrentUnitedHealthcarePolicy CS2026D0033AF

Xolair® (Omalizumab) – Community Plan Medical Benefit Drug Policy

UnitedHealthcare Community Plan Medical Benefit Drug Policy for provider-administered Xolair (omalizumab) describing covered indications (moderate-severe persistent asthma, chronic urticaria, nasal polyps, IgE-mediated food allergy), detailed clinical criteria for initial and reauthorization approvals, unproven indications, applicable HCPCS/J-codes and diagnosis codes, and administrative requirements (prescriber specialty, dosing per FDA labeling, self-administration attestation). This part (1 of 2) contains coverage rationale, criteria for multiple indications, applicable codes list, background and clinical evidence summaries.

Policy Summary

PayerUnitedHealthcare

PolicyXolair® (Omalizumab) – Community Plan Medical Benefit Drug Policy

Policy CodePolicy CS2026D0033AF

Change TypeTemplate Update (archival of prior version)

Effective DateApr 1, 2026

Next Review Date

Key ActionProvide documentation per indication (diagnosis, prior therapy, IgE level, positive allergen testing, prescriber specialty) for initial and reauthorization approvals; authorizations granted for no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

Template Update removing content/language pertaining to the state of Louisiana and archiving prior policy version CS2025D0033AE.

4Covered Indications (major)

5Unproven/Not Covered Indications listed

1Drug J-code listed

Indications discussed (approved/studied)

4Clinical evidence sections summarized

Coverage Summary

Policy CS2026D0033AF (effective 2026-04-01) covers provider‑administered Xolair (omalizumab) with criteria for specified indications. The scope includes detailed clinical criteria for initial and reauthorization approvals for moderate‑severe persistent asthma, chronic idiopathic/spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE‑mediated food allergy. Authorizations for initial and continuation use are limited to a maximum of 12 months per the policy. The policy describes applicable administrative requirements (prescriber specialty, dosing per FDA labeling, and physician attestation regarding self‑administration) and lists relevant HCPCS and diagnosis codes.

Key thresholds / limits (compact)

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

Age (food allergy)>= 1 year

Asthma symptom controlACQ > 1.5 or ACT < 20

Nasal Polyp Score (NPS)Total NPS >= 5 with >= 2 in each nostril

Nasal Congestion Score (NCS)Weekly average NCS > 1

Peanut DBPCFC primary endpointAbility to consume >= 600 mg peanut protein without dose-limiting symptoms

Authorization durationUp to 12 months

Initial Therapy Criteria (by indication)

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

Diagnosis of moderate or severe asthma.
Asthma classified as uncontrolled
- Poor symptom control (e.g., Asthma Control Questionnaire [ACQ] score consistently > 1.5 or Asthma Control Test [ACT] score consistently < 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., emergency room visit, hospitalization, or unscheduled physician visit for nebulizer or other urgent treatment).

Reauthorization / Continuation Criteria (by indication)

Unproven / Not Medically Necessary

Applicable Codes

Drug HCPCS/J-codeHCPCS

J2357

Injection, omalizumab, 5 mg

Diagnosis codes (examples listed for reference)ICD-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

No specific procedure/drug codes listed in this partmixed

No codes listed

Provider Actions & Administrative Requirements

Prior Authorization

Authorization requirement

Initial and reauthorization approvals require documentation per indication (diagnosis, prior therapy trials, baseline IgE and allergen testing, prescriber specialty). Authorizations are granted for no more than 12 months.

J2357

Documentation Required

Physician attestation for self-administration

Physician must attest that self-administration of the Xolair prefilled syringe is not appropriate and provide documentation supporting one of the listed reasons.

History of anaphylaxis to Xolair or other agents (e.g., bronchospasm, hypotension, syncope, urticaria, angioedema)
Patient is new to Xolair and requires initial provider-administered doses (authorization for three doses)

Clinical Evidence & Professional Guidance

Omalizumab is a monoclonal anti‑IgE antibody that binds IgE and prevents its interaction with high‑affinity Fc receptors on effector cells, markedly reducing free serum IgE and blunting early and late allergic responses. The FDA has approved omalizumab for moderate to severe persistent allergic asthma (age ≥ 6 years), chronic idiopathic/spontaneous urticaria (age ≥ 12 years), chronic rhinosinusitis with nasal polyps (adults ≥ 18 years), and IgE‑mediated food allergy (age ≥ 1 year). Evidence supporting these indications includes randomized controlled trials and observational studies—examples include the 60‑week ICATA randomized trial in inner‑city youth, pivotal trials for chronic urticaria (ASTERIA I), phase 3 nasal polyps trials, and a randomized DBPCFC trial for multiple food allergies—plus observational and retrospective series that include data on patients with very high baseline IgE (e.g., >700 IU/mL).

24.5%ICATA: reduction in symptom days (per 2-week interval)

48.8%→30.3%ICATA: exacerbation rate placebo vs omalizumab

6.3%→1.5%ICATA: hospitalization rate placebo vs omalizumab

68% vs 5%IgE-mediated food allergy: peanut ≥600 mg tolerance (Xolair vs placebo)

51.9% vs 11.3%

Background & Definitions

Omalizumab is an anti‑IgE monoclonal antibody that binds circulating IgE, preventing IgE binding to effector cells and thereby reducing free serum IgE by >90% and blunting allergic responses. The FDA‑approved indications include moderate to severe persistent allergic asthma (age ≥ 6 years), chronic idiopathic/spontaneous urticaria (age ≥ 12 years), nasal polyps (adults ≥ 18 years), and IgE‑mediated food allergy (age ≥ 1 year). The body of evidence comprises randomized controlled trials demonstrating reductions in symptoms and exacerbations for asthma (e.g., ICATA and other trials), CIU/CSU (e.g., ASTERIA I/II), nasal polyps (two phase 3 trials showing improvements in NPS and NCS), and a DBPCFC trial in pediatric food allergy showing clinically meaningful increases in tolerated challenge doses; observational and post‑marketing studies provide additional real‑world support, including data in patients with very high IgE levels.

Term	Definition
Positive clinical response	Reduction in exacerbations, decreased rescue medication use, increased percent predicted FEV1 from pretreatment baseline, or reduction in symptom severity or frequency per indication-specific language
NPS	Nasal Polyp Score: endoscopic score range 0-4 per nostril (total 0-8); trial inclusion required total NPS ≥ 5 with NPS ≥ 2 in each nostril
NCS	Nasal Congestion Score: daily 0-3 severity scale (0 = none to 3 = severe); trial inclusion required weekly average NCS > 1
UAS7	Urticaria Activity Score over 7 days used to assess symptom control; UAS7 ≤ 6 indicates well-controlled disease and UAS7 = 0 indicates complete response

Revision History

2026-04-01revisionLatest

Template Update; archived prior version CS2025D0033AE

Policy Summary

PayerUnitedHealthcare

PolicyXolair® (Omalizumab) – Community Plan Medical Benefit Drug Policy

Policy CodePolicy CS2026D0033AF

Change TypeTemplate Update (archival of prior version)

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Airflow limitation (e.g., post-bronchodilator FEV1 < 80% predicted in the setting of reduced FEV1/FVC defined as less than the lower limit of normal).

Baseline (pre-omalizumab treatment) serum total IgE level greater than or equal to 30 IU/mL and less than or equal to 1,300 IU/mL.

Positive skin test or in vitro reactivity to a perennial aeroallergen.

Used in combination with

One maximally-dosed (appropriately adjusted for age) combination inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) product (e.g., fluticasone/salmeterol, budesonide/formoterol, fluticasone furoate/vilanterol).
Combination therapy including both of the following
- One maximally-dosed (appropriately adjusted for age) ICS product (e.g., ciclesonide, mometasone furoate, beclomethasone).
- One additional asthma controller medication (e.g., LABA, leukotriene receptor antagonist, theophylline).

Physician attestation regarding self-administration

Patient has a history of anaphylaxis (e.g., bronchospasm, hypotension, syncope, urticaria, angioedema) to Xolair or other agents.
Patient is new to Xolair and requires initial doses to be given by a healthcare provider with no hypersensitivity reactions before transitioning to self-administration (authorization for three doses).
If selected, authorization limited to three doses for transition.
Patient's prior Xolair therapy was interrupted ≥ 6 months and will be re-initiated under provider supervision before transitioning to self-administration (authorization for three doses).
If selected, authorization limited to three doses for re-initiation.
Patient or caregiver is unable to recognize or treat anaphylaxis appropriately.
Patient or caregiver is unable to perform subcutaneous injections with proper technique or adhere to prescribed dosing.
Location/circumstances for self-administration are not adequate for potential treatment of anaphylaxis.

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

Dosing in accordance with FDA-approved labeling.

Prescribed by an allergist/immunologist or pulmonologist.

Initial authorization will be for no more than 12 months.

Chronic Urticaria - 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 chronic urticaria.
Prior therapy/trial requirement
- Patient remains symptomatic despite at least a 2-week trial of, or has contraindication or intolerance to, two H1-antihistamines (e.g., fexofenadine, diphenhydramine, loratadine).
- Combination antihistamine options
  - Patient remains symptomatic despite at least a 2-week trial of, or has contraindication or intolerance to, a second-generation H1-antihistamine.
  - Plus one of the following
    A different second-generation H1-antihistamine (e.g., fexofenadine, loratadine, cetirizine).
    A first-generation H1-antihistamine (e.g., diphenhydramine, chlorpheniramine, hydroxyzine).
    An H2-antihistamine (e.g., famotidine, cimetidine, ranitidine).
    A leukotriene modifier (e.g., montelukast).
Physician attestation regarding self-administration
- Patient has a history of anaphylaxis to Xolair or other agents.
- Patient is new to Xolair and requires initial doses administered under provider guidance with no hypersensitivity reactions before transitioning to self-administration (authorization for three doses).
  If selected, authorization limited to three doses for transition.
- Patient's prior Xolair therapy was interrupted ≥ 6 months and will be re-initiated under provider supervision before transitioning to self-administration (authorization for three doses).
  If selected, authorization limited to three doses for re-initiation.
- Patient or caregiver is unable to recognize or treat anaphylaxis appropriately.
- Patient or caregiver is unable to perform subcutaneous injections with proper technique or adhere to prescribed dosing.
Patient is not receiving Xolair in combination with anti-IL-5, anti-IL-4, or TSLP inhibitor therapies for the same indication.
Dosing in accordance with FDA-approved labeling.
Prescribed by an allergist/immunologist or dermatologist.
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 chronic rhinosinusitis with nasal polyps (nasal polyps).
Symptom and objective findings
- Presence of at least 2 nasal polyp symptoms (e.g., nasal congestion/obstruction, hyposmia/anosmia, rhinorrhea, facial pressure/pain).n=2
- Objective endoscopy/CT findings
  - Nasal endoscopy demonstrating nasal polyps.
  - Computed tomography (CT) scan of the sinuses showing polyposis or relevant sinonasal disease.
Disease history requirements
- History of prior endoscopic sinus surgery for nasal polyps; or
- Recurrent nasal polyps despite intranasal corticosteroid therapy; or
- Inadequate control with prior systemic corticosteroid therapy or systemic corticosteroid contraindication.
Concurrent therapy
- Used in combination with intranasal corticosteroid (INCS) therapy.
Physician attestation regarding self-administration
- Patient has a history of anaphylaxis to Xolair or other agents.
- Patient is new to Xolair and requires initial doses administered under provider guidance with no hypersensitivity reactions before transitioning to self-administration (authorization for three doses).
  If selected, authorization limited to three doses for transition.
- Patient's prior Xolair therapy was interrupted ≥ 6 months and will be re-initiated under provider supervision before transitioning to self-administration (authorization for three doses).
  If selected, authorization limited to three doses for re-initiation.
- Patient or caregiver is unable to recognize or treat anaphylaxis appropriately.
- Patient or caregiver is unable to perform subcutaneous injections with proper technique or adhere to prescribed dosing.
Dosing in accordance with FDA-approved labeling.
Prescribed by an allergist/immunologist or otolaryngologist (ENT).
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

Age at least 1 year.
Confirmation of IgE-mediated food allergy
- Clinical history consistent with an IgE-mediated allergic reaction to the specific food (e.g., immediate onset of hives, angioedema, respiratory compromise, hypotension, vomiting).
- Objective evidence of IgE sensitization to the implicated food by one of the following: positive skin prick test or serum-specific IgE to the food.
Patient has access to at least one epinephrine autoinjector and caregiver/patient education on its use.
Physician attestation regarding self-administration
- Patient has a history of anaphylaxis to Xolair or other agents.
- Patient is new to Xolair and requires initial doses administered under provider guidance with no hypersensitivity reactions before transitioning to self-administration (authorization for three doses).
  If selected, authorization limited to three doses for transition.
- Patient's prior Xolair therapy was interrupted ≥ 6 months and will be re-initiated under provider supervision before transitioning to self-administration (authorization for three doses).
  If selected, authorization limited to three doses for re-initiation.
- Patient or caregiver is unable to recognize or treat anaphylaxis appropriately.
- Patient or caregiver is unable to perform subcutaneous injections with proper technique or adhere to prescribed dosing.
Prescribed by an allergist/immunologist.
Dosing in accordance with FDA-approved labeling.
Initial authorization will be for no more than 12 months.

Previous Xolair therapy interrupted ≥ 6 months and requires re-initiation under provider guidance (authorization for three doses)

Patient or caregiver unable to recognize or treat anaphylaxis appropriately

Patient or caregiver unable to perform subcutaneous injections with proper technique or adhere to dosing regimen

Location/circumstances for self-administration inadequate for potential treatment of anaphylaxis

Documentation Required

Baseline IgE and allergen testing

For asthma, baseline (pre-omalizumab) total serum IgE must be provided and meet the threshold (>= 30 IU/mL and <= 1,300 IU/mL) and there must be evidence of positive skin test or in vitro reactivity to a perennial aeroallergen.

Denial Risk

Concurrent biologic therapy exclusion

Claims may be denied if the patient is receiving Xolair in combination with an anti-IL-4 therapy (e.g., dupilumab), anti-IL-5 therapies (e.g., mepolizumab, reslizumab, benralizumab), or a TSLP inhibitor (e.g., tezepelumab) for the same indication.

Documentation Required

Prescriber specialty restriction

Prescriptions must be from the specified specialists depending on indication.

Asthma: allergist/immunologist or pulmonologist
Chronic urticaria: allergist/immunologist or dermatologist
Nasal polyps: allergist/immunologist, otolaryngologist, or pulmonologist
IgE-mediated food allergy: allergist/immunologist

Billing Rule

Dosing per FDA labeling

Dosing must adhere to United States FDA approved labeling.

J2357

Documentation Required

Observation and anaphylaxis preparedness

Because of the risk of anaphylaxis, providers administering Xolair should observe patients closely for an appropriate period and be prepared to manage anaphylaxis per FDA labeling.

Documentation Required

Use with allergen avoidance in food allergy

When used for IgE-mediated food allergy, Xolair should be used in conjunction with food allergen avoidance and is not indicated for emergent treatment of allergic reactions.

Chronic Urticaria: UAS7 ≤6 response (omalizumab 300 mg vs placebo)

SMD -0.67Seasonal allergic rhinitis: DNSSS meta-analysis (standardized mean difference)

Clinical trial and evidence findings summarized: randomized trials show indication‑specific efficacy but some studies are small or have limited long‑term data, indicating a need for larger studies in some populations.

Key evidence items:

• ICATA (inner‑city asthma, randomized 60‑week trial): omalizumab reduced symptom days (24.5% reduction) and exacerbations (48.8% placebo vs 30.3% omalizumab) with fewer hospitalizations (6.3% vs 1.5%).

• ASTERIA I (CIU/CSU, randomized): omalizumab 300 mg q4w reduced weekly itch severity and met multiple secondary endpoints; UAS7 ≤ 6 response 51.9% vs 11.3% and UAS7 = 0 response 35.8% vs 8.8% versus placebo.

• Nasal polyps (two randomized phase 3 trials): statistically significant improvements in nasal polyp score (NPS) and nasal congestion score (NCS) at Week 24 versus placebo with benefits observed by Week 4.

• IgE‑mediated food allergy (randomized DBPCFC pediatric trial, n=165): increased rates of tolerating ≥600 mg peanut protein (68% vs 5%) and secondary food challenge endpoints (e.g., milk, egg, cashew).

Limitations: some studies are small or open‑label, meta‑analyses note heterogeneity and call for larger trials to establish long‑term efficacy, safety and cost‑effectiveness.

Professional society guidance (summarized recommendations): GINA 2024 defines uncontrolled, difficult‑to‑treat, and severe asthma and recommends add‑on biologic therapy including anti‑IgE (omalizumab) for patients age ≥6 years with severe allergic asthma. ERS/ATS guidance and updates endorse phenotype‑based management, note biomarkers (blood eosinophils, FeNO) and provide cut‑points to help identify patients more likely to respond to specific biologics (for anti‑IgE: examples include eosinophil ≥260/μL and FeNO ≥19.5 ppb). The 2023 JTFPP guidance for CRSwNP conditionally recommends considering biologics (including omalizumab) for patients with inadequate response to intranasal corticosteroids or high disease burden, and highlights that comorbid indications (e.g., asthma) may influence biologic selection. The JTFPP/AAAAI/ACAAI chronic urticaria parameters recommend a step‑care approach culminating in adding omalizumab or cyclosporine for antihistamine‑refractory disease.

Location/circumstances for self-administration are not adequate for potential treatment of anaphylaxis.