ModifiedCareSourcePolicy N/A

Immunologicals Xolair (omalizumab) Utilization Management Medical Policy

Defines prior authorization, clinical criteria, dosing limits, and coverage stance for Xolair (omalizumab) for asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE-mediated food allergy; applies to CareSource medical benefit coverage.

Policy Summary

PayerCareSource

PolicyImmunologicals Xolair (omalizumab) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeClarified co-therapy languagerevised continuation criteria

Effective Date

Next Review DateApr 23, 2025

Key ActionObtain prior authorization with documentation of baseline total IgE ≥ 30 IU/mL and required prior therapies or response criteria as specified for the indication.

SourceLink

POLICY UPDATE CHANGES

Use of Xolair with another monoclonal antibody therapy is specific to Cinqair; Fasenra, Nucala, Dupixent, Tezspire and Adbry.

Approval duration for chronic spontaneous urticaria was changed from 4 months to 6 months and continuation criteria updated to require at least 6 months of prior therapy and defined beneficial clinical response.

4FDA-approved indications covered

30 IU/mLBaseline IgE threshold

375Max asthma dose (mg)

600

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Max CRSwNP/food allergy dose (mg)

6 moMin prior therapy for continuation

3Distinct not-recommended conditions

Recommended Authorization Criteria

Initial and Continuation Therapy (Asthma)

Covered when ALL of the following are met for Initial Therapy (approve 4 months):

Asthma Initial Therapy: Patient is >= 6 years of age; AND baseline total IgE >= 30 IU/mL; AND baseline positive skin test or in vitro test for allergen-specific IgE to one or more perennial or seasonal aeroallergens; AND has received at least 3 consecutive months of combination therapy with BOTH an inhaled corticosteroid and at least one additional asthma controller/maintenance medication (or a combination inhaler fulfilling both); AND asthma is uncontrolled or was uncontrolled at baseline as defined by one of: >=2 exacerbations requiring systemic corticosteroids in the previous year; OR >=1 exacerbation requiring hospitalization, emergency department, or urgent care visit in the previous year; OR FEV1 < 80% predicted; OR asthma worsens on tapering oral corticosteroids; AND medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist.N/A

Approve for 4 months; dosing up to 375 mg subcutaneously not more frequently than once every 2 weeks.

Continuation Therapy (Asthma)

Continuation (extension) criteria:

Asthma Continuation: Patient has already received at least 4 months of Xolair; AND continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler; AND patient has responded to therapy as determined by the prescriber (examples: decreased exacerbations, decreased symptoms, decreased hospitalizations/ED/urgent care visits).N/A

Dosing: approve up to a maximum of 375 mg administered subcutaneously not more frequently than once every 2 weeks.

Chronic Rhinosinusitis with Nasal Polyps

Covered when ONE of the following sets is met:

CRSwNP Initial Therapy: Patient is >= 18 years of age; AND chronic rhinosinusitis with nasal polyps confirmed by direct exam, endoscopy, or sinus CT; AND has experienced >=2 of the following symptoms for at least 6 months: nasal congestion, nasal obstruction, nasal discharge, and/or reduction/loss of smell; AND baseline total IgE >= 30 IU/mL; AND has received at least 4 weeks of intranasal corticosteroid therapy; AND at least one of: contraindication to systemic corticosteroids OR at least one course of systemic corticosteroids (>=5 days) within the previous 2 years OR prior nasal polyp surgery; AND patient will continue intranasal corticosteroid concomitantly with Xolair; AND medication prescribed by or in consultation with an allergist, immunologist, or otolaryngologist (ENT).N/A

Approve initial for 6 months; dosing up to 600 mg subcutaneously not more frequently than once every 2 weeks.

CRSwNP Ongoing Therapy: Patient is currently receiving Xolair and has already received at least 6 months of therapy; AND continues intranasal corticosteroid therapy; AND has responded to therapy as determined by the prescriber (examples: reduced nasal polyp size, improved nasal congestion, reduced sinus opacification, decreased sino-nasal symptoms, or improved sense of smell).N/A

Chronic Spontaneous Urticaria

Covered when ONE of the following sets is met:

CSU Initial Therapy: Patient is >= 12 years of age; AND has or had urticaria for >= 6 weeks with symptoms present >3 days per week despite daily non-sedating H1-antihistamine therapy with doses titrated up to a maximum of four times the standard FDA-approved dose; AND medication prescribed by or in consultation with an allergist, immunologist, or dermatologist.N/A

Approve initial for 6 months; dosing options: 150 mg subcutaneously every 4 weeks or 300 mg subcutaneously every 4 weeks.

CSU Ongoing Therapy: Patient is currently receiving Xolair and has already received at least 6 months of therapy; AND has experienced a beneficial clinical response defined by one of: decreased itch severity; OR decreased number of hives; OR decreased size of hives.N/A

Approve for 1 year; dosing: 150 mg or 300 mg subcutaneously every 4 weeks.

IgE-mediated Food Allergy

Covered when ALL of the following are met (approve for 1 year):

IgE-mediated Food Allergy: Patient is >= 1 year of age; AND baseline total IgE >= 30 IU/mL; AND evidence of sensitization to one or more foods by positive skin prick test and/or positive in vitro specific IgE; AND prescriber documents history of an allergic reaction to the food consistent with a significant systemic allergic reaction occurring soon after ingestion (signs such as wheezing, hypotension, gastrointestinal symptoms) and deems the reaction significant enough to warrant a prescription for an epinephrine auto-injector; AND patient has been prescribed an epinephrine auto-injector; AND prescriber will use Xolair in conjunction with food allergen avoidance; AND medication prescribed by or in consultation with an allergist or immunologist.N/A

Approve for 1 year; dosing up to 600 mg subcutaneously not more frequently than once every 2 weeks.

Not Recommended for Approval

Use of Xolair is not recommended for the following conditions based on available evidence and guideline recommendations:

Eosinophilic gastrointestinal disorders: Eosinophilic gastroenteritis, eosinophilic esophagitis, or eosinophilic colitis.

Limited and conflicting data from very small studies and case series; ACG guideline (2025) recommends against use in eosinophilic esophagitis.

Occupational latex allergy: Latex allergy in health care workers with occupational latex allergy.

Small European study showed some ocular and glove-challenge improvements but well-controlled trials are needed; not recommended for approval.

Other unspecified circumstances: Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Criteria will be updated as new published data are available.

The policy does not recommend coverage for indications where evidence is insufficient or conflicting. Examples include atopic dermatitis, where trial results are mixed and guideline statements note insufficient data to recommend Xolair, and situations involving the concurrent use of Xolair with another monoclonal antibody therapy, for which safety and efficacy have not been established. Providers should not rely on anecdotal case reports of combined monoclonal antibody use as a basis for coverage without stronger evidence or guideline support.

Requests for Xolair outside of the indications listed in the Recommended Authorization Criteria are not recommended for approval. The policy explicitly excludes uses that are not supported by published evidence or current guideline recommendations, and such requests should be denied until evidence-based criteria are added or updated.

Non-recommended indications include atopic dermatitis, where randomized trial data are inconclusive and larger trials are needed, and other unlisted conditions lacking robust evidence. The policy therefore advises against authorization for these indications at this time.

Eosinophilic gastrointestinal disorders — including eosinophilic gastroenteritis, eosinophilic esophagitis, and eosinophilic colitis — are not recommended for approval due to limited and conflicting data; the American College of Gastroenterology guidelines recommend against Xolair for eosinophilic esophagitis. Occupational latex allergy (e.g., health care workers) is likewise not recommended for routine coverage despite a small study showing some ocular and glove-challenge improvements; well-controlled trials are required before coverage can be supported.

Testing, Thresholds, and Dosing-related Definitions

Baseline total IgE — Required value for dosing

Required baseline total IgE>= 30 IU/mL

Applies to indicationsAsthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE‑mediated food allergy

PurposeUsed to determine dosing based on body weight and IgE for asthma, CRSwNP, and food allergy per dosing tables

Minimum prior Xolair therapy for continuation

Updated minimum prior Xolair therapy for continuation>= 6 months

Applies toChronic spontaneous urticaria continuation criteria (patient currently receiving Xolair)

Prescriber and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for medical benefit coverage of Xolair. Approvals are provided for the durations noted in the policy and extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside of the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Initial approval requires Xolair to be prescribed by or in consultation with a physician who specializes in the condition treated (for example, allergist, immunologist, pulmonologist, or otolaryngologist) as specified per indication.

Approvals provided for specified durations (months = 30 days where noted).
Requests for off-label dosing considered case-by-case by clinician review.
Prescriber specialty or consultation required per indication (allergist, immunologist, pulmonologist, or ENT as specified).

Denial Risk

Not Recommended Situations

Clinical Background and Indication Summary

Xolair (omalizumab) is an anti-IgE monoclonal antibody indicated as add-on therapy for several allergic conditions. It binds circulating IgE, preventing IgE interaction with receptors on mast cells and basophils, thereby reducing allergic inflammation. FDA-approved indications addressed in this policy include moderate-to-severe allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and certain IgE-mediated food allergies; dosing and eligibility vary by indication and are informed by baseline total IgE and clinical response assessments.

Key Definitions and Clinical Thresholds

Baseline IgE — Timing definition

Definition of 'baseline' IgEMeasurement taken prior to receiving Xolair or another monoclonal antibody therapy that may lower IgE (e.g., dupilumab, tezepelumab)

RationaleMonoclonal antibodies that lower IgE or interfere with allergen testing can alter results; baseline must be before such therapies

Referenced indicationsRequired for asthma, CRSwNP, and IgE‑mediated food allergy criteria

Uncontrolled asthma (examples)

Frequent exacerbations>= 2 exacerbations requiring systemic corticosteroids in prior year as example of uncontrolled asthma

Healthcare utilization>=1 exacerbation requiring hospitalization, emergency department, or urgent care visit

Policy Summary

PayerCareSource

PolicyImmunologicals Xolair (omalizumab) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeClarified co-therapy languagerevised continuation criteria

Effective Date

Next Review DateApr 23, 2025

Key ActionObtain prior authorization with documentation of baseline total IgE ≥ 30 IU/mL and required prior therapies or response criteria as specified for the indication.

SourceLink

On This Page

Approve for 1 year; dosing up to 600 mg subcutaneously not more frequently than once every 2 weeks.

Documentation required

Prescriber must document that patient has experienced a beneficial clinical response (decreased itch severity, decreased number of hives, or decreased size of hives)

Intranasal corticosteroid duration for CRSwNP (prior revision)

Prior revision intranasal corticosteroid duration4 weeks

Indication contextRequirement applies to initial therapy for chronic rhinosinusitis with nasal polyps (CRSwNP)

Concurrent therapyPatient must continue intranasal corticosteroid concomitantly with Xolair

Coverage is not recommended for uses not listed in the Recommended Authorization Criteria. Specific conditions with limited/conflicting evidence are explicitly listed below and are not recommended for approval.

Not recommended for any circumstance not listed in the Recommended Authorization Criteria; criteria will be updated as new published data are available.

Denial Risk

Conditions Not Recommended

Coverage of Xolair is not recommended for eosinophilic gastrointestinal conditions and for occupational latex allergy in health care workers due to limited, conflicting, or insufficient evidence and guideline recommendations against use in some conditions.

Eosinophilic gastroenteritis, eosinophilic esophagitis, and eosinophilic colitis — limited/conflicting data; guidelines recommend against use for eosinophilic esophagitis.
Occupational latex allergy in health care workers — small studies only; well-controlled trials are needed.

Documentation Required

Required Baseline Tests and Prescriber

Baseline testing and prescriber requirements must be documented prior to approval for applicable indications.

Baseline total IgE level required (baseline defined as prior to receiving Xolair or another monoclonal antibody therapy that may lower IgE, e.g., dupilumab, tezepelumab).
Baseline allergen sensitization demonstrated by a positive skin test or positive in vitro (blood) test for allergen-specific IgE to one or more relevant allergens, where required by indication.
Prescriber requirement: Xolair must be prescribed by or in consultation with an appropriate specialist for the treated condition (examples: allergist, immunologist, pulmonologist, or otolaryngologist/ENT).

Documentation Required

Continuation Documentation

Documentation to support continuation/renewal must be provided and demonstrate prior duration of therapy and clinical benefit.

For continuation in chronic spontaneous urticaria: patient has already received at least 6 months of therapy with Xolair and has experienced a beneficial clinical response (e.g., decreased itch severity, decreased number of hives, or decreased size of hives).
For other indications, documentation should show the patient meets the indication-specific continuation criteria (for example, having received the initial approval duration and demonstrating clinical response as defined in the applicable indication).

Step Therapy

Prior Therapy Requirements (Examples) and Asthma Controller Therapy Requirement

Prior therapy requirements must be met and documented before initiating Xolair where specified by indication.

Asthma: Patient must have received at least 3 consecutive months of combination controller therapy (an inhaled corticosteroid plus at least one additional asthma controller or maintenance medication) prior to initiation, unless otherwise specified.
Chronic Rhinosinusitis with Nasal Polyps (initial therapy): Patient must have received at least 4 weeks of intranasal corticosteroid therapy and meet other listed prior therapy requirements (e.g., prior systemic corticosteroid course(s) or prior surgery) as applicable.
Examples: intranasal corticosteroid requirement duration for CRSwNP is 4 weeks; systemic corticosteroid course(s) or prior nasal polyp surgery as specified in the CRSwNP criteria.

Lung functionFEV1 < 80% predicted noted as an example of uncontrolled asthma

Oral corticosteroid dependenceAsthma that worsens on tapering oral corticosteroids per guideline criteria

Conditions Not Recommended for Approval

Eosinophilic gastrointestinal disordersEosinophilic gastroenteritis, eosinophilic esophagitis, eosinophilic colitis — use not recommended

Occupational latex allergyLatex allergy in health care workers (occupational latex allergy) — not recommended

Atopic dermatitis and other unlisted conditionsAtopic dermatitis and other indications not listed in Recommended Authorization Criteria — coverage not recommended