This policy defines Cigna's prior authorization, coverage criteria, dosing limits, and prescribing specialist requirements for Xolair (omalizumab) across FDA‑approved indications (asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE‑mediated food allergy) and lists uses considered not medically necessary. It applies to members covered under Cigna-administered health benefit plans.
Policy Summary
PayerCigna
PolicyXolair (omalizumab) coverage
Policy CodePolicy IP0487
Change TypeMaterial revisions to criteria and authorization durations
Effective DateJul 15, 2025
Next Review Date
Key ActionObtain prior authorization with documentation that the patient meets the applicable indication-specific criteria and required clinical documentation (age, baseline IgE when required, prior therapies, and specialist involvement).
Updated diagnostic criteria requirements for confirmation of asthma and shortened initial authorization durations (e.g., initial authorization from 12 months to 4 months for asthma and chronic idiopathic urticaria).
New approval criteria for IgE-mediated food allergy were added, including change to require either a positive skin prick test OR a positive in vitro IgE test.
Concurrent use section expanded to add Ebglyss and Nemluvio to the list of monoclonal antibody therapies that should not be used concurrently with Xolair.
For Chronic Spontaneous Urticaria: approval duration changed from 4 months to 6 months and continuation criteria updated to require at least 6 months of prior Xolair therapy plus documented beneficial clinical response (decreased itch, number or size of hives).
Updated policy title from Omalizumab to Immunologicals - Xolair.
4FDA‑approved indications listed
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≥30minimum baseline IgE required for dosing
375 mgmaximum asthma dose authorized
600 mgmaximum nasal polyps/food allergy dose
PAcoverage requirement
AnnualPolicy revision frequency
Coverage and Medical Necessity Criteria
inv-01: Asthma Initial Therapy (Approve for 4 months)
Approve Xolair for 4 months if the patient meets ALL of the following (i–vii):
Asthma initial therapy criteria
i: Patient is ≥ 6 years of age
ii: Patient has a history of ONE of the following (a or b): a) BOTH: FEV1 < 80% predicted AND FEV1/FVC < 0.80; OR b) ONE of: bronchodilator reversibility (>12% and >200 mL or >12% for ages 6–11), positive exercise challenge, or positive bronchial challenge
Reduced FEV1 should not be due to smoking‑related COPD; children 6–11 do not require >200 mL change
iii: Patient has a baseline IgE level ≥ 30 IU/mL>= 30 IU/mL
Baseline defined as prior to receiving Xolair or another mAb that may lower IgE
iv: Baseline positive skin test or in vitro test for one or more perennial or seasonal aeroallergens
Baseline prior to therapies that interfere with testing
v: Patient has received at least 3 consecutive months of combination therapy with: a) inhaled medium‑ or high‑dose corticosteroid AND b) at least one additional asthma controller/maintenance medication3 months
Combination inhaler can fulfill both criteria
vi: Asthma is uncontrolled or was uncontrolled at baseline as defined by: a) ≥ 2 exacerbations requiring systemic corticosteroids in the previous year, OR b) ≥ 1 exacerbation requiring hospitalization/ED/urgent care in the previous year, OR c) asthma worsens upon tapering oral corticosteroids
vii: Medication prescribed by or in consultation with an allergist, immunologist, or pulmonologist
Dosing limit: Maximum dose for asthma: 375 mg subcutaneously, not more frequently than once every 2 weeks<= 375 mg; >= 2 weeks interval
Approve Xolair for 1 year if the patient meets ALL of the following (i–iii):
Asthma continuation criteria
i: Patient has already received at least 4 months of therapy with Xolair>= 4 months
Patients restarting or with <4 months should be considered as initial therapy
ii: Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler
iii: Patient has responded to therapy as determined by the prescriber (examples: decreased exacerbations, symptoms, healthcare utilization, rescue medication use, improved lung function)
inv-03: Chronic Spontaneous Urticaria Initial Therapy (Approve for 6 months)
Approve Xolair for 6 months if the patient meets ALL of the following (i–iii):
CSU initial criteria
i: Patient is ≥ 12 years of age
ii: Urticaria > 6 weeks with symptoms > 3 days/week despite daily non‑sedating H1 antihistamine therapy titrated up to 4× standard dose>6 weeks
Examples of non‑sedating H1 antihistamines: cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine
iii: Medication prescribed by or in consultation with an allergist, immunologist, or dermatologist
Approve Xolair for 1 year if the patient meets BOTH of the following (i and ii):
CSU continuation criteria
i: Patient has already received at least 6 months of therapy with Xolair>= 6 months
Patients restarting or with <6 months should be considered as initial therapy
ii: Patient has experienced a beneficial clinical response defined by: decreased itch severity OR decreased number of hives OR decreased size of hives
Documentation requirement: Prescriber must document clinical response and prior duration of Xolair therapy (≥ 6 months)
inv-05: Chronic Rhinosinusitis with Nasal Polyps Initial Therapy (Approve for 6 months)
Approve Xolair for 6 months if the patient meets ALL of the following (i–vii):
Nasal polyps initial criteria
i: Patient is ≥ 18 years of age
ii: Diagnosis of chronic rhinosinusitis with nasal polyps evidenced by direct exam, endoscopy, or sinus CT scan
iii: Patient has experienced ≥ 2 of the following symptoms for ≥ 6 months: nasal congestion, nasal obstruction, nasal discharge, and/or reduction/loss of smell>= 6 months
Approve Xolair for 1 year if the patient meets ALL of the following (i–iii):
Nasal polyps continuation criteria
i: Patient has already received at least 6 months of therapy with Xolair>= 6 months
Patients restarting or with <6 months should be considered as initial therapy
ii: Patient continues to receive therapy with an intranasal corticosteroid
iii: Patient has responded to Xolair therapy as determined by the prescriber (examples: reduced polyp size, improved congestion, reduced sinus opacification, decreased sino-nasal symptoms, improved smell)
inv-07: IgE‑Mediated Food Allergy (Approve for 1 year)
Approve Xolair for 1 year if the patient meets ALL of the following (A–G):
Food allergy criteria
A: Patient is ≥ 1 year of age
Baseline IgE ≥ 30 IU/mL>= 30 IU/mL
Baseline defined as prior to receiving Xolair or another mAb that may lower IgE
C: Positive skin prick test response to ≥1 foods OR positive in vitro IgE test to ≥1 foods
Either test is acceptable; both are not required if sensitization can otherwise be documented
D:
inv-08: Indications overview
Coverage and medical necessity statements reference FDA-approved and off-label indications with varying levels of evidence; specific criteria are required per indication.
FDA-Approved and other discussed indications: Indications discussed include: asthma; chronic spontaneous (idiopathic) urticaria; chronic rhinosinusitis with nasal polyps; IgE‑mediated food allergy; and off‑label uses discussed in the policy such as atopic dermatitis (insufficient evidence), eosinophilic gastrointestinal diseases (guidelines recommend against use), and occupational latex allergy. Coverage and medical necessity depend on meeting the applicable condition‑specific criteria elsewhere in the policy.
Concurrent use with other monoclonal antibody therapies is not established and examples are listed; see policy for full list and not‑medically‑necessary uses.
Xolair (omalizumab) for any indication not explicitly listed as medically necessary in this policy is considered not medically necessary. Examples include, but are not limited to, atopic dermatitis, concurrent use with another monoclonal antibody therapy, eosinophilic gastrointestinal disorders (eosinophilic gastroenteritis, eosinophilic esophagitis, eosinophilic colitis), and occupational latex allergy in healthcare workers. See the policy Scope for the specific FDA‑approved indications covered and the condition‑specific criteria required for coverage.
Use of Xolair for eosinophilic esophagitis and related eosinophilic gastrointestinal conditions is considered unsupported by sufficient evidence and is not recommended by the American College of Gastroenterology 2025 guidance; requests for coverage for these indications may be denied.
Uses of Xolair that lack adequate supporting evidence or are not FDA‑approved are considered not medically necessary. The policy lists several examples of such uses (e.g., atopic dermatitis, eosinophilic gastrointestinal diseases, occupational latex allergy), and absence of condition‑specific criteria or guideline support may lead to denial of coverage.
For certain conditions such as atopic dermatitis and eosinophilic gastrointestinal disorders, the evidence base is limited or conflicting. Available trials for atopic dermatitis are small and provide mixed results, and guideline panels have concluded there are insufficient data to recommend routine use. Similarly, small studies and case series for eosinophilic GI conditions are limited and conflicting, and the ACG 2025 guideline recommends against use. Routine approval for these indications is not recommended pending more robust supportive data and guideline endorsement.
Coding, Dosing Thresholds, and Authorization Durations
Product referencemixed
Xolair® (omalizumab subcutaneous injection)
Drug product referenced
HCPCS Codes - Considered Medically Necessary when criteria are metHCPCSCovered
J2357
Injection, omalizumab, 5 mg
Baseline total IgE
Baseline total IgE threshold≥ 30 IU/mL — required for dosing in asthma, chronic rhinosinusitis with nasal polyps, and IgE‑mediated food allergy
When measuredPretreatment (baseline) serum total IgE measured before start of Xolair therapy
RationaleDosing for asthma and nasal polyps is based on body weight and serum total IgE and is only provided for patients with pretreatment IgE ≥ 30 IU/mL
Asthma age
Minimum age for asthma indication≥ 6 years
ContextApplies to allergic asthma with moderate to severe persistent disease and inadequate control on inhaled corticosteroids
Provider Requirements, Documentation, and Billing Guidance
Prior Authorization
Prior Authorization Required
Prior Authorization is required for Xolair (omalizumab). Initial approvals must be prescribed by or in consultation with a specialist who treats the condition (e.g., allergist, immunologist, pulmonologist, dermatologist, or otolaryngologist) as specified by indication. Approval durations vary by indication; see the policy criteria for specific durations.
Prior authorization required for benefit coverage of Xolair (J2357).
Initial approval requires prescription by or consultation with a physician who specializes in the treated condition.
Approvals provided for the durations noted in the applicable indication criteria (months = 30 days).
Prior Authorization
Indication-specific Prior Authorization and Durations
Criteria and required approval durations differ by indication (asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, IgE‑mediated food allergy). Submit requests against the specific criteria block for the applicable indication to ensure correct review and duration of approval.
Background and Scope
Xolair (omalizumab) is a monoclonal antibody that binds immunoglobulin E (IgE) and is indicated for several allergic conditions. FDA‑approved indications include treatment of allergic asthma (patients ≥ 6 years of age), chronic spontaneous/idiopathic urticaria (≥ 12 years), chronic rhinosinusitis with nasal polyps (≥ 18 years), and IgE‑mediated food allergy (≥ 1 year). Dosing and some eligibility depend on baseline total IgE (for certain indications a baseline IgE ≥ 30 IU/mL is required) and on indication‑specific clinical criteria documented by the prescriber.
Definitions and Clinical Terms
Baseline IgE (definition)
Definition of 'baseline' IgEIgE level measured prior to receiving any treatment with Xolair or another monoclonal antibody therapy that may lower IgE levels (e.g., dupilumab, tezepelumab)
Use for dosing decisionsBaseline IgE is used to determine eligibility and dosing for asthma, CRSwNP, and food allergy indications
Timing noteMeasure before initiation of any monoclonal antibody therapy to avoid falsely lowered IgE values
Uncontrolled asthma (examples)
Examples of uncontrolled asthma≥ 2 exacerbations requiring systemic corticosteroid bursts in the previous year
Examples of uncontrolled asthma≥ 1 exacerbation requiring hospitalization, emergency department, or urgent care in the previous year
Policy Summary
PayerCigna
PolicyXolair (omalizumab) coverage
Policy CodePolicy IP0487
Change TypeMaterial revisions to criteria and authorization durations
Effective DateJul 15, 2025
Next Review Date
Key ActionObtain prior authorization with documentation that the patient meets the applicable indication-specific criteria and required clinical documentation (age, baseline IgE when required, prior therapies, and specialist involvement).
Dosing limit: Maximum dose for asthma: 375 mg subcutaneously, not more frequently than once every 2 weeks<= 375 mg; >= 2 weeks interval
Dosing:
Approved dosing regimens: 150 mg subcutaneously once every 4 weeks OR 300 mg subcutaneously once every 4 weeks
Baseline IgE ≥ 30 IU/mL
>= 30 IU/mL
Baseline defined as prior to Xolair or other mAbs that may lower IgE
v: Patient has received ≥ 4 weeks of intranasal corticosteroid therapy AND will continue intranasal corticosteroid with Xolair>= 4 weeks
vi: ONE of: systemic corticosteroid course ≥5 days in past 2 years OR contraindication to systemic corticosteroids OR prior nasal polyp surgery
vii: Medication prescribed by or in consultation with an allergist, immunologist, or otolaryngologist (ENT)
Dosing limit: Maximum dose for nasal polyps: 600 mg subcutaneously, not more frequently than once every 2 weeks<= 600 mg; >= 2 weeks interval
Dosing limit: Maximum dose for nasal polyps: 600 mg subcutaneously, not more frequently than once every 2 weeks<= 600 mg; >= 2 weeks interval
Prescriber documents history of an allergic reaction to a food that: i) had signs/symptoms of a significant systemic allergic reaction, ii) occurred shortly after known ingestion, and iii) was deemed significant enough to require an epinephrine auto‑injector
Examples of signs: hives, swelling, wheezing, hypotension, GI symptoms
E: Patient has been prescribed an epinephrine auto‑injector
F: Xolair will be used in conjunction with a food allergen‑avoidant diet per prescriber
G: Medication prescribed by or in consultation with an allergist or immunologist
Dosing limit: Maximum dose for food allergy: 600 mg subcutaneously, not more frequently than once every 2 weeks<= 600 mg; >= 2 weeks interval
Food allergy dosing requires baseline IgE compatible with dosing (eg, >30 to <1850 IU/mL per guideline context)
Note on testingLung function criteria may be met at any time prior to or during asthma treatment; children 6–11 y have modified bronchodilator criteria (>12% increase without >200 mL requirement)
Chronic spontaneous urticaria age
Minimum age for chronic spontaneous urticaria (CSU)≥ 12 years
Duration requirementUrticaria > 6 weeks with symptoms > 3 days/week despite daily non‑sedating H1 antihistamine therapy (up‑titrated to ≤4× standard dose)
Prescriber requirementMedication prescribed by or in consultation with an allergist, immunologist, or dermatologist
Chronic rhinosinusitis with nasal polyps age
Minimum age for CRSwNP indication≥ 18 years
Evidence requirementDiagnosis evidenced by direct exam, endoscopy, or sinus CT scan
Baseline IgEBaseline IgE ≥ 30 IU/mL required for dosing
IgE‑mediated food allergy age
Minimum age for IgE‑mediated food allergy indication≥ 1 year
Continuation approvalsContinuation approvals generally grant up to 1 year when continuation criteria are met
Refer to the indication-specific criteria and dosing sections for required elements and authorized durations.
Initial vs continuation therapy have different required documentation and durations (e.g., asthma initial = 4 months; asthma continuation = 1 year).
Billing Rule
Billing Code and Clinical Documentation
When submitting HCPCS code J2357 (Injection, omalizumab, 5 mg), include documentation that the patient meets the applicable policy criteria for the requested indication.
Submit J2357 with supporting clinical documentation that aligns to the indication-specific criteria (age, baseline IgE, prior therapies, response to therapy, specialist involvement).
Denial Risk
Coding and Claim Denial Risk
Claims submitted without covered diagnosis or procedure codes that match the applicable Coverage Policy will be denied. Ensure the submitted codes and documentation correspond to an indication listed as medically necessary in this policy.
Claims without covered diagnosis or procedure codes under this policy will be denied as not covered.
Denial Risk
Atopic Dermatitis — Evidence Limited
Atopic dermatitis is not supported as a medically necessary indication based on current evidence. Limited, mixed data and guideline statements note insufficient evidence to recommend Xolair for atopic dermatitis; requests for this indication may be denied.
Available randomized evidence is small and inconsistent and guideline recommendations (American Academy of Dermatology) state insufficient data to recommend Xolair for atopic dermatitis.
Prior authorization for atopic dermatitis is unlikely to meet medically necessary criteria and may be denied per policy.
Documentation Required
Antihistamine Requirement for Chronic Spontaneous Urticaria
For chronic spontaneous (idiopathic) urticaria, document prior failure or intolerance of non-sedating H1 antihistamines at doses titrated up to a maximum of four times the standard FDA‑approved dose with symptoms present >3 days per week before initial approval is granted.
Examples of non‑sedating H1 antihistamines: cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine.
Documentation should state antihistamine agent(s), dosing (including up‑titration to up to 4x standard dose), duration, and that symptoms persisted >3 days per week.
Denial Risk
Concurrent Biologic Therapy — Denial Risk
Concurrent use of Xolair with other monoclonal antibody therapies (e.g., Nucala, Dupixent, Ebglyss, Nemluvio, Fasenra, Tezspire, Adbry, Cinqair) is not recommended and may be denied. If concurrent therapy is being considered, provide detailed justification and supporting documentation for review.
Concurrent monoclonal antibody therapy is generally not supported and may be denied; examples include Nucala, Dupixent, Ebglyss, Nemluvio, Fasenra, Tezspire, Adbry, Cinqair.
Examples of uncontrolled asthmaAsthma that worsens upon tapering oral corticosteroids
Concurrent monoclonal antibody therapy
Definition of concurrent monoclonal antibody therapyUse of Xolair together with another monoclonal antibody; combined efficacy and safety not established
Examples of other monoclonal antibodiesAdbry (tralokinumab), Cinqair (reslizumab), Dupixent (dupilumab), Ebglyss (lebrikizumab), Fasenra (benralizumab), Nemluvio (nemolizumab), Nucala (mepolizumab), Teszpire (tezepelumab)
Policy consequenceConcurrent use may trigger denial of combined therapy requests or is considered not established/unsupported