CurrentCignaPolicy N/A

Omalizumab (Xolair) prior authorization and coverage criteria

Form and clinical criteria governing prior authorization requests for Xolair (omalizumab) for various indications (asthma, chronic spontaneous urticaria, CRSwNP, IgE-mediated food allergy, etc.) submitted to Cigna; affects prescribing clinicians, specialty pharmacies, infusion sites, and Cigna reviewers.

Policy Summary

PayerCigna

PolicyOmalizumab (Xolair) prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeMinor / no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed Cigna Xolair prior authorization form including product strength, dose, quantity, J-code, ICD-10, indication, required clinical documentation, and whether therapy is initial, restarting, or continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysResponse time

AccredoSpecialty pharmacy

multipleIndications

FEV1 thresholdsPFT criteria

Coverage and Medical Necessity Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Indication-specific medical necessity criteria

Coverage consideration when indication-specific clinical criteria are met

General authorization requirements: Completed prior authorization form with prescriber and patient identifiers; specification of Xolair product and J-code; documentation of whether initial, restarting, or continuation therapy; indication selected; documentation of concurrent monoclonal antibody use; administration site and dispensing source.

See authorization.documentation

Indication-specific pathways: Separate pathways for asthma, Chronic Spontaneous Urticaria (CSU), Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Immunoglobulin E–Mediated Food Allergy, and other listed indications.

Each pathway below contains additional AND requirements

Asthma - initial or restarting or <4 months therapy: Baseline IgE ≥30 IU/mL (if asthma or CRSwNP or IgE-mediated food allergy); prescribed by or in consultation with an allergist, immunologist, or pulmonologist; documented FEV1 <80% predicted and FEV1/FVC <0.80 OR bronchodilator reversibility per form (increase in FEV1 >12% and >200 mL for age ≥12 when required) OR positive bronchial challenge/exercise test; during treatment, documentation of at least 3 consecutive months of medium- or high-dose inhaled corticosteroid plus at least 3 consecutive months of at least one additional controller medication; and at baseline ≥2 exacerbations requiring systemic corticosteroids in the prior year OR ≥1 exacerbation requiring hospitalization/ED/urgent care OR asthma worsening on oral steroid taper.

See chunks 8, 11, 13

Asthma - continuation: For patients currently receiving therapy ≥4 months (or ≥6 months when indicated), prescriber documents clinical response (examples: decreased exacerbations, symptoms, hospital/ED visits, rescue medication use, or improved lung function) and continuation of at least one inhaled corticosteroid or combination inhaler.

See chunk 10

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Objective evidence of CRSwNP by direct exam, endoscopy, or sinus CT; two or more symptoms for ≥6 months (nasal congestion/obstruction, nasal discharge, or reduced/loss of smell); trial of intranasal corticosteroid for ≥4 weeks with plan to continue; and prior sinonasal surgery OR at least one course of systemic corticosteroids (≥5 days) within the previous 2 years, or documented contraindication to systemic steroids.

See chunk 15

Chronic Spontaneous Urticaria (CSU): Urticaria symptoms greater than 3 days per week for greater than 6 weeks despite daily non-sedating H1 antihistamine therapy titrated up to a maximum of 4 times the standard dose (examples: cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine).

See chunk 16

IgE-Mediated Food Allergy: Both a positive skin prick test (SPT) to one or more foods and a positive in vitro IgE blood test to one or more foods; prescriber documents signs/symptoms of a significant systemic allergic reaction occurring shortly after ingestion; prescriber deemed reaction significant enough to require prescription for an epinephrine auto-injector; patient has been prescribed an epinephrine self-administered injectable or nasal product; and plan to use the medication in conjunction with a food allergen-avoidant diet.

See chunk 17

Prior Authorization Submission & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Use the Cigna Xolair prior authorization form and complete all required fields. Specify the exact product strength and formulation (for example, 75 mg/0.5 mL syringe; 150 mg vial; 150 mg/mL syringe; 300 mg/2 mL syringe), the prescribed dose, frequency, duration, and total quantity. Include the applicable J‑code and the ICD‑10 diagnosis code on the submission.

Submit using the Cigna Xolair prior authorization form (electronic submission via CoverMyMeds or SureScripts in the EHR is acceptable).
Specify product strength, formulation, dose, frequency, duration, and total quantity.
Provide the appropriate J‑code and ICD‑10 code on the request.

Step Therapy

Required Prior Therapy Trials (by indication)

Document prior therapy trials as applicable to the indication being treated. For asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and IgE‑mediated food allergy, provide evidence of required prior medication trials or failures as detailed below.

Asthma: At baseline and during the period when patient received a medium‑ or high‑dose inhaled corticosteroid, document at least 3 consecutive months of therapy with at least one additional asthma controller/maintenance medication (examples: long‑acting beta2‑agonists, long‑acting muscarinic antagonists, or a combination inhaler). If using a combination inhaler containing a medium/high‑dose ICS plus controller, this may satisfy the requirement.
Asthma exacerbation history: Document ≥2 systemic corticosteroid‑requiring exacerbations in the prior year, or ≥1 exacerbation requiring hospitalization, ED, or urgent care visit.
CRSwNP: Document diagnosis by direct exam, endoscopy, or sinus CT; at least two symptoms for ≥6 months; trial of intranasal corticosteroid for ≥4 weeks; prior surgery or at least one systemic corticosteroid course (≥5 days) in the previous 2 years, or a contraindication to systemic corticosteroids.
Chronic Spontaneous Urticaria (CSU): Document persistent urticaria >3 days/week for >6 weeks despite daily non‑sedating H1 antihistamine therapy titrated up to 4× standard dose.
IgE‑mediated Food Allergy: Document positive skin prick test and positive in‑vitro specific IgE to the food(s), and history of clinically significant systemic allergic reaction as described by the prescriber.

Documentation Required

Required Documentation on Request

Include the following documentation with the prior authorization request to avoid processing delays: completed and signed Cigna Xolair prior authorization form, prescriber specialty and credentials (include specialty if indication‑specific), formulation/strength requested, J‑code and ICD‑10 diagnosis, planned administration setting and administration details (route, frequency, anticipated duration), and whether therapy is initial, restarting, or continuation.

Completed and signed Cigna Xolair prior authorization form (all asterisked items completed).
Prescriber credentials and specialty; for asthma, CRSwNP, CSU, or IgE‑mediated food allergy include relevant specialist or consultation documentation (allergist/immunologist, pulmonologist, ENT, dermatologist as applicable).
Requested product formulation and strength, dose, frequency, duration, and total quantity.
J‑code and ICD‑10 diagnosis on the request.
Planned administration setting (home, physician office, hospital outpatient, etc.) and note if least‑intensive medically appropriate setting considered.
For ongoing therapy: duration of prior therapy and statement of clinical response, if applicable.

Denial Risk

Documentation Gaps That May Cause Denial or Delay

Requests may be denied or delayed if key clinical information is missing. Ensure objective baseline and prior‑therapy evidence is provided.

Missing baseline IgE level (for asthma, CRSwNP, or IgE‑mediated food allergy) — baseline defined prior to exposure to any monoclonal antibody that lowers IgE.
Absent allergy testing for IgE‑mediated food allergy (both positive skin prick test and positive in‑vitro specific IgE required).
Insufficient asthma exacerbation history (no documentation of ≥2 systemic steroid courses in prior year or ≥1 hospitalization/ED/urgent care visit).
Lack of documentation of prior controller therapy trials (e.g., no record of ≥3 months additional controller while on medium/high‑dose ICS for asthma).
No prescriber specialty or consultation documentation when required by indication.
Missing J‑code, ICD‑10 code, or incomplete dosing/quantity details on the form.

Key Definitions

Baseline (for IgE and exacerbation history)

Definition of baselineBaseline is defined as prior to receiving any treatment with the requested medication or another monoclonal antibody therapy that may lower IgE levels or affect exacerbation counts.

Baseline IgE requirement (when applicable)For asthma, CRSwNP, or IgE-mediated food allergy, the form asks whether baseline immunoglobulin E (IgE) was ≥ 30 IU/mL (measured prior to any interfering monoclonal antibody).

Baseline allergy testing for food allergyFor IgE-mediated food allergy, baseline requires both a positive skin prick test (SPT) to one or more foods and a positive in vitro (blood) IgE test to one or more foods, documented prior to treatment that could affect testing.

Baseline documentation of prior reactions (food allergy)Prescriber must document signs/symptoms of a significant systemic allergic reaction occurring shortly after ingestion and that an epinephrine prescription was warranted; patient must have an epinephrine auto-injector prescribed.

OpenPayer

Omalizumab (Xolair) prior authorization and coverage criteria

Coverage and Medical Necessity Criteria

Billing, Codes, and Pulmonary Function Criteria

Prior Authorization Submission & Documentation Requirements

Key Definitions

Background