Xolair
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Defines initial and continuation coverage criteria, quantity limits, dosing tables, authorization periods, and applicable HCPCS code for omalizumab (Xolair) for severe asthma, chronic spontaneous urticaria, and IgE-mediated food allergy.
No material changes
Coverage Summary
This policy covers with criteria omalizumab (Xolair) for the treatment of severe asthma, chronic spontaneous urticaria, and IgE-mediated food allergy, defining initial and continuation approval requirements, dosing/quantity limits, and applicable HCPCS coding.
Initial Therapy Criteria
Initial Approval - Severe asthma
Covered when ALL of the following are met:
ALL of the following
- Age ≥ 6 years
- Prescribed by, or in consultation with an allergist, pulmonologist, or immunologist
- Diagnosis of severe asthma
- Confirmation of diagnosis via skin test or RAST for specific allergy sensitivity
- IgE Levels (> 30 IU/mL) prior to treatment, with baseline level provided> 30 IU/mL
baseline IgE required
- History of ≥ 2 asthma exacerbations requiring systemic corticosteroids or ED visit or hospitalization for asthma within the past year despite adherent use of either an inhaled corticosteroid (ICS) with 1 additional asthma controller medication or maximally tolerated ICS/LABA combination product≥ 2 in past year
Prescriber attestation
- Patient adherence to controller medications
- Will not be used in combination with another targeted immunomodulator product used for asthma
Initial Approval - Chronic spontaneous urticaria
Covered when ALL of the following are met:
Initial Approval - IgE-mediated food allergy
Covered when ALL of the following are met:
Diagnosis supported by either
- Positive skin prick test
- Positive serum IgE test
One of the following
- Diagnosis confirmed by a positive oral food challenge
- History of anaphylaxis to the suspected food allergen
baseline IgE required for dosing
Continuation Therapy Criteria
Continuation of Therapy - Severe asthma
Covered when ALL of the following are met:
Continuation of Therapy - Chronic spontaneous urticaria
Covered when ALL of the following are met:
Continuation of Therapy - IgE-mediated food allergy
Covered when ALL of the following are met:
Age-based continuation
- Patient is age ≥ 18 years
If age 1-17 years, ONE of
- Documentation of an off-treatment rechallenge confirming continued presence of IgE-mediated food allergy
- Rechallenge is not appropriate for the patient at this time (rationale provided)
Applicable Codes
| J2357 | Injection, omalizumab, 5 mg |
Provider Actions
Prior authorization required per clinical criteria
Providers must submit documentation to meet clinical prior authorization criteria: baseline total IgE level (baseline IgE > 30 IU/mL where specified), confirmation of diagnosis by appropriate testing (skin test or RAST for asthma; skin prick or serum IgE for food allergy), history or trials of prior treatments (e.g., high‑dose H1 antihistamines for CSU; prior controller therapy and exacerbation/exacerbation history for asthma), documentation of prescriber specialty or documentation of consultation with an allergist/pulmonologist/dermatologist/immunologist as required, and prescriber attestation regarding adherence to controller therapies and that omalizumab will not be used concurrently with another targeted immunomodulator for asthma.
- Affected code: J2357
Weight required for approval and dosing
Patient body weight must be provided for dosing determination and is required for approval. Dosing tables in the policy reference both baseline IgE and body weight to select the correct omalizumab dose.
- Dosing tables referenced in policy (see Appendix/Table sections for weight-and-IgE based dosing)
Quantity limits per 28 days by dose
Quantity limits are specified by dose and 28‑day period: 75 mg and 150 mg dose levels are limited to 2 injections per 28 days; the 300 mg dose is limited to 1 injection per 28 days.
- Injection volume equivalents: 75 mg = 0.5 mL; 150 mg = 1 mL; 300 mg = 2 mL
- Affected code: J2357
Authorization durations
Authorization durations in the policy: initial approvals for severe asthma and chronic spontaneous urticaria are allowed for 6 months; continuation approvals for those conditions are allowed for 1 year. Approvals for IgE‑mediated food allergy are allowed for 1 year.
Epinephrine dispensing for food allergy
For IgE‑mediated food allergy indications, injectable epinephrine must have previously been dispensed or will be prescribed along with omalizumab as a condition of coverage.
Background
Omalizumab (Xolair) is an anti-IgE monoclonal antibody indicated in this policy for severe allergic asthma, chronic spontaneous urticaria, and certain IgE-mediated food allergy indications. Dosing and quantity limits are determined by baseline total serum IgE and patient body weight; the policy requires a baseline IgE level for initial dosing and documentation of patient weight for approval and dose selection.
RAST: Radioallergosorbent test (specific IgE serum testing).
CSU: Chronic spontaneous urticaria.
Clinical Evidence
The policy references clinical evidence for approved indications and describes coverage criteria and dosing tables, but no trial-level evidence metrics or individual study data were provided in the brief.
Revision History
Last review
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