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Omalizumab Products
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Medical and pharmacy benefit coverage and site-of-service medical necessity criteria for omalizumab products (Xolair and Omlyclo) for indications including moderate to severe persistent asthma, chronic idiopathic urticaria, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy; intended for providers and utilization review.
Updated initial authorization length for all reviews from 6 months to 12 months and removed reference to non-formulary exception reviews.
Added Exdensur (depemokimab-ulaa) to the list of medications not to be used concurrently with omalizumab for the treatment of asthma.
Updated chronic idiopathic urticaria dose limit to 600 mg every 2 weeks.
Updated asthma criteria to use maximum tolerated doses of inhaled corticosteroid rather than maximum doses and added FEV1/FVC < 0.80 as an option.
Updated CRSwNP criteria to require bilateral disease confirmed by exam, CT, or endoscopy and prior use of systemic corticosteroids in last 2 years or prior bilateral polyp surgery or contraindication to systemic steroids.
Clarified that medications listed are subject to the product's FDA dosage and administration prescribing information and that non-formulary exception authorizations may be approved up to 12 months.
Updated initial approval length for Xolair for chronic idiopathic urticaria to 6 months (historical change noted in 2023) then generalized initial authorization update to 12 months in 2026 update.
Initial authorization period for all reviews changed from 6 months to 12 months.
Added Exdensur (depemokimab-ulaa) to the list of medications that should not be used concurrently with omalizumab when treating asthma.
Chronic idiopathic urticaria dose limit updated to 600 mg every 2 weeks.
Policy title updated from "Xolair (omalizumab)" to "Omalizumab Products" and Omlyclo (omalizumab-igec) was added with the same criteria as Xolair.
Site of service medical necessity review can apply to injection drugs.
Coverage Criteria and Indications
Moderate to severe persistent asthma (omlyclo/Xolair)
Covered when ALL of the following are met
Severe chronic idiopathic urticaria (Xolair/Omlyclo)
Covered when ALL of the following are met
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Covered when ALL of the following are met
IgE-mediated food allergy
Covered when ALL of the following are met
General coverage criteria
Covered when clinical criteria consistent with approved indications and benefit management are met:
Covered indications with criteria
Covered when policy-specified diagnostic confirmation, prior therapies, dosing limits, and non-concurrent-biologic rules are met.
Coverage criteria and dosing rules
Coverage and dosing are guided by indication-specific rules and manufacturer dosing tables; key conditions include:
Asthma — Dosing and Dose Determination
Covered for moderate to severe persistent asthma when ALL applicable criteria are met per the policy (criteria detailed elsewhere in the policy).
Chronic Idiopathic Urticaria — Dosing
Covered for chronic idiopathic urticaria when ALL applicable criteria are met.
The following uses are identified as investigational or unapproved and are not covered under this policy: allergic rhinitis, atopic dermatitis, other IgE‑mediated allergic conditions not specifically listed in the policy, latex allergy, bullous pemphigoid, and other uses not specified in the approved indications.
Clinical trial evidence did not demonstrate consistent efficacy for the 75 mg dose in chronic idiopathic urticaria; the 75 mg dose is not approved for that indication and therefore is not an acceptable dosing option for CIU.
Concurrent administration of omalizumab with other biologic therapies for the same indication is restricted. Recent updates explicitly add Exdensur (depemokimab‑ulaa) to biologics not to be used concurrently for asthma and reiterate that agents such as Tezspire (tezepelumab) and Dupixent (dupilumab) are not to be combined with omalizumab when used for overlapping indications; such concurrent use may trigger denial of medical necessity.
The dosing tables include specific cells where combinations of very high pre‑treatment total serum IgE and patient body weight are listed as DO NOT DOSE. Entries labeled DO NOT DOSE indicate that a recommended omalizumab dose is not provided for those IgE/weight strata and such combinations are not supported by the dosing guidance.
The policy states that omalizumab should not be used in combination with certain other biologics for the same treated condition. Examples called out in updates include dupilumab, tezepelumab, mepolizumab, and depemokimab (Exdensur). Combination use with these agents for asthma, CRSwNP, or urticaria is restricted and may be considered not medically necessary.
Site‑of‑service medical necessity criteria apply to omalizumab administration. Infusion or injection at higher‑cost or less appropriate locations may be considered not medically necessary when site‑of‑service criteria are not met. The policy also specifies that initial administration settings (including review of site‑of‑service) can be applied to injection drugs such as omalizumab.
Requests for omalizumab that do not document required diagnostic confirmation or prior therapy trials will not meet medical necessity. Examples include CRSwNP without confirmation by physical exam, sinus CT, or nasal endoscopy or without prior systemic corticosteroid use in the past 2 years (or prior bilateral polyp surgery or a contraindication), and CIU without documented failure/intolerance to the required antihistamine trials.
Cells in the asthma dosing table marked DO NOT DOSE reflect that no dosing recommendation is provided for those high pre‑treatment total serum IgE and weight combinations; such entries indicate the dose cannot be determined from the table and imply the agent should not be dosed for those parameter combinations.
The policy explicitly lists multiple biologics that should not be used concurrently with omalizumab for overlapping indications. For asthma and CRSwNP this includes agents such as Tezspire (tezepelumab), Dupixent (dupilumab), and the newly added Exdensur (depemokimab‑ulaa). Concurrent combination therapy with these specified biologics is considered not medically necessary.
Billing and Coding
| J2357 | Omalizumab (Xolair) injection |
Provider Actions, Prior Authorization, and Documentation
Managed via pharmacy and medical benefits; PA required
Omalizumab is managed through both the pharmacy and medical benefits and requires prior authorization consistent with benefit management.
Prior authorization required; initial approval length standardized
Prior authorization is required and initial approvals are standardized to a 12-month authorization period for all reviews.
Authorization duration — 12 months
Initial authorizations will be issued for 12 months for all reviews.
12-month PA with possible site-of-service review
Prior authorization approvals are issued for an initial 12-month period; site-of-service medical necessity review may be applied to injection drugs including Omlyclo/Xolair.
Confirm prior/concomitant therapies by indication
Document that required prior or concomitant therapies were used per indication: asthma patients must be on appropriate inhaled controller therapy; CIU patients must have failed antihistamines; CRSwNP must have tried intranasal corticosteroid monotherapy.
- Asthma: using maximum tolerated inhaled corticosteroid and an inhaled LABA
- CIU: failed or intolerant to ≥2 H1-antihistamines at high doses or max tolerated dose
- CRSwNP: inadequate response or intolerance to intranasal corticosteroid monotherapy
Therapy sequencing — document failed controller therapy
Omalizumab is positioned as an add-on/last-line therapy; document trials of appropriate inhaled corticosteroid and controller agents prior to approval.
- Provide medication history showing inadequate control despite inhaled corticosteroid and other controller therapy
CRSwNP — prior systemic steroid use or surgery required
For CRSwNP, document prior systemic corticosteroid use within the last 2 years, or contraindication to systemic steroids, or prior bilateral nasal polyp surgery before approval.
- Evidence of systemic corticosteroid treatment for polyps in the last 2 years OR
- Contraindication to systemic corticosteroids OR
- Previous bilateral nasal polyp surgery
Background medication classes — reference appendix
Refer to the appendix for background medication classes used as supportive therapy (inhaled corticosteroids, long-acting bronchodilators, leukotriene modifiers, H1 antihistamines).
- Inhaled corticosteroids (e.g., fluticasone, budesonide, mometasone)
- Long-acting bronchodilators (e.g., salmeterol)
- Leukotriene modifiers (e.g., montelukast)
- H1 antihistamines (e.g., cetirizine, fexofenadine)
Prior medication/step requirements must be documented
Policy includes prior medication/step requirements for indications such as CIU and CRSwNP; ensure documentation of prior medication trials (e.g., ≥2 H1-antihistamines for CIU; intranasal steroid for CRSwNP).
- CIU: failure of ≥2 H1-antihistamines at high doses
- CRSwNP: inadequate response to intranasal corticosteroid monotherapy or prior systemic steroid/surgery
Submit full medical records showing diagnosis and medication history
Submit medical records documenting diagnosis, relevant history, physical evaluation, and complete medication history to demonstrate that medical necessity criteria are met.
- Office visit notes with diagnosis and relevant history
- Physical examination findings
- Medication history including prior controllers and antihistamines
Document ≥3 in-office doses and anaphylaxis assessment before self-administration
When initiating therapy or considering self-administration, document the administration setting and confirm that at least three doses were administered in a healthcare provider's office and that anaphylaxis risk was assessed.
- Record location of each administration and that ≥3 in-office doses were given
- Document assessment of anaphylaxis risk and mitigation strategies prior to self-administration
Include indication-specific supporting documentation
Provide supporting documentation specific to the indication (e.g., for CRSwNP: confirm bilateral disease by physical exam, sinus CT, or nasal endoscopy; for asthma, document positive skin test/RAST and exacerbation history).
- CRSwNP: physical exam, sinus CT, or nasal endoscopy confirming bilateral polyps
- Asthma: positive skin test or RAST to a perennial aeroallergen and exacerbation history
Document baseline total serum IgE and weight for dosing
Document pre-treatment total serum IgE and body weight used for dose determination; note that on-treatment IgE should not be used to guide dosing and re-testing is allowed only if treatment interruption ≥1 year.
- Record baseline total serum IgE value used for initial dosing
- Record body weight at baseline and for dose adjustments
- If treatment interrupted <1 year, use original baseline IgE for re-dosing; re-test if interruption ≥1 year
Record dosing basis, weight, and CIU symptom duration/reassessment
For dosing determinations and for chronic idiopathic urticaria, record the prior dosing determination (initial serum IgE used if interruption <1 year), body weight for adjustments, and for CIU document ≥6 weeks of symptoms and periodic reassessment of ongoing need.
- CIU: document ≥6 weeks of symptoms prior to initiation
- Record prior dosing basis and weight for dose changes
- Periodically reassess need for continued CIU therapy
Site-of-service review may trigger denial if SOS criteria not met
Site-of-service reviews may deem services not medically necessary if site-of-service criteria are not met; ensure the administration location meets policy SOS requirements (preferred sites: physician office, infusion center, home infusion, or hospital outpatient).
- Preferred medically necessary sites include physician office, infusion center, home infusion, hospital outpatient
- Services at nonmedically necessary sites may be denied if SOS criteria are not met
Require ≥3 in-office administrations before self-administration
Before approving self-administration, confirm the patient received at least three doses in a healthcare provider's office; requests lacking this may be subject to benefit management or denial.
- Documented record of ≥3 in-office administrations is required prior to self-administration
Denial risk if diagnostic or prior-therapy criteria not documented
Requests may be denied if the patient does not meet updated diagnostic or prior-therapy criteria for the requested indication (for example, CRSwNP without bilateral confirmation or without prior systemic steroid use/surgery).
- CRSwNP: denial risk if no exam, CT, or endoscopy confirming bilateral disease
- Denial risk when prior therapy requirements (e.g., prior systemic steroids or surgery) are not documented
Do not approve concurrent omalizumab + Exdensur for asthma
Concurrent use of omalizumab with Exdensur (depemokimab-ulaa) for asthma is not permitted; requests for concurrent therapy with listed agents may be denied.
- Do not approve concurrent use of omalizumab with Exdensur for asthma
Concurrent biologic therapy for same indication is restricted
Do not use omalizumab concurrently with certain other biologics (e.g., Tezspire, Dupixent, Exdensur and other listed agents) for the same indication; concurrent biologic therapy requests may be denied.
- Concurrent biologic therapy for the same indication is restricted and may trigger denial
Background — follow indication-specific PA and documentation rules
Omalizumab is an anti-IgE monoclonal antibody indicated for specified allergic conditions; follow indication-specific criteria and the policy's administration and documentation requirements when requesting authorization.
- Indications include moderate to severe persistent allergic asthma, chronic idiopathic urticaria, CRSwNP, and select IgE-mediated food allergy
- Ensure PA, documentation of prior therapies, dosing basis (IgE and weight where applicable), and SOS requirements are met
Background and Clinical Evidence
Omalizumab is a monoclonal antibody that binds circulating IgE and prevents IgE binding to high‑affinity FcεRI receptors on mast cells and basophils, reducing allergic mediator release. It is indicated for selected patients with moderate to severe persistent allergic asthma, chronic idiopathic urticaria refractory to antihistamines, inadequately controlled chronic rhinosinusitis with nasal polyps, and for selected IgE‑mediated food allergy management when used with allergen avoidance. The policy covers Xolair and the biosimilar Omlyclo under the same clinical criteria and includes direction on dosing determination, prior therapy requirements, site‑of‑service review, and documentation needed to support medical necessity.
Policy Revision History
Policy updated: initial authorizations for all reviews changed from 6 months to 12 months; Exdensur (depemokimab-ulaa) added to asthma concurrent-use exclusions; chronic idiopathic urticaria dose limit set to 600 mg every 2 weeks.
Policy title changed to 'Omalizumab Products' and Omlyclo (omalizumab-igec) was added to the policy with the same criteria as Xolair; site-of-service review added for Omlyclo.
CRSwNP criteria clarified to require bilateral disease confirmed by exam, CT, or endoscopy and prior systemic corticosteroid use within 2 years or prior bilateral polyp surgery; added non-concurrent use restriction with tezepelumab for CRSwNP.
Asthma criteria changed from maximum dose to maximum tolerated inhaled corticosteroid and an FEV1/FVC <0.80 option was added; changed oral corticosteroid dependence language to 'worsens on taper'.
Clarified that medications in the policy follow FDA dosing and that non-formulary exception authorizations may be approved up to 12 months.
Updated asthma criteria and related coverage language (recorded as annual review actions in 2025 references).
Updated definition of moderate to severe persistent asthma to include exacerbations requiring oral corticosteroids and adjusted CIU initial approval length historically to 6 months (later changed).
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