CurrentViva HealthPolicy IC-P0146

Xolair (omalizumab) — Dosing and Administration

Guidance on dosing and administration of omalizumab (Xolair) for multiple indications (moderate-to-severe persistent asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy) including dose selection by total serum IgE, body weight, and dosing frequency; includes billing codes and NDCs. Affects providers prescribing/administering omalizumab to Viva Health members.

Policy Summary

PayerViva Health

PolicyXolair (omalizumab) — Dosing and Administration

Policy CodePolicy IC-P0146

Change TypeNo material changes

Effective Date

Next Review DateMar 3, 2026

Key ActionMeasure baseline total serum IgE and record body weight to determine dose and dosing frequency per the indication-specific dosing tables before initiating omalizumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Indications with dosing tables

J2357HCPCS for omalizumab

5 mgBilling unit

15Covered ICD-10 codes listed

partialFood allergy dosing table

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Coverage and Dosing Criteria

Indication-specific dosing criteria

Dose and frequency must follow indication‑specific dosing tables using baseline total serum IgE and body weight (except CSU where fixed dosing applies).

Asthma dosing: For moderate-to-severe persistent asthma: dose range 75 to 375 mg administered subcutaneously every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg); use the provided asthma dosing table which includes 'Do Not Dose' entries for certain high IgE x weight combinations.Serum total IgE + body weight per asthma table

See asthma dosing table in document (includes 'Do Not Dose' cells)

Chronic spontaneous urticaria (CSU): Dose = 150 mg or 300 mg administered subcutaneously every 4 weeks. Dosing for CSU is fixed and is not dependent on serum total IgE level or body weight.Fixed dosing

CSU dosing independent of IgE/weight

Chronic rhinosinusitis with nasal polyps (CRSwNP): Dose range 75 to 600 mg administered subcutaneously every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg) using the CRSwNP dosing table.Serum total IgE + body weight per CRSwNP table

See CRSwNP weight-based table

IgE-mediated food allergy: Dose range 75 to 600 mg administered subcutaneously every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg) using the food allergy dosing tables; higher IgE strata include larger fixed doses (partial table shown).Serum total IgE + body weight per food allergy tables

See food allergy weight-based tables (partial table in document)

General coverage criteria (fragment)

Covered when supported by an appropriate labeled indication and documentation, with dosing and billing per the policy.

Basic coverage requirements: Omalizumab is covered for labeled indications (moderate-to-severe persistent asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy) when dosing follows the indication-specific tables. Baseline serum total IgE (IU/mL) must be measured prior to initiation and body weight (kg) documented to select dose and dosing frequency (except CSU where fixed dosing applies). Claims should be billed using HCPCS J2357 (1 unit = 5 mg) and include an appropriate covered ICD-10 diagnosis from Appendix 1 to support medical necessity.Appropriate indication + required documentation (IgE, weight, ICD-10)

See Appendix 1 for covered diagnosis codes and HCPCS J2357 for billing guidance

Some cells in the asthma dosing tables combine very high baseline total serum IgE and higher body weight ranges and are explicitly labeled “Do Not Dose”. These table entries indicate that no omalizumab dosing recommendation is provided for those specific IgE × weight combinations and therefore dosing should not be selected from the table for those patients. Examples appear in the asthma dosing tables where weight/IgE bands at higher ranges are marked as Do Not Dose (see table fragments showing “Do Not Dose” for certain higher IgE/weight cells).

Medicare (CMS) policies may impose additional or different coverage requirements for outpatient drugs. Where applicable, National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs) take precedence and must be followed for Medicare members. Providers should check the CMS Medicare Coverage Database for current NCD/LCD/LCA guidance relevant to omalizumab prior to making coverage or billing decisions.

The dosing tables include explicit “Do Not Dose” cells for certain very high combinations of total serum IgE and body weight. When a patient’s baseline IgE and weight fall into a table cell marked Do Not Dose, the document provides no dosing recommendation for that combination and omalizumab should not be dosed based on the table.

CMS guidance summarized in Appendix 2 clarifies that the policy content is intended for non‑Medicare determinations and that Medicare Part B coverage is governed by the Medicare Benefit Policy Manual and any applicable NCDs/LCDs/LCAs. The appendix directs users to the CMS Medicare Coverage Database and notes that compliance with applicable Medicare policies is required.

Billing, Codes, and Diagnostic Codes

HCPCSHCPCS

J2357

Injection, omalizumab, 5 mg

NDC(s)NDC

50242-0214-xx	Xolair 75 mg single-dose prefilled syringe or autoinjector
50242-0215-xx	Xolair 150 mg single-dose prefilled syringe or autoinjector
50242-0040-xx	Xolair 150 mg single-dose vial powder for injection
50242-0227-xx	Xolair 300 mg single-dose prefilled syringe or autoinjector

Covered HCPCS CodesHCPCSCovered

J2357

Injection, omalizumab, 5 mg; 1 billable unit = 5 mg

NDCsNDC

50242-0214-xx	Xolair 75 mg single-dose prefilled syringe or autoinjector
50242-0215-xx	Xolair 150 mg single-dose prefilled syringe or autoinjector
50242-0040-xx	Xolair 150 mg single-dose vial powder for injection
50242-0227-xx	Xolair 300 mg single-dose prefilled syringe or autoinjector

Covered ICD-10 Diagnosis CodesICD-10Covered

J33.0	Polyp of nasal cavity
J33.1	Polypoid sinus degeneration
J33.8	Other polyp of sinus
J33.9	Nasal polyp, unspecified
J45.40	Moderate persistent asthma, uncomplicated
J45.50	Severe persistent asthma, uncomplicated
L29.89	Other pruritus
L29.9	Pruritus, unspecified
L50.0	Allergic urticaria
L50.1	Idiopathic urticaria

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Dosing decision inputs — key inputs for dosing

Serum total IgEBaseline total serum IgE (IU/mL) measured before treatment initiation — used with body weight to determine omalizumab dose and dosing frequency

Body weightPatient body weight (kg) measured before treatment — used with baseline total serum IgE to select dose and frequency

IndicationClinical indication (asthma, CRSwNP, IgE-mediated food allergy) — determines whether IgE/weight-based dosing applies (CSU uses fixed dosing)

Dose (mg)Target subcutaneous dose in mg determined from dosing tables using IgE and weight (range varies by indication)

Dosing frequencyAdministration interval (every 2 or 4 weeks) determined from indication-specific dosing tables using IgE and weight

Provider Responsibilities, Prior Authorization, and Billing

Documentation Required

Dose selection and billing

Dose selection must follow indication-specific dosing guidance. For moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy, determine omalizumab dose (mg) and frequency (every 2 or 4 weeks) using baseline total serum IgE (IU/mL) measured before treatment and patient body weight (kg). For chronic spontaneous urticaria, use 150 mg or 300 mg subcutaneously every 4 weeks (dose not dependent on serum IgE or body weight).

Use baseline serum total IgE and body weight to select dose/frequency per indication-specific tables.
Chronic spontaneous urticaria: 150 mg or 300 mg every 4 weeks (no IgE/weight-based dosing).

Prior Authorization

Prior Authorization Required

Prior authorization is required for omalizumab. Ensure requests include supporting documentation demonstrating the indicated diagnosis, relevant prior therapies or trial failures when required by criteria, and baseline labs used for dosing.

Background and Clinical Context

Omalizumab is a monoclonal antibody that binds circulating immunoglobulin E (IgE) and is used to treat IgE‑mediated conditions. Indications covered by this policy include moderate‑to‑severe persistent asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE‑mediated food allergy. Dosing and dosing frequency are determined primarily by baseline total serum IgE (IU/mL) and patient body weight (kg) for most indications; CSU dosing is fixed (150 or 300 mg every 4 weeks).

Key Terms and Dosing Concepts

Serum total IgE — definition and role

DefinitionTotal serum IgE level measured in international units per milliliter (IU/mL) prior to starting omalizumab therapy

RoleUsed with patient body weight (kg) to determine omalizumab dose (mg) and dosing frequency for asthma, CRSwNP, and IgE-mediated food allergy

TimingMust be measured before the start of treatment as the baseline value for dose selection

Dosing frequency — administration interval

DefinitionInterval at which omalizumab is administered, either every 2 weeks or every 4 weeks depending on indication and dosing table results

DeterminationSelected based on baseline total serum IgE (IU/mL), body weight (kg), and the indication-specific dosing tables

Policy Revision History

2012-01-01policy_origin

Policy originated (Date of Origin: 01/01/2012).

2012-06-01reviewed

Document reviewed (Dates Reviewed includes 06/2012).

2013-02-01reviewed

Document reviewed (Dates Reviewed includes 02/2013).

Policy Summary

PayerViva Health

PolicyXolair (omalizumab) — Dosing and Administration

Policy CodePolicy IC-P0146

Change TypeNo material changes

Effective Date

Next Review DateMar 3, 2026

Key ActionMeasure baseline total serum IgE and record body weight to determine dose and dosing frequency per the indication-specific dosing tables before initiating omalizumab.

SourceLink

On This Page

Weight-based dosing bands (IgE-mediated food allergy) — partial table

>60–70 kg450 mg (IgE-mediated food allergy dosing band shown)

>70–80 kg450 mg (IgE-mediated food allergy dosing band shown)

>80–90 kg525 mg (IgE-mediated food allergy dosing band shown)

>90–125 kg(table cell incomplete — no dose shown in source fragment)

>125–150 kg(table cell incomplete — no dose shown in source fragment)

Attach clinical documentation supporting the covered indication and necessity.
Missing prior authorization may result in claim denial or delay.

Denial Risk

Dosing limits

There are explicit dosing limits and 'Do Not Dose' designations for certain high combinations of IgE x weight. Requests for doses or frequencies outside the dosing tables may be denied unless strong clinical justification is provided.

Adhere to the dosing tables; entries marked 'Do Not Dose' (e.g., very high IgE x weight combinations) must not be used.
Requests outside table guidance require detailed justification and may be denied.

Documentation Required

Required baseline tests

Baseline testing required prior to initiating therapy: measure total serum IgE and record body weight to determine appropriate dose and dosing interval for indications that use IgE/weight-based dosing.

Serum total IgE (IU/mL) must be measured before the start of treatment.
Document body weight (kg) at baseline for dose calculation.

Billing Rule

Billing and diagnosis documentation

Billing must use HCPCS J2357 (Injection, omalizumab, 5 mg; 1 billable unit = 5 mg). Include an appropriate covered ICD-10 diagnosis on claims. NDCs for Xolair may be provided when applicable.

Primary billing code: J2357 — 1 unit = 5 mg.
Acceptable covered diagnosis codes include (but are not limited to): J45.40, J45.50, J33.0–J33.9, L50.x, L29.x, Z91.01x–Z91.018 as applicable to the indication.
Optional: Include NDCs for the administered presentation (e.g., Xolair 75 mg: 50242-0214-xx; 150 mg: 50242-0215-xx or 50242-0040-xx; 300 mg: 50242-0227-xx).

Note

NQTL / Prior Authorization Risk

Utilization management (prior authorization) is applied due to indication-specific criteria and drug cost. This NQTL was considered and implemented consistently across benefits; absence of required PA may lead to authorization denial.

NQTL checklist: indication, safety/efficacy, and drug cost supported use of PA for omalizumab.
Ensure PA requirements are met to avoid coverage denial or delay.

ExceptionsChronic spontaneous urticaria (CSU) uses fixed dosing every 4 weeks (150 or 300 mg) independent of IgE/weight

J2357 — HCPCS billing unit for omalizumab

HCPCS J2357J2357 — Injection, omalizumab, 5 mg; 1 billable unit = 5 mg

Billing unitCharge and bill in 5 mg units per J2357; total units correspond to prescribed mg dose divided by 5

Use in claimsBilling must use HCPCS J2357 and may include listed NDCs to reflect the administered omalizumab product

2014-04-01reviewed

Document reviewed (Dates Reviewed includes 04/2014).

2014-09-01reviewed

Document reviewed (Dates Reviewed includes 09/2014).

2015-07-01reviewed

Document reviewed (Dates Reviewed includes 07/2015).

2016-07-01reviewed

Document reviewed (Dates Reviewed includes 07/2016).

2016-09-01reviewed

Document reviewed (Dates Reviewed includes 09/2016).

2016-12-01reviewed

Document reviewed (Dates Reviewed includes 12/2016).

2017-03-01reviewed

Document reviewed (Dates Reviewed includes 03/2017).

2017-06-01reviewed

Document reviewed (Dates Reviewed includes 06/2017).

2017-09-01reviewed

Document reviewed (Dates Reviewed includes 09/2017).

2017-12-01reviewed

Document reviewed (Dates Reviewed includes 12/2017).

2018-03-01reviewed

Document reviewed (Dates Reviewed includes 03/2018).

2018-06-01reviewed

Document reviewed (Dates Reviewed includes 06/2018).

2018-10-01reviewed

Document reviewed (Dates Reviewed includes 10/2018).

2019-10-01reviewed

Document reviewed (Dates Reviewed includes 10/2019).

2020-10-01reviewed

Document reviewed (Dates Reviewed includes 10/2020).

2020-12-01reviewed

Document reviewed (Dates Reviewed includes 12/2020).

2021-01-01reviewed

Document reviewed (Dates Reviewed includes 01/2021).

2021-05-01reviewed

Document reviewed (Dates Reviewed includes 05/2021).

2021-08-01reviewed

Document reviewed (Dates Reviewed includes 08/2021).

2021-10-01reviewed

Document reviewed (Dates Reviewed includes 10/2021).

2022-10-01reviewed

Document reviewed (Dates Reviewed includes 10/2022).

2023-10-01reviewed

Document reviewed (Dates Reviewed includes 10/2023).

2024-03-01reviewed

Document reviewed (Dates Reviewed includes 03/2024).

2024-04-01reviewed

Document reviewed (Dates Reviewed includes 04/2024).

2024-10-01reviewed

Document reviewed (Dates Reviewed includes 10/2024).

2025-01-01reviewed

Document reviewed (Dates Reviewed includes 01/2025).

2025-03-01reviewed

Document reviewed (Dates Reviewed includes 03/2025).

2026-03-03last_reviewLatest

Policy last reviewed (Last Review Date: 03/03/2026).