CurrentBlue Cross Blue Shield - IowaPolicy 05.01.07

Wellmark_Xolair_Medical_Policy

Defines clinical coverage criteria, required documentation, prescriber specialties, dosing/quantity limits, prior authorization durations and continuation criteria for omalizumab (Xolair) for FDA-approved indications: allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark_Xolair_Medical_Policy

Policy CodePolicy 05.01.07

Change TypeRevised (June 2025)

Effective DateAug 18, 2025

Next Review Date

Key ActionSubmit chart notes, medical records, or claims history demonstrating diagnosis-specific required data (e.g., pre-treatment IgE, allergen test results, prior medication trials, endoscopy/CT for CRSwNP) to initiate prior authorization review.

POLICY UPDATE CHANGES

Policy reviewed and revised June 2025; current effective date updated to August 18, 2025.

4Covered Indications

6-12 monthsAuth Durations

J2357Primary Billing Code

Coverage Summary

This policy (Policy # 05.01.07, effective 2025-08-18) covers omalizumab (Xolair) as a benefit when clinical criteria are met for the FDA‑approved indications: allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE‑mediated food allergy. Coverage is subject to the specific authorization criteria, required documentation, prescriber specialty requirements, dosing and quantity limits, and prior authorization durations described in the policy.

Quick facts and key thresholds

Covered indications4 FDA‑approved indications: Allergic asthma, Chronic spontaneous urticaria (CSU), Chronic rhinosinusitis with nasal polyps (CRSwNP), IgE‑mediated food allergy

Authorization durationsInitial authorization up to 6 months; continuation authorization up to 12 months

Primary billing codeJ2357 (Injection, omalizumab, 5 mg)

CSU maximum doseRequested/continuation dose must be within FDA labeling and not exceed 300 mg every 4 weeks

Asthma maximum doseRequested/continuation dose based on pre‑treatment IgE and body weight per FDA labeling and must not exceed 375 mg every 2 weeks

Initial Therapy Criteria (by indication)

Allergic Asthma - Initial Therapy (authorization up to 6 months)

Authorization of 6 months may be granted when ALL of the following criteria are met:

ALL of the following

Member is 6 years of age or older
Member has a pre-treatment IgE level greater than or equal to 30 IU/mL>= 30 IU/mL
Member has a positive skin test or in vitro reactivity to at least one perennial aeroallergen
Uncontrolled asthma demonstrated by at least one of
- One or more asthma exacerbation resulting in hospitalization or emergency medical care visit
- Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment
- Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma)
Failure of background therapy
- Member has inadequate asthma control despite current treatment with a medium-to-high-dose inhaled corticosteroid
- Member has inadequate asthma control despite current treatment with an additional controller (e.g., long-acting beta-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline)
Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Xolair
Member will not use Xolair concomitantly with other biologics indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Tezspire)
Requested dose is based on pre-treatment serum IgE level and individual's body weight per FDA labeling AND does not exceed 375 mg every 2 weeks<= 375 mg every 2 weeks
Dose must follow FDA dosing table

Chronic Spontaneous Urticaria (CSU) - Initial Therapy (authorization up to 6 months)

Authorization of 6 months may be granted when ALL of the following criteria are met:

ALL of the following

Member is 12 years of age or older
Member has experienced spontaneous onset of wheals (hives), angioedema, or both for at least 6 weeks
Member remains symptomatic despite up-dosing (up to 4x recommended dose) of a second-generation H1 antihistamine for at least 2 weeks (unless contraindicated)
Examples: cetirizine, fexofenadine, levocetirizine, loratadine
Member has been evaluated for other causes of urticaria, including bradykinin-related angioedema and IL-1-associated urticarial syndromes (auto-inflammatory disorders, urticarial vasculitis)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) - Initial Therapy (authorization up to 6 months)

Authorization of 6 months may be granted when ALL of the following criteria are met:

ALL of the following

Member is 18 years of age or older
Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 2 months unless contraindicated or not tolerated
One of the following objective findings is present
- Bilateral nasal endoscopy, anterior rhinoscopy, or CT showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril
- Meltzer Clinical Score of 2 or higher in both nostrilsMeltzer >= 2 bilaterally

IgE-mediated Food Allergy - Initial Therapy (authorization up to 6 months)

Authorization of 6 months may be granted for reduction of IgE-mediated food allergy reactions when ALL of the following criteria are met:

ALL of the following

Diagnosis confirmation (one of)
- Pre-treatment allergen-specific IgE level greater than or equal to 6 IU/mL>= 6 IU/mL
- Skin-prick test with wheal diameter greater than or equal to 4 mm>= 4 mm
- Positive physician-controlled oral food challenge (e.g., moderate to severe skin, respiratory, or GI symptoms)
Clinical history (one of)

Continuation Therapy Criteria (by indication)

Continuation Therapy - Asthma (authorization up to 12 months)

Authorization of 12 months may be granted for continuation when ALL of the following criteria are met:

ALL of the following

Member is 6 years of age or older
Evidence of clinical benefit (one of)
- A reduction in the frequency and/or severity of symptoms and exacerbations
- Asthma control has improved on Xolair treatment as demonstrated by at least one of the following: a reduction in the daily maintenance oral corticosteroid dose
Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Xolair
Requested dose based on pre-treatment IgE and body weight per FDA labeling AND does not exceed 375 mg every 2 weeks<= 375 mg every 2 weeks
Member will not use Xolair concomitantly with other biologics indicated for asthma

Continuation Therapy - CSU (authorization up to 12 months)

Authorization of 12 months may be granted for continuation when ALL of the following criteria are met:

ALL of the following

Member is 12 years of age or older
Member has experienced a positive response (e.g., improved symptoms, decrease in weekly urticaria activity score [UAS7]) since initiation of therapy
Requested dose is within the FDA labeled dose AND does not exceed 300 mg every 4 weeks<= 300 mg every 4 weeks

Continuation Therapy - CRSwNP (authorization up to 12 months)

Authorization of 12 months may be granted for continuation when ALL of the following criteria are met:

ALL of the following

Member is 18 years of age or older
Member has experienced a response as evidenced by improvement in signs and symptoms (e.g., nasal congestion, nasal polyp size, loss of smell, rhinorrhea, sinonasal inflammation, hyposmia, facial pressure/pain, or reduction in corticosteroid use)
Member will continue to use a daily intranasal corticosteroid while being treated with Xolair unless contraindicated or not tolerated
Member will not use Xolair concomitantly with other biologics indicated for nasal polyps
Requested dose is within the FDA labeled dose for the requested indication

Continuation Therapy - IgE-mediated Food Allergy (authorization up to 12 months)

Authorization of 12 months may be granted when ALL of the following criteria are met:

ALL of the following

Member is 1 year of age or older
Member has achieved or maintained a positive clinical response to therapy as evidenced by a decrease in hypersensitivity (e.g., moderate to severe skin, respiratory, or GI symptoms) to food allergen
Member will continue to maintain a food-allergen avoidance diet

Unproven / Exclusions

General Exclusion for Concomitant Biologics

For all indications:

ALL of the following

Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication

Limitation of use/exclusion: per FDA labeling, Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus and is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. These limitations are exclusions to coverage under the policy.

Applicable Codes

Drug HCPCS/J-codeHCPCSCovered

J2357

Injection, omalizumab, 5 mg

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required with documentation

Submit chart notes, medical records, or claims history demonstrating the diagnosis-specific data required for prior authorization review (e.g., pre-treatment IgE, allergen test results, prior medication trials, or nasal endoscopy/CT for CRSwNP).

Affected code: J2357
Examples of required data: pre-treatment serum IgE (asthma and food allergy), allergen test results (skin test or in vitro reactivity), documentation of prior medication trials, nasal endoscopy or CT findings for CRSwNP

Documentation Required

Required documentation for continuation

For continuation requests, provide chart notes documenting clinical response such as improved asthma control or reduced exacerbations, reduced maintenance oral corticosteroid use, improved UAS7 or other symptom measures for CSU, or decreased hypersensitivity/clinical reaction severity for food allergy.

Continuation criteria by indication: asthma (reduction in frequency/severity of symptoms or exacerbations; reduced daily maintenance oral corticosteroid dose), CSU (improved symptoms or decreased UAS7), CRSwNP (improvement in nasal symptoms, polyp size, smell, or reduced corticosteroid use), IgE-mediated food allergy (decrease in hypersensitivity to the food allergen)

Prior Authorization

Prescriber specialty requirement

Prescriptions must be written by or in consultation with the specialist(s) specified for the patient’s indication.

Asthma: allergist/immunologist or pulmonologist
CSU: allergist/immunologist or dermatologist
CRSwNP: allergist/immunologist or otolaryngologist
IgE-mediated food allergy: allergist/immunologist

Billing Rule

Quantity limits

Adhere to product-specific vial and syringe standard limits per 28 days and to FDA-recommended dosing ranges for each presentation.

150 mg vial: 8 vials per 28 days
75 mg prefilled syringe/autoinjector: 2 syringes per 28 days
150 mg prefilled syringe: 4 syringes per 28 days
300 mg prefilled syringe: 4 syringes per 28 days

Billing Rule

Dosing limit enforcement

Approvals are subject to dosing limits consistent with FDA labeling and policy maximums (approvals may be limited per FDA-approved dosing tables and practice guidelines).

Policy dosing threshold example: asthma — requested dose must not exceed 375 mg every 2 weeks
CSU maximum: not to exceed 300 mg every 4 weeks
CRSwNP/food allergy: dosing must be within FDA-labeled range for the indication

Clinical Evidence & References

Key evidence and references informing the policy include the Xolair package insert, Genentech, March 2023, guideline sources (NIH/NAEPP asthma guideline updates and GINA 2022), the EAACI urticaria guideline, and CRSwNP clinical trials (POLYP 1 and POLYP 2). Dosing and quantity guidance from the product labeling (including vial/syringe presentations and standard limits) were also incorporated. No additional quantitative trial metrics are required in the policy summary.

Background & Definitions

Background: The policy ensures appropriate selection of patients for omalizumab (Xolair) based on product labeling, clinical guidelines, and clinical studies. It lists the FDA‑approved indications (allergic asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE‑mediated food allergy) and states the limitations of use, including that Xolair is not for acute bronchospasm or the emergency treatment of anaphylaxis.

Term	Definition
NPS
Endoscopic nasal polyp score
UAS7
Weekly urticaria activity score

Revision History

2003-12-01original_effective_date

Policy original effective date December 2003.

2025-06-01review_revision

Policy reviewed and revised June 2025.

2025-08-18effective_date_updateLatest

Policy reviewed and revised June 2025; current effective date updated to August 18, 2025.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark_Xolair_Medical_Policy

Policy CodePolicy 05.01.07

Change TypeRevised (June 2025)

Effective DateAug 18, 2025

Next Review Date

On This Page

Requested dose is within the FDA labeled dose AND does not exceed 300 mg every 4 weeks<= 300 mg every 4 weeks

Total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostrilNPS >= 5; each nostril >= 2

Symptoms required (nasal blockage plus one of)

Reduction or loss of smell
Rhinorrhea (anterior/posterior)
Facial pain or pressure

Member will continue to use a daily intranasal corticosteroid while being treated with Xolair unless contraindicated or not tolerated

Member will not use Xolair concomitantly with other biologics indicated for nasal polyps (e.g., Dupixent, Nucala)

Requested dose is within the FDA labeled dose for the requested indication

History of a systemic reaction to a food

Positive physician-controlled oral food challenge (if not used above)

Member is 1 year of age or older

Member has a pre-treatment serum IgE level greater than or equal to 30 IU/mL>= 30 IU/mL

Member will continue to follow a food-allergen avoidance diet