ModifiedCignaPolicy IP0487

Immunologicals - Xolair

Cigna coverage policy governing prior authorization, medical necessity criteria, dosing, durations, and exclusions for omalizumab (Xolair) for FDA-approved indications (asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy), and not medically necessary uses.

Policy Summary

PayerCigna

PolicyImmunologicals - Xolair

Policy CodePolicy IP0487

Change TypeRevised indications, durations, and criteria

Effective Date

Next Review Date

Key ActionPrior Authorization is required and providers must document age, baseline IgE, allergen sensitization, prior therapies and durations, exacerbation history, and specialist prescribing/consultation.

POLICY UPDATE CHANGES

Updated policy title from Omalizumab to Immunologicals - Xolair; updated asthma diagnostic criteria and initial authorization durations.

Chronic Spontaneous Urticaria changes: updated non-sedating H1 antihistamine requirement to include 'symptoms present > 3 days per week' and changed initial authorization duration.

Chronic Rhinosinusitis with Nasal Polyps: approval condition label updated and intranasal corticosteroid requirement duration changed from 3 months to 4 weeks; initial authorization duration changed.

Added IgE-mediated food allergy as an approved indication with detailed criteria.

Concurrent monoclonal antibody therapy examples expanded to include Ebglyss and Nemluvio.

4FDA-Approved Indications Covered

≥30 IU/mLMinimum baseline IgE requirement

J2357Primary billing HCPCS code

Coverage Summary

covered with criteria for FDA‑approved indications: asthma (≥6 years), chronic spontaneous urticaria (CSU, ≥12 years), chronic rhinosinusitis with nasal polyps (CRSwNP, ≥18 years), and IgE‑mediated food allergy (≥1 year). Policy scope: Cigna prior authorization and medical necessity criteria for omalizumab (Xolair) including required baseline testing, prior therapies, dosing limits, durations, and exclusions. Policy number IP0487. Status: MODIFIED. Headline thresholds: baseline IgE ≥ 30 IU/mL required for asthma, CRSwNP, and food allergy dosing. Primary billing HCPCS code: J2357.

Key thresholds and quick facts

Baseline IgE requirement≥ 30 IU/mL

Ages per FDA indicationAsthma ≥ 6 yrs; CSU ≥ 12 yrs; CRSwNP ≥ 18 yrs; IgE-mediated Food Allergy ≥ 1 yr

Primary billing HCPCSJ2357 (Injection, omalizumab, 5 mg)

Asthma dosing maxUp to 375 mg SC, not more frequently than every 2 weeks

CSU dosing options150 mg SC q4 weeks OR 300 mg SC q4 weeks

CRSwNP dosing maxUp to 600 mg SC, not more frequently than every 2 weeks

Food allergy dosing maxUp to 600 mg SC, not more frequently than every 2 weeks

Initial Therapy Criteria (by indication)

Asthma

Approve Xolair (omalizumab) for asthma when ANY of the following branches are met:

ANY of the following

A) Initial Therapy
- Age ≥ 6 years
- Diagnosis of moderate to severe persistent allergic asthma
- Documentation of positive skin test or in vitro reactivity to a perennial aeroallergen
- Inadequate control despite optimized inhaled corticosteroid (ICS) therapy with at least one additional controller (e.g., LABA) or systemic corticosteroid dependence

Continuation Therapy Criteria (by indication)

Asthma — Continuation

Continuation criteria for patients currently receiving Xolair for asthma:

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Chronic Spontaneous Urticaria — Continuation

Continuation criteria for patients currently receiving Xolair for chronic spontaneous urticaria:

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CRSwNP — Continuation

Continuation criteria for patients currently receiving Xolair for CRSwNP:

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Dosing Limits & Administration

Dosing limits (per indication): Asthma — maximum 375 mg subcutaneously not more frequently than once every 2 weeks. Chronic Spontaneous Urticaria — either 150 mg SC once every 4 weeks or 300 mg SC once every 4 weeks. CRSwNP — approve up to a maximum 600 mg SC not more frequently than once every 2 weeks. IgE‑mediated food allergy — approve up to a maximum 600 mg SC not more frequently than once every 2 weeks.

Billing Rule

Dosing and frequency limits

Do not exceed maximum doses and frequency per indication. Asthma: up to a maximum dose of 375 mg subcutaneously not more frequently than once every 2 weeks. Chronic Spontaneous Urticaria: 150 mg SC once every 4 weeks OR 300 mg SC once every 4 weeks. Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): up to a maximum dose of 600 mg SC not more frequently than once every 2 weeks. IgE-mediated food allergy: up to a maximum dose of 600 mg SC not more frequently than once every 2 weeks.

Asthma: maximum 375 mg SC, not more frequently than every 2 weeks
Chronic Spontaneous Urticaria: 150 mg SC q4 weeks or 300 mg SC q4 weeks
CRSwNP: maximum 600 mg SC, not more frequently than every 2 weeks
IgE-mediated food allergy: maximum 600 mg SC, not more frequently than every 2 weeks

Not Medically Necessary / Exclusions

Not Medically Necessary / Not Covered Uses

Xolair for any other use is considered not medically necessary, including (but may not be limited to):

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Applicable Codes

HCPCS - CoveredHCPCSCovered

J2357

Injection, omalizumab, 5 mg

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for coverage of Xolair. Initial approval requires the medication to be prescribed by or in consultation with a specialist as appropriate to the indication: allergist, immunologist, or pulmonologist for asthma; allergist, immunologist, or dermatologist for chronic spontaneous urticaria; allergist, immunologist, or otolaryngologist (ENT) for CRSwNP; and allergist or immunologist for IgE-mediated food allergy.

Prior authorization required
Initial prescription by or consultation with specialists per indication: allergist, immunologist, pulmonologist, dermatologist, or ENT as specified

Documentation Required

Required clinical documentation

Providers must document: patient age; baseline IgE (defined prior to receiving Xolair or another monoclonal antibody that may lower IgE); baseline allergen sensitization where required (positive skin test or in vitro IgE testing); prior therapies and durations (e.g., at least 3 consecutive months of medium- or high-dose inhaled corticosteroid plus at least one additional asthma controller/maintenance medication for asthma; at least 4 weeks of intranasal corticosteroid for CRSwNP; non-sedating H1 antihistamine therapy with doses titrated up to four times the standard dose for CSU); exacerbation history (e.g., prior systemic corticosteroid courses, hospitalizations, ED/urgent care visits, or worsening with steroid taper); and prescriber specialty or consultation.

Clinical Evidence & Assessment Timing

16Asthma efficacy assessed as early as 16 weeks in many trials

24CRSwNP efficacy assessed at Week 24 in pivotal trials

12-24CSU pivotal trials: 12–24 week double‑blind periods

Background/evidence summary: Xolair (omalizumab) is an anti‑IgE monoclonal antibody approved for allergic asthma (≥6 years), CRSwNP (≥18 years), chronic spontaneous urticaria (≥12 years), and IgE‑mediated food allergy (≥1 year). Dosing for asthma and nasal polyps is based on body weight and pretreatment serum total IgE and is only provided for patients with a pretreatment IgE ≥ 30 IU/mL, whereas CSU dosing is fixed and does not depend on weight or IgE. Timing for efficacy assessment varies by indication: many asthma trials assessed efficacy as early as 16 weeks, CSU pivotal trials included 12–24 weeks double‑blind periods, and CRSwNP pivotal trials evaluated efficacy at Week 24. Baseline is defined as measurements taken prior to receiving any treatment with Xolair or another monoclonal antibody that may lower or interfere with IgE testing.

Revision History

9/1/2024revised

Updated policy title from Omalizumab to Immunologicals - Xolair; updated asthma diagnostic criteria and initial authorization duration changed from 12 months to 4 months.

9/1/2024revised

Chronic Spontaneous Urticaria: updated non-sedating H1 antihistamine requirement to include 'symptoms present > 3 days per week' and updated initial authorization duration to 4 months (later revised).

9/1/2024revised

Chronic Rhinosinusitis with Nasal Polyps: approval condition label updated from 'Nasal Polyps' to 'Chronic Rhinosinusitis with Nasal Polyps'; intranasal corticosteroid requirement duration changed from 3 months to 4 weeks; initial authorization duration changed from 12 months to 6 months.

Policy Summary

PayerCigna

PolicyImmunologicals - Xolair

Policy CodePolicy IP0487

Change TypeRevised indications, durations, and criteria

Effective Date

Next Review Date

On This Page

Includes patients meeting guideline definitions of severe asthma (see Overview).

Pretreatment total serum IgE ≥ 30 IU/mL

Required for weight- and IgE-based dosing

Prescribed by or in consultation with a pulmonologist or allergist/immunologist

B) Currently Receiving (Continuation)

Documentation of prior approval or medical record showing patient has been receiving Xolair
Clinical response to therapy as evidenced by reduction in exacerbations, decreased systemic corticosteroid use, or improved symptom control compared with baseline
Assess at appropriate intervals (e.g., by 16 weeks for many trials).
Prescriber specialty: pulmonologist or allergist/immunologist

Chronic Spontaneous Urticaria

Approve Xolair for chronic spontaneous urticaria when ALL of the following in A) Initial Therapy OR ALL of the items in B) Currently Receiving are met:

ANY of the following

A) Initial Therapy
- Age ≥ 12 years
- Diagnosis of chronic spontaneous urticaria (wheals, angioedema, or both for > 6 weeks)
- Persistent symptoms despite regular use of a second-generation H1-antihistamine at standard dose and after titration up to 4-fold for inadequate response
  Antihistamine titration should be attempted for 2–4 weeks as tolerated prior to biologic therapy.
- Symptoms are present daily or almost daily or have an intermittent recurrent course with clinically significant impact
- Prescribed by or in consultation with a dermatologist, allergist/immunologist, or other relevant specialist
B) Currently Receiving (Continuation)
- Documentation that patient has been receiving Xolair with clinical benefit (reduction in hive activity, angioedema, or need for rescue medications)
- Prescriber specialty: dermatologist or allergist/immunologist

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Approve Xolair for chronic rhinosinusitis with nasal polyps (CRSwNP) when ANY of the following branches are met:

ANY of the following

A) Initial Therapy
- Age ≥ 18 years
- Diagnosis of CRSwNP with confirmation of sinonasal inflammation (e.g., endoscopy or CT) and symptoms consistent with chronic rhinosinusitis
- Inadequate response to at least 4 weeks of intranasal corticosteroid therapy
- Either prior systemic corticosteroid use for nasal polyps OR prior endoscopic sinus surgery OR documented contraindication to systemic corticosteroids or surgery
  One of these options must be documented
- Baseline total serum IgE ≥ 30 IU/mL
  Required for weight- and IgE-based dosing
- Prescribed by or in consultation with an otolaryngologist (ENT) or allergist/immunologist
B) Currently Receiving (Continuation)
- Documentation that patient has been receiving Xolair for CRSwNP with clinical benefit (reduction in polyp size, improved symptoms, or decreased need for systemic steroids or surgery)
- Prescriber specialty: otolaryngologist (ENT) or allergist/immunologist

IgE-Mediated Food Allergy

Approve Xolair for 1 year if ALL of the following are met:

title":"IgE-Mediated Food Allergy","type":"criteria_group"}],

id":"initial-therapy-criteria","label":"CRITERIA","title":"Initial Therapy Criteria (by indication)"}{

Age
Baseline IgE (prior to Xolair or other interfering monoclonal antibody)
Baseline allergen sensitization (skin prick test or in vitro IgE where required)
Prior therapies and durations (inhaled corticosteroid and controller meds; intranasal corticosteroid duration; H1 antihistamine dosing and titration)
Exacerbation history (systemic corticosteroid courses, hospitalizations/ED/urgent care, steroid-dependent disease)
Prescriber specialty or documentation of consultation

Denial Risk

Denial conditions

Claims are subject to denial if they lack a covered diagnosis code, if required baseline IgE or required allergen testing evidence (skin or in vitro) is not provided, if prior therapy or duration documentation is missing, or if the medication was not prescribed by or in consultation with the required specialist for the indication.

No covered diagnosis code → denial as not covered
Missing baseline IgE or required allergen testing → denial
Insufficient prior therapy or duration documentation → denial
Lack of required specialist prescribing or consultation → denial

Documentation Required

Sample product

Receipt of sample product does not satisfy criteria requirements for coverage; documentation of sample receipt alone is not sufficient to authorize coverage.

9/1/2024added

Added IgE-mediated food allergy as an approved indication with detailed criteria (including baseline IgE ≥ 30 IU/mL and requirement of either positive skin prick test OR positive in vitro IgE test).

06/01/2025revised

Concurrent monoclonal antibody therapy examples expanded to include Ebglyss and Nemluvio (added to list of therapies not established for concurrent use).

2025-07-15reviewLatest

Policy last reviewed on 2025-07-15.