CurrentCignaPolicy N/A

POLICY: Immunologicals -Xolair Prior Authorization Policy

Defines Cigna prior authorization criteria, durations, prescriber qualifications, covered FDA-approved indications (asthma, CRSwNP, chronic spontaneous urticaria, IgE-mediated food allergy), not medically necessary uses, and associated clinical requirements for Xolair (omalizumab) subcutaneous injection.

Policy Summary

PayerCigna

PolicyPOLICY: Immunologicals -Xolair Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual/Selected revisions (criteria clarifications and additions)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; document baseline IgE ≥ 30 IU/mL and required baseline testing, prior treatment history, and ensure prescriber is or consults a relevant specialist.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered updated to specify which monoclonal antibody therapies are referenced (Cinqair, Fasenra, Nucala, Dupixent, Tezspire, Adbry).

CRSwNP criteria updated: intranasal corticosteroid duration changed from 3 months to 4 weeks and requirement added that diagnosis present ≥ 6 months and symptoms ≥ 8 weeks.

New approval criteria for Immunoglobulin (Ig)E-Mediated Food Allergy were added.

Food allergy criteria changed to require either a positive skin prick test OR a positive in vitro IgE test (previously required both).

Chronic Spontaneous Urticaria criteria updated: approval duration changed from 4 months to 6 months; continuation criteria updated to require at least 6 months prior therapy and defined beneficial response.

References to 'epinephrine auto-injectors' updated to 'epinephrine self-administered injectable or nasal products'; examples expanded to include Neffy.

Coverage Summary

Scope: This policy covers FDA‑approved indications for Xolair (omalizumab) including asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and IgE‑mediated food allergy. The coverage stance is covered_with_criteria, with prior authorization recommended and approvals provided for indication‑specific durations. Initial approval durations are: Asthma – 4 months (initial therapy), CRSwNP – 6 months (initial therapy), and Chronic Spontaneous Urticaria – 6 months (initial therapy). For patients already receiving therapy who meet continuation criteria, approvals are typically 1 year (e.g., asthma, CRSwNP, CSU, and food allergy continuation criteria specify 1‑year approvals when met). Prescriber requirement: medication must be prescribed by or in consultation with a specialist for the condition (examples include allergist, immunologist, pulmonologist, ENT, or dermatologist as appropriate). Not medically necessary uses: claims for uses not listed in the Recommended Authorization Criteria are considered not medically necessary (examples called out include atopic dermatitis, eosinophilic gastrointestinal conditions, latex allergy in health care workers, and concurrent use with specified other monoclonal antibodies such as Cinqair, Fasenra, Nucala, Dupixent, Tezspire, Adbry).

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Quick facts & thresholds

Baseline IgE threshold>= 30 IU/mL

Minimum age — Asthma>= 6 years

Minimum age — CRSwNP>= 18 years

Minimum age — Chronic Spontaneous Urticaria (CSU)>= 12 years

Minimum age — IgE‑mediated Food Allergy>= 1 year

Prescriber requirementPrescribed by or in consultation with a specialist (e.g., allergist, immunologist, pulmonologist, ENT, dermatologist)

Approval duration — Asthma (initial)4 months

Approval duration — CRSwNP (initial)6 months

Approval duration — CSU (initial)6 months

Continuation approval (currently receiving) — all applicable indications1 year

Asthma — Authorization Criteria

Prior Authorization

Prior authorization required

Prior authorization (PA) is recommended for prescription benefit coverage of Xolair. Initial approvals depend on indication: asthma — initial approval 4 months; CRSwNP — initial approval 6 months; chronic spontaneous urticaria and some other indications — initial approval as specified. Continuation (patients currently receiving therapy) approvals are for 1 year. Xolair must be prescribed by or in consultation with a specialist appropriate to the condition (e.g., allergist, immunologist, pulmonologist).

Documentation Required

Baseline testing documentation

Document a baseline total IgE ≥ 30 IU/mL obtained prior to receiving Xolair or any other monoclonal antibody that may lower IgE. For indications requiring allergen sensitization, document baseline positive skin testing or in vitro (blood) testing for allergen-specific IgE as required by the indication.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) — Authorization Criteria

Documentation Required

Treatment history documentation — CRSwNP specifics

For CRSwNP, document prior treatment history including: use of an intranasal corticosteroid for at least 4 weeks and plan to continue intranasal corticosteroid concomitantly with Xolair; at least one systemic corticosteroid course within the previous year OR a contraindication to systemic corticosteroids OR prior surgery for nasal polyps. Define one course of systemic corticosteroid as ≥ 3 consecutive days of treatment or one long-acting injectable dose. Also document diagnosis duration (≥ 6 months) and symptoms present ≥ 8 weeks, and that medication is prescribed by or in consultation with an allergist, immunologist, or ENT.

Billing Rule

Approval durations and reauthorization

Initial approvals are for fixed durations by indication (e.g., asthma initial = 4 months; CRSwNP initial = 6 months; CSU initial = 6 months). Patients currently receiving Xolair who meet continuation criteria may be approved for 1 year. Reauthorization requires the prescriber to document a response to therapy as specified for the indication.

Chronic Spontaneous Urticaria (CSU) — Authorization Criteria

Documentation Required

Treatment history documentation — Urticaria high‑dose antihistamine

For chronic spontaneous urticaria, document that the patient tried high-dose oral second-generation H1 antihistamine therapy as attested by the prescriber. 'High-dose' is defined as the highest dose tolerated by the patient and can be up to four times the FDA‑approved dose; examples include cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine.

IgE-Mediated Food Allergy — Authorization Criteria

IgE-Mediated Food Allergy

Approve Xolair for 1 year if the patient meets ALL of the following (A–G).

ALL of the following

Patient is ≥ 1 year of age
Patient has a baseline IgE level ≥ 30 IU/mL≥ 30 IU/mL
Baseline defined as prior to any Xolair or other monoclonal antibody that may lower IgE
Evidence of sensitization (choose ONE)
- Positive skin prick test response to one or more foods

Not Medically Necessary / Exclusions

Denial Risk

Not medically necessary for other uses

Claims for uses not listed in the Recommended Authorization Criteria (examples include atopic dermatitis, eosinophilic GI conditions, latex allergy in healthcare workers) and claims for concurrent use with certain other monoclonal antibody therapies (Cinqair, Fasenra, Nucala, Dupixent, Tezspire, Adbry) are considered not medically necessary and may be denied.

Applicable Codes

Relevant referenced biologics/monoclonal antibodies (not covered combination)mixed

Cinqair	reslizumab (IV) - referenced as monoclonal antibody therapy
Dupixent	dupilumab - referenced as monoclonal antibody therapy
Fasenra	benralizumab - referenced as monoclonal antibody therapy
Nucala	mepolizumab - referenced as monoclonal antibody therapy
Tezspire	tezepelumab - referenced as monoclonal antibody therapy
Adbry	tralokinumab - referenced
Ebglyss	lebrikizumab - referenced
Nemluvio	nemolizumab - referenced

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required (summary)

Prior authorization is recommended for prescription benefit coverage of Xolair. Initial authorization durations vary by indication (e.g., asthma initial = 4 months; CRSwNP initial = 6 months; CSU initial = 6 months) and continuation approvals for ongoing responders are for 1 year. Prescriptions must be by or in consultation with a specialist relevant to the indication (e.g., allergist, immunologist, pulmonologist, ENT, dermatologist).

Documentation Required

Baseline testing documentation (summary)

Document baseline IgE prior to any treatment that may lower IgE (baseline defined as before Xolair or another monoclonal antibody such as dupilumab or tezepelumab). For indications requiring sensitization, document baseline positive skin testing or in vitro specific IgE testing per the indication (e.g., aeroallergen testing for asthma; food SPT or in vitro test for food allergy).

Clinical Evidence & Assessment Timing

16 wksAsthma efficacy assessment timing — as early as 16 weeks in most trials

Wk 24CRSwNP efficacy assessment timing — pivotal trials evaluated at Week 24

12–24 wksChronic spontaneous urticaria pivotal trials — double-blind periods of 12 to 24 weeks

Testing revisedFood allergy criteria changed — now requires either positive skin prick OR positive in vitro IgE test

Efficacy assessment timing varies by indication: for asthma trials efficacy was assessed as early as 16 weeks in most trials; chronic spontaneous urticaria pivotal trials included double‑blind treatment periods of 12 to 24 weeks; and CRSwNP pivotal trials assessed efficacy at Week 24.

Background

Background: Xolair (omalizumab) is an anti‑IgE monoclonal antibody indicated for asthma, CRSwNP, chronic spontaneous urticaria, and IgE‑mediated food allergy. Dosing for asthma and CRSwNP is weight‑ and baseline total IgE–dependent and requires a pretreatment (baseline) serum total IgE of ≥ 30 IU/mL. Dosing for CSU is not dependent on serum IgE or body weight. Specific dosing tables and titration details are not reproduced here; prescribers should reference the product labeling/prescribing information for exact dosing instructions.

Definitions

Baseline (definition)Measurement prior to receiving any Xolair or another monoclonal antibody therapy that may lower IgE (e.g., dupilumab, tezepelumab)

One course of systemic corticosteroid (definition)>= 3 consecutive days of treatment or one long-acting injectable dose

High‑dose second‑generation H1 antihistamine (definition)The highest dose tolerated by the patient and can be up to four times the FDA‑approved dose

Revision History

03/22/2023revised

Conditions Not Covered updated to specify which monoclonal antibody therapies are referenced (Cinqair, Fasenra, Nucala, Dupixent, Tezspire, Adbry).

02/14/2024revised

CRSwNP criteria updated: intranasal corticosteroid duration changed from 3 months to 4 weeks and requirement added that diagnosis present ≥ 6 months and symptoms ≥ 8 weeks.

03/06/2024added

New approval criteria for Immunoglobulin (Ig)E-Mediated Food Allergy were added.

Policy Summary

PayerCigna

PolicyPOLICY: Immunologicals -Xolair Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual/Selected revisions (criteria clarifications and additions)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; document baseline IgE ≥ 30 IU/mL and required baseline testing, prior treatment history, and ensure prescriber is or consults a relevant specialist.

SourceLink

On This Page

Documentation Required

Baseline testing documentation — Food allergy

For IgE‑mediated food allergy, document baseline IgE ≥ 30 IU/mL measured prior to any monoclonal antibody that may lower IgE. Demonstrate sensitization with either a positive skin prick test OR a positive in vitro (blood) specific IgE test to one or more foods (either test suffices).

Documentation Required

Treatment history documentation — Food allergy epinephrine requirement

For IgE‑mediated food allergy, document that the patient has been prescribed an epinephrine self‑administered injectable or nasal product and that Xolair will be used in conjunction with a food allergen‑avoidant diet. Examples of epinephrine products include EpiPen, Auvi‑Q, and Neffy (among others).

Documentation Required

Treatment history documentation — required trials by indication

Document prior medication trials and durations per indication (examples): - Asthma: at least 3 consecutive months of an inhaled corticosteroid plus at least one additional asthma controller or maintenance medication; specialist prescriber or consultation required. - CRSwNP: at least 4 weeks of intranasal corticosteroid therapy and plan to continue intranasal corticosteroid with Xolair; plus one systemic corticosteroid course within previous year OR contraindication OR prior surgery when applicable. - Chronic spontaneous urticaria: prescriber‑attested trial of high‑dose second‑generation H1 antihistamine therapy (highest tolerated dose, up to 4× FDA dose). - Food allergy: documentation of prior significant allergic reaction and prescription for an epinephrine self‑administered product; Xolair to be used with allergen‑avoidant diet.

Billing Rule

Approval durations and reauthorization (summary)

Initial approval durations vary by indication (examples: asthma initial = 4 months; CRSwNP initial = 6 months; chronic spontaneous urticaria initial = 6 months). Patients currently receiving therapy who meet continuation criteria may be approved for 1 year. Reauthorization/continuation requires documentation by the prescriber that the patient has responded to therapy, using the indication‑specific response examples defined in the criteria.