ModifiedPremera BluecrossPolicy N/A

Xolair (omalizumab) coverage and site-of-service criteria

Defines medical necessity, site-of-service review, age limits, indications, dosing limits, documentation, and coding for Xolair (omalizumab) under the payer's pharmacy and medical benefits. Applies to providers seeking authorization for administration and coverage of Xolair.

Policy Summary

PayerPremera Bluecross

PolicyXolair (omalizumab) coverage and site-of-service criteria

Policy CodePolicy N/A

Change TypeClinical criteria revisionsexclusions clarifiedindications expanded

Effective DateOct 3, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy trials, baseline IgE and weight (for asthma dosing) and objective confirmation (for CRSwNP) to demonstrate medical necessity.

SourceLink

POLICY UPDATE CHANGES

Updated asthma criteria to remove the adult smoking exclusion and to specify asthma exacerbation and FEV1/FEV1-FVC criteria; added option of FEV1/FVC < 0.80 and changed oral corticosteroid requirement language to worsening on tapering.

Updated criteria that Xolair is not to be used in combination with tezepelumab for asthma or with dupilumab for nasal polyps.

Included treatment of certain individuals with IgE-mediated food allergies as an updated criterion.

Updated initial approval length for chronic idiopathic urticaria (CIU) to 6 months.

Clarified that drugs listed are subject to FDA dosage and administration information and that non-formulary exception authorizations may be approved up to 12 months.

J2357HCPCS

up to 12 moApproval length

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

2+Asthma exacerbation req

FEV1/FVC <0.80Pulmonary function option

restrictedCombination therapy

Coverage Criteria & Indications

Moderate to severe persistent allergic asthma — Initial Therapy

Covered when ALL of the following are met:

ALL of the following

age: Individual is aged 6 years or older>=6 years
[[chunk 6]]
allergen_sensitivity: Positive skin test or in vitro reactivity to a perennial aeroallergen (e.g., dust mite, cockroach, cat, molds)
[[chunk 6]]
max_inhaled_therapy: Using maximum tolerated doses of an inhaled corticosteroid
[[chunk 6]]
LABA: Using an inhaled long-acting beta-agonist (LABA)
[[chunk 6]]
exacerbation_or_function: Meets ONE: 2 or more asthma exacerbations in the previous 12 months requiring oral corticosteroids, OR 1 or more exacerbation requiring hospitalization/ED/urgent care in the previous 12 months, OR FEV1 <80% predicted, OR FEV1/FVC <0.80, OR asthma that worsens upon tapering of oral corticosteroid therapy
[[chunk 6]]
IgE_range: Total serum IgE within 30–1,300 IU/mL (ages 6–12) or 30–700 IU/mL (ages ≥12)
[[chunk 6]]
weight: Weight between 20 kg and 150 kg
[[chunk 6]]
dosing_limit: Dose prescribed limited to 750 mg every 4 weeks per manufacturer's dosing table based on serum IgE and body weight
[[chunk 6]]
no_combination: Not used in combination with other biologics for asthma (e.g., tezepelumab, dupilumab, reslizumab, benralizumab) per policy exclusions
[[chunk 6]]

Severe chronic idiopathic urticaria — Initial Therapy

Covered when ALL of the following are met:

ALL of the following

age: Individual is aged 12 years or older>=12 years
[[chunk 7]]
no_alternate_cause: No evidence of another cause of the urticarial reaction
[[chunk 7]]
duration: At least 6 weeks of symptoms (chronic urticaria, itching, hives, or angioedema)6 weeks
[[chunk 7]]

Chronic rhinosinusitis with nasal polyps (CRSwNP) — Initial Therapy

Covered when ALL of the following are met:

ALL of the following

age: Individual is aged 18 years or older>=18 years
[[chunk 8]]
symptoms: Has at least 2 of: facial pressure or pain; moderate–severe nasal congestion, discharge, or obstruction; or significant loss of smell
[[chunk 8]]
IgE: Pretreatment total serum IgE at least 30 IU/mL
[[chunk 8]]

IgE-mediated food allergy — Initial Therapy

Covered when ALL of the following are met:

ALL of the following

age: Individual is aged 1 year or older>=1 year
[[chunk 8]]
diagnosis: Diagnosed with an IgE-mediated food allergy as demonstrated by appropriate testing and clinical history
[[chunk 31]]
prescriber: Medication prescribed by or in consultation with an allergist/immunologist or otolaryngologist (ENT)
[[chunk 8]]

Medical necessity groups

Covered when ALL of the following are met for allergic asthma:

Asthma coverage criteria

Allergen sensitivity: Positive skin test or in vitro reactivity to a perennial aeroallergen
[[chunk 6]]
Inadequate control on standard therapy: Inadequate control despite optimized inhaled corticosteroid therapy with or without a LABA and other controllers
[[chunk 24],[chunk 26]]
Dosing considerations: Dose determined by total serum IgE and body weight using manufacturer dosing tables
[[chunk 61]]

CIU coverage criteria:

Covered indications and enrollment criteria (summary)

Covered when ALL of the following are met (policy-updated criteria summarized):

Asthma - general: Individual meets updated policy definition of moderate-to-severe persistent asthma; dosing per FDA label; Xolair not used in combination with tezepelumab (tezspire).

[[chunk 48]]

Asthma exacerbation/PFT criteria (one of): Individual has either: >=2 exacerbations in prior 12 months requiring oral corticosteroids; OR >=1 exacerbation requiring hospitalization, ED, or urgent care in prior 12 months; OR FEV1 <80% predicted; OR FEV1/FVC <0.80; OR dependence on oral corticosteroids or asthma that worsens upon tapering of oral corticosteroids.

[[chunk 48],[chunk 49]]

CIU / CSU: Individual age >=12 with chronic spontaneous/idiopathic urticaria refractory to high-dose H1-antihistamines; trial documented; initial approval length 6 months; dosing per FDA label.

[[chunk 37],[chunk 47]]

Covered Indications and Dosing Notes

Coverage is provided when labeled indication-specific clinical criteria and dosing tables are met; dosing determination differs by indication:

Asthma dosing: Dose determined by body weight and baseline total IgE using manufacturer dosing tables for q2w or q4w schedules; baseline total IgE required for initial dose determination; do not re-test IgE during treatment for dose decisions unless treatment interrupted >=1 year; adjust dose for significant weight change.

[[chunk 61],[chunk 67]]

Chronic idiopathic urticaria (CIU): Administer 150 mg or 300 mg subcutaneously every 4 weeks; dosing not dependent on serum IgE or body weight; initial approval length updated to 6 months; periodically reassess need for continued therapy.

[[chunk 68]]

Chronic rhinosinusitis with nasal polyps (CRSwNP): Indication and dosing updated to match FDA label; body weight and IgE referenced for dosing tables; combination use with dupilumab for nasal polyps is prohibited.

[[chunk 8],[chunk 49]]

Asthma — initial coverage conditions (summary)

Covered when ALL of the following are met (policy history indicates the set of options to define moderate to severe persistent asthma):

Exacerbation or care-utilization: Individual has two or more asthma exacerbations in the previous 12 months requiring oral corticosteroids, OR one or more asthma exacerbations requiring hospitalization, ED, or urgent care in the previous 12 months.

[[chunk 72]]

Spirometry criteria: FEV1 <80% predicted OR FEV1/FVC <0.80.

[[chunk 74]]

Oral corticosteroid dependence: Has dependence on oral corticosteroids of at least 5 mg per day prednisone equivalent, OR has asthma that worsens upon tapering of oral corticosteroid therapy.

[[chunk 74]]

Chronic idiopathic urticaria — initial coverage conditions

Covered when CIU criteria met:

Duration: At least 6 weeks of documented symptoms prior to initiating Xolair.6 weeks

[[chunk 72]]

CRSwNP — initial coverage conditions

Covered when CRSwNP criteria are met:

Diagnosis confirmation: Diagnosed with inadequately controlled bilateral CRSwNP confirmed by physical examination, sinus CT, or nasal endoscopy.

[[chunk 75]]

Prior therapy: Prior use of systemic corticosteroids to treat nasal polyps in the last 2 years, OR contraindication to systemic corticosteroid therapy, OR previous surgical removal of bilateral nasal polyps.

[[chunk 75]]

Xolair (omalizumab) is considered investigational for uses not listed in this policy. Examples of investigational or unapproved uses include, but are not limited to: allergic rhinitis, atopic dermatitis, other IgE-mediated allergic conditions not listed, latex allergy, bullous pemphigoid, and eosinophilic gastrointestinal disorders.

Clinical trials in chronic idiopathic urticaria (CIU) showed efficacy for the 150 mg and 300 mg doses; the 75 mg dose did not demonstrate consistent evidence of benefit and is not approved for CIU.

Policy updates explicitly prohibit concurrent use of Xolair with certain biologic agents: not to be used in combination with Tezspire (tezepelumab) for asthma and not to be used in combination with Dupixent (dupilumab) for nasal polyps.

More broadly, the policy restricts combination use of Xolair with other biologic therapies for the same indication. Requests to use Xolair concurrently with agents such as dupilumab, tezepelumab, mepolizumab, benralizumab, or reslizumab for asthma or nasal polyps are explicitly excluded from coverage.

In summary, combination biologic therapy is not permitted under this policy: Xolair must not be prescribed or authorized for concurrent use with other listed biologics for the same disease indication (examples include Dupixent, Tezspire, Cinqair, Fasenra, Nucala, and similar agents). Such combination-use requests will be denied as not covered.

Site-of-service medical necessity review applies to injectable therapies including Xolair. Medically necessary sites include the physician office, infusion center, home infusion, and hospital-based outpatient setting under specified conditions. Sites that do not meet the policy's SOS criteria (for example outside the specified initial 90-day hospital outpatient exceptions or without documented risk/distance criteria) may be considered not medically necessary.

Xolair is positioned as an add-on or last-line agent for patients who remain inadequately controlled despite optimized standard therapy (for asthma: maximal tolerated inhaled corticosteroid plus other controllers; for CIU: high-dose H1-antihistamines). The clinical rationale and cost-effectiveness evidence support restricting use to these refractory populations.

Requests that propose dosing or combination regimens inconsistent with the FDA prescribing information or with the policy's documented coverage criteria (for example non-standard doses, off-label combinations, or omitting required prior therapy evidence) will be considered not medically necessary and are subject to denial.

The policy explicitly states that combination use of Xolair with other listed biologics for the treatment of asthma or nasal polyps is not medically necessary and will be excluded from coverage.

Recent policy updates (annual and interim reviews) reinforce that combination biologic therapy with Xolair is not permitted. The 2024–2025 updates specifically added prohibitions against combining Xolair with Tezspire (tezepelumab) for asthma and with Dupixent (dupilumab) for nasal polyps; such combination requests are not covered.

Coding and Clinical Thresholds

HCPCS codesHCPCSCovered

J2357

Injection, omalizumab (Xolair), 5 mg

Covered HCPCS CodesHCPCSCovered

J2357

Omalizumab (Xolair) injection

inv-23: serum IgE thresholds and age-specific ranges

Serum total IgE (ages 6–12)30–1,300 IU/mL

Serum total IgE (ages ≥12)30–700 IU/mL

CRSwNP pretreatment IgE threshold>= 30 IU/mL

inv-24: weight ranges for dosing

Asthma weight range (for dosing table)20 kg to 150 kg

CRSwNP weight range (for dosing table)30 kg to 150 kg

General upper weight limit referenced

Prior Authorization, Documentation & Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xolair (omalizumab) for allergic asthma, chronic idiopathic urticaria (CIU), chronic rhinosinusitis with nasal polyps (CRSwNP), and other covered indications. Requests must document that medical necessity criteria are met and that the prescriber is following FDA dosing and administration guidance. Xolair is managed through both the pharmacy and medical benefits and is subject to site-of-service review for administration location when applicable.

Prior authorization required for allergic asthma, CIU, CRSwNP and other indications listed in this policy.
Xolair is managed through the pharmacy benefit and the medical benefit; site-of-service medical necessity review may apply for injection/IV administration (see Site-of-Service guidance).

Note

Authorization Duration

Initial approvals and non-formulary exception authorizations may be granted up to 12 months when medical necessity criteria are met and ongoing benefit is documented. For some indications (for example CIU) initial approval lengths and continuation requirements may differ per current policy history; verify approval duration at time of review.

Administration, Initial Dosing & Monitoring

Initial administration and monitoring

Administration and initial monitoring

ALL of the following

admin_in_office: Xolair must be administered in a health care provider's office for at least three doses to establish safety before considering self-administration
[[chunk 16]]
self_admin_assessment: After initial doses, provider may determine appropriateness for self-administration based on assessment of anaphylaxis risk and mitigation strategies
[[chunk 16]]

Initial therapy — trial evidence alignment

Initial therapy is supported where trial evidence matches the patient's condition and prior therapy history.

Reauthorization & Continuation

Reauthorization criteria

Reauthorization may be approved up to 12 months when medical necessity criteria are met and clinical improvement is documented.

ALL of the following

clinical_response_asthma: Documentation of decreased oral steroid use, decreased exacerbation frequency, fewer ER/urgent care visits or hospitalizations, or decreased symptom frequency/severity
[[chunk 11]]
clinical_response_urticaria: Decrease in itch severity or hives
[[chunk 10]]
clinical_response_crs: Documented decrease from baseline in nasal polyp size AND improvement in Nasal Congestion Score (NCS) or decrease from baseline in nasal congestion

Required Prior Treatments / Step Requirements

Requirement	Details / Documentation
Maximum tolerated inhaled corticosteroid plus inhaled LABA
Member is using maximum tolerated doses of an inhaled corticosteroid AND is using an inhaled long-acting beta-agonist (LABA). Document medication names, doses, and duration in office notes.
Exacerbation or lung function criteria (one of)
Meets ONE: ≥2 asthma exacerbations in prior 12 months requiring oral corticosteroids; OR ≥1 exacerbation requiring hospitalization, ED, or urgent care in prior 12 months; OR FEV1 <80% predicted; OR FEV1/FVC <0.80; OR asthma that worsens upon tapering of oral corticosteroids. Provide records of exacerbation events, steroid prescriptions, hospital/ED/urgent care notes, and most recent spirometry.
Allergic sensitization
Positive skin test or in vitro reactivity (e.g., RAST) to a perennial aeroallergen (e.g., dust mite, cockroach, cat, molds). Include test results in documentation.
IgE and weight parameters for dosing
Total serum IgE within 30–1,300 IU/mL (ages 6–12) or 30–700 IU/mL (≥12) and weight between 20 kg and 150 kg. Provide baseline IgE and weight for dose determination per manufacturer dosing table.

Required Trial	Documentation Expected
Inhaled corticosteroid therapy
Document trial of an inhaled corticosteroid at maximally tolerated dose with dates and response. Include medication name, dose, duration, and reason for discontinuation or inadequate control.
Long-acting beta-agonist (LABA)
Document concurrent use of an inhaled LABA (e.g., salmeterol, formoterol) with the inhaled corticosteroid, with dose and duration noted.
Other controller therapies as indicated
Document trials of other controller agents as appropriate (e.g., leukotriene modifiers, theophylline) and inadequate response or intolerance. Rationale supports Xolair as last-line add-on when control not achieved on these strategies.

Prior trial / failure	Evidence to supply
Failure on optimized inhaled corticosteroid ± controllers
Document inadequate control despite optimized inhaled corticosteroid therapy with or without LABA and other controllers (medication names, doses, durations, and clinician assessment). Rationale: omalizumab is positioned as an add-on/last-line agent for individuals inadequately controlled despite optimized therapy.
Exacerbation history or PFTs supporting severity
Provide records showing ≥2 oral steroid–requiring exacerbations in prior 12 months or ≥1 exacerbation requiring hospitalization/ED/urgent care, or spirometry showing FEV1 <80% predicted or FEV1/FVC <0.80, or documentation that asthma worsens on tapering oral steroids.
Baseline IgE and weight for dosing
Include baseline total serum IgE and body weight to determine dose per manufacturer's dosing table; note that IgE should be baseline (pre-treatment) for dose selection.

Required prior medication	Documentation / Duration
High‑dose H1‑antihistamine trial(s)
Document trial(s) of H1 antihistamines at high dose (2–3× usual dose) with inadequate response. Include medication names, doses, dates, and clinician assessment of inadequate control.
Adjunct therapies (H2 antihistamine, corticosteroid, leukotriene modifier)
If used, document trials of adjunct agents (e.g., H2 antihistamine, short oral corticosteroid course, leukotriene modifier) and reason for failure or intolerance.
Symptom duration prior to Xolair
Document at least 6 weeks of chronic urticaria symptoms prior to initiating omalizumab per CIU criteria and history updates. Include UAS7 or other symptom scales if available.

Indication / Step requirement	Summary of policy requirement
Allergic asthma (step requirement)
Member must be on maximum tolerated inhaled corticosteroid plus LABA and meet exacerbation or lung function criteria (see asthma block). Provide medication history and exacerbation/PFT documentation.
Chronic idiopathic urticaria (CIU)
Document at least 6 weeks of symptoms and failure of high‑dose H1 antihistamines (and adjunct therapies if used). Initial CIU approval length is 6 months; dosing 150 or 300 mg q4w.
CRSwNP (nasal polyps)
Require diagnosis of inadequately controlled bilateral CRSwNP confirmed by exam, sinus CT, or nasal endoscopy, and prior use of systemic corticosteroids within last 2 years OR contraindication to systemic corticosteroids OR prior bilateral polyp surgery. Document prior intranasal corticosteroid trial and inadequate response.
IgE‑mediated food allergy
Consideration for select patients per policy update; document diagnostic testing and specialist management as per policy (use in context of clinical trial evidence).

Dosing Limits & Quantity Rules

inv-76: omalizumab (Xolair) dose limits per indication (750 mg q4w; 600 mg q2w; 150–300 mg q4w)

Asthma maximum dosing limitUp to 750 mg every 4 weeks

CRSwNP maximum dosing limitUp to 600 mg every 2 weeks

CIU dosing range150–300 mg every 4 weeks

inv-77: Xolair dosing per FDA weight-and-IgE table

FDA weight-and-IgE dosingDosing per FDA/manufacturer table based on body weight and baseline total IgE (tables provided for q2w and q4w schedules)

Baseline IgE requiredBaseline total serum IgE required for initial dose determination for asthma dosing

Site-of-Service & Administration Settings

Note

Site‑of‑service medical necessity review applies to IV and injectable drugs; permitted sites listed

Site‑of‑service medical necessity review applies to IV and injectable drugs including Xolair; medically necessary settings include physician office, infusion center, home infusion, and hospital outpatient under specific conditions (initial 90 days, re‑initiation after ≥6 months, lack of local infusion/home infusion access, or certain clinical risk factors).

Hospital outpatient may be considered medically necessary for the initial 90 days for initial course or re‑initiation after ≥6 months.
Consider patient clinical risk factors (e.g., cardiac or pulmonary conditions) when requesting hospital outpatient setting.

Billing Rule

Office administration — subcutaneous injection and observation for initial doses

Office administration: Xolair is given by subcutaneous injection and must be administered in a health care provider's office for at least three doses to establish safety; thereafter, self‑administration may be considered based on anaphylaxis risk assessment and mitigation.

Clinical Background & Definitions

Xolair (omalizumab) is a recombinant, humanized monoclonal antibody that targets IgE. It binds circulating IgE, preventing IgE binding to FcεRI, which reduces surface-bound IgE and receptor expression on effector cells. It is used as add-on therapy for moderate to severe allergic asthma, chronic idiopathic urticaria unresponsive to antihistamines, chronic rhinosinusitis with nasal polyps, and selected IgE-mediated food allergy contexts per the policy.

inv-53: Definition — IgE-mediated food allergy

DefinitionIgE-mediated food allergy: diagnosis demonstrated by appropriate testing and clinical history for type I hypersensitivity to food.

Age considerationPolicy includes IgE‑mediated food allergy as an indication for individuals aged 1 year and older when criteria are met

Specialist involvementTreatment should be prescribed by or in consultation with an allergist/immunologist or otolaryngologist per policy

inv-54: Definition — Omalizumab (Xolair)

Key Terms

inv-53: IgE-mediated food allergy definition (redundant key-term entry)

IgE-mediated food allergy (redundant)Diagnosis demonstrated by appropriate testing and clinical history for type I hypersensitivity to food.

Specialist prescriberPrescribed by or in consultation with an allergist/immunologist or otolaryngologist per policy

Age threshold notedPolicy states indication can apply to individuals aged 1 year and older when criteria met

inv-54: Omalizumab (Xolair) key term

Omalizumab (Xolair) — key termRecombinant, humanized monoclonal antibody targeting IgE; inhibits IgE binding to FcεRI and reduces surface-bound IgE and receptor expression.

AdministrationSubcutaneous injection per prescribing information; dosing tables provided for q2w and q4w schedules

Policy Summary

PayerPremera Bluecross

PolicyXolair (omalizumab) coverage and site-of-service criteria

Policy CodePolicy N/A

Change TypeClinical criteria revisionsexclusions clarifiedindications expanded

Effective DateOct 3, 2025

Next Review DateN/A

SourceLink

On This Page

failed_therapy: Failed to respond to one of the following unless contraindicated: two or more H1 antihistamines at high doses (2–3x) OR H1 inhibitor plus one of H2 antihistamine, oral corticosteroids, or leukotriene modifier

[[chunk 7]]

plan_continue_H1: Plans to continue low-dose H1 antihistamine during treatment

[[chunk 7]]

dose: Dose prescribed is 150 mg or 300 mg every 4 weeks

[[chunk 7]]

prescriber: Prescribed by or in consultation with an allergist/immunologist or pulmonologist

[[chunk 7]]

weight: Weighs between 30 kg and 150 kg

objective_confirmation: Diagnosis of inadequately controlled bilateral CRSwNP confirmed by physical exam, sinus CT, or nasal endoscopy

[[chunk 8]]

prior_treatment: Tried and had inadequate response or intolerance to intranasal corticosteroid monotherapy

[[chunk 8]]

concomitant_intranasal: Prescribed in combination with an intranasal corticosteroid

[[chunk 8]]

additional_criteria: Has ONE: prior systemic corticosteroid use for nasal polyps in the last 2 years, OR contraindication to systemic corticosteroids, OR prior bilateral nasal polyp surgery

[[chunk 8]]

dose_limit: Dose limited to 600 mg every 2 weeks per prescribing information based on serum IgE and body weight

[[chunk 8]]

Patient has chronic idiopathic urticaria (UAS7 ≥16) refractory to H1 antihistamine therapy

CRSwNP coverage criteria: Patient has bilateral nasal polyps with required NPS and inadequate response to intranasal corticosteroids

[[chunk 29]]

IgE-mediated food allergy coverage criteria: Patient with IgE-mediated food allergy considered for Xolair within contexts supported by trial evidence (e.g., OUtMATCH) and specialist management

[[chunk 31]]

CRSwNP: Diagnosed inadequately controlled bilateral CRSwNP confirmed by exam, CT, or endoscopy; prior systemic corticosteroid use in last 2 years or contraindication to systemic corticosteroids or prior bilateral sinus surgery; not combined with dupilumab for nasal polyps.

[[chunk 49],[chunk 73]]

inv-25: Asthma exacerbation count requirement (updated)

Asthma exacerbation requirement (updated)Two or more exacerbations in the previous 12 months requiring oral corticosteroids

Alternate care-utilization optionOne or more exacerbations in prior 12 months requiring hospitalization, ED, or urgent care

Policy effective wording changeExacerbation-based criteria revised in 2024–2025 updates

inv-26: Pulmonary function option added

Pulmonary function option addedFEV1 < 80% predicted OR FEV1/FVC < 0.80

FEV1 threshold referenced separatelyFEV1 <80% predicted

FEV1/FVC physiologic criterionFEV1/FVC <0.80 (added in 2025 updates)

inv-27: CIU initial approval length (key value)

Initial approval length for CIU6 months

CIU dosing schedule150 mg or 300 mg subcutaneously every 4 weeks

Reassessment notePeriodically reassess need for continued therapy after initial approval

inv-28: Weight-and-IgE dosing matrix presence

Weight-and-IgE dosing matrix presenceManufacturer weight-and-baseline total IgE tables provided for every 2- and 4-week schedules

Dose determined byBaseline total serum IgE and body weight per manufacturer dosing tables

Multiple schedule formatsBoth q2w and q4w dosing matrices present in policy

inv-29: Asthma exacerbation count (alternate phrasing)

Asthma exacerbation phrasing (alternate)Two or more exacerbations in previous 12 months requiring oral corticosteroids, or one or more requiring hospitalization/ED/urgent care

Oral steroid dependence alternativeAsthma that worsens upon tapering of oral corticosteroid therapy (alternative to fixed-dose dependence wording)

Effective update timingExacerbation criteria revised in 2024–2025 policy history

inv-30: FEV1 threshold

FEV1 thresholdFEV1 < 80% predicted

Use in coverage criteriaFEV1 <80% predicted may satisfy pulmonary-function criterion for asthma coverage

Added/confirmed in historyFEV1 criterion referenced in multiple policy history entries (2020–2025)

inv-31: FEV1/FVC threshold

FEV1/FVC thresholdFEV1/FVC < 0.80

Policy addition dateFEV1/FVC <0.80 added as an option in 2025 updates

Counts as alternative spirometric criterionMeets pulmonary-function criterion for asthma coverage when below threshold

Non-formulary exception reviews and other reviews may be approved up to 12 months.
Initial approval length for CIU has been updated historically (see policy history); periodically reassess duration at review.

Denial Risk

Site‑of‑Service Denial Risk

Site-of-service for administration may be denied if medical necessity for a higher-cost setting (e.g., hospital outpatient or infusion center) is not demonstrated. Site-of-service medical necessity criteria apply to medical benefit reviews; Alaska fully‑insured members are an exception per policy. Confirm whether site-of-service review applies for the requesting member.

Site-of-Service review applies ONLY to medical benefit reviews (not to Alaska fully‑insured members).
Denial risk if higher-cost site is requested without documentation supporting medical necessity for that setting.

Denial Risk

Documented Inadequate Response to Prior Therapy

Documented inadequate response to prior therapies is required for many indications. For asthma, documentation must show inadequate control despite use of maximum tolerated doses of an inhaled corticosteroid plus an inhaled long‑acting beta‑agonist (LABA) and meeting one of the other required clinical criteria (exacerbations, FEV1/FVC thresholds, or corticosteroid dependence/worsening on taper). For CRSwNP, lack of documented inadequate response to intranasal corticosteroids during the run‑in may trigger denial.

Asthma: document use of maximum tolerated inhaled corticosteroid AND an inhaled LABA, plus one of the specified exacerbation or lung function criteria.
CRSwNP: document inadequate response to nasal corticosteroids (run‑in use) or other required prior treatments to support approval.

Documentation Required

Documentation Supporting Diagnosis and Prior Treatments

Medical record documentation must support the diagnosis and prior treatments consistent with the applicable trial inclusion and policy criteria. Submit office visit notes with diagnosis, pertinent history, physical exam, and complete medication history. For asthma, provide evidence of prior controller therapy trials and exacerbation history or objective lung function testing per criteria.

Include office visit notes with diagnosis, relevant history, physical exam findings, and medication history.
For asthma: document trials of inhaled corticosteroid (maximum tolerated dose) and LABA, exacerbation count, hospital/ED/urgent care visits, and FEV1 or FEV1/FVC as applicable.

Documentation Required

IgE Testing and Dosing Documentation

For dosing rationale and IgE‑dependent dosing (asthma and some other indications), provide total serum IgE and body weight per the manufacturer dosing table when dosing requires IgE‑based calculations. Note that total IgE increases during treatment and should not be re‑used to retitrate doses during ongoing therapy; re‑testing is only useful if treatment has been interrupted for ≥1 year.

Provide baseline total serum IgE and body weight when initial dose determination is based on IgE.
Do not use IgE measurements taken during active treatment to determine dose; if therapy interrupted ≥1 year, re‑test IgE for dose determination.

Documentation Required

Required Supporting Documentation by Condition

Condition‑specific supporting documentation requirements: For CRSwNP, include physical exam findings, sinus CT scan or nasal endoscopy confirming inadequately controlled bilateral CRSwNP, and documentation of prior use of systemic corticosteroids within the last 2 years or prior bilateral polypectomy or contraindication to systemic corticosteroids. For CIU, document at least 6 weeks of symptoms despite high‑dose H1 antihistamines and trials of required adjunctive therapies; report dosing chosen (150 mg or 300 mg every 4 weeks) per approved labeling.

CRSwNP: exam, sinus CT or nasal endoscopy confirming bilateral disease; prior systemic corticosteroid use in last 2 years, contraindication to systemic steroids, or prior bilateral polypectomy.
CIU: at least 6 weeks of symptoms and failure of ≥2 H1 antihistamines (high dose) or H1 plus H2, leukotriene modifiers, or oral corticosteroids when appropriate.
Ensure prescribed dose and dosing interval align with FDA labeling (e.g., CIU dosing 150 mg or 300 mg every 4 weeks).

Step Therapy

Step Therapy and Positioning

Step‑therapy expectations: For asthma, Xolair is positioned as an add‑on or last‑line agent after inadequate control on guideline‑directed inhaled corticosteroid therapy plus other controllers (e.g., LABA). For CIU, confirm trial of first‑line agents (high‑dose H1 antihistamines and adjunctive therapies) before Xolair. Combination use of Xolair concurrently with other biologics for the same indication (e.g., dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab) is not allowed and may trigger denial.

Asthma: require trial of inhaled corticosteroid (maximum tolerated) plus LABA and other appropriate controllers prior to Xolair.
CIU: require failure of high‑dose H1 antihistamines ± adjunctive agents for at least 6 weeks.
Xolair should not be used concurrently with other biologics listed in policy (e.g., dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab).

Initial asthma therapy: Supported by pivotal trials showing reduction in exacerbations when added to standard therapy; patient should meet asthma coverage criteria and have baseline IgE and weight for dosing determination.

Initial CIU therapy: Supported by randomized trials demonstrating efficacy of 150 mg and 300 mg doses; 75 mg not consistently effective; requires prior antihistamine use and UAS7 criteria per trials.

[[chunk 27]]

Initial CRSwNP therapy: Supported by two randomized trials requiring bilateral NPS and inadequate response to nasal corticosteroids during run-in; co-therapy with intranasal steroid was used in trials.

[[chunk 29]]

Initial food allergy therapy: Evidence from OUtMATCH trial supports use in select patients with multiple food allergies under specialist management and controlled DBPCFC assessment.

[[chunk 31]]

Initial therapy criteria

Initial authorization requirements vary by indication; highlights below summarize updated policy requirements.

Initial - Asthma: Applicant must meet policy definition of moderate-to-severe persistent asthma (exacerbation or PFT options), be on maximally tolerated inhaled corticosteroid therapy plus other controllers per label, and not be receiving tezepelumab concurrently; dosing per FDA label.

[[chunk 44],[chunk 49]]

Initial - CIU: Age >=12, refractory to high-dose H1-antihistamines (or combination regimens per policy), dosing 150 or 300 mg q4w; initial approval length 6 months.

[[chunk 37],[chunk 47]]

Initial - CRSwNP: Confirmed bilateral CRSwNP with inadequate control and prior systemic corticosteroid use in last 2 years or contraindication to systemic corticosteroids or prior bilateral nasal polyp surgery; not combined with dupilumab.

[[chunk 49],[chunk 73]]

Initial therapy dosing guidance by indication

Initial dosing guidance by indication

CIU initial therapy: Initiate Xolair 150 mg or 300 mg subcutaneously every 4 weeks; dosing is independent of serum IgE or body weight; periodically reassess therapy need.

[[chunk 68]]

Asthma initial therapy: Initiate dose per manufacturer's weight-and-baseline IgE tables for q2w or q4w schedules; baseline total IgE required for initial dose determination.

[[chunk 61]]

Initial therapy requirements summarized from policy history

Initial therapy requirements summarized from policy history:

CIU initial: Policy history documents at least 6 weeks of documented symptoms and prior medication trials required before initiating Xolair for CIU; initial approval length updated to 6 months.

[[chunk 72],[chunk 73]]

clinical_response_food_allergy: Decrease in significant systemic allergic reactions from baseline

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Continuation therapy — clinical benefit demonstrated

Continuation may be appropriate when clinical benefit is demonstrated on therapy:

Continuation criteria: Demonstrated clinical benefit while on omalizumab, such as reduced exacerbations, symptom improvement, or improved quality of life, consistent with pivotal trials and subsequent studies.

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Continuation therapy — renewal considerations summarized

Continuation/renewal considerations summarized from updates:

Continuation for CIU: After initial 6-month approval, continued benefit requires documentation of response and ongoing clinical need per policy and FDA dosing.

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Continuation for asthma/CRSwNP: Continued therapy requires documentation of ongoing benefit and adherence to dosing per FDA label; site-of-service medical necessity criteria may be applied to injection drugs.

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Continuation therapy and dose determination

Continuation and re-dosing guidance

IgE re-testing after interruption: Do not use IgE levels obtained during treatment to determine dose; if treatment interrupted <1 year, use initial baseline IgE for dose determination; if interruption >=1 year, re-test total serum IgE to determine dose; adjust doses for significant weight change.interruption >= 1 year

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Continuation therapy notes (history referenced)

Continuation/renewal rules referenced in history:

CIU continuation: Initial approval length for CIU was updated to 6 months (implying reauthorization after the initial period with documentation of benefit).6 months

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Do not re-test during treatment

Total IgE elevated during treatment; re-testing not used for dose determination unless interruption ≥1 year

inv-78: Xolair dose per manufacturer table (variable mg per administration)

Manufacturer dosing table variabilityManufacturer tables list variable mg per administration across weight and IgE bands for q2w and q4w schedules

Dose adjustmentsDoses should be adjusted for significant changes in body weight

Post-treatment IgE noteTotal IgE may remain elevated up to 1 year after discontinuation — use initial IgE for dose if interruption <1 year

Initial administration and observation in a clinical setting recommended for at least 3 doses.
Self‑administration may be allowed after provider assessment of safety and risk.

Note

Site‑of‑service review may be required to determine appropriate setting (office/infusion/home)

Site‑of‑service medical necessity review may be required to determine the appropriate setting (office, infusion center, or home) for injection administration; document access issues or clinical risk factors if requesting a higher‑acuity site.

If requesting hospital outpatient or infusion center, provide rationale such as lack of local outpatient infusion center within 50 miles, no contracted home infusion agency, or specific clinical risk factors.

Billing Rule

Office administration details — q2w or q4w schedules per prescribing information

Follow prescribing information for q2w or q4w schedules and dosing tables when administering subcutaneous omalizumab in the office; dosing matrices for every‑2‑week and every‑4‑week regimens are provided in the policy.

Use manufacturer/ FDA dosing tables based on baseline total IgE and body weight for asthma schedules.
CIU dosing is 150 or 300 mg every 4 weeks per prescribing information.

Note

Site‑of‑service medical necessity review added — applies to office, infusion center, hospital outpatient

A site‑of‑service medical necessity review was added and may apply to injection drugs including Xolair, with applicable settings including office, infusion center, or hospital outpatient depending on clinical and access criteria.

Policy clarifies that SOS medical necessity criteria can apply to injection drugs and that a formal site‑of‑service review may be performed.

Agent descriptionOmalizumab (Xolair): a recombinant, humanized monoclonal antibody targeting human IgE that inhibits IgE binding to FcεRI and reduces surface-bound IgE on effector cells.

Route and formulationAdministered by subcutaneous injection per prescribing information

Indications summarizedUsed as add-on therapy for allergic asthma, CIU, CRSwNP, and select IgE-mediated food allergies per policy and labeling

inv-55: Definition — Nasal Polyp Score (NPS)

NPS scoringNasal Polyp Score (NPS): endoscopic score per nostril 0–4 (total 0–8) used in trials to quantify polyp burden; enrollment required NPS ≥4 with ≥2 in each nostril.

Use in CRSwNP trialsNPS was a co-primary endpoint in pivotal CRSwNP trials demonstrating improvement with Xolair

Confirmation requirementPolicy requires diagnosis of inadequately controlled bilateral CRSwNP confirmed by exam, CT, or nasal endoscopy

inv-56: Definition — UAS7 (urticaria activity score)

UAS7 descriptionUAS7 (Weekly Urticaria Activity Score): composite 0–42 from weekly itch severity (0–21) and hive count (0–21); trials required UAS7 ≥16 for enrollment.

Trial useUAS7 used to measure disease severity and response in CIU pivotal trials

CIU enrollment criteriaIndividuals in CIU trials had UAS7≥16 despite H1 antihistamine use

inv-57: Definition — CIU/CSU

CIU/CSU definitionChronic idiopathic/spontaneous urticaria (CIU/CSU): persistent hives and/or angioedema unresponsive to H1-antihistamines (symptoms ≥6 weeks).

Treatment contextCIU indication requires documented failure of high‑dose H1 antihistamines (and other adjuncts when applicable) prior to Xolair

Age thresholdPolicy applies CIU initial therapy to individuals aged ≥12 years

inv-58: Definition — Moderate-to-severe persistent asthma (policy definition)

Policy definition (moderate-to-severe asthma)Moderate‑to‑severe persistent asthma: includes individuals with ≥2 exacerbations in prior 12 months requiring oral corticosteroids, or ≥1 exacerbation requiring hospitalization/ED/urgent care, FEV1 <80% predicted, FEV1/FVC <0.80, or asthma that worsens upon tapering of oral corticosteroids.

Therapy contextRequires maximum tolerated inhaled corticosteroid plus LABA and other controllers per step-therapy requirements

Allergen sensitivity requirementPositive skin test or in‑vitro reactivity to a perennial aeroallergen required for allergic asthma coverage

inv-59: CIU dosing independence (150 or 300 mg q4w independent of IgE/weight)

CIU dosing independenceFor chronic idiopathic urticaria, dosing is 150 mg or 300 mg subcutaneously every 4 weeks and is not dependent on serum IgE level or body weight.

Initial approval lengthInitial CIU approval length updated to 6 months

Reassessment notePeriodically reassess need for continued therapy; duration not formally established in trials

inv-60: Moderate to severe persistent asthma (alternate policy definition)

Alternate asthma definition entryModerate to severe persistent asthma defined by exacerbation history (2+ OCS-requiring exacerbations or ≥1 hospitalization/ED/urgent care), FEV1 <80% predicted, or asthma worsening on steroid taper; FEV1/FVC <0.80 later added as option.

Step therapy requirement reminderMember must be on maximum tolerated inhaled corticosteroid plus LABA and meet exacerbation or lung function criteria prior to Xolair

Effective dates notedDefinition and options updated across 2024–2025 policy history

Indication summaryUsed as add-on therapy for allergic asthma, CIU, CRSwNP, and select IgE-mediated food allergies as detailed in policy

inv-55: Nasal Polyp Score (NPS) definition repeated for clarity

NPS definition (repeated)Nasal Polyp Score (NPS): endoscopic score per nostril 0–4 (total 0–8); trials required NPS ≥4 with ≥2 in each nostril for enrollment.

CRSwNP confirmationDiagnosis must be confirmed by physical exam, CT, or nasal endoscopy per updated criteria

NPS as trial endpointNPS used as co-primary endpoint demonstrating benefit in CRSwNP trials

inv-56: UAS7 definition

UAS7 (repeated)Weekly Urticaria Activity Score (UAS7): 0–42 composite of itch severity (0–21) and hive count (0–21); trials required UAS7 ≥16.

Use in CIU trialsUAS7 used to enroll and measure response; CIU trial participants had UAS7 ≥16 despite H1 antihistamine use

Clinical relevanceUAS7 decrease indicates improvement in urticaria symptoms during treatment

inv-57: CIU/CSU definition

CIU/CSU definition (repeated)Chronic idiopathic/spontaneous urticaria: persistent hives and/or angioedema unresponsive to H1-antihistamines, with symptoms ≥6 weeks.

Dosing independence restatedCIU dosing of 150 or 300 mg q4w is independent of IgE or body weight

Prior therapy requirementDocumented trial of high‑dose H1 antihistamines required prior to Xolair