ModifiedCignaPolicy N/A

Xolair (omalizumab) drug quantity management

Defines Cigna's drug quantity limits and authorization guidance for Xolair (omalizumab) auto‑injectors, prefilled syringes, and vials (retail and home delivery) including exceptions for specific indications.

Policy Summary

PayerCigna

PolicyXolair (omalizumab) drug quantity management

Policy CodePolicy N/A

Change TypeMaterial operational and quantity-limit updates (new retail/home limitsappendix-based overrides)

Effective DateN/A

Next Review DateN/A

Key ActionWhen requesting quantities above standard limits, document patient weight and baseline IgE to match the Appendix A–C override tables that justify the higher quantity.

SourceLink

POLICY UPDATE CHANGES

New quantity limits of 2 auto-injectors per 28 days at retail and 6 auto-injectors per 84 days at home delivery were added for Xolair 75 mg and 150 mg auto-injectors.

Override criteria added to approve quantities listed in Appendix A for Xolair 150 mg auto-injectors when used for IgE-mediated food allergy or CRSwNP.

Specific approved quantities for 450 mg and 525 mg dosing scenarios were specified in history/appendix summary (e.g., 3 auto-injectors per 28 days for 450 mg Q4W and 6 per 28 days for 450 mg Q2W or 525 mg Q2W).

New quantity limits were added for Xolair 75 mg, 150 mg, 300 mg auto-injectors and prefilled syringes (retail: 2 per 28 days; home delivery: 6 per 84 days) and for certain higher-dose override approvals in Appendix tables.

Quantity limits for Xolair 150 mg prefilled syringes were changed from 4 per 28 days (retail) and 12 per 84 days (home delivery) to 2 per 28 days (retail) and 6 per 84 days (home delivery).

Override quantities for several weight/baseline IgE-determined dosing regimens were added or updated (e.g., 450 mg Q4W and 525 mg/600 mg Q2W scenarios) in Appendix A-C.

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retail limit (per 28 days)

6home delivery limit (per 84 days)

6150 mg vials per 28 days

18150 mg vials per 84 days

1 yearstandard approval duration

Appendices A–Coverride rules location

Coverage Criteria

inv-01: Drug Quantity Limits and Overrides

Xolair products are covered as medically necessary when the Drug Quantity Management rule is met at point of service and the criteria below are satisfied. All approvals are provided for 1 year unless otherwise noted.

General quantity limits: Retail and home delivery maximum quantities are limited by strength and form as specified in the policy tables.see policy tables

Examples: 2 auto-injectors/prefilled syringes per 28 days (retail) and 6 per 84 days (home delivery) for 75 mg, 150 mg and 300 mg presentations; 150 mg vials: 6 per 28 days retail, 18 per 84 days home delivery.

Overrides for specific indications: For requests for immunoglobulin E-mediated food allergy or chronic rhinosinusitis with nasal polyps (CRSwNP), approve the quantities listed in the applicable Appendix table (A, B, or C) per 28 days (retail) or per 84 days (home delivery).appendix table quantities

Override quantities refer only to the listed strength; certain doses may require combinations of different strengths and additional claims may appear.

Strength-specific notes: No overrides are recommended for Xolair 75 mg auto-injectors/prefilled syringes. Override tables exist for 150 mg auto-injectors/prefilled syringes (Appendix A), 150 mg vials (Appendix B), and 300 mg auto-injectors/prefilled syringes (Appendix C) when the indication is food allergy or CRSwNP.N/A

See Appendices A–C for weight and baseline IgE mapping to allowed override quantities.

inv-02: Override approval criteria

Overrides to standard quantity limits are permitted when ALL of the following are met as documented in the Appendices:

Appendix match: Patient weight and baseline total IgE correspond to an entry in the appropriate Appendix table (Appendix A for 150 mg auto-injectors/prefilled syringes, Appendix B for 150 mg vials, Appendix C for 300 mg auto-injectors/prefilled syringes) that specifies an override quantity for the required mg dose.see Appendix table entries

Appendix tables list weight bands, IgE ranges, recommended mg doses (e.g., 450 mg Q4W, 525 mg Q2W, 600 mg Q2W) and the corresponding allowed override quantities (for example: 3 per 28 days / 9 per 84 days; 6 per 28 days / 18 per 84 days).

inv-03: Table-based quantity allowances

Covered quantities and dosing are allowed when the requested number of 300 mg auto-injectors/prefilled syringes falls within a tableed quantity band and the patient weight corresponds to the specified dose/interval or a 'Food allergy dosing only' designation.

Table-driven allowance: For each requested quantity band the Appendix C table lists patient weight subranges and the permitted dosing statement (examples: 'No Override (300 mg Q4W)', '4 per 28 days or 12 per 84 days (600 mg Q2W)', or 'Food allergy dosing only. NO OVERRIDES.').refer to Appendix C rows

Use the table mapping in Appendix C to determine whether the requested quantity is allowable, designated as No Override, or restricted to food allergy dosing only.

Any request for a quantity that exceeds the policy's specified Drug Quantity Limits and that is not supported by an approved Appendix/table override for the listed indications will be considered not medically necessary. If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the policy criteria and uncovered excess quantities are not approved without the appendix-based justification.

Appendices A–C contain multiple weight and baseline IgE combinations that are explicitly annotated as "No Override" or "NO OVERRIDES". These entries indicate that override approval for higher quantities is not permitted for those specific weight/IgE bands and therefore requests matching those combinations are not eligible for quantity increases beyond the standard limits.

For several tableed quantity bands, patient weight subranges beginning at ≥10–30 kg are designated "Food allergy dosing only. NO OVERRIDES." This designation means those weight ranges are eligible only when treating IgE‑mediated food allergy and are not eligible for override for other indications.

Any exception beyond the stated criteria and the documented quantity limits in this policy (including retail and home delivery maximums) is considered not medically necessary. Approvals are limited to the conditions and quantities specified in the policy and appendices.

Override requests for quantities are not eligible when the applicable Appendix row for the patient’s weight and baseline IgE explicitly states "NO OVERRIDES" or "No Override." Such requests should not be approved because the tableed guidance precludes overrides for that weight/IgE band.

Quantity Limits (Retail per 28 days / Home delivery per 84 days)

Xolair 75 mg prefilled syringe — retail limit (per 28 days) reference

Strength & formXolair 75 mg prefilled syringe

Retail limit (per 28 days)2 syringes

Home delivery limit (per 84 days)6 syringes

Xolair 75 mg prefilled syringe — home delivery limit (per 84 days) reference

Strength & formXolair 75 mg prefilled syringe

Home delivery limit (per 84 days)6 syringes

Retail limit (per 28 days)

Initial Therapy Criteria

inv-28: Indication-based dosing

Dosing depends on indication and for some indications on baseline total IgE and body weight; apply the indication-specific dosing rules below when determining the required mg dose and whether an override table entry supports the requested quantity.

Asthma dosing: 75 mg to 375 mg administered SC Q2W or Q4W based on serum total IgE measured before treatment and body weight.75-375 mg

Not for acute bronchospasm or status asthmaticus.

CRSwNP dosing: 75 mg to 600 mg administered SC Q2W or Q4W based on serum total IgE measured before treatment and body weight.75-600 mg

Appendix override quantities apply for CRSwNP when listed in Appendices A–C.

Chronic idiopathic urticaria (CIU) dosing:

Provider Actions & Documentation Requirements

Prior Authorization

Authorization duration and quantity limits

All approvals are provided for 1 year unless otherwise noted. Drug quantity limits are enforced at point of service; if the Drug Quantity Management rule is not met for the requested medication at point of service, coverage will be determined by the policy criteria.

Retail maximums: typically 2 units per 28 days (varies by strength/form).
Home delivery maximums: typically 6 units per 84 days (varies by strength/form).

Prior Authorization

Prior authorization and quantity limits

Prior authorization is required for quantities that exceed standard point-of-service limits. Requests must follow the policy’s standard quantity limits and point-of-service checks; if limits are exceeded, submission of supporting documentation is required for review.

Point-of-service quantity checks apply per retail (28-day) and home delivery (84-day) periods.
No clinical overrides apply for certain presentations unless specified in appendices.

Coding & References

Referencesmixed

Xolair prescribing information

Reference document: Xolair® [prescribing information], Genentech; February 2024

Weight and baseline IgE-based dosing — multiple weight bands and IgE ranges map to specific mg doses and override quantities (Appendices A–C)

DescriptionMultiple weight bands and baseline total IgE ranges map to specific mg doses and the corresponding allowed override quantities in Appendices A–C

AppendicesAppendix A: 150 mg auto-injectors/prefilled syringes; Appendix B: 150 mg vials; Appendix C: 300 mg auto-injectors/prefilled syringes

Actionable requirementOverride approvals require documented patient weight and baseline IgE that match an Appendix table entry

Definitions

Dosing frequency definitions — Q2W and Q4W

Q2WOnce every 2 weeks

Q4WOnce every 4 weeks

ContextDosing frequency (Q2W/Q4W) is referenced in Appendix dosing tables and informs allowable quantities

Override — definition and context

DefinitionAn approval for a quantity greater than standard quantity limits based on patient-specific dosing requirements (weight and baseline IgE) as shown in Appendix A–C

ContextOverrides apply when patient weight and baseline IgE correspond to an Appendix entry specifying a higher quantity for the required mg dose

Provider requirement

Site of Care

Note

Follow product labeling for home vs clinic administration

Prefilled syringes are labeled for patient or caregiver administration (home use); vials are labeled for healthcare‑provider administration only. Auto‑injectors are labeled for patients aged ≥12 years.

Prefilled syringes: patient/caregiver administration allowed (suitable for home delivery).
Vials: labeled for HCP administration only (clinic use).
Auto‑injector labeling restricts use to patients ≥12 years.

Background

Xolair (omalizumab) is an anti‑IgE monoclonal antibody indicated for moderate‑to‑severe allergic asthma (≥6 years), chronic idiopathic urticaria (≥12 years), chronic rhinosinusitis with nasal polyps (≥18 years), and IgE‑mediated food allergy (≥1 year). Dosing varies by indication: asthma, CRSwNP and food allergy dosing depend on patient body weight and baseline total IgE; CIU dosing is fixed at 150 mg or 300 mg every 4 weeks. Approvals under this policy follow the Drug Quantity Management rules and any Appendix‑based override mapping for weight and IgE where applicable.

Step Therapy / Drug Quantity Management

Step	Rule	Action if rule not met
1	Drug Quantity Management rule applies at point of service	If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the policy criteria; approvals are provided for 1 year unless otherwise noted.

Policy Summary

PayerCigna

PolicyXolair (omalizumab) drug quantity management

Policy CodePolicy N/A

Change TypeMaterial operational and quantity-limit updates (new retail/home limitsappendix-based overrides)

Effective DateN/A

Next Review DateN/A

Key ActionWhen requesting quantities above standard limits, document patient weight and baseline IgE to match the Appendix A–C override tables that justify the higher quantity.

SourceLink

On This Page

Xolair 75 mg auto-injector — retail limit (per 28 days)

Strength & formXolair 75 mg auto-injector

Retail limit (per 28 days)2 auto-injectors

Home delivery limit (per 84 days)6 auto-injectors

Xolair 75 mg auto-injector — home delivery limit (per 84 days)

Strength & formXolair 75 mg auto-injector

Home delivery limit (per 84 days)6 auto-injectors

Retail limit (per 28 days)2 auto-injectors

Xolair 150 mg prefilled syringe/auto-injector — retail limit (per 28 days)

Strength & formXolair 150 mg prefilled syringe/auto-injector

Retail limit (per 28 days)2 syringes/auto-injectors

Home delivery limit (per 84 days)6 syringes/auto-injectors

Xolair 150 mg prefilled syringe/auto-injector — home delivery limit (per 84 days)

Strength & formXolair 150 mg prefilled syringe/auto-injector

Home delivery limit (per 84 days)6 syringes/auto-injectors

Retail limit (per 28 days)2 syringes/auto-injectors

Xolair 150 mg vial — retail limit (per 28 days)

Strength & formXolair 150 mg vial

Retail limit (per 28 days)6 vials

Home delivery limit (per 84 days)18 vials

Xolair 150 mg vial — home delivery limit (per 84 days)

Strength & formXolair 150 mg vial

Home delivery limit (per 84 days)18 vials

Retail limit (per 28 days)6 vials

Xolair 300 mg prefilled syringe/auto-injector — retail limit (per 28 days)

Strength & formXolair 300 mg prefilled syringe/auto-injector

Retail limit (per 28 days)2 syringes/auto-injectors

Home delivery limit (per 84 days)6 syringes/auto-injectors

Xolair 300 mg prefilled syringe/auto-injector — home delivery limit (per 84 days)

Strength & formXolair 300 mg prefilled syringe/auto-injector

Home delivery limit (per 84 days)6 syringes/auto-injectors

Retail limit (per 28 days)2 syringes/auto-injectors

Xolair (multiple presentations) — new retail quantity limit (summary)

ScopeApplies to Xolair auto-injectors and prefilled syringes across strengths (75 mg, 150 mg, 300 mg)

New retail quantity limit (summary)2 auto-injectors or prefilled syringes per 28 days for 75/150/300 mg strengths

New home delivery quantity limit (summary)6 auto-injectors or prefilled syringes per 84 days for 75/150/300 mg strengths

Xolair (multiple presentations) — new home delivery quantity limit (summary)

ScopeApplies to Xolair auto-injectors and prefilled syringes across strengths (75 mg, 150 mg, 300 mg)

New home delivery quantity limit (summary)6 auto-injectors or prefilled syringes per 84 days for 75/150/300 mg strengths

New retail quantity limit (summary)2 auto-injectors or prefilled syringes per 28 days for 75/150/300 mg strengths

Xolair 300 mg auto-injector/prefilled syringe — varies by table mapping with examples (per 28 / per 84 days)

ProductXolair 300 mg auto-injector/prefilled syringe

Table-driven variationsPermitted quantities vary by Appendix C weight-by-quantity mapping; examples include 4 per 28 days (12 per 84 days) for certain weight bands and 6 per 28 days (18 per 84 days) for other dosing scenarios

RequirementOverride requires patient weight and baseline IgE matching an Appendix C entry

150 mg or 300 mg administered SC Q4W; dosing is not dependent on serum IgE level or body weight.

CIU dosing typically does not require weight/IgE-based overrides.

IgE-mediated food allergy dosing: 75 mg to 600 mg administered SC Q2W or Q4W based on serum total IgE measured before treatment and body weight.75-600 mg

Appendix override quantities apply for food allergy when listed; many pediatric weight bands are designated 'Food allergy dosing only. NO OVERRIDES.'

Documentation Required

Quantity override governed by weight table

Quantity override approvals for higher-than-standard quantities are governed by weight-by-quantity tables in the appendices. Overrides are specific to strength/form (see Appendix A for 150 mg, Appendix C for 300 mg, Appendix B for vials) and are granted only when the patient’s weight and baseline total IgE match the tableed dosing rows.

Overrides for 150 mg presentations are listed in Appendix A.
Overrides for 300 mg presentations are listed in Appendix C.
Overrides for vial presentations are listed in Appendix B.

Denial Risk

Quantity limit exceedance triggers override review

If a requested quantity exceeds the standard limits, the request will trigger an override review. The provider must supply documentation to justify the higher quantity per the appendix tables; lack of required documentation may result in denial.

Requests exceeding limits require matching justification per the applicable Appendix (A, B, or C).
Approved override quantities correspond to specific weight and baseline IgE bands in the tables.

Denial Risk

Quantity outside table may be denied

Requests for quantities that do not correspond to entries in the appendix weight/quantity tables may be denied or will require additional clinical review and justification. Only the exact tableed quantities tied to a patient’s weight and baseline IgE are eligible for automatic override approval.

Quantities outside the appendix tables are not automatically approved.
Additional clinical justification and review are required for non-table quantities.

Documentation Required

Required clinical dosing information

Provide indication-specific dosing information when requesting quantities or overrides. Recommended dosing per indication: Asthma — 75 mg to 375 mg SC Q2W or Q4W based on total serum IgE and body weight; CRSwNP — 75 mg to 600 mg SC Q2W or Q4W based on total serum IgE and body weight; Chronic Idiopathic Urticaria — 150 mg or 300 mg SC Q4W (dose not dependent on IgE or weight); IgE-mediated Food Allergy — 75 mg to 600 mg SC Q2W or Q4W based on total serum IgE and body weight.

For CIU, dosing is independent of serum IgE and body weight.
For other indications, dose selection must be supported by baseline total IgE and patient weight.

Documentation Required

Weight and quantity documentation

When requesting an override tied to weight-based dosing, the prescriber must document the patient’s current weight and baseline total serum IgE level. Include the requested quantity and the specific appendix table row that justifies the override (appendix letter, weight band, and resulting mg dose/frequency).

Document: patient weight (kg), baseline total IgE (IU/mL), requested quantity, and corresponding appendix table row.
Specify the indication (e.g., CRSwNP, food allergy) that supports use of the appendix override table.

Provider must document weight and baseline IgE when requesting an override

No Override — definition

DefinitionNo Override — indicates the Appendix table does not permit quantities above the standard limits for the listed weight/IgE band

ImplicationRequests for higher quantities in 'No Override' bands are not eligible for override and may be denied

ExamplesMany weight/IgE combinations in Appendices A–C are labeled 'No Override' or 'NO OVERRIDES'

Food allergy dosing only — definition

Definition'Food allergy dosing only' — the table designation indicating the weight band is reserved for food allergy dosing and does not permit overrides for other indications

ImplicationWeight ranges (e.g., ≥10–30 kg) are often designated 'Food allergy dosing only. NO OVERRIDES.' in Appendices A–C

Provider actionIf patient is treated for non–food-allergy indications, these bands do not allow override quantities