ModifiedCignaPolicy N/A

Immunologicals - Xolair Drug Quantity Management Policy

Defines Cigna's drug quantity limits and override criteria for Xolair (omalizumab) formulations and who is affected (members receiving Xolair under Cigna-administered health benefit plans).

Policy Summary

PayerCigna

PolicyImmunologicals - Xolair Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeQuantity limits and override criteria added/updated

Effective DateN/A

Next Review DateN/A

Key ActionWhen requesting an override quantity, provide patient weight and baseline IgE–derived dose determination and obtain prior authorization per the applicable Appendix.

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.

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 150 mg.

Override criteria were added to approve higher quantities (per Appendix A/B/C) when Xolair is requested for IgE-mediated food allergy or chronic rhinosinusitis with nasal polyps.

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.

Quantity limits for Xolair 150 mg prefilled syringes changed from 4 syringes per 28 days retail to 2 syringes per 28 days retail (and corresponding home delivery changes).

2 per 28 daysretail maximum quantity for most Xolair syringe/auto-injector strengths

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.

6 per 84 dayshome delivery maximum quantity for most Xolair syringe/auto-injector strengths

1 yearstandard approval duration

3 per 28 daysoverride quantity for 450 mg Q4W (several weight bands)

4 per 28 daysoverride quantity for some 300 mg products at 600 mg Q2W

Coverage Criteria for Xolair (omalizumab)

COVERAGE CRITERIA

Covered as medically necessary when Drug Quantity Management limits or approved overrides per indication and appendices are met. All approvals are provided for 1 year unless otherwise noted.

ALL of the following

Policy Statement: This Drug Quantity Management program manages potential dose escalation of Xolair. If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria below. All approvals are provided for 1 year unless otherwise noted.
chunk 11
Drug Quantity Limits: Retail maximum quantity per 28 days and home delivery maximum per 84 days are specified by strength and form (75 mg, 150 mg, 300 mg; prefilled syringe, auto-injector, vial). Retail limits generally 2 units per 28 days; home delivery limits generally 6 units per 84 days, with exceptions noted in appendices.
chunk 12|chunk 13
General rule: Covered when the Drug Quantity Management limits are met. If limits are exceeded, coverage requires meeting the override criteria in the applicable Appendix for the requested strength/form and indication.
chunk 11|chunk 12
Xolair 75 mg auto-injectors/prefilled syringes: No overrides recommended (not eligible for higher override quantities).
chunk 14
Xolair 150 mg auto-injectors/prefilled syringes: For immunoglobulin E-mediated food allergy or chronic rhinosinusitis with nasal polyps (CRSwNP), approve the quantity listed in Appendix A per 28 days at retail or per 84 days at home delivery. Note: override quantities refer only to quantity of 150 mg devices needed to provide the appropriate dose; some doses may require use of two different strengths.
chunk 15
Xolair 150 mg vials: For IgE-mediated food allergy or CRSwNP, approve the quantity listed in Appendix B per 28 days at retail or per 84 days at home delivery.
chunk 16
Xolair 300 mg auto-injectors/prefilled syringes: For IgE-mediated food allergy or CRSwNP, approve the quantity listed in Appendix C per 28 days at retail or per 84 days at home delivery. Note: override quantities refer only to quantity of 300 mg devices needed to provide the appropriate dose; some doses may require use of two different strengths.
chunk 17

Quantity limits and override criteria

Quantity limits and override criteria — Covered with quantity limits and specified overrides when ALL conditions in the applicable Appendix row are met.

ALL of the following

Overrides apply only for the indicated clinical indications: immunoglobulin E-mediated food allergy or chronic rhinosinusitis with nasal polyps (CRSwNP), and only when the member’s weight and baseline IgE-based dosing match an Appendix row.
chunk 15|chunk 16|chunk 17
Appendix tables specify weight and baseline IgE brackets with approved override quantities or explicit 'NO OVERRIDES' entries. Weight/dose combinations listed as 'NO OVERRIDES' are not eligible for higher override quantities.
chunk 22|chunk 29|chunk 31|chunk 33
Retail and home delivery override quantities are presented per 28-day (retail) and 84-day (home delivery) supply periods respectively; approve the corresponding quantity for the period requested.
chunk 12|chunk 13

Quantity Limits by Strength and Form (Coding)

Quantity limits by strength and formmixed

75 mg prefilled syringe	Xolair 75 mg prefilled syringe — retail max 2 per 28 days; home delivery max 6 per 84 days
75 mg auto-injector	Xolair 75 mg auto-injector — retail max 2 per 28 days; home delivery max 6 per 84 days
150 mg prefilled syringe	Xolair 150 mg prefilled syringe — retail max 2 per 28 days; home delivery max 6 per 84 days
150 mg auto-injector	Xolair 150 mg auto-injector — retail max 2 per 28 days; home delivery max 6 per 84 days
300 mg prefilled syringe	Xolair 300 mg prefilled syringe — retail max 2 per 28 days; home delivery max 6 per 84 days
300 mg auto-injector	Xolair 300 mg auto-injector — retail max 2 per 28 days; home delivery max 6 per 84 days
150 mg vial	Xolair 150 mg vial — retail max 6 vials per 28 days; home delivery max 18 vials per 84 days

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Approval duration and point-of-service rule

All approvals are provided for 1 year unless otherwise noted. Drug Quantity Management rules apply at point of service; if the rule is not met for the requested medication at point of service, coverage will be determined by the criteria below and may be denied.

Approvals default to a 1-year duration.
Drug Quantity Management rules enforced at point of service; exceptions require prior review.

Denial Risk

Quantity limit exceedance

Requests that exceed the policy's established quantity limits (retail or home delivery) may be denied unless prior authorization is obtained or an approved override applies. Examples from the policy history include limits of 2 auto-injectors per 28 days at retail and 6 auto-injectors per 84 days at home delivery for certain Xolair presentations.

Quantity limit exceedance at point of sale requires prior authorization or will follow plan determination.

Background

Xolair (omalizumab) is an anti‑IgE monoclonal antibody indicated for asthma, chronic idiopathic urticaria (CIU), chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE‑mediated food allergy in specified age groups. Dosing and administration vary by indication: for asthma dosing is typically 75–375 mg administered subcutaneously every 2 or 4 weeks based on body weight and baseline total IgE; for CIU the recommended dose is 150 mg or 300 mg every 4 weeks independent of IgE/weight; and for CRSwNP and food allergy dosing ranges from 75–600 mg given every 2 or 4 weeks depending on indication and IgE/weight. This policy’s Drug Quantity Management program is designed to manage potential dose escalation of Xolair and to set retail and home‑delivery maximum quantities unless an approved override from the appendices applies.

Indications, Dosing, and Appendix Definitions

Xolair indications and typical dosing by indication and age

Asthma indicationPatients ≥6 years with moderate-to-severe persistent asthma; dosing 75–375 mg SC Q2W or Q4W based on baseline serum total IgE and body weight.

Chronic idiopathic urticaria (CIU)Patients ≥12 years; dosing 150 mg or 300 mg SC Q4W independent of serum IgE or body weight.

Chronic rhinosinusitis with nasal polyps (CRSwNP)Patients ≥18 years as add‑on maintenance therapy; dosing 75–600 mg SC Q2W or Q4W based on baseline serum total IgE and body weight.

IgE‑mediated food allergyPatients ≥1 year for reduction of allergic reactions including anaphylaxis with accidental exposure; dosing 75–600 mg SC Q2W or Q4W based on baseline serum total IgE and body weight.

Override quantity tables (Appendix A–C) — approved quantities per 28‑day retail and 84‑day home delivery

Policy Summary

PayerCigna

PolicyImmunologicals - Xolair Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeQuantity limits and override criteria added/updated

Effective DateN/A

Next Review DateN/A

Key ActionWhen requesting an override quantity, provide patient weight and baseline IgE–derived dose determination and obtain prior authorization per the applicable Appendix.

SourceLink

On This Page

Examples from appendices: many weight ranges and dosing combinations are explicitly labeled 'NO OVERRIDES' (e.g., food allergy dosing categories and multiple weight brackets across Appendices A–C). Certain higher-dose regimens (e.g., 450 mg Q4W, 450 mg Q2W, 525 mg Q2W, 600 mg Q2W) have specific override quantities listed in the appendices where applicable.

chunk 20|chunk 21|chunk 33

Operational note: Some approved override quantities reflect use of multiple device strengths to achieve the appropriate total dose; members may have claims for more than one strength when clinically indicated.

chunk 15|chunk 17

Example limits: 2 auto-injectors per 28 days (retail); 6 auto-injectors per 84 days (home delivery) for Xolair (per policy history).

Note

Decision-making context

Coverage determinations must consider the terms of the applicable benefit plan document in effect on the date of service, any applicable laws/regulations, relevant collateral materials (including coverage policies), and the specific facts of the individual case. Medical Directors retain clinical judgment and discretion when making determinations.

Consider: (1) applicable benefit plan terms; (2) applicable laws/regulations; (3) relevant collateral materials; (4) specific facts of the situation.
Delegated vendor guidelines may be used in certain markets to support decisions.

Documentation Required

Weight and dosing documentation for overrides

When requesting an override quantity (per Appendix A), the provider must supply the patient's weight and the baseline IgE-derived dose determination used to justify the higher quantity. The Appendix A weight/dose tables define which higher quantities are approvable for specific weight and baseline IgE combinations.

Provider must document patient weight and baseline IgE-derived dose determination for override requests.
Overrides are granted only when the weight and IgE-based dosing in Appendix A support the higher quantity (e.g., 450 mg Q4W or 525/450 mg Q2W dosing scenarios).

Step Therapy

Step/override constraints

Some new quantity limits do not allow clinical overrides except where specific override criteria are listed in the appendix tables. Providers should confirm whether the patient's clinical situation meets the explicit override criteria before requesting an exception.

No clinical overrides apply to certain newly set limits unless the patient meets the specific override criteria in Appendix A.
Override approval is limited to the quantities and conditions enumerated in Appendix A (e.g., higher auto-injector or syringe counts tied to weight and baseline IgE dosing requirements).

Appendix A (150 mg auto‑injectors/prefilled syringes)

Contains weight‑banded override determinations for IgE‑mediated food allergy or CRSwNP; many weight/dose bands are listed as 'NO OVERRIDES' — providers must use the table to determine eligibility for higher quantities.

Appendix B (150 mg vials)Provides weight‑based override guidance for food allergy or CRSwNP; several weight bands specify 'NO OVERRIDES' (e.g., 10–30 kg food allergy dosing only).

Appendix C (300 mg auto‑injectors/prefilled syringes)Defines override quantities by weight for food allergy or CRSwNP and similarly lists multiple weight/dose combinations as 'NO OVERRIDES'.