ModifiedCignaPolicy N/A

Immunologicals - Xolair Drug Quantity Management Policy - Per Days

Defines Cigna's drug quantity limits and exception criteria for Xolair (omalizumab) formulations and supply intervals for health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyImmunologicals - Xolair Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeQuantity limits addedoverride criteria revised

Effective DateN/A

Next Review DateN/A

Key ActionApprove quantities listed in the applicable appendix table for IgE-mediated food allergy or CRSwNP when criteria are met; standard approvals are valid for 1 year.

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, 150 mg, and 300 mg strengths.

Override criteria updated to allow approval of higher quantities listed in appendix tables for patients requesting Xolair for IgE-mediated food allergy or CRSwNP.

Previously available override for 600 mg Q2W dosing for some 150 mg prefilled syringe patients was removed.

2Retail max per 28 days

6Home delivery max per 84 days

6150 mg vial retail max

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300 mg override (Appendix C)

1 yrStandard approval duration

Coverage Criteria and Exceptions

Drug Quantity Limit Exceptions and Approval Criteria

Exceptions to the listed quantity limits are covered as medically necessary when the listed criteria are met; any other exception is not medically necessary.

General rule: Quantity limits apply by strength and formulation as specified; approvals for exceptions are provided when indication-specific criteria are met.

Approvals are provided for 1 year; quantity limits enforced at point of service (see chunk 12)

Strength-specific exception criteria

150 mg auto-injectors/prefilled syringes: If the patient is requesting Xolair for immunoglobulin E-mediated food allergy or chronic rhinosinusitis with nasal polyps, approve the quantity listed in Appendix A per 28 days (retail) or per 84 days (home delivery).
Override quantities refer only to 150 mg auto-injectors/prefilled syringes; some doses require use of two different strengths (chunk 16)
150 mg vials: If the patient is requesting Xolair for immunoglobulin E-mediated food allergy or chronic rhinosinusitis with nasal polyps, approve the quantity listed in Appendix B per 28 days (retail) or per 84 days (home delivery).
Override quantities refer only to 150 mg vials (chunk 17)
300 mg auto-injectors/prefilled syringes: If the patient is requesting Xolair for immunoglobulin E-mediated food allergy or chronic rhinosinusitis with nasal polyps, approve the quantity listed in Appendix C per 28 days (retail) or per 84 days (home delivery).
Override quantities refer only to 300 mg auto-injectors/prefilled syringes; some doses require use of two different strengths (chunk 18)
75 mg auto-injectors/prefilled syringes: No overrides recommended.
Chunk 14 and chunk 15 indicate no overrides for 75 mg devices

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Quantity limits and approved overrides

Covered quantities and overrides by presentation and indication

Standard quantity limits for auto-injectors/prefilled syringes: Standard quantity limits for Xolair auto-injectors/prefilled syringes are 2 per 28 days (retail) and 6 per 84 days (home delivery) for multiple strengths.

See chunks 13 and 20-22 for specifics

Override approval for IgE-mediated food allergy or CRSwNP: If the patient is requesting Xolair for immunoglobulin E-mediated food allergy or chronic rhinosinusitis with nasal polyps, approve the quantity listed in the relevant 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).

Override quantities are weight- and dose-dependent; tables provide per-28-day and per-84-day quantities (see chunks 16–18 and Appendix tables)

Dose combination note: Certain doses require use of two different strengths of Xolair; patient may have claims for another strength to reach the appropriate dose.

See chunks 16 and 18

Quantity override application

Override quantities for Xolair are permitted only where the lookup table for the specific formulation, weight band, and total dose range lists an override; many combinations list 'NO OVERRIDES' or 'No Override'.

Table-based override rule: Determine formulation (150 mg vial or 300 mg auto-injector/prefilled syringe), identify patient total dose range and weight band in the applicable appendix table, and apply the specified override quantity if the table entry provides an override quantity.Refer to Appendix tables for weight band and total dose range entries

Entries explicitly state 'No Override', 'NO OVERRIDES', 'Insufficient Data to Recommend a Dose NO OVERRIDES', or provide exact quantities (e.g., '4 per 28 days or 12 per 84 days', '6 per 28 days or 18 per 84 days').

Exceptions to the listed quantity limits are covered as medically necessary only when the specific criteria in this policy (including the strength-specific appendix tables) are met. Any other exception is considered not medically necessary.

Many entries in the appendix lookup tables for weight bands and total dose ranges explicitly state "NO OVERRIDES" or "No Override", particularly for lower pediatric weight bands and some higher total-dose ranges; these table notes indicate that no quantity override is permitted for that weight/dose combination.

Where an appendix table entry reads "NO OVERRIDES" or the text indicates "Insufficient Data to Recommend a Dose NO OVERRIDES," override dispensing is excluded for the specified weight and total-dose range and no higher quantity will be authorized for that combination.

Exceptions to the quantity limits that do not meet the criteria listed in this policy (including the appendix tables and strength-specific rules) are not medically necessary; requests exceeding established limits without meeting these criteria will be denied.

Standard Quantity Limits and Appendix Overrides

inv-26: Xolair 75 mg prefilled syringe — standard quantity limit (retail/home delivery context elsewhere)

Standard retail limit (per 28 days)2 syringes

Standard home delivery limit (per 84 days)6 syringes

Approval contextExceptions require appendix-based override criteria for specific indications (see Appendix A/B/C)

inv-27: Xolair 75 mg auto-injector — standard quantity limit

Standard retail limit (per 28 days)2 auto-injectors

Standard home delivery limit (per 84 days)6 auto-injectors

Dosing, Weight Bands, and Dose Ranges

inv-08: Dosing ranges — 75–600 mg depending on indication, weight, and serum total IgE

Dosing range (all indications)75–600 mg depending on indication, body weight, and serum total IgE

Asthma dosing75 mg to 375 mg Q2W or Q4W based on IgE and weight

CRSwNP and food allergy dosing75 mg to 600 mg Q2W or Q4W based on IgE and weight

inv-09: Weight bands — list of example weight bands used in lookup tables

Example weight bands used in tables10-30 kg; >30-40 kg; >40-50 kg; >50-60 kg; >60-70 kg; >70-80 kg; >80-90 kg; >90-125 kg; >125-150 kg

PurposeUsed to determine override eligibility and required dose strength/frequency in Appendix tables

Provider-facing Requirements and Denial Risks

Documentation Required

General documentation and billing

All approvals are provided for 1 year unless otherwise noted. Coverage determinations consider the applicable benefit plan terms, any relevant laws/regulations, and collateral materials. If the Drug Quantity Management (DQM) rule is not met at the point of service, coverage will be determined by the policy criteria and benefit terms.

Approvals: 1 year by default; exceptions only when criteria met.
Coverage decisions require review of plan terms, laws/regulations, and collateral materials.

Billing Rule

Quantity limits and override rule

Standard quantity limits apply by strength/form and dispensing channel. Retail: maximum 2 units per 28 days. Home delivery: maximum 6 units per 84 days. These limits were added for 75 mg, 150 mg, and 300 mg auto-injectors and prefilled syringes.

Definitions and Appendix Notes

inv-22: Indications — approved indications and age restrictions for Xolair

Approved indicationsAsthma (≥6 years), Chronic spontaneous urticaria (≥12 years), CRSwNP (≥18 years), IgE-mediated food allergy (≥1 year)

Limitations of useNot indicated for relief of acute bronchospasm, status asthmaticus, or emergency treatment of allergic reactions including anaphylaxis

Override-specific indicationsIgE-mediated food allergy and CRSwNP are indications referenced for appendix-based override approvals

inv-23: Dosing frequency and dependence — Q2W or Q4W dosing, indication-specific statements

Dosing frequenciesDoses may be given every 2 weeks (Q2W) or every 4 weeks (Q4W) depending on indication, weight, and IgE

CSU dosing

Background

Xolair (omalizumab) is an anti-IgE monoclonal antibody indicated for conditions including asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy. Dosing varies by indication and is determined by body weight and, for some indications, baseline serum total IgE; the policy uses weight- and total-dose-range lookup tables to determine allowable override quantities when appropriate. If the table for a given formulation, weight band, and total dose range permits an override, the specified appendix quantity may be authorized; otherwise no override is allowed.

Policy Summary

PayerCigna

PolicyImmunologicals - Xolair Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeQuantity limits addedoverride criteria revised

Effective DateN/A

Next Review DateN/A

Key ActionApprove quantities listed in the applicable appendix table for IgE-mediated food allergy or CRSwNP when criteria are met; standard approvals are valid for 1 year.

SourceLink

On This Page

Clinical override note

No clinical overrides recommended for 75 mg strength

inv-28: Xolair 150 mg prefilled syringe — standard quantity limit

Standard retail limit (per 28 days)2 syringes

Standard home delivery limit (per 84 days)6 syringes

Override availabilityOverrides may be approved per Appendix A when used for IgE-mediated food allergy or CRSwNP

inv-29: Xolair 150 mg auto-injector — standard quantity limit

Standard retail limit (per 28 days)2 auto-injectors

Standard home delivery limit (per 84 days)6 auto-injectors

Override availabilityNew override criteria added to approve appendix-listed quantities for IgE-mediated food allergy or CRSwNP (see Appendix A)

inv-30: Xolair 300 mg prefilled syringe — standard quantity limit

Standard retail limit (per 28 days)2 syringes

Standard home delivery limit (per 84 days)6 syringes

Override availabilityAppendix C provides override quantities for 300 mg devices for food allergy or CRSwNP

inv-31: Xolair 150 mg vial — standard quantity limit (retail/home delivery differentiated in source)

Standard retail limit (per 28 days)6 vials

Standard home delivery limit (per 84 days)18 vials

Override availability150 mg vial overrides are listed in Appendix B for food allergy or CRSwNP

inv-32: Xolair auto-injectors/prefilled syringes (all strengths) — new retail standard quantity limit (2 per 28 days)

New retail standard limit (per 28 days)2 auto-injectors/prefilled syringes (all strengths)

Applies to strengths75 mg, 150 mg, 300 mg auto-injectors/prefilled syringes

ExceptionsHigher quantities may be approved per appendix tables for specified indications (food allergy/CRSwNP)

inv-33: Xolair auto-injectors/prefilled syringes (all strengths) — new home delivery standard quantity limit (6 per 84 days)

New home delivery standard limit (per 84 days)6 auto-injectors/prefilled syringes (all strengths)

Applies to strengths75 mg, 150 mg, 300 mg auto-injectors/prefilled syringes

ExceptionsAppendix-based overrides may permit higher home-delivery quantities for food allergy/CRSwNP

inv-34: Xolair 300 mg override quantity (food allergy/CRSwNP) — per-28-day override value

Override (per 28 days) for some 300 mg requests4 auto-injectors/prefilled syringes per 28 days

IndicationApplies when patient is requesting Xolair for IgE-mediated food allergy or CRSwNP and table entry lists this quantity

ReferenceSee Appendix C Table 1 for weight band and total dose range specifics

inv-35: Xolair 300 mg override quantity (food allergy/CRSwNP) — per-84-day override value

Override (per 84 days) for some 300 mg requests12 auto-injectors/prefilled syringes per 84 days

IndicationApplies when patient is requesting Xolair for IgE-mediated food allergy or CRSwNP and table entry lists this quantity

ReferenceSee Appendix C Table 1 for weight band and total dose range specifics

inv-36: Xolair (omalizumab) — overarching note that override quantities are in Appendix C Table 1 by formulation, weight band, and total dose range

Appendix lookup ruleOverride quantities are specified in Appendix C Table 1 by formulation, weight band, and total dose range

Table contentsTable entries include exact quantities (e.g., '4 per 28 days or 12 per 84 days', '8 per 28 days or 24 per 84 days') or 'No Override/NO OVERRIDES'

inv-10: Total dose ranges — example total-dose-range buckets referenced in tables

Total-dose-range bucketsExamples include 30-100; >100-200; >200-300; >300-400; >400-500; >500-600; >600-700; >700-800; >800-900; >900-1000; >1000-1100; >1100-1200; >1200-1300; >1300-1500; >1500-1850

Table specificityTables list entries per total dose range and weight band with either 'No Override' or exact override quantities

Retail maximum: 2 per 28 days.
Home delivery maximum: 6 per 84 days.

Denial Risk

Quantity limit denial risk / Override not permitted

Overrides to the standard quantity limits are only allowed when the request meets the specific override criteria in the applicable appendix table (by formulation/strength). Entries labeled "NO OVERRIDES" in the appendix tables indicate that higher quantities are not permitted. Requests exceeding standard quantity limits without meeting appendix override criteria may be denied.

Only approve higher quantities when the applicable appendix table explicitly authorizes an override.
Entries labeled "NO OVERRIDES" exclude higher-quantity approvals.
Requests above the DQM limits that do not meet override criteria risk denial.

Documentation Required

Override documentation and use table-based weight and dose ranges

When an override is requested for IgE‑mediated food allergy or CRSwNP, approve the quantities listed in the applicable appendix table for the specific strength/formulation (see Appendix A/B/C as applicable). The appendix tables specify allowable override quantities by weight band and total dose range; use those table values to determine the authorized quantity.

For 300 mg auto-injectors/prefilled syringes: follow Appendix C table when indication is food allergy or CRSwNP.
For 150 mg vials/supplies: follow Appendix B (or Appendix A historically) as specified.
Appendix tables map weight bands and total dose ranges to approved override quantities.

Note

Quantity override determination — use table-based weight and dose ranges

Overrides are determined by lookup of the appendix tables by formulation, patient weight band, and total dose range. Operationally, reference the table row matching the patient’s weight and dose to find the allowable override quantity. Some dose/weight combinations are explicitly marked "NO OVERRIDES" or "Insufficient Data to Recommend a Dose" and must not be authorized.

Determine override eligibility by matching formulation, weight band, and total dose range in the appendix table.
Do not authorize combinations marked "NO OVERRIDES" or "Insufficient Data to Recommend a Dose".

Prior Authorization

75 mg strength override policy

No overrides are recommended for Xolair 75 mg auto-injectors or 75 mg prefilled syringes; standard quantity limits apply and higher quantities should not be approved.

75 mg auto-injectors/prefilled syringes: NO OVERRIDES recommended.

150 mg or 300 mg Q4W not dependent on IgE or weight

Dose determinationFor asthma, CRSwNP, and food allergy, dose is based on body weight and baseline serum total IgE

inv-24: Override quantities — pre-approved higher quantities listed in appendix tables for certain indications

Appendix-based overridesPre-approved higher quantities are listed in Appendix A (150 mg auto-injectors/prefilled syringes), Appendix B (150 mg vials), and Appendix C (300 mg devices) for food allergy or CRSwNP

Application ruleApprove the quantity listed in the applicable appendix per 28 days (retail) or per 84 days (home delivery) when indicated

Table specificityOverride quantities refer to the specified formulation and are weight- and total-dose-range dependent

inv-25: NO OVERRIDES — definition of 'NO OVERRIDES' entry in tables

Meaning of 'NO OVERRIDES'Indicates that for the specified weight and total dose range, no quantity override is permitted

Policy effectRequests exceeding standard limits that do not have an appendix-listed override entry will be denied as not medically necessary

Where it appears'NO OVERRIDES' appears frequently in Appendix tables for pediatric and some high-weight/total-dose combinations