CurrentCommunity-CarePolicy N/A

Xolair

Defines initial and continuation coverage criteria, quantity limits, dosing tables, authorization periods, and applicable HCPCS code for omalizumab (Xolair) for severe asthma, chronic spontaneous urticaria, and IgE-mediated food allergy.

Policy Summary

PayerCommunity-Care

PolicyXolair

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProviders must document baseline IgE level (>30 IU/mL where specified), diagnosis confirmation, prior treatment trials, prescriber specialty or consultation, prescriber attestation of adherence and non-concurrent targeted immunomodulator use, and patient weight for dosing.

SourceLink

POLICY UPDATE CHANGES

No material changes

3Covered Indications

6m / 1yAuth periods (initial/cont)

Dose-specificQuantity limits

Coverage Summary

This policy covers with criteria omalizumab (Xolair) for the treatment of severe asthma, chronic spontaneous urticaria, and IgE-mediated food allergy, defining initial and continuation approval requirements, dosing/quantity limits, and applicable HCPCS coding.

Key thresholds and limits

Baseline IgE requirement> 30 IU/mL

Asthma exacerbations requirement≥ 2 exacerbations in past year (systemic steroids, ED visit, or hospitalization)

Authorization periodsInitial: 6 months for asthma/CSU; Continuation: 1 year (IgE-mediated food allergy: 1 year)

Quantity limits per 28 days — 75 mg2 injections per 28 days (75 mg = 0.5 mL)

Quantity limits per 28 days — 150 mg2 injections per 28 days (150 mg = 1 mL)

Quantity limits per 28 days — 300 mg1 injection per 28 days (300 mg = 2 mL)

Initial Therapy Criteria

Initial Approval - Severe asthma

Covered when ALL of the following are met:

ALL of the following

Age ≥ 6 years
Prescribed by, or in consultation with an allergist, pulmonologist, or immunologist
Diagnosis of severe asthma
Confirmation of diagnosis via skin test or RAST for specific allergy sensitivity
IgE Levels (> 30 IU/mL) prior to treatment, with baseline level provided> 30 IU/mL
baseline IgE required
History of ≥ 2 asthma exacerbations requiring systemic corticosteroids or ED visit or hospitalization for asthma within the past year despite adherent use of either an inhaled corticosteroid (ICS) with 1 additional asthma controller medication or maximally tolerated ICS/LABA combination product≥ 2 in past year
Prescriber attestation
- Patient adherence to controller medications
- Will not be used in combination with another targeted immunomodulator product used for asthma

Initial Approval - Chronic spontaneous urticaria

Covered when ALL of the following are met:

Age ≥ 12 years

Prescribed by, or in consultation with, an allergist, dermatologist, or immunologist

Diagnosis of chronic spontaneous urticaria

Trial of high dose H1 antihistamines was ineffective, contraindicated, or not tolerated

Initial Approval - IgE-mediated food allergy

Covered when ALL of the following are met:

Prescribed by, or in consultation with an allergist or immunologist

Diagnosis of an IgE-mediated food allergy

Diagnosis supported by either

Positive skin prick test
Positive serum IgE test

One of the following

Diagnosis confirmed by a positive oral food challenge

Continuation Therapy Criteria

Continuation of Therapy - Severe asthma

Covered when ALL of the following are met:

Diagnosis of severe asthma at baseline

Positive clinical response has been achieved

Will not be used in combination with another targeted immunomodulator product used for asthma

Continuation of Therapy - Chronic spontaneous urticaria

Covered when ALL of the following are met:

Diagnosis of chronic spontaneous urticaria

Documentation of positive clinical response

Continuation of Therapy - IgE-mediated food allergy

Covered when ALL of the following are met:

Diagnosis of IgE-mediated food allergy

Prescribed by, or in consultation with, an allergist or immunologist

Will not be used in combination with peanut allergen powder (Palforzia)

Injectable epinephrine has been dispensed

Age-based continuation

Patient is age ≥ 18 years
If age 1-17 years, ONE of

Provider Actions

Prior Authorization

Prior authorization required per clinical criteria

Providers must submit documentation to meet clinical prior authorization criteria: baseline total IgE level (baseline IgE > 30 IU/mL where specified), confirmation of diagnosis by appropriate testing (skin test or RAST for asthma; skin prick or serum IgE for food allergy), history or trials of prior treatments (e.g., high‑dose H1 antihistamines for CSU; prior controller therapy and exacerbation/exacerbation history for asthma), documentation of prescriber specialty or documentation of consultation with an allergist/pulmonologist/dermatologist/immunologist as required, and prescriber attestation regarding adherence to controller therapies and that omalizumab will not be used concurrently with another targeted immunomodulator for asthma.

Affected code: J2357

Documentation Required

Weight required for approval and dosing

Patient body weight must be provided for dosing determination and is required for approval. Dosing tables in the policy reference both baseline IgE and body weight to select the correct omalizumab dose.

Dosing tables referenced in policy (see Appendix/Table sections for weight-and-IgE based dosing)

Billing Rule

Quantity limits per 28 days by dose

Quantity limits are specified by dose and 28‑day period: 75 mg and 150 mg dose levels are limited to 2 injections per 28 days; the 300 mg dose is limited to 1 injection per 28 days.

Injection volume equivalents: 75 mg = 0.5 mL; 150 mg = 1 mL; 300 mg = 2 mL
Affected code: J2357

Note

Authorization durations

Authorization durations in the policy: initial approvals for severe asthma and chronic spontaneous urticaria are allowed for 6 months; continuation approvals for those conditions are allowed for 1 year. Approvals for IgE‑mediated food allergy are allowed for 1 year.

Documentation Required

Epinephrine dispensing for food allergy

For IgE‑mediated food allergy indications, injectable epinephrine must have previously been dispensed or will be prescribed along with omalizumab as a condition of coverage.

Background

Omalizumab (Xolair) is an anti-IgE monoclonal antibody indicated in this policy for severe allergic asthma, chronic spontaneous urticaria, and certain IgE-mediated food allergy indications. Dosing and quantity limits are determined by baseline total serum IgE and patient body weight; the policy requires a baseline IgE level for initial dosing and documentation of patient weight for approval and dose selection.

RAST: Radioallergosorbent test (specific IgE serum testing).

CSU: Chronic spontaneous urticaria.

Policy Summary

PayerCommunity-Care

PolicyXolair

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Xolair

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Applicable Codes

Provider Actions

Background

Clinical Evidence

Revision History