CurrentUnitedHealthcarePolicy N/A

Prior authorization for Xolair (omalizumab) — NC

This form governs prior authorization requests for Xolair (omalizumab) for beneficiaries in North Carolina, covering new and continuation therapy for allergic asthma and chronic idiopathic urticaria and specifying required clinical and administrative documentation.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization for Xolair (omalizumab) — NC

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete and submit the prior authorization form with prescriber signature and required clinical documentation to request Xolair for beneficiaries in NC.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications

>=12min age CIU

20–150 kgweight req

>30 IU/mLIgE threshold

prescriber sigadmin req

Coverage Criteria for Xolair (omalizumab)

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Allergic Asthma: New Therapy

Covered when ALL of the following are met

Allergic asthma initiation: Patient has a diagnosis of asthma; patient weight between 20 kg and 150 kg; evidence of inhaled corticosteroid use in the past 45 days PLUS one of: excessive short-acting beta-agonist use in the past 60 days, short-term oral steroid use in the past 45 days, or an emergency department visit in the past 45 days; positive percutaneous skin test or RAST within 12 months to at least one perennial aeroallergen; IgE level above 30 IU/mL when requested.see nodes

Form captures these specific items; length of therapy options include up to 30, 60, 90, 120, or 365 days (see prescriber form).

Allergic Asthma: Continuation of Therapy

Covered when ALL of the following are met

Allergic asthma continuation: While on Xolair, patient has demonstrated continued clinical benefit and reductions in asthma exacerbations from baseline; provide current asthma status and response to Xolair; submit supporting medical records if requested.clinical benefit documented

Prescriber must attest to benefit and provide clinical details; smoking status may be requested.

Chronic Idiopathic Urticaria: New Therapy

Covered when ALL of the following are met

CIU initiation: Patient is 12 years of age or older; diagnosis of moderate to severe chronic idiopathic urticaria; remains symptomatic despite treatment with at least two H1 antihistamines AND one leukotriene modifier; Xolair is prescribed by or in consultation with an allergy specialist.age >= 12; prior therapies failed

Form requests prescriber specialty/consultation.

Chronic Idiopathic Urticaria: Continuation of Therapy

Covered when ALL of the following are met

CIU continuation: Beneficiary is receiving continued clinical benefit from baseline supported by medical records; prescriber signs the form and may need to attach medical records to confirm benefit.documented clinical benefit

Prescriber signature is mandatory on the prior authorization form; attach records when asked.

If the beneficiary does not meet the form-captured clinical requirements, the request is implicitly excluded from coverage. Examples of such missing requirements include: patient weight outside 20 kg to 150 kg, patient age below the form-specified minimum for the indication (for CIU, age < 12 years), absence of requested laboratory results such as an IgE level when asked, or lack of documented allergy testing (percutaneous skin test or RAST within the prior 12 months).

For both allergic asthma and chronic idiopathic urticaria, failure to document prior-treatment requirements described on the form (for example, prior inhaled corticosteroid use and the asthma exacerbation/rescue-medication criteria for allergic asthma, or failure of at least two H1 antihistamines plus a leukotriene modifier for CIU) will result in the request being considered outside the scope of the coverage criteria.

Use of Xolair (omalizumab) will be considered not medically necessary when the patient does not meet the form-specified clinical criteria. Examples include lack of required prior therapies (such as the inhaled corticosteroid and exacerbation/rescue use criteria for allergic asthma or the two H1 antihistamines plus leukotriene modifier requirement for CIU), missing age or weight thresholds, or absent laboratory/allergy test results requested on the form (for example, an IgE level when prompted or a percutaneous/RAST showing perennial aeroallergen sensitization).

Continuation requests without documentation of ongoing clinical benefit as captured on the continuation section of the form (attestation and supporting medical records when requested) will also be considered not medically necessary if benefit is not demonstrated.

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior authorization submission

Prior authorization required. Complete and submit the prior authorization request form with the prescriber's signature. For North Carolina (NC) beneficiaries, a prescriber signature is mandatory on the NC Pharmacy Prior Approval Request for Monoclonal Antibodies: Xolair.

Submit beneficiary demographics (name, beneficiary ID, DOB, gender).
Include prescribing provider NPI, requester contact name and phone.
Specify drug name, strength, quantity per 30 days, and requested length of therapy.
Attach signed prescriber attestation and signature (mandatory for NC).

Documentation Required

Required documentation

Provide complete documentation to support the request. Missing or incomplete documentation may result in denial.

Beneficiary demographics (last name, first name, beneficiary ID, DOB, gender).
Prescriber NPI and contact information (name and phone).
Drug name, strength, quantity, and requested length of therapy.
Signed prescriber attestation and date.
For continuation requests: attach medical records demonstrating continued clinical benefit from baseline.

Denial Risk

Triggers for denial

Requests will be denied if clinical criteria or required fields are not met. Review clinical thresholds and prior-therapy evidence before submission.

Clinical fields out of accepted ranges (e.g., beneficiary weight outside 20–150 kg when required).
IgE not >30 IU/mL when an elevated IgE is requested for allergic asthma criteria.
Lack of documented prior therapies per indication (see CIU and allergic asthma requirements).
Patient does not meet age or diagnosis requirements (e.g., CIU: <12 years or not moderate-to-severe).

Denial Risk

Administrative denial triggers

Administrative denials may occur for missing signatures or requested records. Ensure all administrative items are present at time of submission.

Missing prescriber signature (mandatory; NC requests have prescriber signature requirement).
Failure to provide requested medical records for continuation of therapy.
Incomplete requester contact information or missing prescriber NPI.

Step Therapy

Required prior therapies for CIU

For chronic idiopathic urticaria (CIU), document prior therapeutic failure as required by policy.

Patient age ≥12 years.
Diagnosis of moderate to severe chronic idiopathic urticaria.
Documented failure to control symptoms despite at least two (2) H1 antihistamines AND one leukotriene modifier.
Xolair prescribed by or in consultation with an allergy specialist (document specialist or consult note).

Step Therapy

Required prior therapies/criteria for allergic asthma

For allergic asthma (new therapy), document required prior therapies and clinical criteria.

Patient weight between 20 kg (44 lbs) and 150 kg (330 lbs).
Diagnosis of asthma documented in the medical record.
Evidence of prior use of inhaled corticosteroids within the past 45 days PLUS one of the following within the specified lookback periods: excessive short-acting beta-agonist (SABA) use in the past 60 days; short-term oral steroid use in the past 45 days; or an emergency room visit for asthma in the past 45 days.
Documentation of percutaneous skin test or RAST within the past 12 months showing reactivity to at least one perennial aeroallergen, when applicable.
Serum IgE level documented and >30 IU/mL when IgE criterion is requested (include numeric level).

Definitions

inv-17: Allergic asthma — definition including perennial aeroallergen sensitization, weight limits (20–150 kg), prior inhaled corticosteroid use

DefinitionAsthma in a patient with evidence of perennial aeroallergen sensitization (positive percutaneous skin test or RAST within 12 months)

Weight limitsPatient must weigh between 20 kg and 150 kg

Prior controller therapyDocumented use of inhaled corticosteroids in the past 45 days

Markers of exacerbation/rescue usePlus one of: excessive short-acting beta-agonist use in past 60 days, short-term oral steroid use in past 45 days, or an ER visit in past 45 days

inv-18: Chronic idiopathic urticaria (CIU) — persistent urticaria in patients age >= 12 years who remain symptomatic despite at least two H1 antihistamines and one leukotriene agent

DefinitionPersistent moderate to severe chronic idiopathic urticaria in patients aged 12 years or older

Age requirementPatient age must be 12 years or older

Prior therapy failureRemains symptomatic despite treatment with at least two H1 antihistamines AND one leukotriene modifier

Prescriber specialtyXolair prescribed by or in consultation with an allergy specialist (as requested on the form)

OpenPayer

Prior authorization for Xolair (omalizumab) — NC

Coverage Criteria for Xolair (omalizumab)

Key Dosing and Measurement Parameters

Provider Requirements, Documentation, and Denial Triggers

Background

Definitions