CurrentUnitedHealthcarePolicy CSIND0033.06

Xolair (Omalizumab) (for Indiana Only)

Defines UnitedHealthcare Community Plan medical benefit coverage guidance for omalizumab (Xolair) for members in Indiana; references InterQual specialty drug criteria for clinical coverage determination.

Policy Summary

PayerUnitedHealthcare

PolicyXolair (Omalizumab) (for Indiana Only)

Policy CodePolicy CSIND0033.06

Change TypeRoutine reviewno content changes

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization using the current InterQual Specialty Rx Non-Oncology Omalizumab criteria to determine coverage.

SourceLink

POLICY UPDATE CHANGES

Routine review; no content changes.

J2357HCPCS code listed for omalizumab

IndianaApplies to state

InterQualClinical criteria source

Coverage Criteria for Omalizumab (Xolair)

Medical Necessity (InterQual referenced)

Covered when InterQual CP: Specialty Rx Non-Oncology Omalizumab (Xolair) medical necessity criteria are met.

Policy Summary

PayerUnitedHealthcare

PolicyXolair (Omalizumab) (for Indiana Only)

Policy CodePolicy CSIND0033.06

Change TypeRoutine reviewno content changes

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization using the current InterQual Specialty Rx Non-Oncology Omalizumab criteria to determine coverage.

SourceLink

On This Page

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization/coverage is determined using the current InterQual Specialty Rx Non-Oncology Omalizumab criteria. Refer to the InterQual guideline CP: Specialty Rx Non-Oncology, Omalizumab (Xolair) for the specific medical necessity criteria that must be met for coverage.

HCPCS J2357
InterQual criteria (current release) required for prior authorization

Step Therapy

Coverage Decisions Follow InterQual Criteria

Coverage determinations follow the InterQual criteria which may include step therapy elements and other clinical requirements. Providers should consult the InterQual guideline for any required prior therapies, dosing, or stepwise treatment requirements that apply to initial and continuation requests.

Step therapy elements may be specified within InterQual
Refer to InterQual for initial vs continuation therapy requirements

Denial Risk

InterQual-based Denial Risk

Coverage determinations are based on the InterQual guideline; requests that do not meet the InterQual criteria may be denied. Providers should ensure documentation demonstrates how the patient meets each applicable InterQual criterion to reduce the risk of denial.

Requests not meeting InterQual criteria may be denied
Document clinical justification aligned to InterQual to avoid denials

Documentation Required

Documentation and Applicability

When deciding coverage, reference federal, state, or contractual requirements for benefit plan coverage, as they may differ from UnitedHealthcare standard plan policy. This policy is informational; in the event of a conflict, the federal, state, or contractual requirements govern. UnitedHealthcare may use third-party tools such as InterQual to assist in administering benefits.

Check applicable federal, state, and contractual plan terms before submitting requests
Policy is informational and does not replace plan-specific benefit terms

Background

Omalizumab (Xolair) is an anti-IgE monoclonal antibody that is recognized as medically necessary for certain indications when the criteria in the InterQual ® guideline, CP: Specialty Rx Non-Oncology, Omalizumab (Xolair) are met. UnitedHealthcare uses the current InterQual criteria to determine medical necessity for coverage under this medical benefit drug policy. This policy is informational and does not replace review of the applicable federal, state, or contractual benefit terms that ultimately govern coverage decisions.

Definitions

InterQual ® guideline reference — CP: Specialty Rx Non-Oncology, Omalizumab (Xolair)

InterQual guideline referencedInterQual ® guideline, CP: Specialty Rx Non-Oncology, Omalizumab (Xolair)

Coverage determinationCovered when the current InterQual Omalizumab (Xolair) medical necessity criteria are met

Where to find criteriaRefer to the current release of the InterQual CP: Specialty Rx Non-Oncology, Omalizumab (Xolair) guideline for indication‑specific requirements

Clinical roleInterQual criteria define the clinical and prior‑treatment requirements used to determine medical necessity for Xolair

Denial implicationRequests that do not meet the InterQual Omalizumab criteria may be denied as not medically necessary

Step	Requirement
1	Refer to the current InterQual® guideline CP: Specialty Rx Non‑Oncology, Omalizumab (Xolair) for any step therapy requirements prior to approval.

Site-of-Care Guidance

Note

Site-of-care: Follow contractual and state requirements

Decisions about infusion center or site-of-care must comply with applicable contractual and state requirements; this policy offers informational guidance only and does not replace plan-specific or state-mandated site-of-care rules.

Confirm site-of-care authorization requirements in the member’s contract and state regulations before scheduling infusion.
This policy does not supersede contractual or state mandates regarding site of care.

OpenPayer

Xolair (Omalizumab) (for Indiana Only)

Coverage Criteria for Omalizumab (Xolair)

Applicable Codes

Provider Actions and Authorization Requirements

Background

Definitions

Initial Therapy Criteria

Step Therapy Requirements

Site-of-Care Guidance