CurrentUnitedHealthcarePolicy CSOH2O2500033.B

Xolair (omalizumab) — Medical Benefit Drug Policy (Ohio)

Defines UnitedHealthcare's Medical Benefit Drug Policy for Xolair (omalizumab) administered by a healthcare professional in Ohio; self‑administered Xolair is covered under the pharmacy benefit. Affects providers and prior authorization reviewers for Ohio members.

Policy Summary

PayerUnitedHealthcare

PolicyXolair (omalizumab) — Medical Benefit Drug Policy (Ohio)

Policy CodePolicy CSOH2O2500033.B

Change TypeReferences moved to Ohio Medicaid PDLInterQual removed

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization per UnitedHealthcare medical benefit processes and document that Xolair will be administered by a healthcare professional, using Ohio Medicaid Unified PDL clinical criteria.

SourceLink

POLICY UPDATE CHANGES

Added language that Xolair is considered medically necessary in certain circumstances and directs users to the Ohio Department of Medicaid Unified Preferred Drug List Criteria for medical necessity clinical coverage criteria.

Removed language indicating Xolair was proven and medically necessary per InterQual criteria and instead references external criteria sources.

Updated reference link to the Ohio Department of Medicaid Unified Preferred Drug List Criteria (no change to policy guidelines).

Ohio-onlyapplicability

Medicalsite/benefit

Pharmacyalternative benefit

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Medical Benefit Coverage Criteria for Xolair (omalizumab)

Medical Benefit Coverage Criteria (policy-level)

Covered when ALL of the following are met:

Medical benefit administration: Xolair is administered subcutaneously by a healthcare professional (medical benefit).

See chunk 2

Clinical criteria source: Medical necessity and clinical coverage criteria for non-oncology indications must meet the Ohio Department of Medicaid Unified Preferred Drug List Criteria referenced by this policy.

See chunks 2 and 3

State applicability: Policy applies only to members in Ohio; requests for services stated as unproven or with coverage/quantity limits will be evaluated under Ohio Administrative Code 5160-1-01.

See chunk 3

This policy distinguishes benefit routing by administration method: self-administered Xolair (omalizumab) is not covered under the medical benefit and instead is obtained under the pharmacy benefit. Providers should bill Xolair as a pharmacy-dispensed product when the member or caregiver will self-administer the subcutaneous injection.

The policy removed prior text that referenced InterQual as the internal clinical criteria source. Current language does not list specific non-medical-necessity (NMN) conditions within this document and instead directs reviewers to the external clinical criteria referenced by the policy. For medical necessity determinations for non-oncology indications, consult the external criteria identified in the policy.

Initial Therapy Requirements

Initial therapy

Initial therapy requirements are determined by the external Ohio Medicaid PDL criteria.

Refer to external criteria: Initial authorization requires meeting the Ohio Department of Medicaid Unified Preferred Drug List Criteria as referenced by this policy.

See chunks 2 and 3

Step Therapy and Prior Authorization Controls

Step	Requirement
1	Any step therapy requirements are those specified in the Ohio Department of Medicaid Unified Preferred Drug List Criteria referenced by this policy.

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required per UnitedHealthcare medical benefit processes for Xolair (omalizumab) when administered by a healthcare professional.

Applicable to medical benefit claims for Xolair administered by a healthcare professional
Self-administered Xolair is obtained under the pharmacy benefit and is not covered under this medical benefit policy

Step Therapy

Step Therapy Governed Externally

Step therapy requirements and specific clinical criteria for medical necessity are governed by the Ohio Department of Medicaid Unified Preferred Drug List (PDL) Criteria. Providers must follow the Ohio Medicaid PDL for non-oncology indications.

Refer to the Ohio Department of Medicaid Unified Preferred Drug List Criteria for step therapy and clinical requirement details
This policy defers to the Ohio Medicaid PDL for the applicable coverage criteria

Coding References

Coding referencesmixed

no explicit codes listed

Document does not list CPT, HCPCS, ICD-10, or NDC codes; refers to benefit distinctions (medical vs pharmacy).

Site of Care and Benefit Assignment

Note

Office administration required for medical‑benefit dosing

When billed to the medical benefit, Xolair must be administered by a healthcare professional (provider‑administered subcutaneous injection).

Benefit Definitions

Medical benefit definition

DefinitionMedical benefit = administration of Xolair (omalizumab) as a provider‑administered subcutaneous injection by a healthcare professional.

Benefit pathwayClaims for provider‑administered subcutaneous Xolair are processed under the medical benefit.

Site of care requirementWhen billed to the medical benefit, Xolair must be administered by a healthcare professional (e.g., in office or clinic).

Pharmacy benefit definition

DefinitionPharmacy benefit = self‑administered subcutaneous injection formulation of Xolair (omalizumab).

Benefit pathwaySelf‑administered Xolair is obtained and billed under the pharmacy benefit, not the medical benefit.

Background

This policy addresses use of omalizumab (Xolair) administered subcutaneously by a healthcare professional when billed to the medical benefit. Self-administered formulations are handled under the pharmacy benefit. Clinical coverage criteria for non-oncology indications are not contained in this document; instead, the policy references the Ohio Department of Medicaid Unified Preferred Drug List Criteria for medical necessity determinations. The policy history notes an update replacing the prior InterQual reference with the Ohio Medicaid PDL reference and an administrative link update.