CurrentUnitedHealthcarePolicy CSOH2026D0004.C

Infliximab (for Ohio Only)

This Medical Benefit Drug Policy governs coverage and medical necessity criteria for infliximab products for members of UnitedHealthcare Community Plan in the state of Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (for Ohio Only)

Policy CodePolicy CSOH2026D0004.C

Change TypeAdministrative (non-material)

Effective Date03/01/2026

Next Review DateN/A

Key ActionRefer to the Ohio Department of Medicaid Unified Preferred Drug List Criteria to determine medical necessity for Avsola, Inflectra, Remicade, or Renflexis when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Removed reference link to the Medical Benefit Drug Policy titled Maximum Dosage and Frequency (for Ohio Only).

Archived previous policy version CSOH2025D0004.B.

4Infliximab products named

OhioState-specific application

03/01/2026Effective date

Coverage and Medical Necessity Criteria (Ohio Medicaid)

Medical necessity (state-referenced)

Covered when ALL of the following are met per Ohio Medicaid criteria

State criteria: Use Ohio Department of Medicaid Unified Preferred Drug List Criteria to determine medical necessity for Avsola, Inflectra, Remicade, or Renflexis.

This policy defers to Ohio Medicaid clinical criteria; refer to that source for specific step/diagnosis requirements.

This policy applies only to the state of Ohio. Coverage determinations, prior authorization, and medical necessity reviews described in this document are limited to UnitedHealthcare Community Plan members in Ohio and do not apply to members in other states.

Any requests for services described as unproven or requests subject to a coverage or quantity limit will be evaluated for medical necessity under Ohio Administrative Code 5160-1-01. Services that do not meet the OAC 5160-1-01 medical necessity criteria may be considered not medically necessary and may be denied.

Coding and Procedure Codes

No CPT/HCPCS/ICD-10 codes listedmixed

No codes listed

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (for Ohio Only)

Policy CodePolicy CSOH2026D0004.C

Change TypeAdministrative (non-material)

Effective Date03/01/2026

Next Review DateN/A

Key ActionRefer to the Ohio Department of Medicaid Unified Preferred Drug List Criteria to determine medical necessity for Avsola, Inflectra, Remicade, or Renflexis when requesting authorization.

SourceLink

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Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Avsola, Inflectra, Remicade, and Renflexis may require prior authorization and are considered medically necessary only when Ohio Department of Medicaid Unified Preferred Drug List clinical criteria are met. Check state and federal guidance (Ohio Administrative Code 5160-1-01 and any applicable contractual requirements) when determining coverage; in case of conflict, federal, state (OAC), or contractual requirements govern.

Prior authorization may be required for medical benefit coverage.
Medical necessity determinations will follow Ohio Department of Medicaid Unified Preferred Drug List Criteria.
Requests for unproven services or services subject to coverage or quantity limits will be evaluated under OAC 5160-1-01.

Documentation Required

Provide complete clinical documentation demonstrating that the member meets the Ohio Department of Medicaid Unified Preferred Drug List clinical coverage criteria. Include diagnosis, prior therapies tried and response, dosing regimen, and documentation of any contraindications or intolerance to alternatives.

Include prior treatment history and objective response or intolerance to other therapies.
Document dosing, planned schedule, and justification for treatment duration.
Attach relevant medical records, labs, and prior authorization forms as required.

Denial Risk

Denial Triggers

Requests for services that are unproven or exceed coverage/quantity limits are denial triggers. UnitedHealthcare may use third‑party clinical tools (e.g., InterQual) to assist coverage decisions; ensure submitted documentation aligns with those tools when applicable.

Denial likely if clinical criteria from the Ohio Unified Preferred Drug List are not met.
Requests lacking required documentation (prior therapy, dosing, labs) may be denied.
Services deemed unproven or exceeding quantity limits will be evaluated per OAC 5160-1-01 and may be denied.

Note

Required Decision‑Making References

When deciding coverage, always reference the member's federal, state (Ohio Administrative Code), or contractual benefit terms before applying this policy. In the event of any conflict, the federal, state (OAC), or contractual requirements take precedence over this policy.

Confirm state (OAC) requirements apply — this policy applies to Ohio.
This policy is informational and does not supersede contractual or legal mandates.
UnitedHealthcare reserves the right to modify policies; verify current requirements at time of decision.

Background and Drug Overview

Infliximab is a tumor necrosis factor (TNF) inhibitor — a monoclonal antibody that targets TNF-alpha and is used to treat multiple inflammatory conditions. This policy references specific infliximab products (for example, branded and biosimilar infliximab products) and defers to the Ohio Department of Medicaid Unified Preferred Drug List Criteria and Ohio Administrative Code 5160-1-01 for clinical coverage and medical necessity determinations.

Drug Definitions and Products

Infliximab products referenced in this policy

AvsolaAvsola (infliximab-axxq)

InflectraInflectra (infliximab-dyyb)

RemicadeRemicade (infliximab)

RenflexisRenflexis (infliximab-abda)

Initial Therapy Medical Necessity Criteria

Initial Therapy

Initial therapy approvals are subject to Ohio Medicaid clinical coverage criteria.

Initial Therapy: Initial authorizations must satisfy Ohio Department of Medicaid Unified Preferred Drug List Criteria and Ohio Administrative Code 5160-1-01 medical necessity requirements.

No specific diagnosis- or dose-based initial criteria are detailed in this document; refer to the Ohio Department of Medicaid Unified Preferred Drug List for specific requirements.

Continuation Therapy Criteria

Continuation Therapy

Continuation therapy governed by the same state Medicaid criteria.

Continuation approvals must meet Ohio Department of Medicaid Unified Preferred Drug List Criteria.

Specific renewal or monitoring requirements are not included in this document; follow Ohio Medicaid criteria for renewal conditions.

Step Therapy and Preferred Drug List Guidance

Drug / Product	Step therapy requirement
Avsola (infliximab-axxq)	Coverage and any step therapy requirements are defined by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.
Inflectra (infliximab-dyyb)	Coverage and any step therapy requirements are defined by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.
Remicade (infliximab)	Coverage and any step therapy requirements are defined by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.
Renflexis (infliximab-abda)	Coverage and any step therapy requirements are defined by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

Site-of-Care Considerations

Note

Infusion site-of-care decisions

No site-of-care restrictions are specified in this document; site-of-care decisions should follow contractual and state requirements for administration of infusion therapies.

Follow contract and Ohio state rules when selecting infusion facility or setting.

Biosimilar Product Notes

Billing Rule

Remicade coverage determined by OH PDL

Remicade (infliximab) is listed among the infliximab products referenced by this policy; coverage and any preferred-product determinations are governed by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

Billing Rule

Remicade coverage determined by OH PDL

Remicade (infliximab) is a referenced infliximab product in this policy and coverage decisions should follow the Ohio Medicaid Unified Preferred Drug List Criteria.

Billing Rule

Remicade coverage determined by OH PDL

Remicade (infliximab) is included in the list of infliximab products; providers must use Ohio Medicaid preferred drug list criteria to determine coverage eligibility.

Policy Updates and Revision History

2026-03-01updateLatest

Removed reference link to the Medical Benefit Drug Policy titled 'Maximum Dosage and Frequency (for Ohio Only)' and archived previous policy version CSOH2025D0004.B.