CurrentUnitedHealthcarePolicy CSOH2026D0150.E

Immunomodulatory Agents for Systemic Inflammatory Diseases (for Ohio Only)

Defines UnitedHealthcare Community Plan medical-benefit coverage guidance for provider-administered immunomodulatory agents for systemic inflammatory diseases for Ohio Medicaid members; self-administered subcutaneous products are covered under the pharmacy benefit.

Policy Summary

PayerUnitedHealthcare

PolicyImmunomodulatory Agents for Systemic Inflammatory Diseases (for Ohio Only)

Policy CodePolicy CSOH2026D0150.E

Change TypeRevised drug list

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization per the Ohio Department of Medicaid Unified Preferred Drug List for provider-administered immunomodulatory agents.

SourceLink

POLICY UPDATE CHANGES

Revised list of applicable immunomodulatory agents for systemic inflammatory diseases; added Avtozma (tocilizumab-anoh), Starjemza (ustekinumab-hmny), Tofidence (tocilizumab-bavi), and Tyenne (tocilizumab-aazg).

20+listed immunomodulatory agents

Ohio-onlystate-specific application

Medical benefitprovider-administered agents

Pharmacy benefitself-administered subcutaneous agents

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Medical benefit coverage conditions

Covered when ALL of the following are met and per Ohio Department of Medicaid Unified Preferred Drug List Criteria:

Medicaid and policy scope: Member is covered under Ohio Medicaid and the request is for a provider-administered immunomodulatory agent listed in this policy; self-administered subcutaneous agents are excluded from the medical benefit and are obtained under the pharmacy benefit.

based on Coverage Rationale

Medical necessity determination: Medical necessity for the specific agent and indication is established according to Ohio Administrative Code 5160-1-01 and the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

requests for unproven services or those not meeting criteria may be denied

Self-administered subcutaneous immunomodulatory agents are excluded from this medical benefit policy and are obtained under the pharmacy benefit. This policy applies only to provider-administered immunomodulatory agents for systemic inflammatory diseases; self‑administered subcutaneous products should be billed and managed through the pharmacy benefit.

Requests for services described as unproven or services that do not meet Ohio Administrative Code 5160-1-01 medical necessity criteria will be evaluated and may be denied. Providers should expect medical necessity determinations to follow the state code and supporting documentation requirements.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required per Ohio Medicaid criteria for provider-administered immunomodulatory agents covered under this medical benefit policy. Providers must obtain authorization before administration to avoid claim denials or delays.

Applies to provider-administered biologics/immunomodulatory agents listed in the policy coverage rationale.
Self-administered products are covered under the pharmacy benefit and are not subject to this medical-benefit prior authorization.

Step Therapy

Step Therapy / Fail-First

Refer to the Ohio Department of Medicaid Unified Preferred Drug List Criteria for any step therapy (fail-first) requirements that apply to agents covered under this policy. Providers should confirm step-therapy prerequisites and document prior failures when required.

Step-therapy requirements in state criteria supersede internal plan guidance where applicable.
Document previous therapies, dates, and clinical response when submitting authorization requests.

Documentation Required

Documentation and Governing Rules

Documentation submitted with authorization requests must comply with federal, state (Ohio Administrative Code), and contractual requirements and should support both administrative and medical necessity decisions. Include clinical records, prior therapy history, relevant diagnostic results, and any Ohio-specific forms or attestations.

Include indication, prior treatments (drug names, doses, dates), response or intolerance to prior therapies, and relevant labs or imaging.
Ensure documentation aligns with Ohio Medicaid medical necessity standards; incomplete documentation may result in delays or denials.

Note

Ohio Medical Necessity Evaluation

Requests for services described as unproven or subject to coverage/quantity limits will be evaluated for medical necessity using Ohio Administrative Code standards. Providers should anticipate medical necessity review when submitting requests that fall outside standard coverage parameters.

Medical necessity determinations will follow Ohio Administrative Code and applicable contract terms.
Anticipate requests for additional clinical information if a service is experimental, unproven, or exceeds quantity limits.

Definitions

inv-09: Definition — Provider-administered immunomodulatory agents

DefinitionProvider-administered immunomodulatory agents: products administered by a healthcare provider and billed through the medical (provider-administered) benefit.

Coverage scopeThis policy applies only to immunomodulatory agents intended for provider administration (medical benefit).

Related requirementsMedical necessity for provider-administered agents is determined using Ohio Department of Medicaid Unified Preferred Drug List Criteria and Ohio Administrative Code 5160-1-01 as applicable.

Site of careProvider administration settings (e.g., infusion center) are governed by this medical benefit policy.

Exclusions noteSelf-administered subcutaneous immunomodulatory agents are not included in this medical-benefit definition and are obtained under the pharmacy benefit.

inv-10: Definition — Self-administered subcutaneous immunomodulatory agents

DefinitionSelf-administered subcutaneous immunomodulatory agents: products intended for patient self-administration by subcutaneous injection and obtained under the pharmacy benefit.

Benefit assignmentThese self-administered subcutaneous products are covered under the pharmacy benefit rather than this medical-benefit policy.

Policy distinctionThis medical-benefit policy explicitly addresses provider-administered agents and excludes self-administered subcutaneous agents.

Reference for coverage criteriaClinical coverage and medical necessity for immunomodulatory agents are determined by the Ohio Department of Medicaid Unified Preferred Drug List Criteria; see that list for pharmacy-managed agents as applicable.

OpenPayer

Immunomodulatory Agents for Systemic Inflammatory Diseases (for Ohio Only)

Coverage Criteria

Provider Actions and Requirements

Background

Definitions

Step Therapy / Fail-First Requirements

Site of Care