CurrentUnitedHealthcarePolicy CSOH2025D0047.B

Factor Mimetics and Rebalancing Agents for Hemophilia (for Ohio Only)

Defines medical benefit drug policy for specific factor mimetics and rebalancing agents for hemophilia for UnitedHealthcare Ohio members; governs coverage assessment and directs use of Ohio Medicaid criteria for clinical coverage.

Policy Summary

PayerUnitedHealthcare

PolicyFactor Mimetics and Rebalancing Agents for Hemophilia (for Ohio Only)

Policy CodePolicy CSOH2025D0047.B

Change TypeRevised agent listadded Qfitlia (fitusiran)

Effective Date11/01/2025

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation demonstrating medical necessity per the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

SourceLink

POLICY UPDATE CHANGES

Revised list of applicable factor mimetics and rebalancing agents for hemophilia; added Qfitlia (fitusiran).

4named agents covered by policy

Ohio-onlyjurisdiction this policy applies to

11/01/2025effective date

Coverage Criteria and Scope

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Services identified as unproven, or services subject to a coverage or quantity limit, will be evaluated for medical necessity in accordance with Ohio Administrative Code 5160-1-01. Coverage determinations for the agents referenced in this policy are made by applying the Ohio Department of Medicaid Unified Preferred Drug List medical necessity criteria.

Regulatory References and Coding

Regulatory reference — Ohio Administrative Code 5160-1-01

Regulation citedOhio Administrative Code 5160-1-01

Scope of applicationMedical necessity determinations referenced in this policy will be evaluated using Ohio Administrative Code 5160-1-01

Policy geographic limitThis Medical Benefit Drug Policy applies only to the state of Ohio and uses OAC 5160-1-01 for medical necessity reviews

Prior Authorization, Documentation, and Decision Tools

Prior Authorization

Prior authorization and medical necessity

Coverage of the listed factor mimetics and rebalancing agents is subject to medical necessity criteria as defined by the Ohio Department of Medicaid Unified Preferred Drug List Criteria; prior authorization is implied when medical benefit drugs require a medical necessity determination under Ohio rules.

Step Therapy

Use of external clinical criteria/tools

UnitedHealthcare may use third‑party tools (for example, InterQual) to assist in administering benefit determinations, which could include step therapy assessments or other utilization management processes.

Documentation Required

Documentation expectations and supporting records

Providers must reference applicable federal, state (Ohio Administrative Code), or contractual requirements when requesting coverage and may be asked to provide documentation consistent with those requirements to support medical necessity determinations.

Denial Risk

Denial risk for unproven or limited services

Requests for services identified as unproven or that are subject to a coverage or quantity limit will be evaluated for medical necessity under Ohio Administrative Code 5160-1-01; failure to meet those criteria may result in denial.

Clinical Background

Factor mimetics and rebalancing agents are non‑factor therapies used to prevent or reduce bleeding episodes in persons with hemophilia by either mimicking factor activity or altering hemostatic balance. This policy references specific agents in that class and defers to the Ohio Medicaid Unified Preferred Drug List criteria and Ohio Administrative Code 5160-1-01 when determining medical necessity for initiation and continuation of these therapies.

Definitions and Agent List

Definitions — factor mimetics and rebalancing agents

DefinitionFactor mimetics and rebalancing agents: agents used to mimic factor activity or rebalance coagulation in hemophilia

Examples (named in policy)Alhemo (concizumab-mtci); Hemlibra (emicizumab-kxwh); Hympavzi (marstacimab-hncq); Qfitlia (fitusiran)

Clinical roleNon-factor therapies used to prevent or reduce bleeding episodes by mimicking factor function or altering hemostatic balance

Coverage guidanceConsidered medically necessary in certain circumstances; refer to Ohio Department of Medicaid Unified Preferred Drug List Criteria for specific clinical coverage criteria

Initial Therapy Coverage

Initial therapy coverage

Agents listed are considered medically necessary in certain circumstances per Ohio PDL criteria.

Agent coverage: Coverage for initiation of listed agents requires meeting medical necessity criteria in the Ohio Department of Medicaid Unified Preferred Drug List Criteria.see Ohio PDL

Specific initiation criteria (e.g., diagnosis codes, prior treatments) are contained in Ohio PDL and are not enumerated in this policy.