CurrentUnitedHealthcarePolicy CSOH2026D0044.C

Hereditary Angioedema (HAE), Treatment and Prophylaxis (for Ohio Only) – Community Plan Medical Benefit Drug Policy

State-specific UnitedHealthcare Medical Benefit Drug Policy that governs coverage for specified HAE drug products (Berinert, Cinryze, Ruconest, Kalbitor) for members of the Community Plan in Ohio, referencing Ohio Department of Medicaid Unified Preferred Drug List Criteria for clinical medical necessity. Applies only to Ohio; state rules govern when conflicts exist.

Policy Summary

PayerUnitedHealthcare

PolicyHereditary Angioedema (HAE), Treatment and Prophylaxis (for Ohio Only) – Community Plan Medical Benefit Drug Policy

Policy CodePolicy CSOH2026D0044.C

Change TypeAdded Ruconestremoved pharmacy benefit language

Effective DateJan 1, 2026

Next Review Date

Key ActionProviders must document and meet the Ohio Department of Medicaid Unified Preferred Drug List clinical coverage criteria for medical necessity for the requested HAE drug (treatment or prophylaxis); this policy defers to those criteria for approval.

SourceLink

POLICY UPDATE CHANGES

Removed language indicating Firazyr (icatibant), Haegarda (C1 esterase inhibitor [human]), and Takhzyro (lanadelumab) are self-administered injections and obtained under the member's pharmacy benefit.

Added language to indicate Ruconest is considered medically necessary in certain circumstances and referrals to Ohio Department of Medicaid Unified Preferred Drug List Criteria for medical necessity.

Archived previous policy version CSOH2025D0044.B.

4Drugs referenced as medically necessary in certain circumstances

OHState-specific (Ohio only)

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Coverage Summary

This state-specific UnitedHealthcare Medical Benefit Drug Policy covers select Hereditary Angioedema (HAE) products for Ohio Community Plan members. The listed products — Berinert, Cinryze, Ruconest, and Kalbitor — are considered medically necessary in certain circumstances. Clinical coverage criteria and medical necessity decisions defer to the Ohio Department of Medicaid Unified Preferred Drug List Criteria and applicable Ohio Administrative Code provisions.

Medically Necessary Coverage (summary)

These listed products are considered medically necessary in certain circumstances; medical necessity clinical coverage criteria are governed by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

Covered drug products: Drug product is one of the following: Berinert (C1 esterase inhibitor, human, IV), Cinryze (C1 esterase inhibitor, human, IV), Ruconest (C1 esterase inhibitor, recombinant, IV), or Kalbitor (ecallantide, plasma kallikrein inhibitor, SC).
Operational requirement: Clinical coverage criteria from the Ohio Department of Medicaid Unified Preferred Drug List Criteria are met for the requested indication (treatment or prophylaxis of HAE).
Provider must refer to and satisfy Ohio Department of Medicaid Unified Preferred Drug List clinical criteria; this policy defers to that criteria for specifics.

Applicable Codes

Drugs referencedNDC|mixedCovered

Berinert	C1 esterase inhibitor (human) for intravenous injection
Cinryze	C1 esterase inhibitor (human) for intravenous injection
Ruconest	C1 esterase inhibitor (recombinant) for intravenous injection
Kalbitor	Ecallantide, plasma kallikrein inhibitor, for subcutaneous injection

Provider Requirements & Billing Rules

Documentation Required

Follow Ohio Medicaid clinical criteria

Providers must document and meet the Ohio Department of Medicaid Unified Preferred Drug List clinical coverage criteria for medical necessity for the requested HAE drug (treatment or prophylaxis); this policy defers to those criteria for approval. Providers must document and meet the Ohio Department of Medicaid Unified Preferred Drug List clinical coverage criteria for medical necessity for the requested HAE drug (treatment or prophylaxis); this policy defers to those criteria for approval.

Billing Rule

Policy applies only in Ohio

This Medical Benefit Drug Policy only applies to services provided in the state of Ohio; requests will be evaluated using Ohio Administrative Code 5160-1-01 when services are stated as unproven or have coverage/quantity limits. This Medical Benefit Drug Policy only applies to services provided in the state of Ohio; requests will be evaluated using Ohio Administrative Code 5160-1-01 when services are stated as unproven or have coverage/quantity limits.

Background & Definitions

This is a state-specific (Ohio) UnitedHealthcare Medical Benefit Drug Policy for treatment and prophylaxis of Hereditary Angioedema (HAE). The policy specifically references the Ohio Department of Medicaid Unified Preferred Drug List Criteria and Ohio Administrative Code for medical necessity determinations. Per recent revisions, Ruconest was explicitly added as a product considered medically necessary in certain circumstances; clinical criteria for medical necessity continue to be governed by the Ohio Department of Medicaid Unified Preferred Drug List Criteria.

Medical Necessity Clinical Coverage Criteria: Clinical criteria established by the Ohio Department of Medicaid Unified Preferred Drug List that determine when the listed HAE drugs are medically necessary.

Clinical Evidence

Clinical coverage decisions for the listed HAE medications defer to the Ohio Department of Medicaid Unified Preferred Drug List Criteria. No additional clinical trial metrics or formal evidence entries are provided in this policy.

Revision History

01/01/2026removed

Administrative/coding coverage statement removed regarding pharmacy benefit assignment: Removed language indicating Firazyr (icatibant), Haegarda (C1 esterase inhibitor [human]), and Takhzyro (lanadelumab) are self-administered injections and obtained under the member's pharmacy benefit.

01/01/2026addedLatest

Ruconest explicitly included among products considered medically necessary; added language indicating Ruconest is considered medically necessary in certain circumstances and referrals to Ohio Department of Medicaid Unified Preferred Drug List Criteria for medical necessity.

01/01/2026