CurrentUnitedHealthcarePolicy CS2025D0047C

Factor Mimetics and Rebalancing Agents for Hemophilia

UnitedHealthcare medical benefit drug policy defining medical necessity criteria, initial and continuation authorization requirements, age and inhibitor-status indications, dosing requirement (per FDA label), and authorization duration (up to 12 months) for concizumab-mtci (Alhemo), emicizumab-kxwh (Hemlibra), marstacimab-hncq (Hympavzi), and fitusiran (Qfitlia). Excludes specified states where state-specific policies apply.

Policy Summary

PayerUnitedHealthcare

PolicyFactor Mimetics and Rebalancing Agents for Hemophilia

Policy CodePolicy CS2025D0047C

Change TypeAdded Qfitlia; revised Hemlibra and Hympavzi criteria; application update

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization is required; document diagnosis, factor levels, inhibitor status, prior treatment history, and inability to self-inject or receipt from contracted hemophilia treatment center as applicable.

POLICY UPDATE CHANGES

Added antithrombin-directed siRNA Qfitlia (fitusiran) to the list of applicable products

Revised coverage criteria for emicizumab-kxwh (Hemlibra) removing requirement that prescriber attest the patient will not receive extended half-life factor VIII replacement products for breakthrough bleeding

Revised coverage criteria for marstacimab-hncq (Hympavzi) removing requirement that prescriber attest the patient will not receive extended half-life factor IX replacement products for breakthrough bleeding

Added Arizona to list of states where this policy does not apply

Archived previous policy version CS2025D0047B

4Drugs addressed (Alhemo, Hemlibra, Hympavzi, Qfitlia)

>=5 BU

High-titer inhibitor threshold

12 moMax authorization duration

12 yrsMinimum age for most agents

Coverage summary

This UnitedHealthcare medical benefit drug policy is covered with criteria for the following agents for routine prophylaxis in hemophilia: concizumab (Alhemo), emicizumab (Hemlibra), marstacimab (Hympavzi), and fitusiran (Qfitlia). The policy defines specific medical necessity criteria (age, inhibitor status, endogenous factor levels where applicable), requires dosing per the U.S. FDA label, and limits authorizations to no more than 12 months. The scope is a UnitedHealthcare medical benefit drug policy and excludes specified states where state-specific policies apply.

Initial therapy criteria (by agent/indication)

Continuation therapy criteria (by agent/indication)

Unproven indications and exclusions

The policy applies to use for routine prophylaxis only to prevent or reduce the frequency of bleeding episodes; it does not cover other indications outside the listed medical necessity criteria. The policy document expressly does not apply to certain states (for example, Arizona and other states listed in the Application) where state-specific policies or guidelines govern. Each agent is noted as a self-injectable medication that should ordinarily be obtained under the member's pharmacy benefit unless the policy criteria specify circumstances (e.g., inability to self-inject or receipt from a contracted hemophilia treatment center) that require medical benefit handling.

Provider actions and requirements

Prior Authorization

Authorization required (initial and continuation)

Prior authorization is required for initial and continuation therapy. Authorizations are issued for no more than 12 months. Continuation requests must include documentation of prior treatment and evidence of a positive clinical response to therapy.

Documentation Required

Required clinical documentation

Required clinical documentation includes: diagnosis; endogenous factor level with thresholds (severe < 0.01 i.u./mL, moderate >= 0.01 to < 0.05 i.u./mL, mild >= 0.05 i.u./mL); inhibitor status reported in Bethesda units (high-titer defined as >= 5 BU); prior treatment history (e.g., trial of prophylactic factor replacement or bypassing agents as applicable); and documentation that the patient cannot self-inject and has no trainable caretaker or that the patient is receiving the agent from a contracted hemophilia treatment center where applicable.

Applicable codes

HCPCS / J-codes referencedHCPCS

J7170	Injection, emicizumab-kxwh, 0.5 mg
J7172	Injection, marstacimab-hncq, 0.5 mg
C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs
J3590	Unclassified biologics

ICD-10 Diagnosis codes referencedICD-10

D66	Hereditary factor VIII deficiency
D67	Hereditary factor IX deficiency

Clinical evidence and trial outcomes

86%Alhemo (concizumab) ABR reduction vs no prophylaxis

96-97%Hemlibra (emicizumab) ABR reduction vs no prophylaxis (study arms)

0.084Hympavzi (marstacimab) ABR ratio: observational 38.00 vs 3.18 (ratio 0.084)

73% / 71%Qfitlia (fitusiran) ABR reduction: 73% (inhibitors) and 71% (non-inhibitors) with antithrombin‑based dosing

The policy background and clinical evidence sections summarize pivotal trials, FDA indications, and National Hemophilia Foundation guidance: mechanisms and trial outcomes for Alhemo, Hemlibra, Hympavzi, and Qfitlia are described (including ABR reductions and study references). Evidence labels and full trial citations are provided in the source policy; reviewers are encouraged to consult those references (package inserts and cited trials) in the policy for full details.

Background and definitions

Background: this policy governs monoclonal antibodies and siRNA agents — described as 'factor mimetics' (e.g., Hemlibra) and 'rebalancing agents' (e.g., Alhemo, Hympavzi, Qfitlia) — when used for routine prophylaxis in hemophilia A and B. The policy notes that these products are typically pharmacy benefit self-injectable medications unless criteria (such as inability to self-inject or administration via a contracted hemophilia treatment center) trigger medical benefit administration; contracted hemophilia treatment centers are referenced as an alternative pathway for provision of therapy.

Revision history

2025-08-01addedLatest

Added antithrombin-directed siRNA Qfitlia (fitusiran) to the list of applicable products; Qfitlia included with coverage criteria for routine prophylaxis when all listed criteria are met

2025-08-01revisedLatest

2025-08-01

Policy Summary

PayerUnitedHealthcare

PolicyFactor Mimetics and Rebalancing Agents for Hemophilia

Policy CodePolicy CS2025D0047C

Change TypeAdded Qfitlia; revised Hemlibra and Hympavzi criteria; application update

Effective DateAug 1, 2025

Next Review Date

On This Page

Endogenous factor levels with thresholds: severe < 0.01 i.u./mL; moderate >= 0.01 to < 0.05 i.u./mL; mild >= 0.05 i.u./mL

Inhibitor status (Bethesda units), high-titer defined as >= 5 BU

Prior treatment history (trial of prophylactic factor replacement or bypassing agents as applicable)

Documentation of inability to self-inject or evidence of receipt from a contracted hemophilia treatment center

Billing Rule

Dosing per FDA label

All agents must be dosed according to U.S. Food and Drug Administration labeled dosing. Qfitlia (fitusiran) must be dosed using the approved antithrombin-based dosing regimen.

Documentation Required

Age requirements

Document patient age to confirm eligibility per the policy. Most agents require patients to be 12 years of age or older; Hemlibra’s FDA labeling includes newborns and older, but the policy specifies age-based criteria in the Hemlibra sections.

2025-08-01addedLatest

Added Arizona to list of states where this policy does not apply (policy does not apply to Arizona; refer to state-specific policy/guideline if noted)

2025-08-01archivedLatest

Archived previous policy version CS2025D0047B