CurrentUnitedHealthcarePolicy IEXD0047.02

Clotting Factors, Coagulant Blood Products, & Other Hemostatics

Defines medical necessity coverage criteria for multiple clotting factor products, non-factor replacement therapies, fibrinogen and factor XIII products across indications including congenital factor deficiencies, von Willebrand disease, hemophilia A and B, Glanzmann thrombasthenia, and fibrinogen deficiency; includes applicable HCPCS/J codes and ICD-10 diagnosis codes.

Policy Summary

PayerUnitedHealthcare

PolicyClotting Factors, Coagulant Blood Products, & Other Hemostatics

Policy CodePolicy IEXD0047.02

Change TypeAdditions and coverage revisions

Effective DateAug 1, 2025

Next Review Date

Key ActionSubmit medical records documenting failure to meet clinical goals after a trial of prophylactic factor replacement products when requesting non-factor therapies and follow the Review at Launch prior authorization process for Qfitlia.

POLICY UPDATE CHANGES

Added antithrombin-directed siRNA Qfitlia (fitusiran) to the list of applicable products and brand names.

Qfitlia (fitusiran) added to the Review at Launch program.

Revised coverage criteria for emicizumab-kxwh (Hemlibra): removed prescriber attestation prohibiting use of extended half-life factor VIII replacement products for breakthrough bleeding.

Revised coverage criteria for marstacimab-hncq (Hympavzi): removed prescriber attestation prohibiting use of extended half-life factor IX replacement products for breakthrough bleeding.

Added HCPCS code J7172 to applicable codes.

Removed HCPCS code C9304 from applicable codes.

Updated Background, Clinical Evidence, FDA, and References sections to reflect current information.

MultipleCovered Indications (products/indications listed)

Coverage Summary

Scope: Clotting Factors, Coagulant Blood Products, & Other Hemostatics. Coverage stance: covered_with_criteria. Effective date: 2025-08-01. Policy number: IEXD0047.02. Note: Qfitlia (fitusiran) was added to the list of covered products and to the Review at Launch program, and coverage criteria for emicizumab-kxwh (Hemlibra) and marstacimab-hncq (Hympavzi) were revised to remove prior prescriber attestation requirements.

Thresholds / Dosing & Age Limits (policy-specified)

High-titer inhibitor definition≥ 5 Bethesda units (BU)

Endogenous factor level — severe< 1% (˂ 0.01 i.u./mL)

Endogenous factor level — moderate≥ 1% and < 5% (≥ 0.01 to < 0.05 i.u./mL)

Endogenous factor level — mild≥ 5% (≥ 0.05 i.u./mL)

Eloctate dosing limitsDose does not exceed 50 i.u./kg; infusing no more frequently than every 4 days (alternative ceilings described for pediatrics/PK-guided dosing)

Altuviiio dosing limitsDose does not exceed 50 IU/kg; patient is infusing no more frequently than every 7 days

Common age threshold (highlight)12 years — many non-factor and rebalancing agents and initial therapy criteria require patient ≥ 12 years

Medical-Necessity Criteria (by indication/product)

Congenital Factor XIII Deficiency (Corifact & Tretten)

Factor XIII (plasma-derived) [Corifact] and Coagulation Factor XIII A-subunit (recombinant) [Tretten] are proven and medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of congenital factor XIII deficiency (for Corifact) or congenital factor XIII A-subunit deficiency (for Tretten).
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episodes.

Product Coverage Rationale & Recent Revisions

Emicizumab-kxwh (Hemlibra) coverage revision

Coverage when ALL of the following are met:

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Applicable Codes (HCPCS / ICD-10)

Applicable HCPCS / J-codes (listed)HCPCS

J3490	Unclassified drugs
J3590	Unclassified biologics
J7170	Injection, emicizumab-kxwh, 0.5 mg
J7172	Injection, marstacimab-hncq, 0.5 mg
J7175	Injection, factor X (human), 1 i.u.
J7177	Injection, human fibrinogen concentrate (Fibryga), 1 mg
J7178	Injection, human fibrinogen concentrate, not otherwise specified, 1 mg
J7179	Injection, von Willebrand factor (recombinant), (Vonvendi), 1 i.u. vWF: RCo
J7180	Injection, factor XIII (antihemophilic factor, human), 1 i.u.
J7181	Injection, factor XIII A-subunit, (recombinant), per i.u. (Tretten)

1–10 of 37

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Applicable ICD-10 Diagnosis Codes (listed)ICD-10

D66	Hereditary factor VIII deficiency
D67	Hereditary factor IX deficiency
D68.00	Von Willebrand's disease, unspecified
D68.01	Von Willebrand disease, type 1
D68.020	Von Willebrand disease, type 2A
D68.021	Von Willebrand disease, type 2B
D68.022	Von Willebrand disease, type 2M
D68.023	Von Willebrand disease, type 2N
D68.029	Von Willebrand disease, type 2, unspecified
D68.03	Von Willebrand disease, type 3

1–10 of 15

1/2

Added HCPCSHCPCS

J7172

Newly added HCPCS code (policy notes indicate addition)

Removed HCPCSHCPCS

C9304

Removed from applicable codes

Provider Actions & Operational Requirements

Documentation Required

Medical record submission for non-factor therapies

Submit medical records (chart notes, laboratory values) documenting failure to meet clinical goals after a trial of prophylactic factor replacement products when requesting emicizumab, fitusiran, marstacimab, or other non-factor therapies as specified.

J7170
J7204
J7175
J7172

Documentation Required

Inhibitor documentation

Provide documentation of inhibitors when required by product-specific criteria.

Examples: Bethesda inhibitor assay

Background, Evidence Summary, and Definitions

Background: Hemostasis is achieved through a cascade of coagulation factors and supporting proteins; replacement or mimetic therapies act to restore missing factors or rebalance coagulation. Factor VIIa (recombinant) forms complexes with tissue factor to activate factors IX and X leading to thrombin generation and fibrin formation. Factor VIII and IX act as cofactors in activation of factor X, ultimately producing thrombin to convert fibrinogen to fibrin. Factor XIII (A-subunit or plasma-derived) promotes cross-linking of fibrin to stabilize clots and retard fibrinolysis. Fibrinogen (factor I) is converted by thrombin into fibrin, the structural end-product of clot formation; replacement restores substrate for clot formation in congenital or acquired fibrinogen deficiency.

Study / Source	Key result
Tretten phase 3 trial
Monthly 35 i.u./kg recombinant FXIII (Tretten) reduced mean bleed rate to 0.138 bleeds/patient/year vs historic 2.91 (prophylaxis period) in congenital FXIII-A subunit deficiency
Humate-P perioperative study
Effective hemostasis achieved in 91.4% (32/35) of subjects immediately after elective surgery using Humate-P
Wilate trials
Bleeding successfully controlled in 84.1% of episodes (898/1068); 93% control in VWD type 3
Emicizumab prophylaxis ABR reduction
Emicizumab prophylaxis resulted in annualized bleeding rate reductions of 96% (1.5 mg/kg weekly) and 97% (3.0 mg/kg every 2 weeks) vs no prophylaxis; >50% had no treated bleeding events
Altuviiio ABR
Altuviiio routine prophylaxis in adults/adolescents: mean ABR 0.7 (95% CI 0.5-1.0); 100% resolution of target joints at 12 months (45/45)
Rixubis prophylaxis ABR
Rixubis routine prophylaxis: mean total ABR 4.3 vs 33.9 in on-demand arm
Alhemo (concizumab) ABR
Alhemo prophylaxis estimated mean ABR 1.7 vs 11.8 with no prophylaxis (86% reduction)
Hympavzi ABR
Hympavzi (on-demand cohort) ABR 38.00 during observation vs 3.18 with Hympavzi prophylaxis (BASIS study)
Qfitlia ATLAS studies ABR reduction
Qfitlia (fitusiran) antithrombin-based dosing in extension studies: 73% ABR reduction with inhibitors and 71% reduction without inhibitors vs on-demand control
Policy revision effective date
Policy effective date / revision: August 1, 2025

Definitions (policy-specified)

High-titer inhibitorDefined as ≥ 5 Bethesda units (BU)

Severe endogenous factor levelEndogenous factor level < 1% (˂ 0.01 i.u./mL)

Moderate endogenous factor levelEndogenous factor level ≥ 1% and < 5% (≥ 0.01 to < 0.05 i.u./mL)

Mild endogenous factor level

Revision History

2025-08-01policy_effective_dateLatest

Policy revision effective date; new policy version IEXD0047.02 becomes effective.

2025-08-01material_change_addition

Added antithrombin-directed siRNA Qfitlia (fitusiran) to the list of applicable products and specified as proven/medically necessary for routine prophylaxis when criteria are met.

2025-08-01material_change_program

Qfitlia (fitusiran) added to the Review at Launch program; some members may not be eligible for coverage during Review at Launch.

Policy Summary

PayerUnitedHealthcare

PolicyClotting Factors, Coagulant Blood Products, & Other Hemostatics

Policy CodePolicy IEXD0047.02

Change TypeAdditions and coverage revisions

Effective DateAug 1, 2025

Next Review Date

On This Page

Von Willebrand Disease (Humate-P, Alphanate, Wilate, Vonvendi)

Factor VIII (plasma-derived)/von Willebrand Factor Complex (Humate‑P, Alphanate, Wilate) and von Willebrand factor (recombinant) (Vonvendi) are proven and medically necessary when the following criteria (product-specific) are met:

Humate-P

ALL of the following
- Diagnosis of severe von Willebrand disease;
ALL of the following
- Diagnosis of mild or moderate von Willebrand disease;
- History of failure, contraindication, or intolerance to treatment with desmopressin;
AND one of the following
- Treatment of bleeding episodes.
- Peri-operative management of surgical bleeding.

Alphanate

Diagnosis of mild or moderate von Willebrand disease.
Peri-operative management of surgical bleeding.
History of failure, contraindication, or intolerance to treatment with desmopressin.

Wilate

Diagnosis of von Willebrand disease.
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episodes.

Vonvendi

Diagnosis of von Willebrand disease.
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episodes.

Congenital Factor VII Deficiency (NovoSeven RT)

Factor VIIa (recombinant) [NovoSeven RT] is proven and medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of congenital factor VII deficiency.
AND one of the following
- Routine prophylactic treatment.
- Treatment of bleeding episodes.

Hemophilia A (multiple FVIII products)

Factor VIII products are proven and medically necessary for Hemophilia A when product-specific criteria below are met. For branded product branches, product name is shown with any dosing and age-based exceptions preserved.

ALL of the following

Diagnosis of hemophilia A.
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episodes.

Altuviiio

Diagnosis of hemophilia A.
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episodes.
Dose does not exceed 50 IU/kg.
Patient is infusing no more frequently than every 7 days.

Jivi

Diagnosis of hemophilia A.
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episodes.
Patient has previously received Factor VIII replacement therapy.
Patient is 12 years of age or older.

Afstyla

Diagnosis of hemophilia A.
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episode.

Hemophilia B (Factor IX products)

Factor IX products and related inhibitor management are proven and medically necessary when product-specific criteria are met. Includes Alhemo initial/continuation logic where applicable.

ALL of the following

Diagnosis of hemophilia B (factor IX deficiency).
AND one of the following
- Routine prophylactic treatment.
- Peri-operative management of surgical bleeding.
- Treatment of bleeding episodes.

Alhemo (concizumab) - NOTE: Review at Launch

Coverage subject to Review at Launch program; some members may not be eligible for coverage at this time.
ANY of the following
- Initial therapy requests: meet applicable clinical criteria per Review at Launch and product labeling.
- Continuation therapy requests: documented clinical benefit on therapy and adherence to monitoring/authorization requirements as specified by Review at Launch.

Inhibitor management

Use of FEIBA and/or NovoSeven RT for hemophilia A or B with inhibitors per standard inhibitor management guidelines and product labeling.

Non-Factor Replacement Therapies (Alhemo, Hemlibra, Hympavzi, Qfitlia)

Non‑factor replacement therapies (Alhemo, Hemlibra, Hympavzi, Qfitlia) have product- and indication-specific coverage determinations. Alhemo and Qfitlia are in Review at Launch. Marstacimab‑hncq (Hympavzi) coverage revision is incorporated below.

Alhemo (concizumab-mtci) - Review at Launch

Subject to Review at Launch program; some members may not be eligible for coverage at this time.
Initial and continuation coverage require meeting criteria per the Review at Launch medical benefit drug policy and product labeling.

Hemlibra (emicizumab-kxwh)

Diagnosis of hemophilia A (with or without factor VIII inhibitors) where product is indicated per labeling and clinical guidelines;
ANY of the following
- Routine prophylactic treatment;
- Peri-operative management of surgical bleeding where indicated;
- Treatment of bleeding episodes where indicated.

Hympavzi (marstacimab-hncq) - coverage revision

Diagnosis of hemophilia A with or without inhibitors as per product labeling;
ANY of the following
- Covered when member meets initial therapy criteria defined by labeling and demonstrated clinical need;
- Continuation coverage requires documented clinical benefit (reduction in bleeding frequency or clinically meaningful improvement) compared with baseline and adherence to recommended monitoring;
Marstacimab-hncq (Hympavzi) coverage has been revised to clarify initial and continuation requirements; include documentation of prior therapies, inhibitor status, and bleeding history in authorization request.

Qfitlia (fitusiran) - Review at Launch

Subject to Review at Launch program; some members may not be eligible for coverage at this time.
Initial therapy: meet applicable clinical criteria per Review at Launch and product labeling;
Continuation therapy: documented clinical benefit on therapy and adherence to monitoring/authorization requirements.

Fibrinogen Deficiency (Fibryga, RiaSTAP)

Fibrinogen concentrates (Fibryga, RiaSTAP) are proven and medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of fibrinogen deficiency (congenital or acquired) or hypofibrinogenemia requiring replacement;
AND one of the following
- Routine prophylactic treatment when indicated by clinical guidelines;
- Peri-operative management of surgical bleeding;
- Treatment of bleeding episodes.

Glanzmann Thrombasthenia (NovoSeven RT)

Glanzmann Thrombasthenia: NovoSeven RT (factor VIIa recombinant) is proven and medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of Glanzmann thrombasthenia;
ANY of the following
- Treatment of bleeding episodes;
- Peri-operative management of surgical bleeding.

Congenital Factor X Deficiency (Coagadex)

Coagadex (factor X concentrate) is proven and medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of congenital factor X deficiency;
ANY of the following
- Routine prophylactic treatment;
- Peri-operative management of surgical bleeding;
- Treatment of bleeding episodes.

Documentation Required

Inhibitor screening frequency

For newly diagnosed hemophilia A and B, perform inhibitor screening at least every 6–12 months and then annually; for patients who receive clotting factor concentrate for >5 consecutive days, suggest inhibitor screening within 4 weeks of the last infusion.

New diagnosis: screen every 6–12 months, then annually
After >5 consecutive days of concentrate: screen within 4 weeks of last infusion

Documentation Required

DDAVP pediatric cautions

DDAVP should not be used in children <2 years due to increased seizure risk from water retention/hyponatremia; for adults limit DDAVP to no more than 3 consecutive days and monitor closely if used twice in a single day.

Do not use DDAVP in children < 2 years
Adults: limit to ≤ 3 consecutive days; if given twice in one day, subsequent dosing limited to once daily and monitor closely

Prior Authorization

Review at Launch program for Qfitlia (fitusiran)

Qfitlia has been added to the Review at Launch program; follow the Review at Launch prior authorization process per the Medical Benefit Drug Policy for New to Market Medications. Some members may not be eligible for coverage at this time.

Follow the Review at Launch prior authorization process
Coverage eligibility may be limited for some members

Documentation Required

Follow full policy criteria

Document that all policy criteria are met for the requested agent (e.g., fitusiran and other specified non-factor therapies) per the full policy. Note: certain prescriber attestation requirements for Hemlibra and Hympavzi have been removed.

Ensure all product-specific criteria in the full policy are documented
Prescriber attestation prohibiting use of extended half-life factor products for breakthrough bleeding was removed for Hemlibra and Hympavzi