Anthem clotting agents Coverage & Prior Auth Update

Coverage Criteria — Agent-specific Clinical Criteria

Coagadex (Human-plasma derived Coagulation Factor X) — Initial and Continuation

Covered when ALL of the following are met for initial requests:

Initial Coagadex: I. Diagnosis of severe or moderate hereditary Factor X deficiency (defined as 5 IU/dL or 5% endogenous Factor X or less); AND II. Using for one of: A. Treatment of acute bleeding episodes; OR B. Peri-procedural management for surgical, invasive or interventional radiology procedures; OR C. Routine prophylaxis to prevent or reduce frequency of bleeding episodes.severe ≤5 IU/dL

NHF, Srivastava 2020

Initial Coagadex - mild deficiency: OR: III. Diagnosis of mild hereditary Factor X deficiency (greater than 5 IU/dL) AND IV. Using for treatment of acute bleeding episodes OR peri-procedural management OR routine prophylaxis when there is documentation of one of: 1) ≥1 spontaneous joint bleed; OR 2) ≥1 severe/life-threatening spontaneous bleed per prescriber; OR 3) severe phenotype risk factors increasing clinically significant bleed risk.mild >5 IU/dL

Continuation Coagadex: I. Diagnosis of hereditary Factor X deficiency; AND II. Positive therapeutic response to treatment (e.g., reduced frequency/severity of bleeding).

FEIBA (Anti-inhibitor Coagulant Complex) — Initial and Continuation

Covered when ALL of the following are met for initial requests:

FEIBA Initial: I. Diagnosis of hemophilia A or B with inhibitors to Factor VIII or Factor IX; AND II. Using for one of: A. Treatment of bleeding episodes; OR B. Peri-procedural operative management for surgical, invasive, or interventional radiology procedures; OR C. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA Continuation: I. Diagnosis of hemophilia A or B with inhibitors to Factor VIII or Factor IX; AND II. Positive therapeutic response to treatment (for example, reduction in frequency and/or severity of bleeding episodes).

NovoSeven RT and SevenFact (Factor VIIa recombinant) — Initial and Continuation

Covered when ALL of the following are met for initial requests:

NovoSeven eligible diagnoses: I. Hemophilia A or B with inhibitors to Factor VIII or IX; OR II. Acquired hemophilia; OR III. Congenital Factor VII deficiency; AND II. Using for treatment of bleeding episodes or prevention of bleeding in surgical/invasive procedures.

Glanzmann's for NovoSeven: I. Diagnosis of Glanzmann's thrombasthenia; AND II. Using for the treatment of bleeding episodes and peri-operative management; AND III. Documented refractoriness to platelet transfusions with or without antibodies to platelets.

SevenFact Initial: I. Age ≥12 years; AND II. Diagnosis of hemophilia A or B with inhibitors to Factor VIII or IX; AND III. Using for treatment and control of bleeding episodes.

Continuation NovoSeven/SevenFact: Positive therapeutic response to treatment and continuing diagnosis consistent with initial approval.

Fibrinogen concentrates (Fibryga, RiaSTAP) — Initial and Continuation

Covered when ALL of the following are met for initial requests:

Fibryga Initial: I. Diagnosis of acquired or congenital fibrinogen deficiency (afibrinogenemia or hypofibrinogenemia); AND II. Using for the treatment of acute bleeding episodes.

RiaSTAP Initial: I. Diagnosis of congenital fibrinogen deficiency (afibrinogenemia or hypofibrinogenemia); AND II. Using for the treatment of acute bleeding episodes.

Continuation fibrinogen concentrates: Diagnosis of fibrinogen deficiency and positive therapeutic response to treatment (for example, reduction in frequency and/or severity of bleeding episodes).

Factor XIII products (Corifact, Tretten) — Initial and Continuation

Covered when ALL of the following are met for initial requests:

Corifact Initial: I. Diagnosis of Factor XIII deficiency; AND II. Using for routine prophylactic treatment OR peri-procedural management.

Tretten Initial: I. Diagnosis of congenital Factor XIII A-subunit deficiency; AND II. Using as routine prophylaxis for bleeding.

Continuation FXIII: Positive therapeutic response to treatment AND ongoing diagnosis consistent with product indication.

Hympavzi (marstacimab-hncq) — Initial and Continuation

Covered when ALL of the following are met for initial requests:

Hympavzi severe: I. Age ≥12 years; AND II. Diagnosis of moderate to severe hemophilia A (≤5 IU/dL) without factor VIII inhibitors; AND III. Using for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Hympavzi hemophilia B: I. Age ≥12 years; AND II. Diagnosis of moderate to severe hemophilia B (≤5 IU/dL) without factor IX inhibitors; AND III. Using for routine prophylaxis.

Hympavzi mild: I. Age ≥12 years; AND II. Diagnosis of mild hemophilia A or B (endogenous factor >5 IU/dL and <40 IU/dL) without inhibitors; AND III. Using for routine prophylaxis AND IV. Presence of one of: A) ≥1 spontaneous joint bleed; OR B) ≥1 severe/life-threatening/spontaneous bleed per prescriber; OR C) severe phenotype risk factors increasing clinically significant bleed risk.

Continuation Hympavzi: Diagnosis of hemophilia A or B without inhibitors and positive therapeutic response to treatment.

Alhemo (concizumab-mtci) — Initial

Covered when ALL of the following are met for initial requests:

Alhemo Initial: I. Age ≥12 years; AND II. Diagnosis of moderate to severe hemophilia A (≤5 IU/dL) with or without factor VIII inhibitors; AND III. Using for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Hympavzi continuation

Continuation requests for Hympavzi (marstacimab-hncq) may be approved when ALL of the following are met

Hympavzi continuation: I. Diagnosis of hemophilia A or B without factor VIII (for hemophilia A) or factor IX (for hemophilia B) inhibitors; AND II. Positive therapeutic response to treatment (for example, reduction in frequency and/or severity of bleeding episodes).

Hympavzi may not be approved when these criteria are not met or for other indications.

Alhemo initial and continuation

Initial requests for Alhemo (concizumab-mtci) may be approved when ANY ONE of the following agent-specific pathways is met

Alhemo pathway - moderate/severe hemophilia A: I. Age ≥ 12 years; AND II. Diagnosis of moderate to severe hemophilia A (≤ 5 IU/dL endogenous Factor VIII) with or without factor VIII inhibitors; AND III. Using for routine prophylaxis to prevent or reduce bleeding frequency.

(Rezende 2024)

Alhemo pathway - moderate/severe hemophilia B: IV. Age ≥ 12 years; AND V. Diagnosis of moderate to severe hemophilia B (≤ 5 IU/dL endogenous Factor IX) with or without factor IX inhibitors; AND VI. Using for routine prophylaxis to prevent or reduce bleeding frequency.

(Rezende 2024)

Alhemo pathway - mild hemophilia A or B: VII/VIII. Age ≥ 12 years; AND diagnosis of mild hemophilia A or B (endogenous Factor VIII or IX < 40 IU/dL but > 5 IU/dL) with or without inhibitors; AND using for routine prophylaxis; AND X. One or more of: A) ≥1 episode of spontaneous bleeding into joint; OR B) ≥1 episode of severe, life-threatening, or spontaneous bleeding as determined by prescriber; OR C) severe phenotype as determined by individual risk factors increasing risk of clinically significant bleed.

Qfitlia initial, continuation, exclusions

Initial requests for Qfitlia (fitusiran) may be approved when ANY ONE of the following agent-specific pathways is met; continuation requires response; exclusions apply

Qfitlia pathway - moderate/severe hemophilia A: I. Age ≥ 12 years; AND II. Diagnosis of moderate to severe hemophilia A (≤ 5 IU/dL endogenous Factor VIII) with or without factor VIII inhibitors; AND III. Using for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

(Rezende 2024, Young, Srivastava)

Qfitlia pathway - moderate/severe hemophilia B: IV. Age ≥ 12 years; AND V. Diagnosis of moderate to severe hemophilia B (≤ 5 IU/dL endogenous Factor IX) with or without factor IX inhibitors; AND VI. Using for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

(Rezende 2024, Young, Srivastava)

Qfitlia pathway - mild hemophilia A or B: VII/VIII. Age ≥ 12 years; AND diagnosis of mild hemophilia A or B (endogenous Factor VIII or IX < 40 IU/dL but > 5 IU/dL) with or without inhibitors; AND using for routine prophylaxis; AND X. One or more of: A) ≥1 episode of spontaneous bleeding into joint; OR B) ≥1 episode of severe, life-threatening, or spontaneous bleeding as determined by the prescriber; OR C) severe phenotype determined by individual risk factors increasing risk of clinically significant bleed.

Coding-linked Coverage Criterion

Coverage and continuation criteria have been updated for several agents

Coding requirement: Use the updated HCPCS and ICD-10 codes effective on their stated dates when requesting coverage or submitting claims.

J7173 for Alhemo effective 10/1/25; J7174 for Qfitlia effective 10/1/25; J7172 for Hympavzi effective 7/1/25

This policy does not address products that are surgical sealants or blood-bank–supplied blood products. Specifically, fibrin products, fibrin sealants, and blood products provided by blood banks are not included in this document and are covered under separate policies or operational workflows. Additionally, nonbypassing factor products for hemophilia A/B, Hemlibra, and agents for von Willebrand disease are addressed in other documents rather than here.

Fibrinogen concentrates have specific labeled indications in this policy. Fibryga and RiaSTAP are approved for afibrinogenemia or hypofibrinogenemia and for treatment of acute bleeding episodes, but Fibryga and RiaSTAP are not approved for dysfibrinogenemia and requests for that diagnosis will not be approved.

Established hepatic impairment is an explicit exclusion for Qfitlia. The policy states that requests for Qfitlia will not be approved for individuals with established hepatic impairment (Child-Pugh A, B, or C), and such impairment must be considered when evaluating eligibility for fitusiran therapy.

The document history and coding updates include several operational, coding-only changes (for example, removal of NOC entries and addition of permanent HCPCS codes). These coding updates do not by themselves introduce new clinical exclusions; the sections cited focus on code removals/additions and diagnostic code mapping rather than adding explicit clinical exclusion language.

Use of listed agents outside the policy’s stated diagnostic criteria, age thresholds, severity thresholds, or without documented therapeutic response for continuation requests is considered unsupported. In practice, agents used for indications not meeting the above stated diagnostic criteria, severity thresholds, age restrictions, or without documented therapeutic response for continuation requests are not approved and may be denied.

For the newer branded agents, the policy specifies that use of Hympavzi, Alhemo, or Qfitlia when the specified initial or continuation criteria are not met, or for indications other than those listed, may be considered not medically necessary and will not be approved. Providers should ensure all agent-specific criteria are documented when requesting these therapies.

Portions of the document emphasizing coding updates do not contain standalone not-medically-necessary (NMN) statements. The coding-focused chunks primarily document code additions/removals and diagnostic mapping; explicit NMN language appears in the clinical criteria sections rather than in the coding-history entries.

Coding — HCPCS, ICD-10 and Procedure Codes

HCPCS (selected)HCPCS

J7198

Anti-inhibitor; per IU [FEIBA]

HCPCS (factor VIIa)HCPCS

J7189	Factor VIIa (anti-hemophilic factor, recombinant), (NovoSeven RT), 1 mcg
J7212	Factor VIIa (antihemophilic factor, recombinant)-jncw (Sevenfact), 1 mcg

HCPCS (Factor X)HCPCS

J7175

Injection, Factor X, (human), 1 IU [Coagadex]

HCPCS (Factor XIII)HCPCS

J7180	Injection, Factor XIII (anti-hemophilic factor, human), 1 IU [Corifact]
J7181	Injection, Factor XIII A-subunit, (recombinant), per IU [Tretten]

HCPCS (listed biologics and concentrates)HCPCS

J7177	Injection, human fibrinogen concentrate (Fibryga), 1 mg
J7178	Injection, human fibrinogen concentrate, not otherwise specified, 1 mg [RiaSTAP]
J7172	Injection, marstacimab-hncq, 0.5 mg [Hympavzi]
J7173	Injection, concizumab-mtci, 0.5 mg [Alhemo]
J7174	Injection, fitusiran, 0.04 mg [Qfitlia]

ICD-10 DiagnosisICD-10

D66	Hereditary factor VIII deficiency [hemophilia A]
D67	Hereditary factor IX deficiency [hemophilia B]
D68.2	Hereditary deficiency of other clotting factors
D68.311	Acquired hemophilia
D68.318	Hemorrhagic disorder due to intrinsic circulating anticoagulants
D68.4	Acquired coagulation factor deficiency
D69.1	Qualitative platelet defects
D68.8	Other coagulation defects
D68.9	Coagulation defect, unspecified
Z29.89	Encounter for other specified prophylactic measures

1–10 of 11

1/2

ICD-10 Procedure (when specified)mixed

XW133YB	Transfusion of Nonautologous (Human) Fibrinogen Concentrate, peripheral vein, new technology group 11 (when specified as Fibryga)
XW143YB	Transfusion of Nonautologous (Human) Fibrinogen Concentrate, central vein, new technology group 11 (when specified as Fibryga)

Covered HCPCS for listed agentsHCPCSCovered

J7177	Injection, human fibrinogen concentrate (Fibryga), 1 mg
J7178	Injection, human fibrinogen concentrate, not otherwise specified, 1 mg [RiaSTAP]
J7172	Injection, marstacimab-hncq, 0.5 mg [Hympavzi]
J7173	Injection, concizumab-mtci, 0.5 mg [Alhemo]
J7174	Injection, fitusiran, 0.04 mg [Qfitlia]

ICD-10-PCS procedure codes (Fibryga administration)ICD-10

XW133YB	Transfusion of Nonautologous (Human) Fibrinogen Concentrate, Shelf-stable into Peripheral Vein, Percutaneous Approach, New Technology Group 11
XW143YB	Transfusion of Nonautologous (Human) Fibrinogen Concentrate, Shelf-stable into Central Vein, Percutaneous Approach, New Technology Group 11

Applicable ICD-10-CM diagnosis codesICD-10Covered

D68.2	Hereditary deficiency of other clotting factors
D66	Hereditary factor VIII deficiency [hemophilia A]
D67	Hereditary factor IX deficiency [hemophilia B]
Z29.89	Encounter for other specified prophylactic measures
Z79.899	Other long term (current) drug therapy [prophylactic]

Severe hemophilia or deficiency threshold (≤ 5 IU/dL)

Severe hemophilia/deficiency threshold≤ 5 IU/dL (≤ 5%) endogenous factor activity

Clinical mappingUsed to define moderate-to-severe hemophilia for coverage of agents such as Coagadex, Hympavzi, Alhemo, Qfitlia

Source guidanceThreshold referenced to NHF and Srivastava/Rezende guidance in policy criteria

Mild hemophilia threshold (<40 IU/dL and >5 IU/dL)

Mild hemophilia threshold

Provider Actions — Prior Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for these agents. Submit prior authorization requests before dispensing or administration to avoid claim denials or retrospective review.

Prior authorization must be obtained for branded hemophilia and related hemostatic agents included in this policy (examples: Coagadex, FEIBA, NovoSeven RT, SevenFact, Fibryga, Hympavzi, Alhemo, Qfitlia).
Use the plan's prior authorization system and include the specific drug name, indication, dosing regimen, and relevant clinical documentation.

Prior Authorization

Prior Authorization Required for Branded Hemophilia Agents

Branded hemophilia agents listed in this policy require prior authorization. Requests for these agents submitted without a completed prior authorization may be denied.

This includes (but is not limited to) Coagadex, FEIBA, NovoSeven RT, SevenFact, Fibryga, Hympavzi, Alhemo, Qfitlia.
Ensure the request clearly identifies the branded product (do not submit as a generic or NOC code unless directed).

Definitions and Thresholds

Prophylactic therapy definition

DefinitionRoutine/preventive infusion of factor replacement to prevent bleeding episodes (prophylactic therapy)

PurposeGiven to prevent or reduce frequency of spontaneous or activity-related bleeding

DocumentationPrior authorization requires indication of prophylactic intent and supporting clinical history

On-demand (episodic) therapy definition

DefinitionInfusion of factor replacements given to stop a bleeding episode (on-demand or episodic therapy)

Use casesUsed for treatment of acute bleeding episodes or peri-procedural bleeding control

Background — Therapeutic Context

Factor replacement and bypassing therapies are used to treat or prevent bleeding in hereditary and acquired clotting factor deficiencies. These products may be plasma-derived or recombinant and are applied for acute bleeding, peri-procedural management, or routine prophylaxis. While inventory considerations (product availability) may affect delivery, the policy focuses on clinical coverage criteria, required documentation, and coding rather than on inventory management.

Revision History and Policy Changes

This policy includes material coding and clinical clarifications effective in the documented history. Key recent changes include addition of permanent HCPCS codes (J7173 for Alhemo and J7174 for Qfitlia), removal of prior NOC/J‑codes, updated ICD‑10 diagnosis mappings, and clarifications to continuation and inhibitor‑related criteria for several agents. See the document history entries for the specific effective dates and the list of coding updates.

2025-11-14annual_reviewLatest

Annual review: clarified continuation requests for Corifact and Tretten, clarified Hympavzi inhibitor-related criteria, expanded Alhemo indication to include individuals without inhibitors, and clarified Qfitlia criteria regarding hemophilia with/without inhibitors.

2025-09-03coding_update

OpenPayer

Select Clotting Agents for Bleeding Disorders

Coverage Criteria — Agent-specific Clinical Criteria

Coding — HCPCS, ICD-10 and Procedure Codes

Provider Actions — Prior Authorization, Documentation, and Billing

Definitions and Thresholds

Background — Therapeutic Context

Revision History and Policy Changes