Factor and Non-Factor Anti-Hemophilic Therapies (Hemophilia and Related Coagulation Disorders)
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Medical-benefit coverage policy for a broad set of coagulation factor and non-factor anti-hemophilic drugs (including factor VIII, IX, X, XIII, fibrinogen concentrate, anti-inhibitor complexes, TFPI antagonists, von Willebrand products, and related agents) for Commercial members (multiple product-specific indications described). Prior authorization is required. Policy does not apply to Medicare Advantage members.
Updated Vonvendi's expanded indication.
Updated FDA labeling for Alhemo and updated formatting and references.
Updated HCPCS codes for Qfitlia and Alhemo; added Qfitlia previously.
Coverage Summary
This policy covers a broad set of medical-benefit coagulation therapies including coagulation factor concentrates (Factor VIII, IX, X, XIII), von Willebrand factor products, fibrinogen concentrate, anti-inhibitor coagulant complexes, and non-factor agents (e.g., TFPI antagonists, factor IXa-/X-directed antibodies, siRNA agents). Indications include treatment and prevention of bleeding in hemophilia A and B (including with or without inhibitors), von Willebrand disease, congenital factor deficiencies (e.g., Factor X, XIII, fibrinogen), and acquired factor deficiencies. Coverage under this document is for Commercial members only (medical benefit), and prior authorization is required for these medications.
Medical-Necessity Criteria
General Coverage Statements
ANY of the following
- Anti-Inhibitor Coagulant Complex is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients.
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.
- Coagulation factor indicated for the treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann's thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets & Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia.
- Human anti-hemophilic factor (AHF) maintenance therapy (prophylaxis) as needed to maintain trough levels at 1% or greater in patients with severe Hemophilia A (AHF activity less than 1% of normal).>= 1%
- Human anti-hemophilic factor (AHF) for treatment and/or management of bleeding episodes in surgical patients with mild hemophilia (AHF activity 5%-30%) or moderately severe hemophilia (AHF activity 1%-5%).
- Human antihemophilic factor (AHF) for treatment of moderate to severe Von Willebrand's disease in appropriate settings, for example, major surgery, trauma.
- Human anti-hemophilic factor (AHF) for acquired factor VIII deficiency.
- On-demand treatment and control of bleeding episodes.
- Coagulation Factor IX concentrate indicated in adults and children with hemophilia B (congenital Factor IX deficiency) control and prevention of bleeding episodes, perioperative management, and routine prophylaxis control and prevention of bleeding episodes.
- Coagulation Factor IX [Recombinant] is an antihemophilic factor indicated in adults and children with hemophilia B for: Control and prevention of bleeding episodes, perioperative management, on-demand treatment, and routine prophylaxis.
- Plasma-derived human blood coagulation Factor X indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for On-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild or moderate hereditary Factor X deficiency.
- Routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency.
- Factor IXa- and factor X-directed antibodies are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
- Fibrinogen Concentrate indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency.
- Tissue factor pathway inhibitor (TFPI) antagonists (Alhemo, Hympavzi) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without respective inhibitors, per product-specific labeling.
- Recombinant Von Willebrand Factor for treatment (on demand) and control of bleeding episodes, perioperative management, and routine prophylaxis in adult and pediatric patients with von Willebrand disease.
- We do not cover Factor and Non-Factor Anti-Hemophilic Drugs for conditions other than those listed above.
Prior Authorization and Individual Consideration
ALL of the following
- Prior authorization is required for coverage of Factor and Non-Factor Anti-Hemophilic Drugs under this medical benefit policy for Commercial Members (Managed Care HMO/POS, PPO/EPO, Indemnity).
- To request prior authorization, physicians may call, fax, or mail the Formulary Exception/Prior Authorization form to: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043. Tel: 1-800-366-7778. Fax: 1-800-583-6289.
- Requests that do not meet the clinical criteria of this policy may be submitted for Individual Consideration. For Individual Consideration, physicians should send relevant clinical information for the individual patient to: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043. Tel: 1-800-366-7778. Fax: 1-800-583-6289. Decisions will be made based on the member's unique clinical circumstances and current scientific literature.
Coding
| J7174 | Injection, fitusiran, 0.04 mg (Qfitlia) |
| C9132 | Factor IX : Prothrombin complex concentrate (human), per i.u. of Factor IX activity (Kcentra) |
| J7173 | Injection, concizumab-mtci (Alhemo) |
| C9304 | Injection, marstacimab-hncq, 0.5 mg (Hympavzi) |
| C9399 | Unclassified drugs or biologicals (NOC) (i.e. Hemlibra) |
| J7170 | Injection, emicizumab-kxwh, 0.5 mg |
| J7175 | Injection, factor x, (human), 1 i.u. (Coagadex) |
| J7177 | Injection, human fibrinogen concentrate (fibryga), 1 mg |
| J7178 | Injection, human fibrinogen concentrate, not otherwise specified, 1 mg (RiaSTAP) |
| J7179 | Injection, Von Willebrand factor (recombinant), 1 i.u. vwf:rco (Vonvendi) |
| No codes listed |
Inclusion of a code in this policy is informational and does not guarantee coverage or reimbursement; providers should report services using current CPT/HCPCS/ICD-10 codes and modifiers and verify member-specific benefits. Coverage for listed codes requires that the medical necessity criteria in this policy be met.
Provider Actions
Prior Authorization Required
Prior authorization is required for medical-benefit hemophilia and related coagulation factor and non-factor therapies. Requests must be submitted to Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department.
- Phone: 1-800-366-7778
- Fax: 1-800-583-6289
- Mail: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043 (use Formulary Exception/Prior Authorization form)
Individual Consideration Process
Clinicians may request individual consideration for patients whose clinical circumstances do not meet the policy's clinical criteria by submitting relevant clinical information for review by the Pharmacy Operations Department.
- Mail: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043
- Fax: 1-800-583-6289
- Phone: 1-800-366-7778
Use industry-standard codes and modifiers
Report services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes (CPT/HCPCS/ICD-10) including modifiers where applicable. Inclusion of a code in this policy is informational only and does not guarantee coverage or reimbursement; medical necessity criteria must be met for coverage.
Background and Evidence
This policy references FDA-approved indications and product package inserts for specific therapies and addresses both prophylaxis (routine maintenance to prevent bleeding) and on-demand treatment (control of acute bleeding or perioperative management). Product-specific labeling and indications are noted where they differ (for example, VonVendi's expanded routine prophylaxis indication was recently updated).
References: product package inserts (multiple products including Advate, Alhemo, VonVendi, Hemlibra and others) and clinical guidance (e.g., World Federation of Hemophilia guidelines) are cited to support the policy.
Revision History
Updated Vonvendi's expanded indication (policy history notes change dated 1/15/2026 updating Vonvendi labeling and indication).
Updated FDA labeling for Alhemo and updated formatting and references (policy history entry 11/2025).
Multiple policy history entries in 2025 reflecting coding updates and added products: updated HCPCS codes for Qfitlia and Alhemo (10/2025), added Qfitlia to the policy (7/2025), and other administrative/coding updates noted across 2025.
Definitions & Thresholds
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