Last Review Date: 06/05/2025

Date of Origin: 12/16/2014

Dates Reviewed: 12/2014, 4/2015, 5/2015, 09/2015, 12/2015, 03/2016, 06/2016, 12/2016, 06/2017, 09/2017, 11/2017, 11/2018, 03/2019, 02/2020, 06/2021, 06/2022, 06/2023, 06/2024, 06/2025

1. Length of Authorization

Perioperative management of surgical bleeding:

• Coverage will be for 1 month and may NOT be renewed.

Control and prevention of acute bleeding episodes:

• Coverage will be provided for 3 months and may be renewed every 6 months thereafter.

Routine prophylaxis:

• Coverage will be provided for 3 months and may be renewed annually thereafter.

Note: The cumulative amount of medication the patient has on-hand will be taken into account for authorizations. Up to 5 ‘on-hand’ doses for the treatment of acute bleeding episodes will be permitted at the time of the authorization request.

2. Dosing Limits

   Max Units (per dose and over time) [HCPCS Unit]:

• 136,850 billable units per 28 day supply

3. Initial Approval Criteria ^1-3,7-11

Coverage is provided in the following conditions:

Hemophilia A (congenital factor VIII deficiency) † Ф

• Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND
• Patient has inhibitors to Factor VIII with a current or historical titer of ≥ 5 Bethesda Units (BU)**; AND
• Used as treatment in at least one of the following:

• Control and prevention of acute bleeding episodes (episodic treatment of acute hemorrhage); OR
• Perioperative management; OR
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
  • Will not be used in combination with another agent used as prophylactic therapy for Hemophilia A; AND

• • • Used as primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level of <1%); OR
    • Used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints; OR
    • Patient has a documented trial and failure of Immune Tolerance Induction (ITI)

Hemophilia B (congenital factor IX deficiency aka Christmas disease) † Ф

• Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing; AND
• Patient has inhibitors to Factor IX with a current or historical titer of ≥ 5 Bethesda Units (BU)**; AND
• Used as treatment in at least one of the following:

• Control and prevention of acute bleeding episodes (episodic treatment of acute hemorrhage); OR
• Perioperative management; OR
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
  • Will not be used in combination with another agent used as prophylactic therapy for Hemophilia B; AND
    • Used as primary prophylaxis in patients with severe factor IX deficiency (factor VIII level of <1%); OR
    • Used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints; OR
    • Patient has documented trial and failure of Immune Tolerance Induction (ITI)

**Note: Patients with inhibitor titer levels >0.6 BU to <5 BU who are not responding to or are not a candidate for standard factor replacement, will be evaluated on a case-by-case basis.

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Dispensing Requirements for Rendering Providers (Hemophilia Management Program)

• Prescriptions cannot be filled without an expressed need from the patient, caregiver or prescribing practitioner. Auto-filling is not allowed.
• Monthly, rendering provider must submit for authorization of dispensing quantity before delivering factor product. Information submitted must include:
  • • Original prescription information, requested amount to be dispensed, vial sizes available to be ordered from the manufacturer, and patient clinical history (including patient product inventory and bleed history)
    • Factor dose should not exceed +1% of the prescribed dose and a maximum of three vials may be dispensed per dose. If unable to provide factor dosing within the required threshold, below the required threshold, the lowest possible dose able to be achieved above +1% should be dispensed. Prescribed dose should not be increased to meet assay management requirements.

• The cumulative amount of medication(s) the patient has on-hand should be taken into account when dispensing factor product. Patients should not have more than 5 extra doses on-hand for the treatment of acute bleeding episodes.

• Dispensing requirements for renderings providers are a part of the hemophilia management program. This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide.

5. Renewal Criteria ^1-3,7

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the indication-specific relevant criteria identified in section III; AND
• Duration of authorization has not been exceeded (refer to Section I); AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions (severe anaphylactoid reactions, urticaria, angioedema, gastrointestinal manifestations, bronchospasm, etc.), embolic and thromboembolic events (venous thrombosis, pulmonary embolism, myocardial infarction, stroke, etc.), etc; AND
• Any increases in dose must be supported by an acceptable clinical rationale (i.e. weight gain, half-life study results, increase in breakthrough bleeding when patient is fully adherent to therapy, etc.); AND
• The cumulative amount of medication(s) the patient has on-hand will be taken into account when authorizing. The authorization will allow up to 5 doses on-hand for the treatment of acute bleeding episodes as needed for the duration of the authorization; AND

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

• Patient has demonstrated a beneficial response to therapy (i.e., the frequency of bleeding episodes has decreased from pre-treatment baseline)

6. Dosage/Administration^1-3

7. Billing Code/Availability Information

HCPCS Code & NDC:

8. References

1. Feiba [package insert]. Cambridge, MA; Takeda Pharmaceuticals U.S.A., Inc.. December 2024. Accessed May 2025.
2. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System. Revised October 02, 2024. National Hemophilia Foundation. MASAC Document #290. Available at: https://www.bleeding.org. Accessed April 2025.
3. Guidelines for the Management of Hemophilia. 3^rd Edition. World Federation of Hemophilia. 2020. Available at: https://www1.wfh.org/publications/files/pdf-1863.pdf.
4. Graham A1, Jaworski K. Pharmacokinetic analysis of anti-hemophilic factor in the obese patient. Haemophilia. 2014 Mar;20(2):226-9.
5. Croteau SE1, Neufeld EJ. Transition considerations for extended half-life factor products. Haemophilia. 2015 May;21(3):285-8.
6. Mingot-Castellano, et al. Application of Pharmacokinetics Programs in Optimization of Haemostatic Treatment in Severe Hemophilia a Patients: Changes in Consumption, Clinical Outcomes and Quality of Life. Blood. 2014 December; 124 (21).
7. MASAC Recommendation Concerning Prophylaxis for Hemophilia A and B with and without Inhibitors. Revised April 27, 2022. National Hemophilia Foundation. MASAC Document #267. Available at: https://www.bleeding.org. Accessed April 2025.
8. Sjamsoedin LJ, Heijnen L, Mauser-Bunschoten EP, et al. The effect of activated prothrombin-complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial. N Engl J Med. 1981 Sep 24;305(13):717-21.
9. Hilgartner M, Knatterud G, and the FEIBA Study Group. The Use of Factor Eight Inhibitor By-Passing Activity (FEIBA Immuno) Product for Treatment of Bleeding Episodes in Hemophiliacs With Inhibitors. Blood, Vol 6. No. 1 (January). 1983.
10. Stasyshyn S, Antunes S, Mamonov V, et al. Prophylaxis with anti‐inhibitor coagulant complex improves health‐related quality of life in haemophilia patients with inhibitors: results from FEIBA NF Prophylaxis Study. Haemophilia, 03 March 2014. https://doi.org/10.1111.hae.12390.
11. Malec J (2025) Hemophilia A and B: Routine management including prophylaxis. In Shapiro AD, Tirnauer JS (Eds.), UptoDate. Last updated: April 23, 2025. Accessed April 25, 2025. Available from https://www.uptodate.com/contents/hemophilia-a-and-b-routine-management-including-prophylaxis.
12. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Hemophilia Factor Products (A56482). Centers for Medicare & Medicaid Services Inc. Updated on 09/29/2023 with effective date 10/01/2023. Accessed April 2025.
13. Palmetto GBA. Local Coverage Article: Billing and Coding: Guidance for Anti-Inhibitor Coagulant Complex (AICC) National Coverage Determination (NCD) 110.3 (A56065). Centers for Medicare & Medicaid Services Inc. Updated on 11/14/2022 with effective date 11/24/2022. Accessed April 2025.
14. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Hemophilia Factor Products (A56433). Centers for Medicare & Medicaid Services Inc. Updated on 09/29/2023 with effective date 10/01/2023. Accessed April 2025.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.