FEIBA, Antiinhibitor Coagulant Complex Form

Anti-inhibitor coagulant complex, human (Feiba®) is a human plasma fraction with factor VIII inhibitor bypassing activity. It contains mainly non-activated factors II, IX, and X and activated factor VII. FDA Approved Indication(s) Feiba is indicated for use in hemophilia A and B patients with inhibitors for:
• Control and prevention of bleeding episodes; • Perioperative management; • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Limitation(s) of use: Feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Feiba is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hemophilia A or B with Inhibitors (must meet all):

1. Diagnosis of hemophilia A or B with inhibitors;
2. Prescribed by or in consultation with a hematologist;
3. Request is for one of the following uses (a, b, or c):
   a. Control and prevention of bleeding episodes; b. Perioperative management; c. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes;
   4. Documentation of member’s current body weight (in kg);

4. Dose does not exceed the FDA approved maximum recommended dose for the relevant indication. Approval duration: 3 months for bleeding episodes/surgery or 6 months for prophylaxis (12 months for prophylaxis for HIM Texas) Page 1 of 6

   CLINICAL POLICY Anti-inhibitor Coagulant Complex, Human B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Hemophilia A or B with Inhibitors (must meet all):
5. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
6. Member is responding positively to therapy;
7. Documentation of member’s current body weight (in kg);

8. If request is for a dose increase, new dose does not exceed the FDA approved maximum recommended dose for the relevant indication.
   Approval duration: 3 months for bleeding episodes/surgery or 6 months for prophylaxis (12 months for prophylaxis for HIM Texas) B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 2 of 6

   CLINICAL POLICY Anti-inhibitor Coagulant Complex, Human

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of anaphylactic or severe hypersensitivity reactions to Feiba or any of its components, including factors of the kinin generating system; disseminated intravascular coagulation; acute thrombosis or embolism (including myocardial infarction) • Boxed warning(s): thromboembolic events V. Dosage and Administration Indication Control and prevention of bleeding episodes Perioperative management Routine prophylaxis Dosing Regimen Joint hemorrhage: 50-100 units/kg IV every 12 hours Maximum Dose 200 units/kg/day Mucous membrane bleeding: 50-100 units/kg IV every 6 hours Soft tissue hemorrhage (e.g., retroperitoneal bleeding): 100 units/kg IV every 12 hours Other severe hemorrhage (e.g., central nervous system bleeds): 100 units/kg IV every 6-12 hours Pre-operative: 50-100 units/kg IV as a single dose
      Post-operative: 50-100 units/kg IV every 6-12 hours
      85 units/kg IV every other day 200 units/kg/day 85 units/kg/2 days Page 3 of 6

   CLINICAL POLICY Anti-inhibitor Coagulant Complex, Human VI. Product Availability
   Powder for reconstitution in single-use vial: 500 units, 1,000 units, 2,500 units VII.