CORIFACT, Factor XIII Concentrate (Human) Form

Factor XIII, human (Corifact®) is a plasma-derived factor XIII concentrate. FDA Approved Indication(s) Corifact is indicated for adult and pediatric patients with congenital factor XIII deficiency for: • Routine prophylactic treatment • Perioperative management of surgical bleeding
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 Corifact is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Congenital Factor XIII Deficiency (must meet all):

1. Diagnosis of congenital factor XIII deficiency;
2. Prescribed by or in consultation with a hematologist;
3. Request is for one of the following uses (a, b, or c): a. Control of acute bleeding; b. Perioperative management; c. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes;

4. For routine prophylaxis requests, member meets one of the following (a, b, or c): a. Member has previously used factor XIII for routine prophylaxis; b. Member has severe hemophilia (defined as factor level of < 1%); c. Member has experienced at least one serious spontaneous bleed (see Appendix D). Approval duration: 3 months (surgical/acute bleeding) or 6 months (prophylaxis)
   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 Page 1 of 6

   CLINICAL POLICY Factor XIII, Human 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. Congenital Factor XIII Deficiency (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. Approval duration: 3 months (surgical/acute bleeding) or 6 months (prophylaxis)
   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.
      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 documents.
      Page 2 of 6

   CLINICAL POLICY Factor XIII, Human 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): known anaphylactic or severe systemic reactions to human plasma- derived products • Boxed warning(s): none reported Appendix D: General Information • Serious bleeding episodes include bleeds in the following sites: intracranial; neck/throat; gastrointestinal; joints (hemarthrosis); muscles (especially deep compartments such as the iliopsoas, calf, forearm); or mucous membranes of the mouth, nose and genitourinary tract. • Spontaneous bleed is defined as a bleeding episode that occurs without apparent cause and is not the result of trauma. • May 2016: coverage for acute bleed was added to clinical policy based on specialist feedback. V. Dosage and Administration Indication Routine prophylaxis Peri-operative management and management of acute bleeding episodes Dosing Regimen 40 IU/kg IV every 28 days Maximum Dose Individualized Individualized Adjust dose ± 5 IU/kg to maintain 5% to 20% trough level of FXIII activity. Dosing is individualized and depends on the time since the patient’s last prophylactic dose. • • • If the last dose was within the past 7 days, then an additional dose may not be needed.
   If the last dose was 8-21 days prior, then an additional partial or full dose may be needed based on Factor XIII activity level. If the last dose was 21-28 days prior, then a full prophylactic dose can be given.
   VI. Product Availability
   Single-use vial: 1,000-1,600 units/vial
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   CLINICAL POLICY Factor XIII, Human VII.