Fibrinogen Concentrate [Human] (Fibryga, RiaSTAP) Form

The following are fibrinogen (coagulation factor I) concentrates requiring prior authorization: fibrinogen concentrate [human] (Fibryga® and RiaSTAP®).
FDA Approved Indication(s) Fibryga and RiaSTAP are indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Limitation(s) of use: Fibryga and RiaSTAP are not indicated for dysfibrinogenemia.
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 Fibryga and RiaSTAP are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Congenital Fibrinogen Deficiency (must meet all):

1. Diagnosis of congenital fibrinogen deficiency, including afibrinogenemia or hypofibrinogenemia;
2. Confirmation that the member does not have dysfibrinogenemia;
   3. Prescribed by or in consultation with a hematologist;
   4. Request is for treatment of acute bleeding episodes;
   5. For members who have not previously used fibrinogen concentrate (samples do not count), documentation of both of the following (a and b): a. Plasma functional and immunoreactive fibrinogen levels are < 150 mg/dL; b. Prolonged prothrombin time and activated partial thromboplastin time as determined by laboratory-specific reference values;

3. Dose does not exceed the FDA-approved maximum recommended dose for the relevant indication. Approval duration: 3 months
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   CLINICAL POLICY Fibrinogen Concentrate (Human) B. Other diagnoses/indications (must meet 1 or 2):

4. 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
5. 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 Fibrinogen Deficiency (must meet all):
   
   1. 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);
   2. Member is responding positively to therapy;
   3. 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
      B. Other diagnoses/indications (must meet 1 or 2):
6. 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

7. 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 Page 2 of 6

   CLINICAL POLICY Fibrinogen Concentrate (Human) 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 policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents;
   B. Dysfibrinogenemia.
   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): individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to Fibryga or its components (sodium citrate dihydrate; glycine; L-arginine hydrochloride); known anaphylactic or severe systemic reactions to human plasma-derived products (RiaSTAP) • Boxed warning(s): none reported V. Dosage and Administration
   Drug Name Fibrinogen concentrate (Fibryga) Dosing Regimen The recommended target fibrinogen plasma level is 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding. When baseline fibrinogen level is known • Age ≥ 12 years: [Target fibrinogen level (mg/dL) – measured fibrinogen level (mg/dL)]/1.8 (mg/dL per mg/kg body weight) by IV infusion • Age < 12 years: [Target fibrinogen level (mg/dL) – measured fibrinogen level (mg/dL)]/1.4 (mg/dL per mg/kg body weight) by IV infusion Fibrinogen concentrate (RiaSTAP) When baseline fibrinogen level is not known 70 mg/kg/dose by IV infusion When baseline fibrinogen level is known [Target fibrinogen level (mg/dL) – measured fibrinogen level (mg/dL)]/1.7 (mg/dL per mg/kg body weight) by IV infusion Maximum Dose Individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient Individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient Page 3 of 6

   CLINICAL POLICY Fibrinogen Concentrate (Human) Drug Name Dosing Regimen When baseline fibrinogen level is not known 70 mg/kg/dose by IV infusion Maximum Dose VI. Product Availability
   Drug Name Fibrinogen concentrate (Fibryga) Fibrinogen concentrate (RiaSTAP) Availability Lyophilized powder for reconstitution in a single-dose bottle: approximately 1 gram Lyophilized powder for reconstitution in a single-dose vial: 900-1,300 mg VII.