Subject: RiaSTAP 2983-A SGM P2024

Drug

RIASTAP  (fibrinogen concentrate [human])

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          A.  FDA-Approved Indication
               RiaSTAP is indicated for the treatment of acute bleeding episodes in pediatric and adult
               patients with congenital fibrinogen deficiency, including afibrinogenemia and
               hypofibrinogenemia.

               Limitation of use:
               RiaSTAP is not indicated for dysfibrinogenemia.

          B.  Compendial Uses
               1.  Perioperative management of bleeding in afibrinogenemia
               2.  Prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia

          All other indications are considered experimental/investigational and not medically necessary.


     II.  DOCUMENTATION
         
          Submission of the following information is necessary to initiate the prior authorization review:
          For prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia, justification
          from the medical records.


    III.  CRITERIA FOR INITIAL APPROVAL

          Congenital Fibrinogen Deficiency
          A.  Authorization of 1 month may be granted for treatment of acute bleeding episodes in
               members with a diagnosis of congenital fibrinogen deficiency, including afibrinogenemia and
               hypofibrinogenemia.
          B.  Authorization of 1 month may be granted for perioperative management of bleeding in
               members with a diagnosis of afibrinogenemia.
          C.  Authorization of 12 months may be granted for prophylaxis to reduce the frequency of
               bleeding episodes in members with afibrinogenemia (with justification from the medical
               records).


    IV.  CONTINUATION OF THERAPY

          A.  Prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia
               Authorization of 12 months may be granted for continued treatment in members requesting
               reauthorization for prophylaxis to reduce the frequency of bleeding episodes in
               afibrinogenemia when the member is experiencing benefit from therapy (e.g., reduced 
               frequency of bleeding episodes).

          B.  All other indications
               All members (including new members) requesting authorization for continuation of therapy
               must meet all initial authorization criteria.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. RiaSTAP [package insert]. Kankakee, IL: CSL Behring LLC; June 2021.
2. National Hemophilia Foundation. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System. Revised August 2023. MASAC Document #280. https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-280-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-selected-disorders-of-the-coagulation-system. Accessed October 4, 2023.
3. American Hospital Formulary Service Drug Information. American Society of Health-System Pharmacists. Bethesda, Maryland. Wolters Kluwer Clinical Drug Information, Inc., Last Updated April 21, 2023. URL: https://online.lexi.com/lco/action/home. Accessed October 4, 2023.
4. Kruez W, Meili E, Peter-Salonen K, et al. Efficacy and tolerability of a pasteurized human fibrinogen concentrate in patients with congenital fibrinogen deficiency. Transfus Apher Sci. 2005;32(3):247-253.

 

 

 

 

 

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 17, 2024