Subject: RiaSTAP SGM 2983-A P2025

Drug

RIASTAP  (fibrinogen concentrate [human])

Policy:

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.

FDA-Approved Indications¹

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.

Compendial Uses^3-4

• Perioperative management of bleeding in afibrinogenemia
• Prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia

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

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.

Coverage Criteria

Congenital Fibrinogen Deficiency^1-4

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.

Authorization of 1 month may be granted for perioperative management of bleeding in members with a diagnosis of afibrinogenemia.

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).

Continuation of Therapy

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).

All Other Indications

All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria section.

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 April 2024. MASAC Document #284. https://www.bleeding.org/sites/default/files/document/files/MASAC-Products-Licensed.pdf. Accessed October 15, 2024.
3. American Hospital Formulary Service Drug Information. American Society of Health-System Pharmacists. Bethesda, Maryland. Wolters Kluwer Clinical Drug Information, Inc., Last Updated October 2, 2024. URL: https://online.lexi.com/lco/action/home. Accessed October 15, 2024.
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 20, 2025