Subject: RiaSTAP 2983-A SGM P2021
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RIASTAP®
(fibrinogen concentrate [human])
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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 in patients with congenital fibrinogen deficiency, including
afibrinogenemia and hypofibrinogenemia, for the treatment of acute bleeding episodes.
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 are 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:
- RiaSTAP [package insert]. Kankakee, IL: CSL Behring LLC; July 2020.
- National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. Revised August 2020. MASAC Document #263. https://www.hemophilia.org/sites/default/files/document/files/263_treatment.pdf. Accessed October 14, 2020.
- American Hospital Formulary Service Drug Information. American Society of Health-System Pharmacists. Bethesda, Maryland. Wolters Kluwer Clinical Drug Information, Inc., Last Updated March 2, 2020. URL: https://online.lexi.com/lco/action/home. Accessed January 6, 2021.
- 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.
May 27, 2021
