Subject: RiaSTAP 2983-A SGM P2023
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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 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:
- RiaSTAP [package insert]. Kankakee, IL: CSL Behring LLC; June 2021.
- National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. Revised March 2022. MASAC Document #272. https://www.hemophilia.org/sites/default/files/document/files/272_Treatment.pdf. Accessed October 4, 2022.
- American Hospital Formulary Service Drug Information. American Society of Health-System Pharmacists. Bethesda, Maryland. Wolters Kluwer Clinical Drug Information, Inc., Last Updated March 28, 2022. URL: https://online.lexi.com/lco/action/home. Accessed October 4, 2022.
- 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 15, 2023
