Subject: Novoseven RT 1947-A SGM P2024
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NOVOSEVEN RT
(coagulation factor VIIa [recombinant])
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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 Indications
1. Hemophilia A or hemophilia B with inhibitors
2. Congenital factor VII deficiency
3. Glanzmann’s thrombasthenia
4. Acquired hemophilia
B. Compendial Uses
1. Acquired von Willebrand syndrome
2. Inhibitors to factor XI
All other indications are considered experimental/investigational and not medically necessary.
II. PRESCRIBER SPECIALTIES
Must be prescribed by or in consultation with a hematologist.
III. CRITERIA FOR INITIAL APPROVAL
A. Congenital Factor VII Deficiency
Authorization of 12 months may be granted for treatment of congenital factor VII deficiency.
B. Hemophilia A with Inhibitors
Authorization of 12 months may be granted for treatment of hemophilia A with inhibitors (see
Appendix) when the inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL) or the member
has a history of an inhibitor titer ≥ 5 BU.
C. Hemophilia B with Inhibitors
Authorization of 12 months may be granted for treatment of hemophilia B with inhibitors
(see Appendix) when the inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL) or the
member has a history of an inhibitor titer ≥ 5 BU.
D. Glanzmann’s Thrombasthenia
Authorization of 12 months may be granted for treatment of Glanzmann’s thrombasthenia.
E. Acquired Hemophilia
Authorization of 12 months may be granted for treatment of acquired hemophilia.
F. Acquired von Willebrand Syndrome
Authorization of 12 months may be granted for treatment of acquired von Willebrand
syndrome when other therapies failed to control the member’s condition (e.g.,
desmopressin or factor VIII/von Willebrand factor).
G. Inhibitors to Factor XI
Authorization of 12 months may be granted for treatment of inhibitors to factor XI.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section III when the member is experiencing benefit
from therapy (e.g., reduced frequency or severity of bleeds).
V. APPENDIX
Appendix: Inhibitors - Bethesda Units (BU)
The presence of inhibitors is confirmed by a specific blood test called the Bethesda inhibitor
assay.
• High-titer inhibitors:
° > 5 BU/mL
° Inhibitors act strongly and quickly neutralize factor
• Low-titer inhibitors:
° < 5 BU/mL
° Inhibitors act weakly and slowly neutralize factor
Place of Service:
Outpatient
The above policy is based on the following references:
- NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; July 2020.
- National Institutes of Health. The diagnosis, evaluation, and management of von Willebrand disease. Bethesda, MD: US Dept of Health and Human Services, National Institutes of Health; 2007. NIH publication No. 08-5832
- Tiede A, Rand J, Budde U, et al. How I treat the acquired von Willebrand syndrome. Blood. 2011;117(25):6777-85.
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
