Subject: Stimate 1950-A SGM P2024
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 with Factor VIII coagulant activity level >5%
2. Mild to moderate type 1 von Willebrand disease (VWD) with Factor VIII activity level >5%
B. Compendial Uses
1. Type 2A, 2M, 2N VWD
2. Qualitative platelet disorders
3. Acquired hemophilia A
4. Acquired von Willebrand syndrome
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Von Willebrand Disease
Type 1, 2A, 2M, or 2N VWD
1. Authorization of one month may be granted for treatment of mild or moderate type 1
and type 2A, 2M, or 2N VWD in members who are initiating therapy.
2. Authorization of 12 months may be granted for treatment of mild or moderate type 1
and type 2A, 2M, or 2N VWD in members who are continuing therapy and have
demonstrated a response to an initial trial of Stimate.
B. Hemophilia A
Authorization of 12 months may be granted for treatment of hemophilia A with factor VIII
activity level greater than 5% (see Appendix).
C. Qualitative Platelet Disorders
Authorization of 12 months may be granted for treatment of a qualitative platelet disorder.
D. Acquired Hemophilia A
Authorization of 12 months may be granted for treatment of acquired hemophilia A.
E. Acquired von Willebrand Syndrome
Authorization of 12 months may be granted for treatment of acquired von Willebrand
syndrome.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section II when the member is experiencing benefit
from therapy (e.g., reduced frequency or severity of bleeds).
IV. APPENDIX
Appendix: Classification of Hemophilia by Clotting Factor Level (% Activity) and Bleeding Episodes
|
Severity
|
Clotting Factor Level % activity^
|
Bleeding Episodes
|
|
Severe
|
<1%
|
Spontaneous bleeding episodes, predominantly into joints and muscles
Severe bleeding with trauma, injury or surgery
|
|
Moderate
|
1% to 5%
|
Occasional spontaneous bleeding episodes
Severe bleeding with trauma, injury or surgery
|
|
Mild
|
6% to 40%
|
Severe bleeding with serious injury, trauma or surgery
|
^Factor assay levels are required to determine the diagnosis and are of value in monitoring treatment response.
*Note: This program addresses the appropriate use of Stimate Nasal Spray only. Stimate Nasal Spray and DDAVP (desmopressin) Nasal Spray are two distinct products and are not interchangeable. DDAVP Nasal Spray is not indicated for hemophilia or VWD.
Place of Service:
Outpatient
The above policy is based on the following references:
- Stimate [package insert]. King of Prussia, PA: CSL Behring LLC; June 2021.
- American Society of Health System Pharmacists. AHFS Drug Information Bethesda, MD. Available with subscription. https://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/413832. Accessed October 6, 2023.
- National Hemophilia Foundation. MASAC recommendations regarding the treatment of von Willebrand disease. Revised February 2021. MASAC Document #266. https://www.hemophilia.org/sites/default/files/document/files/266.pdf. Accessed October 6, 2023.
- 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 6, 2023.
- Desmopressin (DDAVP) in the treatment of bleeding disorders. Montreal, Canada: World Federation of Hemophilia, 2012. http://www1.wfh.org/publications/files/pdf-1131.pdf. Accessed October 6, 2023.
- Tiede A, Collins P, Knoebl P, et al. International recommendations on the diagnosis and treatment of acquired hemophilia A. Haematologica. 2020;105(7)1791-1801.
- Franchini M, Lippi G. The use of desmopressin in acquired haemophilia A: a systematic review. Blood Transfus. 2011;9:377-82.
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
