Subject: Stimate SGM 1950-A P2025

Drug

STIMATE  (desmopressin acetate nasal spray)

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

• Hemophilia A with Factor VIII coagulant activity level >5%
• Mild to moderate type 1 von Willebrand disease (VWD) with Factor VIII activity level >5%

Compendial Uses^2-11

• Type 2A, 2M, 2N VWD
• Qualitative platelet disorders
• Acquired hemophilia A
• Acquired von Willebrand syndrome

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

Coverage Criteria

Von Willebrand Disease^1-4,10

Type 1, 2A, 2M, or 2N VWD

• 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.
• 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.

Hemophilia A^1,4

Authorization of 12 months may be granted for treatment of hemophilia A with factor VIII activity level greater than 5% (see Appendix).

Qualitative Platelet Disorders⁶

Authorization of 12 months may be granted for treatment of a qualitative platelet disorder.

Acquired Hemophilia A^5,6

Authorization of 12 months may be granted for treatment of acquired hemophilia A.

Acquired von Willebrand Syndrome^8,9

Authorization of 12 months may be granted for treatment of acquired von Willebrand syndrome.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when the member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds).

Appendix

Appendix: Classification of Hemophilia by Clotting Factor Level (% Activity) and Bleeding Episodes¹¹

Factor assay levels are required to determine the diagnosis and are of value in monitoring treatment response.¹¹

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

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:

1. Stimate [package insert]. King of Prussia, PA: CSL Behring LLC; June 2021.
2. 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 15, 2024.
3. 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 15, 2024.
4. 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.
5. 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 15, 2024.
6. 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.
7. Franchini M, Lippi G. The use of desmopressin in acquired haemophilia A: a systematic review. Blood Transfus. 2011;9:377-82.
8. 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.
9. Tiede A, Rand J, Budde U, et al. How I treat the acquired von Willebrand syndrome. Blood. 2011;117(25):6777-85.
10. Federici A, Budde U, Castaman G, Rand J, Tiede A. Current diagnostic and therapeutic approaches to patients with acquired von Willebrand syndrome: a 2013 update. Semin Thromb Hemost. 2013;39(2):191-201.
11. Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158.

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