Subject: Wilate 1952-A SGM P2023
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WILATE
(von Willebrand factor/coagulation factor VIII complex [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
1. Wilate is indicated in children and adults with von
Willebrand Disease (VWD) for:
a. On-demand treatment and control of bleeding
episodes
b. Perioperative management of bleeding
2. Wilate is indicated in adolescents and adults with
hemophilia A for:
a. Routine prophylaxis to reduce the frequency of
bleeding episodes
b. On-demand treatment and control of bleeding
episodes
B. Compendial Use
Acquired von Willebrand Syndrome
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. Von Willebrand Disease
Authorization of 12 months may be granted for members with
VWD when either of the following criteria is met:
1. Member has type 1, 2A, 2M, or 2N VWD and has had an
insufficient response to desmopressin or a documented
clinical reason for not using desmopressin (see Appendix B).
2. Member has type 2B or type 3 VWD.
B. Acquired von Willebrand Syndrome
Authorization of 12 months may be granted for treatment of
acquired von Willebrand syndrome.
C. Hemophilia A
Authorization of 12 months may be granted for hemophilia A
when the requested medication will be used for either of the
following:
1. Member has mild disease (see Appendix A) and has had an
insufficient response to desmopressin or a documented
clinical reason for not using desmopressin (see Appendix B).
2. Member has moderate or severe disease (see Appendix A).
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. APPENDICES
Appendix A: Classification of Hemophilia by Clotting
Factor Level (% Activity) and Bleeding Episodes
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Severity
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Clotting Factor
Level % activity*
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Bleeding Episodes
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Severe
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<1%
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Spontaneous bleeding episodes, predominantly into
joints and muscles
Severe bleeding with trauma, injury or surgery
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Moderate
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1% to 5%
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Occasional spontaneous bleeding episodes
Severe bleeding with trauma, injury or surgery
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Mild
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6% to 40%
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Severe bleeding with serious injury, trauma or
surgery
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*Factor assay levels are required to determine the diagnosis and
are of value in monitoring treatment response.
Appendix B: Clinical Reasons For Not Utilizing
Desmopressin in Patients with Hemophilia A and Type 1,
2A, 2M and 2N VWD
A. Age < 2 years
B. Pregnancy
C. Fluid/electrolyte imbalance
D. High risk for cardiovascular or cerebrovascular disease (especially the elderly)
E. Predisposition to thrombus formation
F. Trauma requiring surgery
G. Life-threatening bleed
H. Contraindication or intolerance to desmopressin
I. Severe type 1 von Willebrand disease
J. Stimate Nasal Spray is unavailable due to backorder/shortage issues (where applicable)
Place of Service:
Outpatient
The above policy is based on the following references:
- Wilate [package insert]. Hoboken, NJ: Octapharma USA Inc.; November 2019.
- 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.
- 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.
- 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.
- 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 3, 2022.
- 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 3, 2022.
- Stimate [package insert]. King of Prussia, PA: CSL Behring LLC; June 2021.
- Leissinger C, Carcao M, Gill JC, et al. Desmopressin (DDAVP) in the management of patients with congenital bleeding disorders. Haemophilia. 2014;20:158-167.
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
