Subject: VPRIV 2058-A SGM P2022
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VPRIV
(velaglucerase alfa)
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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
VPRIV is indicated for long-term enzyme replacement
therapy (ERT) for patients with type 1 Gaucher disease.
B. Compendial Uses
1. Gaucher disease type 2
2. Gaucher disease type 3
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: beta-glucocerebrosidase enzyme
assay or genetic testing results supporting diagnosis.
III. CRITERIA FOR INITIAL APPROVAL
A. Gaucher disease type 1
Authorization of 12 months may be granted for treatment of
Gaucher disease type 1 when the diagnosis of Gaucher
disease was confirmed by enzyme assay demonstrating a
deficiency of beta-glucocerebrosidase (glucosidase) enzyme
activity or by genetic testing.
B. Gaucher disease type 2
Authorization of 12 months may be granted for treatment of
Gaucher disease type 2 when the diagnosis of Gaucher
disease was confirmed by enzyme assay demonstrating a
deficiency of beta-glucocerebrosidase (glucosidase) enzyme
activity or by genetic testing.
C. Gaucher disease type 3
Authorization of 12 months may be granted for treatment of
Gaucher disease type 3 when the diagnosis of Gaucher
disease was confirmed by enzyme assay demonstrating a
deficiency of beta-glucocerebrosidase (glucosidase) enzyme
activity or by genetic testing.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment of an indication listed in Section III when the
member is not experiencing an inadequate response or any
intolerable adverse events from therapy.
Place of Service:
Outpatient
The above policy is based on the following references:
- VPRIV [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; September 2021.
- Pastores GM, Hughes DA. Gaucher Disease. [Updated June 21, 2018]. In: Pagon RA, Adam MP, Ardinger HH, et al, editors. GeneReviews® [Internet]. Seattle, WA: University of Washington, Seattle; 1993-2018.
- Kaplan P, Baris H, De Meirleir L, et al. Revised recommendations for the management of Gaucher disease in children. Eur J Pediatr. 2013;172:447-458.
- Vellodi A, Tylki-Szymanska A, Davies EH, et al. Management of neuronopathic Gaucher disease: revised recommendations. European Working Group on Gaucher Disease. J Inherit Metab Dis. 2009;32(5):660.
- National Organization for Rare Disorders. (2003). NORD guide to rare disorders. Philadelphia: Lippincott Williams & Wilkins.
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.
June 26, 2022
