Subject: Valcyte 3100-A Supplemental Specialty PA P2024
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VALCYTE
(valganciclovir hydrochloride)
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valganciclovir hydrochloride
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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. Valcyte is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with
acquired immunodeficiency syndrome (AIDS)
2. Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-
pancreas transplant patients at high risk (donor CMV seropositive/recipient CMV
seronegative [D+/R-])
3. Valcyte is indicated for the prevention of CMV disease in kidney transplant patients (4
months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at
high risk
B. Compendial Uses
1. Prevention of CMV infection in adult and pediatric patients post solid organ transplant or
post hematopoietic stem cell transplant (HSCT)
2. Treatment of CMV infection in solid organ transplant recipients
3. Symptomatic congenital cytomegalovirus infection
4. Treatment of CMV gastrointestinal disease in human immunodeficiency virus (HIV)
infection
5. Multicentric Castleman’s disease, human herpesvirus-8 positive
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Treatment of CMV infection in HIV-infected patients
1. Authorization of 12 months may be granted for induction or maintenance treatment of
CMV retinitis in HIV-infected members.
2. Authorization of 12 months may be granted for treatment of CMV gastrointestinal (GI)
disease (e.g., colitis, esophagitis) in HIV-infected members.
B. Prevention of CMV infection in transplant recipients
Authorization of 12 months may be granted for prevention (either prophylaxis or preemptive
treatment) of CMV infection when the member is post solid organ transplant or post
hematopoietic stem cell transplant (HSCT).
C. Treatment of CMV infection in solid organ transplant recipients
Authorization of 12 months may be granted for treatment of mild to moderate CMV infection
when the member is post solid organ transplant.
D. Symptomatic congenital CMV infection
Authorization of 12 months total may be granted for treatment of symptomatic congenital
CMV infection.
E. Multicentric Castleman’s disease (MCD)
Authorization of 12 months may be granted for treatment of MCD in members who are
human herpesvirus-8 positive.
III. CONTINUATION OF THERAPY
A. Symptomatic congenital CMV infection
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for symptomatic congenital CMV infection when both of the following criteria
are met:
1. Member meets all initial authorization criteria in Section II.
2. Member has received less than 12 months of therapy.
B. All other indications
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for all other indications when the member meets all initial authorization
criteria in Section II.
Place of Service:
Outpatient
The above policy is based on the following references:
- Valcyte [package insert]. South San Francisco, CA: Genentech USA, Inc.; December 2021.
- Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J of Transplantation. 2004;611-620.
- Bilavsky E, Shahar-Nissan K, Pardo J, et al. Hearing outcome of infants with congenital cytomegalovirus and hearing impairment. Arch Dis Child. 2016 May;101(5):433-8.
- IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/8/2023).
- Kimberlin DW, Jester PM, Sanchez PJ, et al. Valganciclovir for symptomatic congenital cytomegalovirus disease. N Engl J Med. 2015 Mar 5;372(10):933-43.
- Lexi-Comp (electronic version). Wolters Kluwer Clinical Information, Hudson, Ohio. Available at: https://online.lexi.com. Accessed November 8,2023.
- Kotton CN, Kumar D, Caliendo AM, et al. The Third International Consensus guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation. 2018;102(6):900-931.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 8, 2023.
- Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Accessed November 8, 2023.
- Clinical Pharmacology [database online]. Philadelphia, PA: Elsevier Inc.; 2023. URL: https://www.clinicalkey.com/pharmacology/. Accessed November 8, 2023.
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 14, 2024
