Subject: Valcyte 3100-A Supplemental Specialty PA P2023
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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 all 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: 11/14/2022).
- 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 (cited: 11/14/2022).
- 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® © 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 14, 2022.
- 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 14, 2022.
- Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2021. URL: https://www.clinicalkey.com/pharmacology/. Accessed November 14, 2022.
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 11, 2023
