Subject: Specialty Quantity Limit valganciclovir-Valcyte 3070-H P2025a

Drug

VALCYTE  (valganciclovir)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for the treatment of cytomegalovirus following solid organ transplant and all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Valcyte (valganciclovir) 450 mg tablets	120 per 30 days
Valcyte (valganciclovir) 50 mg/mL oral solution	1300 mL per 30 days

FDA- and Compendia-recommended Dosing

Abbreviations: CMV = cytomegalovirus; BSA = body surface area; CrCl = creatinine clearance

Treatment of CMV Retinitis in Adults

Induction: 900 mg twice a day for 21 days

Maintenance: 900 mg once a day

Prevention of CMV Disease in Adults

900 mg once a day

Prevention of CMV Disease in Pediatric Patients

Once daily dosage based on BSA and CrCl with a maximum dose of 900 mg

Treatment of CMV Following Solid Organ Transplant

900 mg twice daily based on clinical response

Place of Service:

Outpatient

The above policy is based on the following references:

1. Valcyte [package insert]. South San Francisco, CA: Genentech USA, Inc.; December 2021.
2. valganciclovir oral solution [package insert]. Memphis, TN: Northstar Rx LLC; January 2024.
3. valganciclovir tablet [package insert]. East Brunswick, NJ: Strides Pharma Inc.; January 2024.
4. 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.

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 07, 2025