Subject: Specialty Quantity Limit Valcyte 3070-H P2023

Drug

VALCYTE  (valganciclovir hydrochloride)

valganciclovir hydrochloride

Policy:

      I.  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.

 
    II.  COVERED QUANTITIES

 

Medication	Standard Limit*	FDA- and compendia-recommended dosing
Valcyte (valganciclovir hydrochloride) 450 mg tablet	120 tablets per 30 days	Treatment of CMV retinitis in adults:   Induction: 900 mg orally twice a day for 21 days       Maintenance: 900 mg orally once a day             Prevention of CMV disease in adults:                      900 mg orally once a day            Prevention of CMV disease in pediatric                         patients:  Dosage calculated based on BSA and CrCl given    once a day, with maximum dose 900 mg              Treatment of CMV following solid organ                         transplant:      900 mg orally twice daily based on clinical                    response
Valcyte    (valganciclovir     hydrochloride)    for oral solution 50    mg/mL	1000 mL per 30 days

  Abbreviations: CMV = cytomegalovirus; BSA = body surface area; CrCl = creatinine clearance
 *The initial limits may apply to the generic equivalent medications.

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. 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.

April 11, 2023