Subject: Specialty Quantity Limit Valcyte 3070-H P2022

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.; November 2020.
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 17, 2022