Subject: Livtencity 5076-A Supplemental Specialty PA P2023

Drug

LIVTENCITY  (maribavir)

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.

          FDA-Approved Indications
          Livtencity is a cytomegalovirus (CMV) pUL97 kinase inhibitor
          indicated for the treatment of adults and pediatric patients (12
          years of age and older and weighing at least 35 kg) with post-
          transplant CMV infection/disease that is refractory to treatment
          (with or without genotypic resistance) with ganciclovir,
          valganciclovir, cidofovir or foscarnet

          All other indications are considered experimental/investigational
          and not medically necessary.


    II.  CRITERIA FOR INITIAL APPROVAL

          Treatment of post-transplant cytomegalovirus infection
          Authorization of 3 months may be granted for treatment of
          cytomegalovirus when all of the following criteria are met:
          A.  The patient is a recipient of hematopoietic stem cell or solid
               organ transplant.
          B.  The patient is 12 years of age or older and weighs at least 35
               kilograms.
          C.  Disease is refractory to at least one antiviral treatment for
               cytomegalovirus (e.g., ganciclovir, valganciclovir, cidofovir, or
               foscarnet).


    II.  CONTINUATION OF THERAPY

          All members (including new members) requesting authorization
          for continuation of therapy must meet all initial authorization
          criteria.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Livtencity [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; September 2022.
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 June; 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 11, 2023