Subject: Livtencity Supplemental Specialty PA 5076-A P2025

Policy:

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 Indications¹

Livtencity is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (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.

Coverage Criteria

Treatment of Post-Transplant Cytomegalovirus Infection^1,2

Authorization of 3 months may be granted for treatment of cytomegalovirus when all of the following criteria are met:

• The patient is a recipient of a hematopoietic stem cell transplant (HSCT) or a solid organ transplant.
• The patient is 12 years of age or older and weighs at least 35 kilograms.
• Disease is refractory to at least one antiviral treatment for cytomegalovirus (e.g., ganciclovir, valganciclovir, cidofovir, or foscarnet).

Continuation of Therapy

All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria section.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Livtencity [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; March 2024.
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.

June 06, 2025