Subject: Zolinza SGM 1863-A P2026

Drug

ZOLINZA  (vorinostat)

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 Indication¹

Zolinza is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following two systemic therapies.

Compendial Uses²

·        Mycosis fungoides (MF)/Sézary syndrome (SS)

·        Hodgkin lymphoma

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

Coverage Criteria

Cutaneous T-cell Lymphoma (CTCL)^1-2

Authorization of 12 months may be granted for the treatment of CTCL (e.g., MF, SS).

Hodgkin Lymphoma²

Authorization of 12 months may be granted for the treatment of relapsed or refractory Hodgkin lymphoma, when used in combination with pembrolizumab (Keytruda), after progressing through at least three prior lines of subsequent therapy.

Continuation of Therapy

Hodgkin Lymphoma

Authorization of 12 months may be granted (up to 24 months total) for continued treatment in members requesting reauthorization for the treatment of relapsed or refractory Hodgkin lymphoma who have not experienced disease progression or unacceptable toxicity.

All Other Indications

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the Coverage Criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Zolinza [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; July 2022.

2.     The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed December 1, 2025.

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 13, 2026