Subject: Zolinza 1863-A SGM P2023

Drug

ZOLINZA  (vorinostat)

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.

          A.  FDA-Approved Indication
               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

          B.  Compendial Uses
               Mycosis fungoides (MF)/Sézary syndrome (SS)

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

    II.  CRITERIA FOR INITIAL APPROVAL

          Cutaneous T-cell Lymphoma (CTCL)
          Authorization of 12 months may be granted for the treatment of
          CTCL (e.g., MF, SS).


  III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued
          treatment in members requesting reauthorization for an
          indication listed in Section II 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^® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed January 5, 2023.

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 18, 2023