Subject: bexarotene-Targretin SGM 1795-A P2026

Drug

TARGRETIN CAPSULES  (bexarotene capsules)

TARGRETIN GEL 1%  (bexarotene gel 1%)

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 Indications^1-4

·        Targretin/bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients who are refractory to at least one prior systemic therapy.

·        Targretin/bexarotene gel is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.

Compendial Uses⁵

Targretin/bexarotene capsules

·        Mycosis fungoides (MF)

·        Sézary syndrome (SS)

·        Subcutaneous panniculitis-like T-cell lymphoma

·        Primary cutaneous CD30+ T-cell lymphoproliferative disorders:

§  Primary cutaneous anaplastic large cell lymphoma (ALCL)

§  Lymphomatoid papulosis (LyP)

Targretin/bexarotene gel

·        Mycosis fungoides (MF)

·        Sézary syndrome (SS)

·        Primary cutaneous B-cell lymphomas:

§  Primary cutaneous marginal zone lymphoma

§  Primary cutaneous follicle center lymphoma

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

Coverage Criteria

Targretin/bexarotene Capsules

Mycosis Fungoides (MF)/Sézary Syndrome (SS)^1,2,5

Authorization of 12 months may be granted for treatment of MF or SS.

Subcutaneous Panniculitis-like T-cell Lymphoma^1,2,5

Authorization of 12 months may be granted for treatment of subcutaneous panniculitis-like T-cell lymphoma as a single agent or in combination with prednisone.

Primary Cutaneous CD30+ T-cell Lymphoproliferative Disorders⁵

Authorization of 12 months may be granted for treatment of primary cutaneous ALCL or LyP as a single agent.

Targretin/bexarotene Gel

Mycosis Fungoides (MF)/Sézary Syndrome (SS) ^3,4,6

Authorization of 12 months may be granted for treatment of MF or SS.

Primary Cutaneous B-cell Lymphomas⁶

Authorization of 12 months may be granted for treatment of primary cutaneous marginal zone lymphoma or primary cutaneous follicle center lymphoma.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in 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.      Targretin capsules [package insert]. St. Petersburg, FL: Catalent Pharma Solutions LLC; April 2020.

2.     Bexarotene capsule [package insert]. Piscataway, NJ: Camber Pharmaceuticals Inc.; January 2025.

3.     Targretin gel [package insert]. San Antonio, TX: DPT Laboratories, Ltd.; February 2020.

4.     Bexarotene gel [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals, LLC; December 2023.

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

6.     Targretin gel. The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed December 10, 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.

July 14, 2026