Subject: bexarotene-Targretin 1795-A SGM P2023
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Targretin (bexarotene) capsules
(bexarotene capsules )
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Targretin (bexarotene) gel 1%
(bexarotene gel 1% )
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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 Indications
1. 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.
2. Targretin 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.
B. Compendial Uses
1. Targretin/bexarotene capsules
a. Mycosis fungoides (MF)
b. Sézary syndrome (SS)
c. Primary cutaneous CD30+ T-cell lymphoproliferative
disorders:
i. Primary cutaneous anaplastic large cell
lymphoma (ALCL)
ii. Lymphomatoid papulosis (LyP)
2. Targretin gel
a. Mycosis fungoides (MF)
b. Sézary syndrome (SS)
c. Chronic or smoldering adult T-cell leukemia/lymphoma
(ATLL)
d. Primary cutaneous B-cell lymphoma:
i. Primary cutaneous marginal zone lymphoma
ii. Primary cutaneous follicle center lymphoma
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Targretin/bexarotene Capsules
1. Mycosis Fungoides (MF)/Sézary Syndrome (SS)
Authorization of 12 months may be granted for treatment
of MF or SS.
2. Primary Cutaneous Anaplastic Large Cell Lymphoma
(ALCL)/Lymphomatoid Papulosis (LyP)4
Authorization of 12 months may be granted for treatment
of primary cutaneous ALCL or LyP as a single agent.
B. Targretin Gel
1. Mycosis Fungoides (MF)/Sézary syndrome (SS)
Authorization of 12 months may be granted for treatment
of MF or SS.
2. Adult T-cell Leukemia/Lymphoma (ATLL)
Authorization of 12 months may be granted for treatment
of chronic or smoldering ATLL.
3. Primary Cutaneous B-cell Lymphoma
Authorization of 12 months may be granted for treatment
of primary cutaneous marginal zone lymphoma or
primary cutaneous follicle center lymphoma.
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:
- Targretin capsules [package insert]. St. Petersburg, FL: Catalent Pharma Solutions LLC; April 2020.
- Targretin gel [package insert]. San Antonio, TX: DPT Laboratories, Ltd.; February 2020.
- Bexarotene capsule [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; December 2022.
- Bexarotene gel [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; April 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed January 3, 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
