Subject: Valchlor SGM 1862-A P2026

Drug

VALCHLOR  (mechlorethamine gel)

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

Valchlor is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.

Compendial Uses²

·        Mycosis fungoides/Sezary syndrome (MF/SS)

·        Primary cutaneous B-cell lymphoma

§  Primary cutaneous marginal zone lymphoma

§  Primary cutaneous follicle center lymphoma

·        Lymphomatoid papulosis (LyP)

·        Histiocytic Neoplasms

§  Langerhans Cell Histiocytosis

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

Coverage Criteria

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

Authorization of 12 months may be granted for the treatment of mycosis fungoides or Sezary syndrome.

Primary Cutaneous B-Cell Lymphoma²

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

Lymphomatoid Papulosis (LyP)²

Authorization of 12 months may be granted for the treatment of lymphomatoid papulosis (LyP).

Histiocytic Neoplasms²

Authorization of 12 months may be granted for the treatment of Langerhans Cell Histiocytosis with isolated skin disease.

Continuation of Therapy

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.      Valchlor [package insert]. Iselin, NJ: Helsinn Therapeutics, Inc.; January 2020.

2.     The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed December 9, 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