Subject: Valchlor 1862-A SGM P2022

Drug

VALCHLOR  (mechlorethamine gel)

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
                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.

           B.  Compendial Uses
                1.  Chronic or smoldering adult T-cell leukemia/lymphoma
                     (ATLL)
                2.  Mycosis fungoides/Sezary syndrome (MF/SS)
                3.  Primary cutaneous B-cell lymphoma:
                     a.  Primary cutaneous marginal zone lymphoma
                     b.  Primary cutaneous follicle center lymphoma
                4.  Lymphomatoid papulosis (LyP)
                5.  Histiocytic Neoplasms
                     a.  Langerhans Cell Histiocytosis

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

 
     II.  CRITERIA FOR INITIAL APPROVAL

            A.  Mycosis Fungoides/Sezary Syndrome (MF/SS)
                 Authorization of 12 months may be granted for the
                 treatment of mycosis fungoides or Sezary syndrome.

 
            B.  Adult T-cell leukemia/lymphoma (ATLL)
                 Authorization of 12 months may be granted for the
                 treatment of chronic or smoldering adult T-cell
                 leukemia/lymphoma (ATLL).

            C.  Primary cutaneous B-cell lymphoma
                 Authorization of 12 months may be granted for the
                 treatment of primary cutaneous marginal zone or follicle
                 center lymphoma.

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

            E.  Histiocytic Neoplasms
                 Authorization of 12 months may be granted for the
                 treatment of Langerhans cell histiocytosis with isolated skin
                 disease.

 
    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. Valchlor [package insert]. Iselin, NJ: Helsinn Therapeutics, Inc.; January 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed January 3, 2022.

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 26, 2022