Subject: Valchlor 1862-A SGM P2023

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^® © 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