Subject: Odomzo 1786-A SGM P2024

Drug

ODOMZO  (sonidegib)

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
               Odomzo is indicated for the treatment of adult patients with locally advanced basal cell
               carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are
               not candidates for surgery or radiation therapy.

          B.  Compendial Use
               Basal cell carcinoma

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


    II.  CRITERIA FOR INITIAL APPROVAL

          Basal Cell Carcinoma
          Authorization of 12 months may be granted as a single agent for treatment of locally advanced
          or diffuse (e.g., Gorlin syndrome) basal cell carcinoma.


   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. Odomzo [package insert]. Cranberry, NJ: Sun Pharmaceutical Industries, Inc.; August 2023.
2. The NCCN Drugs & Biologics Compendium^® © 2023 National Comprehensive Cancer Network Drugs, Inc. Available at https://www.nccn.org. Accessed November 1, 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.

May 17, 2024