Subject: Odomzo 1786-A SGM P2022

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 Uses
      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 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.; May 2019.
2. The NCCN Drugs & Biologics Compendium^® © 2021 National Comprehensive Cancer Network Drugs, Inc. Available at https://www.nccn.org. Accessed November 2, 2021.

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.

April 16, 2022