Subject: Orgovyx 4411-A SGM P2022

Drug

ORGOVYX  (relugolix)

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
               Orgovyx is indicated for the treatment of adult patients with
               advanced prostate cancer.

          B.  Compendial Use
               Prostate Cancer

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

 

     II.  CRITERIA FOR INITIAL APPROVAL

           Prostate Cancer
           Authorization of 12 months may be granted for treatment of
           prostate cancer when used as a single agent.

 
   III.  CONTINUATION OF THERAPY

           Authorization of 12 months may be granted for continued
           treatment in members requesting reauthorization who are
           experiencing clinical benefit to therapy (e.g., maintaining serum
           testosterone to less than 50ng/dL) and who have not
           experienced an unacceptable toxicity.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Orgovyx [package insert]. Brisbane, CA: Myovant Sciences, Inc; December 2020.
2. The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed July 6, 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.

December 01, 2022