Subject: Orgovyx SGM 4411-A P2024_R

Drug

ORGOVYX  (relugolix)

Policy:

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.

FDA-APPROVED INDICATIONS

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

Compendial Uses

Prostate Cancer

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

Coverage Criteria

Prostate Cancer

Authorization of 12 months may be granted for treatment of prostate cancer.

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; August 2023.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed August 1, 2024.

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.

January 01, 2025