Subject: Erleada SGM 2498-A P2025

Drug

ERLEADA  (apalutamide)

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 Indications¹

• Erleada is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
• Erleada is indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.

Compendial Uses²

Prostate Cancer

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

Exclusions

Coverage will not be provided if the requested medication is used in combination with a second-generation oral anti-androgen (e.g., enzalutamide [Xtandi]) or an oral androgen metabolism inhibitor (e.g., abiraterone acetate [Zytiga]).

Coverage Criteria

Non-metastatic castration-resistant prostate cancer^1,2

Authorization of 12 months may be granted for treatment of non-metastatic castration-resistant prostate cancer when the member has had a bilateral orchiectomy or will be using the requested medication in combination with a luteinizing hormone-release hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix).

Metastatic castration-sensitive prostate cancer^1,2

Authorization of 12 months may be granted for treatment of metastatic castration-sensitive prostate cancer when the member has had a bilateral orchiectomy or will be using the requested medication in combination with a luteinizing hormone-release hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix).

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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. Erleada [package insert]. Horsham, PA: Janssen Products, LP; August 2024.
2. The NCCN Drugs & Biologics Compendium™ © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org Accessed May 12, 2025.

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.

October 12, 2025