Subject: Erleada 2498-A SGM P2023
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 Indications
1. Erleada is indicated for the treatment of patients with
non-metastatic castration-resistant prostate cancer.
2. Erleada is indicated for the treatment of patients with
metastatic castration-sensitive prostate cancer.
B. Compendial Use
Prostate Cancer
All other indications are considered
experimental/investigational and not medically necessary.
II. 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]).
III. CRITERIA FOR INITIAL APPROVAL
1. Non-metastatic castration-resistant prostate cancer
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 gonadotropin-
releasing hormone (GnRH) agonist or degarelix.
2. Metastatic castration-sensitive prostate cancer
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 gonadotropin-
releasing hormone (GnRH) agonist or degarelix.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section III 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:
- Erleada [package insert]. Horsham, PA: Janssen Products, LP; February 2023.
- The NCCN Drugs & Biologics Compendium™ © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org Accessed August 6, 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.
December 09, 2023
