Subject: Erleada 2498-A SGM P2022

Drug

ERLEADA  (apalutamide)

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.

            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.

           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) analog. 

           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) analog. 

 
    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:

1.  Erleada [package insert]. Horsham, PA: Janssen Products, LP; April 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 29, 2022