Subject: Yonsa 2596-A SGM P2023

Drug

YONSA  (fine-particle abiraterone acetate)

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
               Yonsa is indicated in combination with methylprednisolone
               for the treatment of patients with metastatic castration-
               resistant prostate cancer (CRPC).

          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., apalutamide [Erleada]) or an oral androgen
          metabolism inhibitor (e.g., abiraterone acetate [Zytiga]).


  III.  CRITERIA FOR INITIAL APPROVAL

          Metastatic castration-resistant prostate cancer
          Authorization of 12 months may be granted for treatment of
          metastatic castration-resistant prostate cancer when the
          member has had a bilateral orchiectomy or will be using the
          requested medication in combination with a 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:

1. Yonsa [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; July 2022.
2. The NCCN Drugs & Biologics Compendium™ © 2023 National Comprehensive Cancer Network, Inc. http://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