Subject: Yonsa 2596-A SGM P2022

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.

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

            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 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. Yonsa [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; March 2021.
2. The NCCN Drugs & Biologics Compendium™ © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed July 6, 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