Subject: Scenesse 3355-A SGM P2023

Drug

SCENESSE  (afamelanotide)

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
          Scenesse is a melanocortin 1 receptor (MC1-R) agonist indicated
          to increase pain free light exposure in adult patients with a
          history of phototoxic reactions from erythropoietic
          protoporphyria.

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


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate
          the prior authorization review:
          A.  Initial requests: Increased level of protoporphyrin in
               peripheral red blood cells.


  III.  CRITERIA FOR INITIAL APPROVAL

          Erythropoietic protoporphyria
          Authorization of 12 months may be granted for the treatment of
          biochemically confirmed erythropoietic protoporphyria in adult
          members who have a protoporphyrin level above the lab
          reference range in peripheral red blood cells.


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for adult members
          with an indication in Section III who are experiencing benefit
          from therapy while receiving Scenesse.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Scenesse [package insert]. Burlingame, CA: Clinuvel Inc.; October 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 31, 2023