Subject: Visudyne 3011-A SGM P2024

Drug

VISUDYNE (  (verteporfin injection)

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
               Visudyne for injection is indicated for the treatment of patients with predominantly classic
               subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic
               myopia or presumed ocular histoplasmosis.

          B.  Compendial Indications
               1.  Classic subfoveal choroidal neovascularization due to chronic central serous
                    chorioretinopathy
               2.  Choroidal hemangioma

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


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Choroidal neovascularization
               Authorization of 6 months may be granted for treatment of predominantly classic subfoveal
               choroidal neovascularization (CNV) when both of the following criteria are met:
               1.  Member has predominantly classic subfoveal choroidal neovascularization due to ONE
                    of the following:
                    a.  Age-related macular degeneration
                    b.  Pathologic myopia
                    c.  Presumed ocular histoplasmosis
                    d.  Chronic central serous chorioretinopathy (also includes retinal pigment epithelial
                         leakage without evident CNV)
               2.  The treatment spot size is less than or equal to 6.4 mm in diameter.

          B.  Choroidal hemangioma
          Authorization of 6 months may be granted for treatment of choroidal hemangioma.


  III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment of an indication listed in
          Section II for members who have demonstrated a positive clinical response to therapy.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Visudyne [package insert]. Charleston, SC: Alcami Carolinas Corporation; February 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.

June 16, 2024