Subject: Visudyne 3011-A SGM P2023

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, OR
                    b.  Pathologic myopia, OR
                    c.  Presumed ocular histoplasmosis, OR
                    d.  Chronic central serous chorioretinopathy (also includes
                         retinal pigment epithelial leakage without evident
                         CNV), AND
               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 Visudyne
          therapy.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Visudyne [package insert]. Charleston, SC: Alcami Carolinas Corporation; February 2022.
2. van Rijssen, T.J., van Dijk, E.H.C., Yzer, S., Ohno-Matsui, K., Keunen, J.E.E., Schlingemann, R.O., Sivaprasad, S., Querques, G., Downes, S.M., Fauser, S., Hoyng, C.B., Piccolino, F.C., Chhablani, J.K., Lai, T.Y.Y., Lotery, A.J., Larsen, M., Holz, F.G., Freund, K.B., Yannuzzi, L.A., Boon, C.J.F., Central serous chorioretinopathy: Towards an evidence-based treatment guideline, Progress in Retinal and Eye Research (2019), doi: https://doi.org/10.1016/j.preteyeres.2019.07.003.
3. Tsipursky MS, Golchet PR, Jampol LM. Photogynamic therapy of choroidal hemangioma in sturge-weber syndrome, with a review of treatments for diffuse and circumscribed choroidal hemangiomas. Surv Ophthalmol. 2011; 56 (1): 68-85.

 

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.

August 18, 2023