Subject: Visudyne 3011-A SGM P2021

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:

IV. REFERENCES

1. Visudyne [package insert]. Charleston, SC: Alcami Carolinas Corporation; September 2020.
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 24, 2021