Verteporfin (Visudyne®)
Requires Step Therapy See “Step Therapy Requirements for Provider Administered Specialty Medications” Document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
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.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 1/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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