DESCRIPTION
Epiretinal radiation describes the intraocular administration of radiation to the choroidal vascular bed of the retina to treat age-related macular degeneration (ARMD). This technology is being investigated as a treatment for one form of ARMD.
There are two distinctively different forms of ARMD. The first, called the atrophic, areolar or dry form, evolves slowly. Atrophic ARMD is the most common form of degeneration. It may be a precursor of the more visually impairing exudative neovascular form, also referred to as disciform or wet ARMD. The wet form is distinguished from the atrophic form by the development of choroidal neovascularization (CNV) and serous or hemorrhagic detachment of the retinal pigment epithelium. The risk of developing severe irreversible loss of vision is greatly increased by the presence of CNV.
Epiretinal radiation therapy (e.g., NeoVista Epi-Rad90™ Ophthalmalic System) is being studied as a way to treat CNV by focal delivery of radiation to a subfoveal choroidal neovascular lesion. Using a standard vitrectomy procedure, the cannula tip of a handheld (pipette-like) surgical device is inserted into the vitreous cavity and positioned under visual guidance over the target lesion. The radiation source (strontium-90) is advanced down the cannula until it reaches the tip, which is then held in place over the lesion for a “prescribed” time to deliver focused radiation. The system is designed to deliver a one-time peak dose of beta particle energy (24 Gy) for a target area 3 mm in depth and up to 5.4 mm in diameter. This is believed to be below the dose that is toxic to the retina and optic nerve, and radiation exposure outside of the target area is expected to be minimal.
The NeoVista Epi-Rad90 System™ is accepted by the U.S. Food and Drug Administration (FDA) under the provisions of an Investigational Device Exemption (IDE) which allows the investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval application or a 510(k) submission to the FDA. This is an investigational research use.
POLICY
Intraocular placement of a radiation source for the treatment of choroidal neovascularization is considered investigational.
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, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed studies with long-term follow-up published in peer-reviewed journals regarding the use of intraocular placement of a radiation source for the treatment of choroidal neovascularization are not available. It is not known if this technology improves net health outcomes.
The FDA considers the NeoVista Epi-Rad90 System™ under the provisions of an Investigational Device Exemption (IDE) which allows the investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval application or a 510(k) submission to the FDA. This is a research use.
SOURCES
Avila, M. P., Farah, M. E., Santos, A., Kapran, Z., Duprat, J. P., Woodard, B. W., et al. (2009). Twelve-month safety and visual acuity results from a feasibility study of intraocular, epiretinal radiation therapy for the treatment of subfoveal CNV secondary to AMD. Retina, 29 (2), 157-69.
Avila, M. P., Farah, M. E., Santos, A., Duprat, J. P., Woodard, B. W., Nau, J. (2009). Twelve-month short-term safety and visual-acuity results from a multicentre prospective study of epiretinal strontium-90 brachytherapy with bevacizumab for the treatment of subfoveal choroidal neovascularisation secondary to age-related macular degeneration. British Journal of Ophthalmology, 93 (3), 305-309.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2010). Epiretinal radiation therapy for age-related macular degeneration (9.03.20). Retrieved January 21, 2010 from BlueWeb.
ORIGINAL EFFECTIVE DATE: 7/10/2010
MOST RECENT REVIEW DATE: 7/10/2010
ID_BA
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.
This document has been classified as public information.