Age-related macular degeneration (AMD) is characterized in its earliest stages by minimal visual impairment and the presence of large drusen and other pigmentary abnormalities on ophthalmoscopic examination. Two distinctively different forms of degeneration may be observed. The first, called the atrophic, areolar or dry form, evolves slowly. Atrophic AMD is the most common form of degeneration and may be a precursor of the more visually impairing exudative neovascular form, also referred to as disciform or wet AMD. 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.
Radiation therapy (e.g., NeoVista Epi-Rad90™ Ophthalmic 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.
Intraocular proton beam radiation therapy is being studied in clinical trials for the potential use in the management of choroidal neovascularization. Proton beam radiation is a type of linear line radiation therapy. The greatest amount of energy is expected to be released at the targeted site and should therefore cause less collateral damage to surrounding tissues and structures.
Intraocular placement of a radiation source for the treatment of choroidal neovascularization is considered investigational.
Intraocular proton beam therapy for the treatment of choroidal neovascularization is considered investigational.
Stereotactically guided radiation therapy for the treatment of choroidal neovascularization is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
The U.S. Food and Drug Administration (FDA), under the provisions of an Investigational Device Exemption (IDE), granted the NeoVista Epi-Rad90 System™ 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.
Well-designed studies with long-term follow-up published in peer-reviewed journals regarding the use of intraocular placement of a radiation source (e.g., NeoVista Epi-Rad90 System™) for the treatment of choroidal neovascularization are not available. It is not known if this technology improves net health outcomes.
There is a lack of published evidence of well-designed studies in peer review journals and randomized, controlled trials with long-term follow-up addressing the potential use of the proton beam therapy for the treatment of choroidal neovascularization.
American Academy of Ophthalmology Retina/Vitreous Panel. (2015). Preferred Practice Pattern® Guidelines. Age-related macular degeneration. Retrieved February 15, 2017 from www.aao.org/ppp.
Avila, M. P., Farah, M. E., Santos, A., Carla, L., Fuji, G., Rossi, J., et al. (2012). Three-year safety and visual acuity results of epimacular 90 strontium/90 yttrium brachytherapy with bevacizumab for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration. Retina, 32 (1), 10-18. (Level 2 evidence - Independent study)
BlueCross BlueShield Association. Evidence Positioning System. (3:2018). Intraocular radiation therapy for age-related macular degeneration (9.03.20). Retrieved January 28, 2019 from http://www.evidencepositioningsystem.com/. (16 articles and/or guidelines)
Cantley, J., Hanlon, J., Chell, E., Lee, C., Smith, W., and Bolch, W. (2013). Influence of eye size and beam entry angle on dose to non-targeted tissues of the eye during stereotactic x-ray radiosurgery of AMD. Physical Medical Biology, 58 (19), 6887-6896. (Level 5 evidence - Industry supported)
Chalam, K. V., Balaiya, S., Malyappa, R. S., Hsi, W., Brar, V. S., & Murthy, R. K. (2011). Evaluation of choroidal endothelial cell proliferation after exposure to varying doses of proton beam radiation. Retina, 31 (1), 169-176. (Level 5 evidence)
Dugel, P. U., Petrarca, R., Bennett, M., Barak, A., Weinberger, D., Nau, J., et al. (2012). Macular epiretinal brachytherapy in treated age-related macular degeneration: MERITAGE study: Twelve-month safety and efficacy results. Ophthalmology, 119 (7), 1425-1431. (Level 2 evidence - Industry sponsored)
National Institute for Health and Clinical Excellence (NICE). (2004; last update 2011). Interventional procedures guidance: radiotherapy for age-related macular degeneration. Retrieved January 28, 2019 from http://www.nice.org.uk/nice.
Petrarca, R., & Jackson, T. (2011). Radiation therapy for neovascular age-related macular degeneration. Clinical Ophthalmology, 2011 (5), 57-63. (Level 5 evidence - Industry supported)
Petrarca, R., Dugel, P., Bennett, M., Barak, A., Weinberger, D., Nau, J., et al. (2014). Macular epiretinal brachytherapy in treated age-related macular degeneration (MERITAGE): month 24 safety and efficacy results. Retina, 34 (5), 874-879. Abstract retrieved February 15, 2017 from PubMed database.
Slopsema, R., Mamalui, M., Zhao, T., Yeung, D., Malyappa, R., & Li, Z. (2014). Dosimetric properties of a proton beamline dedicated to the treatment of ocular disease. Medical Physics, 41 (1), 011707. Abstract retrieved February 15, 2017 from PubMed database.
ORIGINAL EFFECTIVE DATE: 7/10/2010
MOST RECENT REVIEW DATE: 3/28/2019
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