DESCRIPTION
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 distinctive 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.
Standard care for neovascular age-related macular degeneration includes intravitreal agents that target vascular endothelial growth factor. The intravitreal therapies may necessitate repeated intravitreal injections; therefore, alternative treatments such as intraocular radiation targeting proliferating cells that cause neovascular AMD are being investigated.
Brachytherapy (e.g., NeoVista Epi-Rad90™ Ophthalmic System) is proposed to treat CNV by delivering focal radiation to a subfoveal choroidal neovascular lesion. Stereotactic radiotherapy uses a robotically controlled device to deliver radiation beams through the inferior sclera to overlap at the macula.
POLICY
Intraocular placement of a radiation source (brachytherapy) for the treatment of choroidal neovascularization is considered investigational.
Stereotactic radiotherapy for the treatment of choroidal neovascularization is considered investigational.
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
No devices are specifically approved by the U.S. Food and Drug Administration (FDA) for intraocular radiation. An investigational device exemption was granted by the FDA for a phase 3 multicenter trial of the EPI-RAD90™ (now known as Vidion Anti-Neovascular Epimacular Brachytherapy [EMBT] System; NeoVista) to provide data for a device application to the FDA. This is a category B procedure.
SOURCES
American Academy of Ophthalmology. (2019). Preferred Practice Pattern® Guidelines. Age-related macular degeneration. Retrieved September 22, 2021 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)
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Intraocular radiotherapy for age-related macular degeneration (9.03.20). Retrieved January 25, 2024 from https://www.bcbsaoca.com/eps/. (19 articles and/or guidelines)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for vitrectomy (80.11). Retrieved September 22, 2021 from http://www.cms.gov.
Jackson, T. L., Soare, C., Petrarca, C., Simpson, A., Neffendorf, J. E., Petrarca, R., et al. (2020). Evaluation of month-24 efficacy and safety of epimacular brachytherapy for previously treated neovascular age-related macular degeneration: The MERLOT randomized clinical trial. JAMA Ophthalmology, 138 (8), 835-842. (Level 2 evidence)
Jackson, T.L., Chakravarthy, U., Slakter, J.S., Muldrew, A., Shusterman, E.M., O’Shaughnessy, D., et al. (2015). Stereotactic radiotherapy for neovascular age-related macular degeneration: year 2 results of the INTREPID study. Ophthalmology, 122 (1), 138-145. Abstract retrieved February 5, 2020 from PubMed database.
Jackson, T.L., Desai, R., Simpson, A., Neffendorf, J.E., Petrarca, R., Smith, K., et al. (2016). Epimacular brachytherapy for previously treated neovascular age-related macular degeneration (MERLOT): a phase 3 randomized controlled trial. Ophthalmology, 123 (6), 1287-1296. (Level 2 evidence)
National Institute for Health and Clinical Excellence (NICE). (2004; last reviewed 2012). Interventional procedures guidance: radiotherapy for age-related macular degeneration. Retrieved January 28, 2019 from http://www.nice.org.uk/nice.
National Institute for Health and Clinical Excellence (NICE). (2011; last reviewed 2012). Epiretinal brachytherapy for wet age-related macular degeneration. Retrieved November 13, 2020 from http://www.nice.org.uk/nice.
National Institute for Health and Clinical Excellence (NICE). (2018, January). Age-related macular degeneration. Retrieved September 22, 2021 from http://www.nice.org.uk/nice.
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.
ORIGINAL EFFECTIVE DATE: 7/10/2010
MOST RECENT REVIEW DATE: 3/14/2024
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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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