Epiretinal Radiation Therapy for Age-Related Macular Degeneration (ARMD)
© Blue Cross and Blue Shield of Montana
Current Effective Date:
July 18, 2013
Original Effective Date:
April 09, 2012
July 18, 2013
April 15, 2013
Epiretinal radiation describes the intraocular administration of radiation to the choroidal vascular bed of the retina to treat age-related macular degeneration (ARMD). ARMD 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 ARMD may be observed. The first, called the atrophic or areolar or dry form, evolves slowly. Atrophic ARMD 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 ARMD. The wet form is distinguished from the atrophic form by the development of CNV and serous or hemorrhagic detachment of the retinal pigment epithelium. Risk of developing severe irreversible loss of vision is greatly increased by the presence of choroidal neovascularization (CNV).
The NeoVista Epi-Rad90™ Ophthalmic System has been developed 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 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. An investigational device exemption (IDE) has been granted by the U.S. Food and Drug Administration (FDA) for a phase III multi-center trial to provide data for application to the FDA; this is a category B procedure.
Blue Cross Blue Shield of Montana (BCBSMT) considers epiretinal radiation therapy using intraocular placement of a radiation source for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (ARMD) experimental, investigational and unproven.
Investigational for all diagnoses
H35.30, H35.31, H35.32, 08B43ZZ, 08B53ZZ, 08H031Z, 08H0X1Z, 08H131Z, 08H1X1Z
- A prospective, randomized, double-masked trial on radiation therapy for neovascular age-related macular degeneration (RAD Study). Radiation Therapy for Age-related Macular Degeneration. Ophthalmology (1999) 106(12):2239-47.
- Stevenson, M.R., Hart, P.M., et al. Visual functioning and quality of life in the SubFoveal Radiotherapy Study (SFRADS): SFRADS report 2. British Journal of Ophthalmology (2005) 89(8):1045-51.
- Avila, M.P., Farah, M.E., et al. 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 (2009) 29(2):157-69.
- Avila, M.P., Farah, M.E., et al. 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. Br J Ophthalmol (2009) 93(3):305-9.
- Chalam, K.V., Balaiya, S., et al. Evaluation of choroidal endothelial cell proliferation after exposure to varying doses of proton beam radiation. Retina (2011) 31(1):169-76.
- Epiretinal Radiation Therapy for Age-Related Macular Degeneration. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 February) Vision 9.03.20.
||New Policy for BCBSMT: Policy created with literature review; considered investigational|
||Policy formatting and language revised. Policy statement unchanged.|