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Intraocular radiation, including brachytherapy, proton beam therapy, and stereotactic radiotherapy, are being evaluated to treat choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).
AMD is the leading cause of legal blindness in individuals older than age 60 in developed nations. 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 or 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. Risk of developing severe irreversible loss of vision is greatly increased by the presence of CNV.
Usual care for neovascular AMD may include photodynamic therapy or intravitreal injections of agents that target vascular endothelial growth factor, which may necessitate repeated intravitreal injections. Therefore, alternative treatments, such as intraocular radiation, including brachytherapy, proton beam therapy (PBT), and stereotactic radiotherapy, are being investigated.
The NeoVista Epi-Rad90 Ophthalmalic System, a brachytherapy device, treats CNV by delivery of focal 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 gray) for a target area 3 mm in depth and up to 5.4 mm in diameter. This dose is believed to be below that toxic to the retina and optic nerve. Radiation exposure outside of the target area is expected to be minimal.
PBT is a type of external radiation that uses charged atomic particles (protons or helium ions) to target a given area. PBT differs from conventional electromagnetic (photon) radiotherapy in that, with PBT, there is less scatter as the particle beams pass through tissue to deposit ionizing energy at precise depths (Bragg peak). The theoretical advantage of PBT over photon therapy is the ability to deliver higher radiation doses to the target without harm to adjacent normal tissue.
Stereotactic radiotherapy is a nonsurgical procedure performed in an office setting. It uses a robotically controlled device to deliver radiation beams through the inferior sclera to overlap at the macula.
Other Treatments for AMD
Other available therapeutic options for AMD not addressed in this policy include photodynamic therapy, (see Photodynamic Therapy for Subfoveal Choroidal Neovascularization) and vascular endothelial growth factor (VEGF) antagonists or angiostatics (see Intravitreal Angiogenesis Inhibitors for Choroidal Vascular Conditions).
For those whose visual losses impair their ability to perform daily tasks, low-vision rehabilitative services offer resources to compensate for deficits. Another treatment for AMD that is considered investigational is addressed in the following policy: Transpupillary Thermotherapy for Treatment of Choroidal Neovasculariation.
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 U.S. Food and Drug Administration (FDA) for a phase III multi-center 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.
POLICYIntraocular placement of a radiation source (brachytherapy) for the treatment of choroidal neovascularization is considered investigational.
Proton beam therapy for the treatment of choroidal neovascularization is considered investigational.
Stereotactic radiotherapy for the treatment of choroidal neovascularization is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/16/2008: Policy added
11/20/2008: Approved by Medical Policy Advisory Committee (MPAC)
04/23/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
04/20/2011: Policy reviewed; no changes.
03/27/2012: Policy reviewed; no changes.
07/19/2013: Policy title changed from "Epiretinal Radiation Therapy for Age-Related Macular Degeneration" to "Intraocular Radiation Therapy for Age-Related Macular Degeneration." Added the following investigational policy statement: Intraocular proton beam therapy for the treatment of choroidal neovascularization is considered investigational.
09/16/2014: Policy reviewed; description updated regarding other treatments for AMD. Added policy statement that stereotactic radiation therapy for the treatment of choroidal neovascularization is considered investigational.
02/27/2015: Policy title updated to change "Radiation Therapy" to "Radiotherapy." Policy description updated. Policy statements unchanged.
08/27/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 14.27 to the Code Reference section.
04/22/2016: Policy description updated regarding proton beam therapy, stereotactic radiotherapy, and devices. Policy statements clarified as to type of radiation therapy used; intent unchanged. Second investigational statement updated to change "Intraocular proton beam therapy" to "Proton beam therapy." Third investigational statement updated to change "radiation therapy" to "radiotherapy." Investigative definition updated in policy guidelines section.
05/27/2016: Policy number added.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 9.03.20
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.