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| Description/Scope |
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This document addresses the use of intraocular epiretinal brachytherapy, which has been proposed as a treatment of exudative age-related macular degeneration.
| Position Statement |
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Investigational and Not Medically Necessary:
Intraocular epiretinal brachytherapy is considered investigational and not medically necessary as a treatment of exudative age-related macular degeneration (AMD) and for all other indications.
| Rationale |
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Intraocular epiretinal brachytherapy is a procedure which utilizes a pen-sized intraocular epiretinal device that delivers strontium-90 radiation directly to the leaking vessels in the retina that affect central vision. Intraocular epiretinal brachytherapy is purported to provide high-dose radiation therapy while reducing the exposure of radiation to the surrounding tissue.
Avila (2009) reported on a study which evaluated the short-term safety and feasibility of epiretinal brachytherapy delivered along with intravitreal bevacizumab for the treatment of AMD for 12 months. Thirty-four participants received a single treatment with 24 Gy beta radiation and two injections of bevacizumab. No radiation-associated adverse events were observed 12 months after treatment. At 12 months, 91% of participants lost less than 3 lines of vision, 68% of participants improved or maintained their best corrected visual acuity and 38% of participants gained greater than 3 lines of vision. The safety and efficacy of intraocular epiretinal brachytherapy given along with bevacizumab for the treatment of AMD looks promising. The authors stated that long-term safety will be assessed for 3 years in a large, multicenter phase III study. Further studies are needed prior to drawing conclusions regarding the safety and efficacy of intraocular, epiretinal brachytherapy for AMD.
Avila and colleagues (2012) reported on 34 participants with subfoveal choroidal neovascularization secondary to AMD in a prospective, multi-center nonrandomized feasibility study. Each participant received epimacular brachytherapy. All participants were followed for 24 months and 19 participants were followed for 36 months. At 24 months, 22 of 34 eyes had lost less than or equal to 15 letters from baseline, 12 of 34 eyes gained greater than or equal to 1 letter from baseline and 5 of 34 eyes had gained greater than or equal to 15 letters. At 36 months, 17 of 19 eyes had lost less than or equal to 15 letters from baseline, 10 of 19 eyes gained greater than or equal to 1 letter, and 4 of 19 eyes gained greater than or equal to 15 letters. During the first year of study, 4 additional treatments were given to 3 eyes, in the second year of study 10 additional treatments were given to 7 eyes, and in the third year of study 4 treatments were given to 4 eyes. The study was not designed nor powered to assess efficacy. And while brachytherapy shows promise, efficacy outcomes will need to be studied using suitably designed trials that are powered with a sufficient sample size.
In a prospective, multicenter, interventional, noncontrolled trial, Dugel (2012) reported on 53 participants with neovascular AMD who received epiretinal brachytherapy. Participants were followed for 12 months and evaluated for safety and efficacy. At 12 months, 81.1% of participants lost less than 15 letters, 47.3% of participants gained 1 or more letters, and 9.4% of participants gained 15 or more letters. Adverse events included subconjunctival hemorrhage (38 participants), cataract development or progression (16 participants), vitreous hemorrhage (6 participants), and ocular pain or discomfort (5 participants). The lack of a control group makes it difficult to attribute adverse events to treatment versus underlying disease process. The authors note “radiation retinopathy may not present within the first year of treatment, and patients will be followed up for 3 years.” In light of these limitations, the efficacy and safety results should be used primarily to support further evaluation. Petrarca and colleagues (2013) reported on the 24 month safety and efficacy of the above trial of 53 participants. The participants underwent vitrectomy with a single dose of brachytherapy. The participants were retreated with ranibizumab as necessary on a monthly basis. The primary outcomes at 24 months were the proportion of participants losing less than 15 letters and the mean number of ranibizumab retreatments. Over 24 months, 68.1% of participants lost less than 15 letters with a mean of 8.7 ranibizumab retreatments. The mean change in visual acuity was 6.3 letters. The reduction in ranibizumab retreatment was less evident in year 2 than in year 1. There was some moderate reduction in visual acuity extending into the second year.
In 2013, Dugel and colleagues reported on the safety and efficacy of epiretinal brachytherapy for the treatment of AMD. In this multicenter, randomized, active-controlled, phase III clinical trial, 494 participants were randomized in a 2:1 ratio to epiretinal brachytherapy or a ranibizumab monotherapy control arm. The participants in the brachytherapy arm received two mandated, monthly loading doses of ranibizumab while the control arm received three mandated, monthly loading injections of ranibizumab then quarterly injections. The outcome was the proportion of participants who lost fewer than 15 letters from baseline visual acuity and the proportion who gained more than 15 letters from baseline visual acuity. At 24 months, 77% of the brachytherapy treatment group and 90% of the control group lost fewer than 15 letters. There was a prespecified margin of 10% which was not met. The brachytherapy group did not meet the endpoint for the proportion of participants gaining more than 15 letters. The authors concluded that the 2-year efficacy data did not support the use of epiretinal brachytherapy for AMD.
A 2015 retrospective study by Zur and colleagues reported on the safety and efficacy of epiretinal brachytherapy in 22 participants with choroidal neovascularization due to AMD who had received prior anti-VEGF injections. The participants received a single dose of brachytherapy and continued to be re-treated with anti-VEGF injections if needed. A total of 20 participants were available after 12 months of follow-up. Stable vision was maintained by 10 participants, vision was gained by 8 participants, and 2 participants lost more than 3 Snellen lines. While some of the participants showed some benefit from epiretinal brachytherapy, larger numbers of participants with prospective studies are needed to determine the therapeutic efficacy.
In a 2016 phase III randomized controlled trial, Jackson and colleagues studied the safety and efficacy of epimacular brachytherapy in participants with AMD who had previously received ranibizumab therapy. The authors hypothesized that the use of epimacular brachytherapy would decrease the number of ranibizumab injections needed. Participants were randomized to one of two treatment arms; pars plana vitrectomy with epimacular brachytherapy and ongoing ranibizumab therapy (n=224) or ongoing ranibizumab monotherapy (n=116). Primary outcome measures included the number of ranibizumab injections and best-corrected visual acuity. In the epimacular brachytherapy treatment arm, the mean number of ranibizumab injections was 4.8 and the mean visual acuity change was -4.8 letters. In the ranibizumab only treatment arm, the mean number of ranibizumab injections was 4.1 and the mean visual acuity change was -0.9 letters. More adverse effects occurred in the epimacular brachytherapy group with the most common events being visually significant cataract requiring surgery, reduced visual acuity, and eye pain. Following participants for 12 months, those who received epimacular brachytherapy averaged more ranibizumab injections and had worse visual acuity than those who continued with ranibizumab monotherapy. At this time, this study does not support the use of epimacular brachytherapy for AMD.
A Cochrane review by Evans in 2010 evaluated the use of radiation therapy for the treatment of AMD. While the incidence of adverse reactions was low, the results of the different trials were inconsistent and the “review currently does not provide convincing evidence that radiotherapy is an effective treatment for neovascular AMD.”
At the time of this review, no device has received approval from the United States Food and Drug Administration (FDA).
| Background/Overview |
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AMD is the leading cause of legal blindness in individuals over age 60 in developed nations. AMD is broadly classified into two types: nonexudative (dry) and exudative (wet). Wet AMD arises from abnormal blood vessels behind the retina which start to grow under the macula (the light sensitive part of the retina). These new blood vessels have a tendency to be very fragile and often leak fluid and blood. The blood and fluid cause the macula to move from its normal position at the back of the eye. Loss of central vision (needed for seeing objects clearly and for activities such as reading and driving), can occur rapidly. Dry (nonexudative) AMD occurs when the light-sensitive cells in the macula gradually break down, resulting in blurred central vision in the affected eye. Over time, as less of the macula functions, central vision is gradually lost in the affected eye.
| Definitions |
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Age-related macular degeneration (AMD): A slowly progressive, painless disease affecting the macula that blurs the sharp, central vision needed for "straight-ahead" activities such as reading, sewing, and driving.
Brachytherapy (also known as internal radiation): A type of radiation treatment used to stop the growth of cancer cells by implanting radioactive material directly into the tumor or into the surrounding tissues.
Neovascular (Wet) AMD: This is a subset of AMD representing approximately 10% of all cases but accounting for 90% of the severe vision loss. AMD occurs when abnormal blood vessels behind the retina start to grow under the macula. These new blood vessels tend to be very fragile and often leak blood and fluid which thickens the macula and damages the photoreceptors. This damage to the macula can occur rapidly, resulting in a sudden loss of central vision. Wet AMD is considered to be advanced AMD and is more severe than the dry form.
Radiation therapy: Also known as radiotherapy, this technique uses ionizing radiation to deposit energy at targeted tissue to injure or destroy it.
| Coding |
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The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Investigational and Not Medically Necessary:
| CPT |
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| 67299 |
Unlisted procedure, posterior segment [when specified as intraocular epiretinal brachytherapy] (used in conjunction with vitrectomy code 67036) |
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| ICD-10 Diagnosis |
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All diagnoses |
| References |
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Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
| Websites for Additional Information |
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| Index |
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Epi-Rad90 Ophthalmic System
Intraocular Epiretinal Brachytherapy
The use of specific product names is illustrative 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.
| Document History |
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| Status |
Date |
Action |
| Reviewed |
01/24/2019 |
Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References section. |
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12/27/2018 |
Updated Coding section with 01/01/2019 CPT changes; removed 0109T deleted 12/31/2018, added 67299. |
| Reviewed |
01/25/2018 |
MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale and References sections. |
| Reviewed |
05/04/2017 |
MPTAC review. Updated References section. |
| Reviewed |
05/05/2016 |
MPTAC review. Updated Rationale and References sections. Removed ICD-9 codes from Coding section. |
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01/01/2016 |
Changed the document number from RAD.00056 to THER-RAD.00009. |
| Reviewed |
05/07/2015 |
MPTAC review. Updated Description, Rationale, Background and Reference sections. |
| Reviewed |
05/15/2014 |
MPTAC review. Updated Rationale and References. |
| Reviewed |
05/09/2013 |
MPTAC review. Updated Rationale and References. |
| Reviewed |
05/10/2012 |
MPTAC review. Rationale and References updated. |
| Reviewed |
05/19/2011 |
MPTAC review. Updated Rationale, Definitions and References. |
| Reviewed |
05/13/2010 |
MPTAC review. Updated Rationale, Definitions, and References. |
| Reviewed |
05/21/2009 |
MPTAC review. Updated Definitions, References, Coding and Web Sites. |
| New |
05/15/2008 |
MPTAC initial document development. |