BlueCross and BlueShield of Montana Medical Policy/Codes
Epiretinal Radiation Therapy for Age-Related Macular Degeneration (ARMD)
Chapter: Radiology
Current Effective Date: July 18, 2013
Original Effective Date: April 09, 2012
Publish Date: July 18, 2013
Revised Dates: April 15, 2013
Description

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.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

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.

Rationale

A search of the MEDLINE database through June 2008 did not identify any peer-reviewed publications on epiretinal radiation.  The search did identify some older randomized trials using external beam radiotherapy for age-related macular degeneration (ARMD)-associated choroidal neovascularization (CNV).  Little to no benefit in visual acuity was observed following repeated single treatments of 2 Gy to a total of 12-20 Gy.  The absence of recent literature on external beam radiotherapy suggests that this treatment approach is not being pursued.

2011 Update

An updated literature search was performed using the MEDLINE database through December 2010. Two publications were identified by Avila and colleagues on epiretinal radiation using the EPI-RAD90™ system.  One report described 12-month safety and visual acuity results of a feasibility study in 34 treatment-naïve patients from Turkey, Mexico, and Brazil recruited between February 2005 and February 2006.  Patients received a single treatment with either 15 Gy (n=8) or 24 Gy (n=26).  Of the 21 patients (62%) who met inclusion criteria and were treated according to protocol, 50% (2 of 4) of the 15 Gy-treated patients and 76% (13 of 17) of the 24 Gy-treated patients improved or maintained their visual acuity at 12 months.  In the 24-Gy group, 29% (5 of 17) gained three lines or more in visual acuity.  The second report described 12-month safety and visual acuity results from 24-Gy epiretinal radiation combined with bevacizumab in 34 treatment-naïve patients enrolled between June 2006 and April 2007.  Although only 24 of the 34 patients enrolled met the protocol-specified eligibility criteria, all patients were included in the intent-to-treat (ITT) safety and efficacy analysis.  Twelve-month follow-up showed an average gain in best-corrected visual acuity (BCVA) of 8.9 letters; 68% of patients had stable or improved vision; and approximately 40% of patients had a gain of 15 or more letters (three lines).  No radiation exposure-related adverse events were detected within the first 12 months, although these events may not be detected for several years.  Adverse events related to the device or procedure included subretinal hemorrhage (n=1), retinal tear (n=1), subretinal fibrosis (n=2), epiretinal membrane (n=1), and cataract (6 of 24; 24 patients were phakic at baseline).  All occurrences of cataracts were deemed to be related to the vitrectomy procedure.  Long-term safety assessments will continue for three years.

The potential use of proton beam focal epiretinal radiation (Chalam et al. 2011) for management of choroidal neovascularization was described for an in vitro dose-response study using choroidal endothelial cells.  The investigators noted that given the radiation complications reported in clinical trials (including radiation retinopathy), further study is needed to test the differential toxicity of proton beam therapy in choroidal endothelial, retinal ganglion, and pigment epithelial cells.

A search of www.clinicaltrials.gov (available online) identified the following studies:

NCT00809419 – A Phase I and II study of the NeoVista Ophthalmic System for the treatment of subfoveal CNV associated with wet AMD in patients who require persistent anti-vascular endothelial growth factor (VEGF) therapy to maintain an adequate response to treatment (MERITAGE).  This study, which is being conducted at one site in the U.S., has closed recruiting with an estimated enrollment of 32 subjects.  The expected study completion date is January 2011.

NCT00679445 – A Phase II feasibility study to evaluate the safety and tolerability of the EPI-RAD90™ system, combined with an injection of ranibizumab (Lucentis®), in patients with AMD who have failed primary anti-VEGF therapy.  This study has closed recruiting (from two sites in the United States) with a projected enrollment of 20 subjects with AMD-related wet CNV.  The expected study completion date is June 2011.

NCT00454389 – This Phase III, CNV secondary to AMD treated with beta radiation epiretinal therapy (CABERNET) trial is a multicenter, randomized, controlled study to evaluate the safety and efficacy of beta radiation epiretinal therapy combined with two injections of ranibizumab (Lucentis®) versus ranibizumab alone.  This study has closed recruiting with a projected enrollment of 450 subjects with AMD-related wet CNV from international locations in addition to 30 sites in the U.S.  Final data collection for the primary outcome measure is expected to be completed September 2010.  The projected study completion date is 2011.

NCT01006538 – A multicenter Phase IV randomized controlled trial of macular epiretinal brachytherapy versus Lucentis [ranibizumab]-only treatment (MERLOT).  The trial is sponsored by King’s College Hospital National Health Service Trust in the United Kingdom (UK) and targets patients who are requiring frequent injections of ranibizumab, to try to reduce or eliminate the need for ongoing, regular eye injections.  The active control group will continue to receive intravitreal injection of ranibizumab on a monthly basis as required.  Fifteen sites in the UK will be participating.

Summary

The EPI-RAD90™ system remains under study, and has not been approved by the FDA.  Therefore, it continues to be considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

Rationale for Benefit Administration
 
ICD-9 Codes
Investigational for all diagnoses
ICD-10 Codes
H35.30, H35.31, H35.32, 08B43ZZ, 08B53ZZ, 08H031Z, 08H0X1Z, 08H131Z, 08H1X1Z 
Procedural Codes: 0190T, 67036
References
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
History
April 2012  New Policy for BCBSMT: Policy created with literature review; considered investigational
April 2013 Policy formatting and language revised.  Policy statement unchanged.
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Epiretinal Radiation Therapy for Age-Related Macular Degeneration (ARMD)