Medicine Section - Epiretinal Radiation Therapy for Age-Related Macular Degeneration

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Epiretinal radiation therapy describes the intraocular administration of focused radiation to the subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration, also known as wet AMD.

The NeoVista Epi-Rad90™ Epiretinal Ophtalmic System (NeoVista® Inc.) is an ophthalmic device designed for delivery of epiretinal radiation. The system delivers focused radiation (Strontium-90) via cannula inserted in the vitreous cavity and positioned over the target tissue. The system received an investigational device exemption (IDE) by the U.S. Food and Drug Administration (FDA) for a phase III multi-center trial. 

POLICY/CRITERIA

Epiretinal radiation therapy for the treatment of subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD) is considered investigational.

POSITION STATEMENT

The evidence is not sufficient to permit conclusions about the benefits of epiretinal radiation therapy in the treatment of wet age-related macular degeneration (AMD):

• There is no reliable, long-term evidence from well-designed, well-executed randomized controlled trials on the effectiveness of epiretinal radiation therapy in the treatment of wet AMD.
• It is uncertain whether epiretinal radiation therapy offers any additional benefit compared to standard treatment, such as treatment with anti–vascular endothelial growth factors.

Effectiveness

Randomized Controlled Studies

No randomized controlled trials evaluated the effectiveness of epiretinal radiation therapy in the treatment of wet age-related macular degeneration (AMD). Three clinical trials are in progress, but there are no published data from these studies yet. (4)

Observational Studies

Two observational studies described the experiences of patients undergoing epiretinal radiation therapy. (5, 6) Both studies found the therapy promising. While these studies contribute to the body of knowledge on epiretinal radiation by providing direction for future research, the evidence from these studies is unreliable due to inherent design flaws such as non-random allocation of treatment and a lack of appropriate comparison groups.

SAFETY

The safety data on epiretinal radiation therapy is limited. In two studies, the patients did not experience short-term radiation-induced toxicity or adverse events that could be attributed to radiation exposure. No long-term safety data is available. Several adverse events unrelated to the radiation exposure were reported including, but not limited to, retinal tears, subretinal hemorrhage, cataracts, epiretinal membranes, subretinal fibrosis, and visual loss of more than three lines. (5, 6)

REFERENCES

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 9.03.20
2. Yanoff M, Duker JS. Ophthalmology, 3rd ed. St. Louis: Mosby, 2008
3. National Institute for Health and Clinical Excellence (NICE). Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Aug. 43 p. (Technology appraisal guidance; no. 155). http://www.guideline.gov/summary/summary.aspx?doc_id=13019&nbr=006 713&string=neovascular+AND+AMD (Verified 09/29/2009)
4. ClinicalTrials.gov: A service of the U.S. National Institutes of Health. http://clinicaltrials.gov/ct2/results?term=NeoVista (verified 09/15/2009)
5. Avila MP, Farah ME, Santos A at 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 Feb;29(2):157-69.
6. Avila MP, Farah ME, Santos A at 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 Mar;93(3):305-9. Epub 2008 Nov 19.

CROSS REFERENCES

Photocoagulation of Macular Drusen, Regence Medical Policy Manual, Surgery, Policy No. 116

Transpupillary Thermotherapy for Treatment of Choroidal Neovascularization, Regence Medical Policy Manual, Surgery, Policy No. 120

Conjunctival Incision with Posterior Juxtascleral Placement of Anecortave Acetate Depot Suspension, Regence Medical Policy Manual, Surgery, Policy No. 148

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