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Medical Policy: 09.03.10
Original Effective Date: November 2009
Reviewed: January 2012
Revised: February 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Ozurdex®, a dexamethasone intravitreal implant, is indicated for the treatment of macular edema occurring after branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and non-infectious uveitis affecting the posterior segment of the eye. It contains a biodegradable steroid which has been injected into a NovadurTM solid polymer drug delivery system (DDS) that provides an extended drug release. Ozurdex® is pre-loaded into a single-use, specifically designed DDS applicator to facilitate injection of the rod-shaped implant directly into the vitreous.
When steroids are administered intravitreally the blood-ocular barrier is bypassed to achieve therapeutic levels in the eye and minimize systemic side effects. Dexamethasone has been shown to control inflammation by inhibiting numerous inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
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Prior Approval:
Not applicable
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Policy:
Ozurdex®/dexamethasone intravitreal implant may be considered medically necessary for the treatment of:
- macular edema occurring after branch retinal vein occlusion
- macular edema occurring after central retinal vein occlusion
- non-infectious uveitis affecting the posterior segment of the eye
Ozurdex®/dexamethasone intravitreal implant for any other indication, including the treatment of diabetic macular edema, is considered investigational because of insufficient evidence of its effectiveness.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- J7312 Injection, dexamethasone, intravitreal implant, 0.1 mg
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Selected References:
- Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Deliv. 2006 Mar;3(2):275-87.
- Janoria KG, Gunda S, Boddu SH, Mitra AK. Novel approaches to retinal drug delivery. Expert Opin Drug Deliv. 2007 Jul;4(4):371-88.
- Booth BA, Vidal Denham L, Bouhanik S, Jacob JT, Hill JM. Sustained-release ophthalmic drug delivery systems for treatment of macular disorders: present and future applications. Drugs Aging. 2007;24(7):581-602.
- Kuppermann B, Blumenkranz M, Haller J, Williams G, et al.; for the Dexamethasone DDS Phase II Study Group. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007 Mar;125(3):309-17.
- Johnson, MW. Etiology and Treatment of Macular Edema. Am J Ophthalmol 2009 Jan;147(1):11-21.
- Lee SS, Hughes PM, Robinson MR. Recent advances in drug delivery systems for treating ocular complications of systemic diseases. Curr Opin Ophthalmol. 2009 Nov;20(6):511-9.
- Haller JA, Dugel P, Weinberg DV, Chou C, Whitcup SM. Evaluation of the safety and performance of an applicator for a novel intravitreal dexamethasone drug delivery system for the treatment of macular edema. Retina. 2009 Jan;29(1):46-51.
- Haller JA, Kupperman BD, Blumendranz MS, et al; Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Archives of Opthalmology. 2010 Mar;128(3):289-296.
- Haller JA, Bandello F, Belfort R Jr, et al; Randomized, sham-controlled trial of dexamethasone intravitreal iplant in patients with macular edema due to retinal vein occlusion. Opthalmology. 2010 Jun;117(6):1061-1063.
- U.S. Food and Drug Administration (FDA). Supplemental approval: Ozurdex (dexamethasone intravitreal implant) in the treatment of non-infectious uveitis affecting the posterior segment of the eye. NDA 022315/S-003. Rockville, MD: FDA; September 24, 2010.
- National Institute for Health and Clinical Excellence (NICE). Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion. Technology Appraisal Guidance 229. London, UK: NICE; July 2011.
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Policy History:
Date Reason Action
February 2011 Annual review Policy revised
January 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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