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Medical Policy: 09.03.03
Original Effective Date: September 2000
Reviewed: December 2011
Revised: December 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:
Age-related macular degeneration (ARMD) is a disease of unknown etiology, which affects the outer aspects of the retina and portions of the choroid. There are two types of ARMD, atrophic or "dry" and neovascular or "wet", both characterized by the growth of excessive choroidal blood vessels. The abnormal new blood vessel formations leak fluid and protein, leading to scarring of the macula and impaired vision.
Photodynamic therapy is a treatment modality designed to selectively occlude choroidal neovascular tissue.Verteporfin, marketed under the trade name Visudyne™, is a light activated drug (photosensitizer) used in the treatment of exudative ARMD. The drug is injected intravenously over a precise period of 10 minutes. After an additional five minute waiting period, a laser is used to activate the drug which has accumulated in the neovascular vessels. Free radicals are released which selectively damages the endothelial cells resulting in localized vascular occlusion of the abnormal vessels.
Photodynamic therapy with half-dose verteporfin administered for half the length of time and followed by laser in half the wait time has demonstrated safety and effectiveness in the treatment of chronic central serous choroidopathy. Improvement in best corrected visual acuity and reduction in macular thickness following half-dose photodynamic therapy have been reported by several authors.
Pegaptanib, marketed under the trade name Macugen®, is an injectable drug for the treatment of ARMD caused by choroidal neovascularization. The drug is injected into the vitreous cavity of the effected eye every six weeks.
Ranibizumab, marketed under the trade name LucentisTM, is another drug for intravitreal injection. The FDA approved labeled indication is for the treatment of patients with neovascular ARMD. The recommended dosage and frequency of treatment is 0.5 mg/0.05mL (10mg/mL), administered by intravitreal injection once in 30 days. Treatment may be continued monthly or reduced to one injection every three months after the first four injections, if monthly treatments are not feasible.
Aflibercept, marketed under the trade name of Eylea™, has received FDA approval for treatment of neovascular age-related macular degeneration. It is administered via intravitreal injection every 4 weeks for the first 3 months, followed by intravitreal injection every 8 weeks.
Anecortave, with the trade name Retaane™, is an angiostatic steroid currently being investigated for the prevention and treatment of ARMD, as well as for its effect on lowering intraocular pressure in patients with open-angle glaucoma. Retaane is deposited into the juxta-scleral space overlying the macula using a blunt-tipped, curved cannula. Once the cannula is in place, Retaane is slowly released over a 6-month period of time. Recent clinical trials have suggested additional research is needed to confirm safety and effectiveness as well as mechanism of action and clinical utility.
Bevacizumab, marketed under the trade name Avastin®, has been employed in the off-label use of intravitreal injection to treat neovascularization associated with ARMD and other ophthalmic conditions. Improvements in visual acuity and decreased retinal thickness by optical coherence tomography have been reported.
Radiation therapy is also being evaluated as a treatment for neovascular ARMD. Delivery methods include external beams or brachytherapy using radioactive isotopes. Radiation therapy has a longer duration of action than anti-VEGF agents, but there is a period of delayed effect on the neovascularization during which time the choroidal proliferation continues.
The VIDION ANV® Therapy System, formerly known as the EPI-RAD90™, delivers beta radiation using an epiretinal plaque brachytherapy technique to the area of neovascularization. The IRay™ stereotactic radiosurgical device delivers low-energy x-rays to the target area. Neither of these devices has received FDA approval.
Proton beam therapy delivers a linear line of radiation precisely to the target area, limiting damage to the surrounding tissue. Proton beam therapy releases the majority of energy at the target area versus conventional external beam radiation that releases the greatest amount of energy at the tissue surface affecting both healthy and diseased tissue.
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Prior Approval:
Not applicable
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Policy:
Photodynamic therapy with verteporfin as monotherapy may be considered medically necessary for the treatment of neovascular ARMD, and for choroidal neovascularization secondary to pathologic myopia and presumed ocular histoplasmosis.
Photodynamic therapy with verteporfin may be considered medically necessary as a treatment of central serous choroidopathy.
Photodynamic therapy with verteporfin is considered investigational when used in combination with one or more of the anti-vascular endothelial growth factor therapies (anti-VEGF), i.e., pegatanib (Macugen®), ranibizumab (Lucentis®), bevacizumab (Avastin®), as a treatment of choroidal neovascularization associated with ARMD, pathologic myopia, presumed ocular histoplasmosis, or for other ophthalmologic disorders, including choroidal neovascularization secondary to central serous chorioretinopathy.
The use of pegaptanib may be considered medically necessary for the treatment of neovasculr ARMD.
The use of pegaptanib for any other indication is considered investigational.
The use of ranibizumab may be considered medically necessary for the treatment of neovascular ARMD. The use of ranibizumab for any other choroidal vascular condition is considered investigational*.
The use of aflibercept may be considered medically necessary for the treatment of neovascular ARMD. The use of aflibercept for any other indication is considered investigational.
The use of anecortave acetate or any other drug not yet approved by the FDA for the treatment of neovascular ARMD, or any other indication, is considered investigational.
Although not FDA approved, the use of bevacizumab intravitreal injections for the treatment of ophthalmic conditions may be considered medically necessary. The peer reviewed medical literature substantiates ophthalmic use.
Radiation therapy for the treatment of neovascular ARMD, including epiretinal brachytherapy and external beam radiation, is considered investigational. The evidence is limited on the safety and efficacy of radiation therapy for the treatment of neovascular ARMD. Additional data from prospective well-designed randomized controlled trials with larger patient populations are needed.
*Please also refer to Wellmark’s policy on Intravitreal Angiogenesis Inhibitors for Retinal Vascular Conditions
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Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 67221 Destruction of localized lesion of choroid (eg, choroidal neovascularization); photodynamic therapy (includes intravenous infusion).
- 67225 Photodynamic therapy, second eye, at single session
- J3396 verteporfin 0.1mg.
- J3590 Unclassified biologics may be used to report ranibizumab
- J2503 Injection pegaptanib sodium, 0.3 mg
- J3590 Unclassified biologics may be used to report bevacizumab or aflibercept when billed for age-related macular degeneration
- C9257 Injection, bevacizumab, 0.25 mg
- C9291 Injection, aflibercept, 2mg
- J2778 Injection, ranibizumab, 0.1 mg
- 0124T Conjunctival incision with posterior juxtascleral placement of pharmacological agent (does not include supply of medication)
- 67028 intravitreal injection of a pharmacologic agent. Report modifier RT or LT with this code, as appropriate. If both eyes are treated on the same date, then the intravitreal injection must be reported on a single claim line using the bilateral modifier (-50), rather than on separate claims lines as for the drug.
- 0190T Placement of intraocular radiation source applicator (List separately in addition to primary procedure)
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Selected References:
- Hays alert summary. Photodynamic therapy drug for vision loss approved. Hays alert® critical development in medical technology assessment. Volume III, number 4 April 2000.
- Fong D, Benson WE, Bloome MA, Frambach DA, Krieger AE, Williams GA, Murphy RP, Cruckshanks K. Ophthalmic procedure preliminary assessment photodynamic therapy using verteporfin for age-related macular degeneration: Draft #2-June 7, 2000, prepared by the committee on ophthalmic procedures assessment retina panel. American Academy of Ophthalmology June 7,2000.
- Hayes Alert technology assessment brief. Photodynamic therapy with verteporfin (Visudyne™) for neovascular age related macular degeneration. Hays Alert® critical development in medical technology assessment. Volume III numbers 9, September 2000.
- Rubin GS, Bressler NM, The treatment of age-related macular degeneration with photodynamic therapy (TAP) study group. Retina 2002 Oct.;22(5):536-544.
- Azab M, Benchaboune M, et al. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trial: Treatment Of Age-Related Macular Degeneration With Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report No. 4. Retina. 2004 Feb;24(1):1-12.
- Gragoudas ES, Adamis AP, et al. Pegaptanib for Neovascular Age-Related Macular Degeneration. N Engl J Med. 2004 Dec 30;351(27):2805-16.
- Cunningham ET Jr, Adamis AP et al. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005 Oct;112(10):1747-57.
- D'Amico DJ, Goldberg MF,et al. Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes. Ophthalmology. 2003 Dec;110(12):2372-83.
- Heier JS, Antoszyk AN, et al. Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study. Ophthalmology. 2006 Apr;113(4):642.e1-4. Epub 2006 Feb 14.
- Avery RL, Pieramici DJ, Rabena MD et al. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmology 2006;113:363-72 e5.
- Maturi RK, Bleau LA, Wilson DL. Electrophysiologic findings after intravitreal bevacizumab (Avastin) treatment. Retina 2006;26:270-4.
- Spaide RF, Laud K, Fine HF et al. Intravitreal bevacizumab treatment of choroidal neovascularization secondary to age-related macular degeneration. Retina 2006; 26:383-90.
- Bashshur ZF, Bazarbachi A, Schakal A et al. Intravitreal bevacizumab for the management of choroidal neovascularization in age-related macular degeneration. Am J Ophthalmol 2006;142:1-9.
- Rich RM, Rosenfeld PJ, Puliafito CA et al. Short-term safety and efficacy of intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Retina 2006;26:496-511.
- American Academy of Ophthalmology Retina Panel. Preferred Practice Pattern® Guidelines. Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2008. Available at: http://www.aao.org/ppp.
- ECRI Institute. Anti-vascular Endothelial Growth Factors for Treatment of Wet Age-related Macular Degeneration. Plymouth Meeting (PA): ECRI Institute Health Technology Assessment Information Service; 2008 November 14. 141 p. (Evidence Report). Also available: http//www.ecri.org.
- Singerman LJ, Masonson H, Patel M, Adamis AP, buggage R, et al. Pegaptanib sodium for neovascular age-related macular degeneration: third-year safety results of the VEGF Inhibition Study in Ocular Neovascularisation (VISION) trial. Br J Ophthalmol. 2008 Dec;92(12):1606-11.
- Ziemssen F, Grisanti S, Bartz-Schmidt KU, spitzer MS. Off-label use of bevacizumab for the treatment of age-related macular degeneration: what is the evidence? Drugs Aging. 2009;26(4):295-320.
- Kaiser PK; Registry of Visudyne AMD therapy Writing committee, Boyer S, Garcia R, Hao Y, Hughes MS, et al. Verteporfin photodynamic therapy combined with intravitreal bevacizumab for neovascular age-related macular degeneration. Ophthalmology. 2009 Apr;116(4):747-55, 755.
- Mitchell P, Korobelnik JF, Lanzetta P, et al. Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials. Br J Ophthalmol. 2009 May 20.
- Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 20120 Dec 24(12):1743-1754. Epub 2010 Oct 08.
- Fujita K, Yuzawa M, Mori R. Retinal sensitivity after photodynamic therapy with half-dose verteporfin for chronic serous chorioretinopathy: Short-term results. Retina. 2010 Sep 30; [Epub ahead of print].
- Ruiz-Moreno JM, Lugo FL, Armada F et al. Photodynamic therapy for chronic central serous chorioretinopathy. Acta Ophthalmol. 2010 May;88(3):371-6. Epub 2009 Nov 27.
- Lim JW, Kang SW, Kim YT et al. Comparative study of patients with central serous chorioretinopathy undergoing focal laser photocoagulation or photodynamic therapy. Br J Ophthalmol. 2010 Jul 19; [Epub ahead of print].
- Prata TS, Tavares IM, Mello PA, et al. Hypotensive effect of juxtascleral administration of anecortave acetate in different types of glaucoma. J Glaucoma. 2009 Dec 30. [Epub ahead of print]
- Brown A, Hodge W, Cruess A, et al. Management of neovascular age-related macular degeneration: Systematic drug class review and economic evaluation. Technology Report No. 110. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); 2008.
- Robin AL, Clark AF, Covert DW, et al. Anterior juxtascleral delivery of anecortave acetate in eyes with primary open-angle glaucoma: A pilot investigation. Am J Ophthalmol. 2009b;147(1):45-50.
- ECRI Institute. Proton Beam Therapy for Age-related Macular Degeneration. Plymouth Meeting (PA): Hotline Service; 2011 September 12. Also available at http://www.ecri.com.
- Petrarca, Robert and Jackson, Timothy L. Radiation therapy for neovascular age-related macular degeneration. Clin Ophthalmol. 2011;5:57-63.
- Eylea™ (aflibercept) prescribing information. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; November 2011.
- National Institute for Health and Clinical Excellence (NICE). Epiretinal brachytherapy for wet age-related macular degeneration. Interventional procedure guidance 415. London, UK: NICE;2011 December. Available at URL address: http://www.nice.org.uk.
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Policy History:
Date Reason Action
December 2010 Annual review Policy revised
December 2011 Annual review Policy revised
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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 © 2012 American Medical Association. All Rights Reserved.
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