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Photodynamic Therapy for Choroidal Neovascularization

Policy Number: MP-047

Latest Review Date: March 2021

Category:  Medication/Drug                                                 

Policy Grade:  A

POLICY:

Photodynamic therapy (PDT) may be considered medically necessary when used as a treatment for one of the following indications:

  • Choroidal neovascularization (CNV) associated with age-related macular degeneration
  • Pathologic myopia
  • Presumed ocular histoplasmosis syndrome
  • Chronic central serous chorioretinopathy
  • Circumscribed choroidal hemangioma

*U.S. Food and Drug Administration (FDA) labeling for Visudyne® (verteporfin) indicates that the physician should reevaluate the patient every three months and, if choroidal neovascularization leakage is detected on fluorescein angiography, therapy should be repeated. However, the total number of treatments is not addressed by FDA. Evidence defining when treatment should stop is not available, but expert opinion (convened by Novartis, Visudyne® [verteporfin] manufacturer) suggested stopping “when the situation is judged to be ‘futile’” (Visudyne® [verteporfin] Roundtable Participants 2005). FDA labeling states that the “safety and efficacy of Visudyne® (verteporfin) beyond two years have not been demonstrated.”

Photodynamic therapy is considered investigational when used as a treatment for other ophthalmologic disorders.

Photodynamic therapy is considered investigational when used in combination with one or more of the anti-vascular endothelial growth factor therapies (anti-VEGF), including, but not limited to: pegaptanib (Macugen®), ranibizumab (Lucentis®), bevacizumab (Avastin®), aflibercept (Eylea™) as a treatment of choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, presumed ocular histoplasmosis, chronic central serous chorioretinopathy, circumscribed choroidal hemangioma, or for other ophthalmologic disorders.

DESCRIPTION OF PROCEDURE OR SERVICE:

Verteporfin photodynamic therapy (VPDT) is a treatment modality designed to selectively occlude ocular choroidal neovascular tissue. The therapy is a two-step process, consisting initially of an injection of the photosensitizer verteporfin, followed 15 minutes later by laser treatment to the targeted sites of neovascularization in the retina. The laser treatment selectively damages the vascular endothelium, thereby occluding choroidal neovascularization tissue. Patients may be retreated if leakage from choroidal neovascularization persists.

Vision Loss

Severe vision loss can occur with ocular neovascularization, the growth of abnormal blood vessels in the retina or choroid. Neovascularization occurs in a number of ocular diseases, including age-related macular degeneration (AMD).

Age-Related Macular Degeneration

Age-related macular degeneration is a degenerative disease of the retina that results in loss of central vision. Two distinctive forms, known as dry and wet degeneration, may be observed. The dry form (also known atrophic or areolar) is more common and is often a precursor of the wet form (also known as exudative neovascular or disciform). The wet form is more devastating and characterized by serous or hemorrhagic detachment of the retinal pigment epithelium and development of choroidal neovascularization, which greatly increases the risk of developing severe irreversible loss of vision. Choroidal neovascularization is categorized as classic or occult. Classic choroidal neovascularization appears as an initial lacy pattern of hyperfluorescence followed by more irregular patterns as the dye leaks into the subretinal space. Occult choroidal neovascularization lacks the characteristic angiographic pattern. Classic choroidal neovascularization carries a worse prognosis for vision than occult choroidal neovascularization, suggesting that the proliferative response that obscures new vessels may also favorably alter the clinical course of age-related macular degeneration.

Pathologic Myopia

Pathologic myopia refers to an abnormal elongation of the eye associated with severe near-sightedness. It generally occurs among people older than 30 years of age and can result in a progressive, severe loss of vision, frequently related to the development of CNV. Verteporfin photodynamic therapy (VPDT) has also been investigated in patients with CNV related to pathologic myopia. Antivascular endothelial growth factor (anti-VEGF) therapy is now considered a first-line intervention in patients with myopic CNV.

Presumed Ocular Histoplasmosis

Presumed ocular histoplasmosis may be the second most common cause of blindness in patients younger than 50 years of age in certain endemic areas (Ohio and Mississippi River Valleys in the United States). This condition is characterized by a positive skin test for histoplasmosis, miliary opacities of the lungs, tiny choroidal scars, peripapillary disruption of the choriocapillaris, and exudation or hemorrhage from choroidal lesions in or near the macula. The condition is asymptomatic and benign, unless the CNV lesions, which may develop many years after chorioretinal scarring has taken place, affect the macula.

Central Serous Chorioretinopathy

Central serous chorioretinopathy (CSC) refers to an idiopathic disease in which there is a serous detachment of the macula due to leakage of fluid from the choriocapillaris through the retinal pigment epithelium. This condition is avascular; however, neovascularization can occur as a secondary complication. In most cases, CSC resolves spontaneously in three to four months. However, in a few cases, chronic progression or recurrence can lead to the progressive decline of visual acuity. CSC has been treated with medication and laser photocoagulation, but these treatments have limited efficacy. Multiple definitions have been used in the literature to classify CSC as acute or chronic based cutoff time points (e.g., persistent fluid for less than three, four, or six months) or less frequently based on the timing of treatment. For example, acute CSC defined as the first attempted treatment to improve visual acuity, and chronic CSC is defined as being refractory to treatment. Further, multiple VPDT strategies that use either reduced-dose or half-fluency have been evaluated for the treatment of CSC because full-dose VPDT used in AMD has shown a potentially higher risk of developing choroidal ischemia and retinal atrophic changes.

Polypoidal Choroidal Vasculopathy

Polypoidal choroidal vasculopathy arises primarily from abnormal choroidal circulation, resulting in characteristic lesions comprising well-defined vascular networks of vessels ending in polyp-like structures. A less common subtype is polypoidal CNV, and it may be considered a subtype of AMD. Eyes that develop a cluster of grape-like polypoidal dilations are at high risk for severe vision loss.

Choroidal Hemangioma

Choroidal hemangioma is an uncommon, benign vascular tumor, manifesting as an orange-red mass in the posterior pole of the eye. Visual loss may be progressive and irreversible because of chronic foveal detachment.

Angioid Streaks

Angioid streaks result from crack-like breaks in the Bruch membrane (the innermost layer of the choroid) and occur in patients spontaneously or due to blunt trauma or associated with some systemic diseases such as pseudoxanthoma elasticum, Paget disease of bone, or sickle hemoglobinopathy. Vision loss in eyes with angioid streaks occurs most frequently as a result of CNV.

Treatment

Available therapeutic options for choroidal neovascularization (CNV) include anti-vascular endothelial growth factor (VEGF) inhibitors, VPDT, antioxidants, thermal laser photocoagulation and corticosteroids.  The safety and efficacy of each treatment depends on the form and location of the neovascularization.

Verteporfin photodynamic therapy is a treatment modality designed to selectively occlude ocular choroidal neovascular tissue. The therapy is a two-step process, consisting of an injection of the photosensitizer verteporfin, followed 15 minutes later by laser treatment to the targeted sites of retinal neovascularization. The laser treatment selectively damages the vascular endothelium and occludes the neovacularized tissue. Patients may be retreated if leakage from choroidal neovascularization persists.

Monotherapy with VEGF inhibitors is now the current standard of care for treatment of CNV due to age-related macular degeneration and pathologic myopia. Combining VPDT with anti-VEGF inhibitors, concurrently or sequentially, has a biologic basis and has been investigated in multiple trials particularly in the treatment of CNV due to age-related macular degeneration and pathologic myopia.

The use of verteporfin photodynamic therapy in choroidal neovascularization has decreased substantially with the availability of antivascular endothelial growth factor therapy. Subsequent to U.S. Food and Drug Administration (FDA) approval of verteporfin photodynamic therapy in 2000, the FDA approved pegaptanib in 2004 and ranibizumab in 2006 for treatment of age-related macular degeneration related choroidal neovascularization. The approval of pegaptanib was based on a sham-controlled RCT, while ranibizumab was approved based on a head-to-head comparison with verteporfin photodynamic therapy in the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration (ANCHOR) trial. Intravitreal injections of antivascular endothelial growth factor drugs such as ranibizumab and bevacizumab have shown superior efficacy compared with verteporfin photodynamic therapy in multiple head-to-head trials. Currently, verteporfin photodynamic therapy is used for patients in whom vascular endothelial growth factor inhibitors are contraindicated or for those who fail to benefit from vascular endothelial growth factor inhibitors.

KEY POINTS:

The most recent literature review was updated through December 13, 2020.

Summary of Evidence

Age-Related Macular Degeneration

For individuals who have classic choroidal neovascularization due to age-related macular degeneration (AMD) who receive VPDT monotherapy, the evidence includes randomized controlled trials (RCTs) and systematic reviews of controlled trials. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Multiple RCTs support the superiority of VPDT in reducing visual loss and decreasing retinal thickness compared to placebo or sham procedure. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have choroidal neovascularization due to age-related macular degeneration who receive verteporfin photodynamic therapy plus antivascular endothelial growth factor therapy, the evidence includes two confirmatory RCTs (and their multiple analyses), multiple smaller RCTs, and a meta-analysis of existing trials. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. This evidence does not demonstrate improvements in visual acuity using combination therapy compared with antivascular endothelial growth factor monotherapy. Combination therapy may reduce the number of intravitreal injections needed, but this result has not been consistently reported across studies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have choroidal neovascularization due to age-related macular degeneration who receive verteporfin photodynamic therapy plus corticosteroids and/or antivascular endothelial growth factor therapy, the evidence includes three small RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The evidence does not demonstrate improvements in visual acuity with combination therapy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Pathologic Myopia

For individuals who have choroidal neovascularization due to pathologic myopia who receive verteporfin photodynamic therapy, the evidence includes a subgroup analysis from a large RCT. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The subgroup analysis showed verteporfin photodynamic therapy was more effective than placebo in preventing vision loss at one year but not in the second year. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have choroidal neovascularization due to pathologic myopia who receive verteporfin photodynamic therapy plus antivascular endothelial growth factor therapy, the evidence includes a small RCT and a retrospective cohort study. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The single RCT was likely underpowered to detect a clinically meaningful change in visual acuity outcomes. The retrospective cohort study did not demonstrate improvements in visual acuity with combination treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Presumed Ocular Histoplasmosis

For individuals who have choroidal neovascularization due to presumed ocular histoplasmosis who receive verteporfin photodynamic therapy, the evidence includes a small RCT and a prospective cohort study. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Lack of a control arm in the prospective cohort study and 50% lost to follow-up in the RCT preclude a meaningful interpretation of data of observed improvements in visual acuity outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Central Serous Chorioretinopathy

For individuals who have choroidal neovascularization due to acute central serous chorioretinopathy who receive verteporfin photodynamic therapy, the evidence includes two RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Although the evidence has demonstrated that full and reduced doses of verteporfin photodynamic therapy result in a small improvement in visual acuity outcomes, the improvements did not meet clinically meaningful thresholds. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have choroidal neovascularization due to chronic central serous chorioretinopathy who receive verteporfin photodynamic therapy, the evidence includes multiple retrospective studies. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Although this relatively large body of retrospective studies has shown that half-dose verteporfin photodynamic therapy yields positive functional and anatomic outcomes while, at the same time, reducing the potential adverse events associated with conventional verteporfin photodynamic therapy, data from RCTs for multiple verteporfin photodynamic therapy strategies are lacking. The evidence is insufficient that the technology results in an improvement in the net health outcome.

Polypoidal Choroidal Vasculopathy

For individuals who have choroidal neovascularization due to polypoidal choroidal vasculopathy who receive verteporfin photodynamic therapy, the evidence includes several prospective cohort studies and a meta-analysis of two RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Prospective cohort studies have reported favorable anatomic and visual acuity outcomes for patients treated with verteporfin photodynamic therapy. However, RCTs comparing verteporfin photodynamic therapy with antivascular endothelial growth factor therapies have reported no statistically significant differences in visual acuity outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have choroidal neovascularization due to polypoidal choroidal vasculopathy who receive verteporfin photodynamic therapy plus antivascular endothelial growth factor therapy, the evidence includes two small RCTs, a meta-analysis, and two retrospective cohort studies. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Results of the two RCTs failed to demonstrate statistically significant differences in visual acuity outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Choroidal Hemangioma

For individuals who have choroidal neovascularization due to choroidal hemangioma who receive verteporfin photodynamic therapy, the evidence includes a systematic review of case series and a prospective cohort study. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Although the prospective cohort suggested a favorable effect of verteporfin photodynamic therapy on various visual acuity and anatomic outcomes in patients with choroidal hemangioma, data from RCTs are lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Angioid Streaks

For individuals who have choroidal neovascularization due to angioid streaks who receive verteporfin photodynamic therapy, the evidence includes a systematic review of case series. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Data from multiple case series have shown conflicting results for visual acuity outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Inflammatory Chorioretinal Conditions

For individuals who have choroidal neovascularization due to inflammatory chorioretinal conditions who receive verteporfin photodynamic therapy, the evidence includes a systematic review of case reports. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Methodologic limitations limit the conclusions drawn from 15 case reports (total N=115 patients) of multiple disease indications. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

In 2019, the American Academy of Ophthalmology updated its 2015 preferred practice pattern guideline on age-related macular degeneration. The 2019 update states that verteporfin photodynamic therapy has approval by the U.S. Food and Drug Administration for the treatment of age-related macular degeneration-related, predominantly classic, subfoveal choroidal neovascularization.

The 2019 update stated that antivascular endothelial growth factor therapies have become first-line therapy for treating and stabilizing most cases of age-related macular degeneration and suggests that verteporfin photodynamic therapy is rarely needed.

National Institute for Health and Care Excellence

In 2018, the National Institute for Health and Care Excellence updated its 2003 guidance on the use of photodynamic therapy for age-related macular degeneration. The Institute made the following recommendations: it recommended against use of photodynamic therapy as monotherapy for late (wet) age-related macular degeneration and against use of photodynamic therapy as first-line adjunctive therapy to antivascular endothelial growth factor therapies for late (wet) age-related macular degeneration; it recommended for photodynamic therapy as second-line adjunctive therapy to antivascular endothelial growth factor therapies for late (wet) age-related macular degeneration in a trial setting.

Canadian Agency for Drugs and Technologies in Health

In 2008, the Canadian Agency for Drugs and Technologies in Health released a health technology assessment on the management of neovascular age-related macular degeneration. The Agency concluded that “Overall, the efficacy of antivascular endothelial growth therapies over V-photodynamic therapy is well supported by RCTs [randomized controlled trials]. What remains unclear is whether combination therapy (and which combinations) are superior or merely equal to monotherapy.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Subfoveal choroidal neovascularization, CNV, presumed ocular histoplasmosis, pathologic myopia, age-related macular degeneration, AMD, photodynamic therapy, VPDT, choroidal hemangioma, verteporfin, Visudyne, central serous chorioretinopathy

APPROVED BY GOVERNING BODIES:

In 2000, verteporfin (Visudyne®; Novartis), an intravenous photodynamic therapy agent, was approved by the U.S. Food and Drug Administration (FDA) for treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization. Subsequently, in 2001, the indication was expanded to include presumed ocular histoplasmosis and pathologic myopia.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity

CURRENT CODING:

CPT codes:

67221

Destruction of localized lesion of choroid (e.g., choroidal neovascularization); photodynamic therapy (includes intravenous infusion)

67225

Destruction of localized lesion of choroid (e.g., choroidal neovascularization); photodynamic therapy, second eye, at single session

HCPCS codes:

J3396

Injection, verteporfin, 0.1 mg

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  58. Ma J, Meng N, Xu X, et al. System review and meta-analysis on photodynamic therapy in central serous chorioretinopathy. Acta Ophthalmol. Dec 2014; 92(8):e594-601.
  59. Maberley D. Photodynamic therapy and intravitreal triamcinolone for neovascular age-related macular degeneration: a randomized clinical trial. Ophthalmology 2009; 116(11):2149-57 e1.
  60. National Institute for Health and Care Excellence (NICE). Age-related macular degeneration [NG82]. 2018; https://www.nice.org.uk/guidance/NG82. Accessed January 27, 2021.
  61. National Institute for Clinical Excellence (NICE). Guidance on the use of photodynamic therapy for age-related macular degeneration. Technology Appraisal Guidance 68. 2003. Available online at: //www.nice.org.uk/nicemedia/live/11512/32728/32728.pdf. Accessed January 28, 2021.
  62. Nicolo M, Zoli D, Musolino M, et al. Association between the efficacy of half-dose photodynamic therapy with indocyanine green angiography and optical coherence tomography findings in the treatment of central serous chorioretinopathy. Am J Ophthalmol. Mar 2012; 153(3):474-480 e471.
  63. Ober MD, Yannuzzi LA, Do DV, et al.  Photodynamic therapy for focal retinal pigment epithelial leaks secondary to central serious chorioretinopathy.  Ophthalmology, December 2005; 112(12): 2088-2094.
  64. Oh KT and Folk J. Chorioretinopathy, central serious. www.emedicine.com/oph/TOPIC689.htm.
  65. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials--TAP report. Treatment of age-related macular degeneration with photodynamic therapy (TAP) Study Group. Arch Ophthalmol. Oct 1999; 117(10):1329-1345.
  66. Piermarocchi S, Sartore M, Lo Giudice G, et al. Combination of photodynamic therapy and intraocular triamcinolone for exudative age-related macular degeneration and long-term chorioretinal macular atrophy. Arch Ophthalmol, October 2008; 126(10): 1367-1374.
  67. Piri N, Ahmadieh H, Taei R, et al. Photodynamic therapy and intravitreal bevacizumab with versus without triamcinolone for neovascular age-related macular degeneration; a randomized clinical trial. J Ophthalmic Vis Res. Oct-Dec 2014; 9(4):469-477.
  68. Ramaiya KJ, Blinder KJ, Ciulla T, et al. Ranibizumab versus photodynamic therapy for presumed ocular histoplasmosis syndrome. Ophthalmic Surg Lasers Imaging Retina. Jan-Feb 2013; 44(1):17-21.
  69. Reibaldi M, Cardascia N, Longo A et al. Standard-fluence versus low-fluence photodynamic therapy in chronic central serous chorioretinopathy: a nonrandomized clinical trial. Am J Ophthalmol 2010; 149(2):307-15 e2.
  70. Rinaldi M, Semeraro F, Chiosi F, et al. Reduced-fluence verteporfin photodynamic therapy plus ranibizumab for choroidal neovascularization in pathologic myopia. Graefes Arch Clin Exp Ophthalmol. Mar 2017; 255(3):529- 539.
  71. Robertson Dennis M.  Photodynamic therapy for choroidal hemangioma associated with serous retinal detachment, Archives of Ophthalmology, September 2002, Vol. 120, No. 9.
  72. Rouvas A, Stavrakas P, Theodossiadis PG, et al. Long-term results of half-fluence photodynamic therapy for chronic central serous chorioretinopathy. Eur J Ophthalmol. May-Jun 2012; 22(3):417-422.
  73. Rubin GS, Bressler NM. Effects of verteporfin therapy on contrast on sensitivity: results from the treatment of age-related macular degeneration with photodynamic therapy (TAP) investigation-TAP report No 4. Retina 2002; 22(5):536-44.
  74. Rudnisky CJ, Liu C, Ng M et al. Intravitreal bevacizumab alone versus combined verteporfin photodynamic therapy and intravitreal bevacizumab for choroidal neovascularization in age-related macular degeneration: visual acuity after 1 year of follow-up. Retina 2010; 30(4):548-54.
  75. Salehi M, Wenick AS, Law HA, et al. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2015; 12:CD011841.
  76. Schachat MD and Andrew P. Verteporfin therapy: the TAP investigation. Ophthalmology Times, Vol. 25, Supplement 2, June 1, 2000.
  77. Schmidt-Erfurth U, Sacu S; Early retreatment study group. Randomized multicenter trial of more intense and standard early verteporfin treatment of neovascular age-related macular degeneration. Ophthalmology, January 2008; 115(1): 134-140.
  78. Schmidt-Erfurth U, Sacu S.Randomized multicenter trial of more intense and standard early verteporfin treatment of neovascular age related macular degeneration. Ophthalmology. Jan 2008; 115(1):134-140.
  79. Semeraro F, Romano MR, Danzi P et al. Intravitreal bevacizumab versus low-fluence photodynamic therapy for treatment of chronic central serous chorioretinopathy. Jpn J Ophthalmol 2012; 56(6):608-12.
  80. Semeraro F, Russo A, Delcassi L, et al. Treatment of exudative age-related macular degeneration with ranibizumab combined with ketorolac eyedrops or photodynamic therapy. Retina. Aug 2015; 35(8):1547-1554.
  81. Senturk F, Karacorlu M, Ozdemir H, et al. Microperimetric changes after photodynamic therapy for central serous chorioretinopathy. Am J Ophthalmol. Feb 2011; 151(2):303-309 e301.
  82. Shin JY, Woo SJ, Yu HG et al. Comparison of efficacy and safety between half-fluence and full-fluence photodynamic therapy for chronic central serous chorioretinopathy. Retina 2011; 31(1):119-26.
  83. Tang K, Si JK, Guo DD, et al. Ranibizumab alone or in combination with photodynamic therapy vs photodynamic therapy for polypoidal choroidal vasculopathy: a systematic review and Meta-analysis. Int J Ophthalmol. 2015; 8(5):1056-1066.
  84. Tong Y, Zhao KK, Feng D, et al. Comparison of the efficacy of anti-VEGF monotherapy versus PDT and intravitreal anti-VEGF combination treatment in AMD: a Meta-analysis and systematic review. Int J Ophthalmol. 2016; 9(7):1028-1037.
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  88. Vedula SS, Krzystolik MG. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration. Cochrane Database Syst Rev 2008; (2):CD005139.
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POLICY HISTORY:

Medical Policy Administration Committee, June 2002

Available for Comment May 31-July 15, 2002

Medical Policy Group, May 2004 (1)

Medical Policy Administration Committee, May 2004

Available for comment May 17-June 30, 2004

Medical Policy Group, June 2006 (1)

Medical Policy Group, August 2008 (1)

Medical Policy Group, September 2009 (1)

Medical Policy Administration Committee, September 2009

Available for comment September 18-November 2, 2009

Medical Policy Group, April 2012 (1): Update to policy statement to include new drug Eylea as an anti-VEGF that is non-covered when used in combo with PDT; Updates to Key Points and References related to MPP update

Medical Policy Panel, August 2012

Medical Policy Group, January 2013 (1): Update to Policy, Key Points and References related to addition of coverage for chronic central serous chorioretinopathy

Medical Policy Administration Committee, January 2013

Available for comment January 10 through February 23, 2013

Medical Policy Panel, June 2013

Medical Policy Group, September 2013 (1): Update to Descriptions, Key Points and References; no change to policy statement

Medical Policy Group, June 2014 (1): Policy updated with literature review through May 2014; no change to policy statement

Medical Policy Panel, June 2015

Medical Policy Group, June 2015 (6):  Updated Title, Key Points and References; no change to policy statement.

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6): Updates to Description, Key Points, Governing Bodies, Coding (removed codes 67299 and J3490), and References; no change to policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (6):  Updates to Description, Key Points, Practice Guidelines, Key Words, Governing Body and References.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Description, Key Points, Practice Guidelines and References.

Medical Policy Panel, March 2019

Medical Policy Group April 2019 (6):  Updates to Description; no change to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020(6): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (9): 2021 Updates to Key Points, Description, References.  Policy statement updated to remove “not medically necessary,” no change to policy intent.


This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.