Medical Policy: 09.03.12 

Original Effective Date: November 2014 

Reviewed: October 2017 

Revised: November 2016 

 

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:

The intent of the vascular endothelial growth factor (VEGF) inhibitor drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies. VEGF, through its promotion of angiogenesis and vascular permeability is a central component of the pathologic process driving wet age-related macular degeneration (AMD), as well as other choroidal and retinal vascular disorders. The VEGF inhibitors referenced within this policy are administered via intravitreal injection. 

Eylea® (aflibercept)

Eylea® (aflibercept) is approved by the Food and Drug Administration (FDA) for the following indications:

  • Neovascular (wet) age-related macular degeneration (AMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy (DR) in patients with DME

Lucentis® (ranibizumab)

Lucentis® (ranibizumab) is approved by the FDA for the following indications:

  • Neovascular (wet) age-related macular degeneration (AMD)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy (DR) in patients with DME
  • Macular edema following retinal vein occlusion (RVO) 
  • Myopic choroidal neovascularization (mCNV)

Macugen® (pegaptanib)

Macugen® (pegaptanib) is approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration (AMD).

While not FDA approved for ophthalmic use, Avastin® (bevacizumab) has the support of peer reviewed literature and is considered medically necessary for the treatment of choroidal and retinal vascular disorders addressed within this policy.

 

Prior Approval:

Not applicable

 

 

Policy:

*Avastin (bevacizumab) is the best value VEGF inhibitor for the treatment of choroidal and retinal vascular disorders addressed within this policy, has the support of peer reviewed literature, and DOES NOT require review.

 

  1. A series of intravitreal injections with Eylea (aflibercept) may be considered medically necessary for the treatment of the following:
    • Neovascular (wet) AMD
    • Macular edema following RVO (both BRVO and CRVO)
    • Diabetic macular edema
    • Diabetic retinopathy in patients with DME
    • Choroidal neovascularization secondary to:
      • Angioid streaks
      • Central serous chorioretinopathy
      • Choroidal rupture or trauma
      • Multifocal choroiditis
      • Pathologic myopia
      • Presumed ocular histoplasmosis syndrome
      • Uveitis
      • Idiopathic choroidal neovascularizati
  1. A series of intravitreal injections with Lucentis (ranibizumab) may be considered medically necessary for the treatment of the following:
    • Neovascular (wet) AMD
    • Macular edema following RVO (both BRVO and CRVO)
    • Diabetic macular edema
    • Proliferative diabetic retinopathy as an adjunct to photocoagulation or vitrectomy
    • Diabetic retinopathy in patients with DME
    • Choroidal neovascularization secondary to:
      • Angioid streaks
      • Central serous chorioretinopathy
      • Choroidal rupture or trauma
      • Multifocal choroiditis
      • Pathologic myopia
      • Presumed ocular histoplasmosis syndrome
      • Uveitis
      • Idiopathic choroidal neovascularization
  1. A series of intravitreal injections with Macugen (pegaptanib) may be considered medically necessary for the treatment of neovascular (wet) AMD.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • J0178 injection, aflibercept, 1 mg
  • J2778 injection, ranibizumab, 0.1 mg
  • J2503 injection, pegaptanib sodium, 0.3 mg

 

Selected References:

  • Eylea [prescribing information]. Regeneron Pharmaceuticals, Inc. Tarrytown NY, May 2016.
  • Lucentis [prescribing information]. Genetech, Inc. South San Francisco CA, February 2015.
  • Macugen [prescribing information]. Eyetech, Inc. Palm Beach Gardens, FL, August 2008.
  • Martin DF, Maguire MG, Fine SL, et al, and the Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 2012; 119:1388-1398.
  • Martin DF, Maguire MG, Ying GS, et al, and the CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011; 364:1897-1908.
  • Chakravarthy U, Harding SP, Rogers CA, et al, on behalf of the IVAN study investigators. Alternative treatments to inhibit VEGF in age-related choroidal neovascularization: 2-year findings of the IVAN randomised controlled trial. Lancet Published online July 19, 2013.
  • Cheung LK, Eaton A. Review of therapeutics: age-related macular degeneration. Pharmacotherapy 2013;33(8):838-855.
  • Evoy KE, Abel SR. Ranibizumab: the first vascular endothelial growth factor inhibitor approved for the treatment of diabetic macular edema. Ann Pharmacother 2013;47:811-818.
  • Stein JD, Newman-Casey PA, Kim DD, Nwanyanwu KH, Johnson MW, Hutton DW. Cost-effectiveness of various interventions for newly diagnosed diabetic macular edema. Ophthalmology 2013;120(9):1835-1842.
  • Rajendram R, Fraser-Bell A, Kaines A, et al. A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema 24-month data: report 3. Arch Ophthalmol 2012;130:972-979.
  • Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: early treatment diabetic retinopathy study report number I. Arch Opthalmol 1985; 103: 1796-1806.
  • Arevalo JF, Sanchez JG, Fromow-Guerra J, et al. PanAmerican Collaborative Retina Study Group (PACORES). Comparison of two doses of primary intravitreal bevacizumab (Avastin) for diffuse diabetic macular edema: results from the PanAmerican Collaborative Retina Study Group (PACORES) at 12-month follow-up. Arch Clin Exp Opthalmol 2009;247:735-743.
  • Campochiaro PA, Heier JS, Femer I, et al. BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology 2010;117(6):1102-1112.
  • Brown DM, Campochiaro PA, Singh RP, et al. CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology 2010;117(6):1124-1133.
  • Brown DM, Heier JS, Clark WL, et al. COPERNICUS Investigators. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1 year results for phase 3 COPERNICUS study. Am J Ophthalmol 2013;155:429-437.
  • GALILEO
  • Epstein DL, Algvere PV, von Wendt G, Seregard S, Kvanta A. Bevacizumab for macular edema in central retinal vein occlusion: a prospective, randomized, double-masked clinical study. Ophthalmology 2012:119:2587-2591.
  • Epstein DL, Algvere PV, von Wendt G, et al. Bevacizumab for macular edema in central retinal vein occlusion: a prospective randomized double masked clinical study. Ophthalmology 2012;119:1184-1189.
  • Cionni DA, Lewis SA, Petersen MR, et al. Analysis of outcomes for intravitreal bevacizumab in the treatment of choroidal neovascularization secondary to ocular histoplasmosis. Ophthalmology 2012; 119:327-332.
  • Evoy KE, Abel SR. Aflibercept: newly approved for the treatment of macular edema following central retinal vein occlusion. Ann Pharmacother 2013;47:819-827.

 

Policy History:

  • October 2017 - Annual Review, Policy Renewed
  • November 2016 - Annual Review, Policy Revised
  • November 2015 - Annual Review, Policy Renewed
  • April 2015 - Interim Review, Policy Revised
  • November 2014 - New policy

 

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.

 

*CPT® is a registered trademark of the American Medical Association.