Notification

Intravitreal Injection of Vascular Endothelial Growth Factor (VEGF) Antagonists and Related Biosimilars


Notification Issue Date: 10/03/2019

This version of the policy will become effective 01/01/2020. This policy was updated to:

  • change policy title to "Intravitreal Injection of Vascular Endothelial Growth Factor (VEGF) Antagonists and Related Biosimilars"
  • include Avastin® and incorporate the Company's designation of Avastin® and related biosimilars as its preferred product.
  • revise the 'Medically Necessary' criteria for Lucentis and Eylea to indicate both vascular endothelial growth factor (VEGF) antagonists are covered for individuals with non-proliferative and proliferative diabetic retinopathy with and without diabetic macular edema.

The following ICD10 codes have been added to the policy for Lucentis only: E08.3521, E08.3522, E08.3523, and E08.3529.

Applicable diagnosis codes have been added to the policy due to criteria changes for Eylea and Avastin.


Medicare Advantage Policy

Title:Intravitreal Injection of Vascular Endothelial Growth Factor (VEGF) Antagonists and Related Biosimilars
Policy #:MA08.073f

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

MEDICALLY NECESSARY

RANIBIZUMAB (LUCENTIS®) AND RELATED BIOSIMILARS
Intravitreal injection of vascular endothelial growth factor (VEGF) antagonist ranibizumab (Lucentis®) and related biosimilars are considered medically necessary and, therefore, covered for individuals who have any of the following conditions and meet the requirements listed in the COMPANY-DESIGNATED PREFERRED PRODUCTS and NON-PREFERRED PRODUCTS Sections below:
  • Neovascular (wet or exudative) age-related macular degeneration (AMD)
  • Macular edema following retinal vein occlusion
  • Diabetic macular edema (DME)
  • Other retinal diseases, including ischemic retinal vein occlusions, and for decreasing the vascularity of proliferative diabetic retinopathy prior to vitreous surgery
  • Non-proliferative and proliferative diabetic retinopathy with and without macular edema
  • Choroidal neovascularization due to angioid streaks, central serous chorioretinopathy, choroidal rupture or trauma, idiopathic choroidal neovascularization, multifocal choroiditis, pathologic myopia, presumed ocular histoplasmosis syndrome, and uveitis

PEGAPTANIB SODIUM (MACUGEN®) AND RELATED BIOSIMILARS
Intravitreal injection of vascular endothelial growth factor (VEGF) antagonist pegaptanib sodium (Macugen®) and related biosimilars are considered medically necessary and, therefore, covered for individuals who have any of the following conditions and meet the requirements listed in the COMPANY-DESIGNATED PREFERRED PRODUCTS and NON-PREFERRED PRODUCTS Sections below:
  • Neovascular (wet or exudative) age-related macular degeneration (AMD)
  • Diabetic macular edema
  • Other retinal diseases, including ischemic retinal vein occlusions, and for decreasing the vascularity of proliferative diabetic retinopathy prior to vitreous surgery

AFLIBERCEPT (EYLEA®) AND RELATED BIOSIMILARS
Intravitreal injection of vascular endothelial growth factor (VEGF) antagonist aflibercept (Eylea®) and related biosimilars are considered medically necessary and, therefore, covered for individuals who have any of the following conditions and meet the requirements listed in the COMPANY-DESIGNATED PREFERRED PRODUCTS and NON-PREFERRED PRODUCTS Sections below:
  • Neovascular (wet or exudative) age-related macular degeneration (AMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Diabetic macular edema
  • Non-proliferative and proliferative diabetic retinopathy in individuals with and without diabetic macular edema
  • Other retinal diseases, including ischemic retinal vein occlusions, and for decreasing the vascularity of proliferative diabetic retinopathy prior to vitreous surgery

BEVACIZUMAB (AVASTIN®) AND RELATED BIOSIMILARS
The intravitreal injection of vascular endothelial growth factor (VEGF) antagonist bevacizumab (Avastin®) and related biosimilars are considered medically necessary and, therefore, covered for vascular diseases of the eye including but not limited to, the following:
  • Choroidal neovascularization due to angioid streaks, central serous chorioretinopathy, choroidal rupture or trauma, idiopathic choroidal neovascularization, multifocal choroiditis, pathologic myopia, and presumed ocular histoplasmosis syndrome, uveitis
  • Diabetic macular edema
  • Diabetic retinopathy
  • Macular edema following retinal vein occlusion (RVO)
  • Neovascular (wet) age-related macular degeneration (AMD)
  • Neovascular glaucoma

COMPANY-DESIGNATED PREFERRED PRODUCTS
Although there are many brands of vascular endothelial growth factor antagonists on the market for the treatment of vascular diseases of the eye, there is no reliable evidence of the superiority of any one brand of vascular endothelial growth factor antagonists compared to other brands. The company has designated Avastin® and related biosimilars as its preferred product.

This product is less costly and at least as likely to produce equivalent therapeutic results as the non-preferred products, which include, but are not limited to Lucentis®, Macugen® and Eylea® and related biosimilars.

NON-PREFERRED PRODUCTS
For individuals who meet the above medical necessity criteria, use of non-preferred products (which include Lucentis®, Macugen® and Eylea® and related biosimilars) is considered medically necessary and, therefore, covered in either the following instances*:
  • The individual has a documented contraindication, or documented non-response to Avastin® and its related biosimilars.
  • The individual is currently receiving or has previously received a non-preferred product for vascular diseases of the eye.

*The use of non-preferred products that do not meet either of these instances are considered not medically necessary and, therefore, not covered.

NOT MEDICALLY NECESSARY

For individuals receiving their first course of vascular endothelial growth factor antagonists, use of non-preferred products (which include, but are not limited to Lucentis®, Macugen® and Eylea® and related biosimilars), is considered not medically necessary and, therefore, not covered with the exception of a documented contraindication to the preferred product (Avastin® and its related biosimilars) because more cost-effective alternatives are available.

EXPERIMENTAL/INVESTIGATIONAL

All other uses of ranibizumab (Lucentis®), pegaptanib sodium (Macugen®), aflibercept (Eylea®), bevacizumab (Avastin®) and related biosimilars are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Policy Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

Certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when ranibizumab (Lucentis®), pegaptanib sodium (Macugen®), aflibercept (Eylea®), bevacizumab (Avastin®) or related biosimilars are covered under a member's medical benefit (Part B benefit). It does not address instances when ranibizumab (Lucentis®), pegaptanib sodium (Macugen®), aflibercept (Eylea®), bevacizumab (Avastin®) or related biosimilars are covered under a member’s pharmacy benefit (Part D benefit).

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, the intravitreal injection of ranibizumab (Lucentis®), pegaptanib sodium (Macugen®), aflibercept (Eylea®), bevacizumab (Avastin®) or related biosimilars are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in the medical policy are met.

ADMINISTRATION GUIDELINES FROM THE PRODUCT'S PACKAGE INSERT

RANIBIZUMAB (LUCENTIS®)
Ranibizumab (Lucentis®) is supplied in a single-dose vial or single-dose prefilled syringe and is administered only by ophthalmic intravitreal injection, no more than once monthly per affected eye for treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in individuals with diabetic macular edema.

Although less effective, treatment for AMD may begin with 3 monthly doses followed by less frequent dosing. In the 9 months after the 3 initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain of visual acuity. Individuals should be evaluated regularly.

Although less effective, treatment for AMD may be reduced to one injection every 3 months after the first 4 injections if monthly injections are not feasible. Compared to continued monthly dosing, dosing every 3 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average, over the following nine months. Individuals should be evaluated regularly.

Monthly dosing for up to three months is the recommendation for the treatment of Myopic Choroidal Neovascularization (mCNV); although individuals may be retreated, if needed.

PEGAPTANIB SODIUM (MACUGEN®)
Pegaptanib sodium (Macugen®) is supplied in a single-dose vial and is administered only by ophthalmic intravitreal injection, once every 6 weeks per affected eye. The safety and efficacy of pegaptanib sodium (Macugen®) administered to both eyes concurrently have not been studied.

AFLIBERCEPT (EYLEA®)
Aflibercept (Eylea®) is supplied as a single-dose vial and is administered only by ophthalmic intravitreal injection as follows:
  • Wet AMD: every 4 weeks (monthly) for the first 3 months, followed by one intravitreal injection every 8 weeks. Additional efficacy was not demonstrated in most individuals when dosing every 4 weeks compared to every 8 weeks; however, some individuals may need dosing every 4 weeks after the first 3 months.
  • Diabetic macular edema and diabetic retinopathy in individuals with diabetic macular edema: every 4 weeks (monthly) for the first 5 months, followed by one intravitreal injection every 8 weeks. Additional efficacy was not demonstrated in most individuals when dosing every 4 weeks compared to every 8 weeks; however, some individuals may need dosing every 4 weeks after the first 20 weeks (5 months).
  • Macular edema following retinal vein occlusion (RVO): every 4 weeks

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Ranibizumab (Lucentis®) was approved by the FDA on June 30, 2006, for the treatment of neovascular (wet) age-related macular degeneration. Supplemental approvals for ranibizumab (Lucentis®) have since been issued by the FDA for macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization (mCNV).

Pegaptanib sodium (Macugen®) was approved by the FDA on December 17, 2004, for the treatment of neovascular (wet) age-related macular degeneration.

Aflibercept (Eylea®) was approved by the FDA on November 18, 2011 for treatment of neovascular (wet) age-related macular degeneration. Supplemental approvals for aflibercept (Eylea®) has since been issued by the FDA for macular edema following central and branch retinal vein occlusion (RVO), and for diabetic macular edema.

The initial approval for the use of bevacizumab (Avastin®) was granted by the FDA on February 26, 2004. Supplemental approvals have since been issued.

The safety and effectiveness of aflibercept (Eylea®), pegaptanib sodium (Macugen®), ranibizumab (Lucentis®), and bevacizumab (Avastin®) have not been established in the pediatric population.

Description

Vascular endothelial growth factor (VEGF) is a secreted protein that selectively binds and activates its receptors, which are located primarily on the surface of vascular endothelial cells. VEGF stimulates new blood vessel formation. Overexpression of VEGF can induce abnormal neovascularization and increase vascular permeability and inflammation.

Neovascularization results in the growth of abnormal blood vessels behind the retina and contributes to the progression of neovascular (wet) age-related macular degeneration (AMD), also known as exudative AMD. Wet AMD occurs when the abnormal blood vessels under the macula leak blood and fluid, leading to vision loss.

Other ocular conditions where VEGF plays a role includes retinal vein occlusion (RVO) where the normal blood flow through a retinal vein becomes blocked, causing edema and hemorrhaging in the retina that can lead to vision loss. RVO is classified according to whether the central retinal vein (CRVO) or one of its branches is obstructed. Diabetic macular edema (DME) is a condition associated with diabetes and causes blurred vision, severe vision loss, and sometimes blindness. Diabetic retinopathy may occur with or without DME and is classified as non-proliferative or proliferative, depending on the severity of the disease. Choroidal neovascularization occurs when abnormal blood vessels begin growing in the choroid (the area beneath the retina) and move into sub-retinal space and leak blood and fluid, leading to vision loss.

Pegaptanib sodium (Macugen®) is a selective VEGF antagonist that received FDA approval in 2004 for the treatment of neovascular (wet) age-related macular degeneration. The mechanism of action for the drug is the suppression of pathological neovascularization by inhibiting a VEGF isoform called extracellular VEGF-165 from binding to its VEGF receptors. Pegaptanib sodium (Macugen®) is administered via ophthalmic intravitreal injection.

Ranibizumab (Lucentis®) is a vascular endothelial growth factor A (VEGF-A) antagonist that received FDA approval in 2006 for the treatment of neovascular (wet) AMD. Ranibizumab (Lucentis®) works by binding to and inhibiting the action of VEGF-A, a substance that binds to certain cells to stimulate new blood vessel formation and growth (e.g., angiogenesis, neovascularization). When VEGF-A binds to ranibizumab (Lucentis®), it cannot stimulate neovascularization. Ranibizumab (Lucentis®) is also administered via ophthalmic intravitreal injection. Ranibizumab (Lucentis®) received supplemental approvals from the FDA in June 2010 for use in the treatment of macular edema following retinal vein occlusion (RVO) and in August 2012 for use in the treatment of DME. In February 2015, ranibizumab (Lucentis®) received FDA approval for use in the treatment of diabetic retinopathy in individuals with DME; in April 2017, the approval was modified to include those without DME. Also, in January 2017, Ranibizumab (Lucentis®) was FDA approved for the treatment of Myopic Choroidal Neovascularization (mCNV).

Aflibercept (Eylea®) is another VEGF antagonist administered via ophthalmic intravitreal injection that received FDA approval in 2011 for the treatment of neovascular (wet) AMD. Aflibercept (Eylea®) acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PIGF), a second growth factor that initiates the formation of new blood vessels. Aflibercept (Eylea®) received supplemental approvals from the FDA in September 2012 for use in the treatment of macular edema following central retinal vein occlusion (CRVO), in July 2014 for use in the treatment of diabetic macular edema, in October 2014 for use in the treatment of macular edema following branch retinal vein occlusion, and in March 2015 for use in the treatment of diabetic retinopathy in individuals with diabetic macular edema.

Bevacizumab (Avastin®) is a recombinant humanized monoclonal IgG1 antibody derived from the same monoclonal antibody as ranibizumab (Lucentis®) that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF).

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

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Heier JS, Clark WL, Boyer DS, et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014;121(7):1414-1420.e1.

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Lexi-Drugs Compendium. Ranibizumab. 07/27/18. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 13, 2019.

Lexi-Drugs Compendium. bevacizumab (Avastin). 04/16/19. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed May 1, 2019.

Lowes R. FDA OKs ranibizumab for all forms of diabetic retinopathy. [Medscape web site]. 04/17/17. Available at: https://www.medscape.com/viewarticle/878691. Accessed July 17, 2019.

Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011;52(10):7498-505.

Lucentis® (ranibizumab injection) [prescribing information]. South San Francisco, CA: Genentech, Inc.; 04/2017. Available at: http://www.lucentis.com/. Accessed February 13, 2019.

Macugen® (Pegaptanib sodium) [prescribing information]. Bridgewater, NJ. Valeant Pharmaceuticals North America, LLC.; 07/2016. Available at: http://www.bauschretinarx.com/macugen/ecp/about. Accessed February 13, 2019.

Mansour AM, Arevalo JF, Fardeau C, et al. Three-year visual and anatomic results of administrating intravitreal bevacizumab in inflammatory ocular neovascularization. Can J Ophthalmol. 2012;47(3):269-74.

Martin DF, Maguire MG, Fine SL, et al; 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(7):1388-98.

Michaelides M, Kaines A, Hamilton RD, et al. A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2. Ophthalmology. 2010;117(6):1078-1086.e2.

Modarres M, Nazari H, Falavarjani KG, et al. Intravitreal injection of bevacizumab before vitrectomy for proliferative diabetic retinopathy. Eur J Ophthalmol. 2009;19(5):848-52.

Moja L, Lucenteforte E, Kwag KH, et al. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014;9:CD011230.

Mitchell P, Bandello F, Schmidt-Erfurth U, et al; RESTORE study: Ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118:615-625.

National Eye Institute (NEI), part of the National Institutes of Health (NIH). Facts about diabetic eye disease. [NEI Web site]. 09/2015. Available at: https://www.nei.nih.gov/health/diabetic/retinopathy . Accessed May 1, 2019.

Nicholson BP, Schachat AP. A review of clinical trials of anti-VEGF agents for diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010;248(7):915-30.

Novitas Solutions, Inc. Local Coverage Article for Billing and Coding Information Regarding Uses, Including Off-Label Uses, of Anti-Vascular Endothelial Growth Factor (anti-VEGF), for The Treatment of Ophthalmological Diseases (A53121). [Novitas-Solutions Web site]. Original: 10/01/2015. (Revised: 07/11/2016). Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7&Date=07%2f11%2f2016&DocID=A53121&bc=hAAAAAgAAAAAAA%3d%3d& . Accessed February 13, 2019.

Pacella E, La Torre G, Impallara D, et al. Efficacy and safety of the intravitreal treatment of diabetic macular edema with pegaptanib: a 12-month follow-up. Clin Ter. 2013;164(2):e121-6.

Pai SA, Shetty R, Vijayan PB, et al. Clinical, anatomic, and electrophysiologic evaluation following intravitreal bevacizumab for macular edema in retinal vein occlusion. Am J Ophthalmol. 2007;143(4):601-606.

Parodi MB, Iacono P, Kontadakis DS, et al. Bevacizumab vs photodynamic therapy for choroidal neovascularization in multifocal choroiditis. Arch Ophthalmol. 2010;128(9):1100-3.

Parodi MB, Iacono P, Papayannis A, et al. Intravitreal bevacizumab for extrafoveal choroidal neovascularization secondary to pathologic myopia. Retina. 2013;33(3):593-7.

Rajagopal R, Shah GK, Blinder KJ, et al. Bevacizumab Versus Ranibizumab in the Treatment of Macular Edema Due to Retinal Vein Occlusion: 6-Month Results of the CRAVE Study. Ophthalmic Surg Lasers Imaging Retina. 2015;46(8):844-50.

Rajendram R, Fraser-Bell S, 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(8):972-9.

Rofagha S, Bhisitkul RB, Boyer DS, Sadda SR, Zhang K; SEVEN-UP Study Group. Seven-Year Outcomes in Ranibizumab-Treated Patients in ANCHOR, MARINA, and HORIZON: A Multicenter Cohort Study (SEVEN-UP). Ophthalmology. 2013 May 3. [Epub ahead of print]

Rouvas A, Petrou P, Douvali M, et al. Intravitreal ranibizumab for the treatment of inflammatory choroidal neovascularization. Retina. 2011;31(5):871-9.

Sawada O, Ohji M. Retinal Vein Occlusion. Dev Ophthalmol. 2016;55:147-53.

Shah M, Amoaku WM. Intravitreal ranibizumab for the treatment of choroidal neovascularisation secondary to angioid streaks. Eye (Lond). 2012;26(9):1194-8.

Soheilian M, Garfami KH, Ramezani A, et al. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012;32(2):314-21.

Soheilian M, Ramezani A, Obudi A, et al. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009;116(6):1142-50.

Solomon SD, Chew E, Duh EJ, et al. Diabetic retinopathy: a position statement by the American Diabetes Association. Diabetic Care. 2017;40:412-418.

Solomon SD, Lindsley K, Vedula SS, et al. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014;8:CD0051.

Sultan MB, Zhou D, Loftus J, Dombi T, Ice KS; Macugen 1013 Study Group. A phase 2/3, multicenter, randomized, double-masked, 2-year trial of pegaptanib sodium for the treatment of diabetic macular edema. Ophthalmology. 2011;118(6):1107-18.

Toich L. FDA approves lucentis for all forms of diabetic retinopathy. AJPB The Amer Journ of Pharm Benefits. Apr 17, 2017. Available at: https://www.ajpb.com/news/fda-approves-lucentis-for-all-forms-of-diabetes-retinopathy. Accessed July 17, 2019.

Tufail A, Patel PJ, Egan C, et al; ABC Trial Investigators. Bevacizumab for neovascular age related macular degeneration (ABC Trial): multicentre randomised double masked study. BMJ. 2010;340:c2459.

Troutbeck R, Bunting R, van Heerdon A, et al. Ranibizumab therapy for choroidal neovascularization secondary to non-age-related macular degeneration causes. Clin Experiment Ophthalmol. 2012;40(1):67-72.

Truven Health Analytics, Inc. Micromedex® DrugDex® Compendium [Internet database]. Aflibercept. Greenwood Village, CO: Thomson Micromedex. [Micromedex Web site]. 12/06/18. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed February 13, 2019.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Bevacizumab (Avastin®). 04/12/19. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/ [via subscription only]. Accessed May 1, 2019.

Truven Health Analytics, Inc. Micromedex® DrugDex® Compendium [Internet database]. Pegaptanib. Greenwood Village, CO: Thomson Micromedex. [Micromedex Web site]. 08/29/17. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed February 13, 2019.

Truven Health Analytics, Inc. Micromedex® DrugDex® Compendium [Internet database]. Ranibizumab. Greenwood Village, CO: Thomson Micromedex. [Micromedex Web site]. 01/28/19. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed February 13, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Drug details: Ranibizumab (Lucentis®). [FDA Web site]. 03/20/18. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 13, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Drug details: Pegaptanib sodium (Macugen®). [FDA Web site]. 01/26/17. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 13, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@ FDA. Drug details: Aflibercept (Eylea®). [FDA Web site]. 08/16/18. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 13, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Avastin (bevacizumab). Package insert. [FDA Web site]. 04/03/2019. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed April 23, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Mvasi™(bevacizumab-awwb). Package insert. [FDA Web site]. 09/14/17. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761028 . Accessed April 26, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Postmarket drug safety information for patients and providers. Questions and answers about avastin. 12/16/2010. Available at: https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm237095.htm . Accessed April 26, 2019.

Virgili G, Parravano M, Menchini F, Brunetti M. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema. Cochrane Database Syst Rev. 2012;12:CD007419.

Wakabayashi T, Oshima Y, Sakaguchi H, et al. Intravitreal bevacizumab to treat iris neovascularization and neovascular glaucoma secondary to ischemic retinal diseases in 41 consecutive cases. Ophthalmology. 2008;115(9):1571-80, 1580.e1-3.

Wells JA, Glassman AR, Ayala AR, et al.; Diabetic Retinopathy Clinical Research Network. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology. 2016;123(6):1351-9.

Wolf S, Balciuniene VJ, Laganovska G, et al; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014;121(3):682-92.e2. Epub 2013 Dec 8.

Wykoff C. Regeneron presents positive data from PANORAMA trial. Healio Ocular Surgery News; 2/14/2019. Available at: https://www.healio.com/ophthalmology/retina-vitreous/news/online/%7B148e238b-9ab5-4cb4-ad7a-d852368bb1d4%7D/regeneron-presents-positive-data-from-panorama-trial. Accessed July 17, 2019.

Yadav NK, Bharghav M, Vasudha K, Shetty KB. Choroidal neovascular membrane complicating traumatic choroidal rupture managed by intravitreal bevacizumab. Eye (Lond). 2009;23(9):1872-3.

Yeh S, Kim SJ, Ho AC, et al. Therapies for macular edema associated with central retinal vein occlusion: a report by the American Academy of Ophthalmology. Ophthalmology. 2015;122(4):769-78.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)



C9257 Injection, bevacizumab, 0.25 mg

J0178 Injection, aflibercept, 1 mg

J2503 Injection, pegaptanib sodium, 0.3 mg

J2778 Injection, ranibizumab, 0.1 mg

J9035 Injection, bevacizumab, 10 mg

Q5107 Injection, bevacizumab-awwb, biosimilar, (mvasi), 10 mg




Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Intravitreal Injection of Vascular Endothelial Growth Factor (VEGF) Antagonists and Related Biosimilars
Description: ICD-10 Codes and Narratives






Policy History

MA08.073f
01/01/2020This version of the policy will become effective 01/01/2020. This policy was updated to:
  • change policy title to "Intravitreal Injection of Vascular Endothelial Growth Factor (VEGF) Antagonists and Related Biosimilars"
  • include Avastin® and incorporate the company's designation of Avastin® and related biosimilars as its preferred product.
  • revise the 'Medically Necessary' criteria for Lucentis and Eylea to indicate both vascular endothelial growth factor (VEGF) antagonists are covered for individuals with non-proliferative and proliferative diabetic retinopathy with and without diabetic macular edema.

The following ICD10 codes have been added to the policy for Lucentis only: E08.3521, E08.3522, E08.3523, and E08.3529.

Applicable diagnosis codes have been added to the policy due to criteria changes for Eylea and Avastin.

MA08.073e
10/30/2017This policy was updated to include a new FDA-labeled indication for Lucentis® for the treatment of non-proliferative and proliferative diabetic retinopathy in individuals with or without diabetic macular edema.

Note: on 05/03/2018 the following ICD-10 codes were removed from Attachment A for Lucentis, Eylea, and Macugen: H34.00, H34.01, H34.02, H34.03, H34.10, H34.11, H34.12, H34.13, H34.211, H34.212, H34.213, H34.219, H34.231, H34.232, H34.233, H34.239, H34.8112, H34.8122, H34.8132, H34.8192, H34.821, H34.822, H34.823, H34.829, H34.8312, H34.8322, H34.8392, H35.89, H36

Note: on 05/22/2018 the following ICD-10 code was removed from Attachment A for Lucentis and Eylea: H34.8332.

MA08.073d
10/01/2017This policy has been identified for the ICD-10 CM code update, effective 10/01/2017.

The following ICD-10 CM codes have been added to this policy for Lucentis® only:
H44.2A1 Degenerative myopia with choroidal neovascularization, right eye
H44.2A2 Degenerative myopia with choroidal neovascularization, left eye
H44.2A3 Degenerative myopia with choroidal neovascularization, bilateral eye
H44.2A9 Degenerative myopia with choroidal neovascularization, unspecified eye
H44.2B1 Degenerative myopia with macular hole, right eye
H44.2B2 Degenerative myopia with macular hole, left eye
H44.2B3 Degenerative myopia with macular hole, bilateral eye
H44.2B9 Degenerative myopia with macular hole, unspecified eye
H44.2C1 Degenerative myopia with retinal detachment, right eye
H44.2C2 Degenerative myopia with retinal detachment, left eye
H44.2C3 Degenerative myopia with retinal detachment, bilateral eye
H44.2C9 Degenerative myopia with retinal detachment, unspecified eye
H44.2D1 Degenerative myopia with foveoschisis, right eye
H44.2D2 Degenerative myopia with foveoschisis, left eye
H44.2D3 Degenerative myopia with foveoschisis, bilateral eye
H44.2D9 Degenerative myopia with foveoschisis, unspecified eye
H44.2E1 Degenerative myopia with other maculopathy, right eye
H44.2E2 Degenerative myopia with other maculopathy, left eye
H44.2E3 Degenerative myopia with other maculopathy, bilateral eye
H44.2E9 Degenerative myopia with other maculopathy, unspecified eye

MA08.073c
03/28/2017This policy has been updated to reflect the FDA-approved prescribing information for Eylea®.

The coding table has been updated to reflect the Policy's covered indications; as such, the following codes have been removed from this policy:

The following ICD-10 codes have been removed from the policy for EYLEA® & MACUGEN® & LUCENTIS®:
E08.3521, E08.3522, E08.3523, E08.3529, E08.3531, E08.3532, E08.3533, E08.3539, E08.3541, E08.3542, E08.3543, E08.3549, E08.3551, E08.3552, E08.3553, E08.3559, E09.3521, E09.3522, E09.3523, E09.3529, E09.3531, E09.3532, E09.3533, E09.3539, E09.3541, E09.3542, E09.3543, E09.3549, E09.3551, E09.3552, E09.3553, E09.3559, E10.3521, E10.3522, E10.3523, E10.3529, E10.3531, E10.3532, E10.3533, E10.3539, E10.3541, E10.3542, E10.3543, E10.3549, E10.3551, E10.3552, E10.3553, E10.3559, E11.3521, E11.3522, E11.3523, E11.3529, E11.3531, E11.3532, E11.3533, E11.3539, E11.3541, E11.3542, E11.3543, E11.3549, E11.3551, E11.3552, E11.3553, E11.3559, E13.3521, E13.3522, E13.3523, E13.3529, E13.3531, E13.3532, E13.3533, E13.3539, E13.3541, E13.3542, E13.3543, E13.3549, E13.3551, E13.3552, E13.3553, E13.3559, H34.11, H34.12, H34.13, H34.231, H34.232, H34.233, H34.8112, H34.8122, H34.8132, H34.8192, H34.821, H34.822, H34.823, H34.8312, H34.8322, H34.8332, H34.8392, H35.3113, H35.3114, H35.3123, H35.3124, H35.3133, H35.3134, H35.3193, H35.3194

The following ICD-10 codes have been removed from the policy for LUCENTIS® only:
H21.1X1, H21.1X2, H21.1X3

MA08.073b
10/01/2016This policy has been identified for the ICD-10 code update, effective 10/01/2016.

The following ICD-10 code has been added to this policy:
H34.8110, H34.8111, H34.8112, H34.8120, H34.8121, H34.8122, H34.8130, H34.8131, H34.8132, H34.8190, H34.8191, H34.8192, H34.8310, H34.8311, H34.8312, H34.8320, H34.8321, H34.8322, H34.8330, H34.8331, H34.8332, H34.8390, H34.8391, H34.8392, H35.3113, H35.3114, H35.3123, H35.3124, H35.3133, H35.3134, H35.3193, H35.3194, H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, H35.3293, E08.3211, E08.3212, E08.3213, E08.3219, E08.3311, E08.3312, E08.3313, E08.3319, E08.3411, E08.3412, E08.3413, E08.3419, E08.3511, E08.3512, E08.3513, E08.3519, E08.3521, E08.3522, E08.3523, E08.3529, E08.3531, E08.3532, E08.3533, E08.3539, E08.3541, E08.3542, E08.3543, E08.3549, E08.3551, E08.3552, E08.3553, E08.3559, E09.3211, E09.3212, E09.3213, E09.3219, E09.3311, E09.3312, E09.3313, E09.3319, E09.3411, E09.3412, E09.3413, E09.3419, E09.3511, E09.3512, E09.3513, E09.3519, E09.3521, E09.3522, E09.3523, E09.3529, E09.3531, E09.3532, E09.3533, E09.3539, E09.3541, E09.3542, E09.3543, E09.3549, E09.3551, E09.3552, E09.3553, E09.3559, E10.3211, E10.3212, E10.3213, E10.3219, E10.3311, E10.3312, E10.3313, E10.3319, E10.3411, E10.3412, E10.3413, E10.3419, E10.3511, E10.3512, E10.3513, E10.3519, E10.3521, E10.3522, E10.3523, E10.3529, E10.3531, E10.3532, E10.3533, E10.3539, E10.3541, E10.3542, E10.3543, E10.3549, E10.3551, E10.3552, E10.3553, E10.3559, E11.3211, E11.3212, E11.3213, E11.3219, E11.3311, E11.3312, E11.3313, E11.3319, E11.3411, E11.3412, E11.3413, E11.3419, E11.3511, E11.3512, E11.3513, E11.3519, E11.3521, E11.3522, E11.3523, E11.3529, E11.3531, E11.3532, E11.3533, E11.3539, E11.3541, E11.3542, E11.3543, E11.3549, E11.3551, E11.3552, E11.3553, E11.3559, E13.3211, E13.3212, E13.3213, E13.3219, E13.3311, E13.3312, E13.3313, E13.3319, E13.3411, E13.3412, E13.3413, E13.3419, E13.3511, E13.3512, E13.3513, E13.3519, E13.3521, E13.3522, E13.3523, E13.3529, E13.3531, E13.3532, E13.3533, E13.3539, E13.3541, E13.3542, E13.3543, E13.3549, E13.3551, E13.3552, E13.3553, E13.3559


The following ICD-10 codes have been deleted from this policy:
H34.811, H34.812, H34.813, H34.831, H34.832, H34.833, H35.31, H35.32, E08.321, E08.331, E08.341, E08.351, E09.321, E09.331, E09.341, E09.351, E10.321, E10.331, E10.341, E10.351, E11.321, E11.331, E11.341, E11.351, E13.321, E13.331, E13.341, E13.351

MA08.073a
07/15/2015This policy has been updated to communicate the Medical Necessity of the new FDA-labeled indications for aflibercept (Eylea®) for the treatment of diabetic macular edema and macular edema following branch retinal vein occlusion. The administration guidelines of aflibercept (Eylea®) were also updated.

The Medical Necessity of a new FDA-labeled indication for ranibizumab (Lucentis®) and aflibercept (Eylea®) was included for the treatment of non-proliferative and proliferative diabetic retinopathy in individuals with diabetic macular edema.

The Medical Necessity of an off-label indication for ranibizumab (Lucentis®) was also included.
  • Choroidal neovascularization due to angioid streaks, central serous chorioretinopathy, choroidal rupture or trauma, idiopathic choroidal neovascularization, multifocal choroiditis, pathologic myopia, and presumed ocular histoplasmosis syndrome, uveitis

Language regarding off-label indications have been updated.

MA08.073
01/01/2015This is a new policy.






Version Effective Date: 01/01/2020
Version Issued Date: 01/02/2020
Version Reissued Date: N/A