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.


Medical Policy Bulletin


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

Policy #:08.00.74m

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


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. 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.

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 Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

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

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
The 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 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)
  • Non-proliferative and proliferative diabetic retinopathy with and without diabetic 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
The 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 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

AFLIBERCEPT (EYLEA®) AND RELATED BIOSIMILARS
The 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 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

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.
Guidelines

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.

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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, 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 products when the medical necessity criteria listed in the medical policy are met.

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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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.

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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.

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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

08.00.74m
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.


Effective 10/05/2017 this policy has been updated to the new policy template format.


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

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