ph-0026
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Eylea (aflibercept)

Policy Number: PH-0026

 

(Intravitreal)

 

Last Review Date: 10/01/2019

Date of Origin: 02/07/2013

Dates Reviewed: 03/07/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 04/2015, 06/2015, 09/2015, 03/2016, 04/2016, 05/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 06/2019, 10/2019

  1. Length of Authorization

Coverage will be provided annually and may be renewed.

  1. Dosing Limits

          A.  Quantity Limit (max daily dose) [Pharmacy Benefit]:

  • 2 mg injection: 1 vial per eye every 25 days

          B.  Max Units (per dose and over time) [Medical Benefit]:

Diagnosis

MU for Initial Dosing

MU for Maintenance Dosing

Neovascular age-related macular degeneration (AMD)

4 units every 28 days x 3 doses

4 units every 28-56 days

Macular edema following retinal vein occlusion (RVO)

4 units every 28 days

4 units every 28 days

Diabetic Macular Edema (DME)/ Diabetic retinopathy (DR)

4 units every 28 days x 5 doses

4 units every 28-56 days

(Max units are based on administration to both eyes)

  1. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is 18 years or older; AND
  • Patient is free of ocular and/or peri-ocular infections; AND
  • Patient does not have active intraocular inflammation; AND
  • Patient has a definitive diagnosis of one of the following:
  • Neovascular (Wet) Age-Related Macular Degeneration (AMD) †*
  • Macular Edema following Retinal Vein Occlusion (RVO) †
  • Diabetic Macular Edema (DME) †*
  • Diabetic Retinopathy (DR)) †*

*Patients with an insufficient response during initial therapy administered every 4 weeks may continue with dosing every 4 weeks. Patients with an inadequate response to maintenance therapy administered every 8 weeks may increase the dosing frequency up to every 4 weeks. (Refer to Section V)

FDA Approved Indication(s)

  1. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: endophthalmitis and retinal detachments; increase in intraocular pressure; arterial thromboembolic events; AND
  • Patient had a beneficial response to therapy; AND
  • Continued administration is necessary for the maintenance treatment of the condition
  1. Dosage/Administration

Indication

Dose

AMD

Initiation:

2 mg intravitreally once every 4 weeks (approximately every 28 days, monthly) per affected eye for the first 12 weeks (3 months)

Maintenance:

2 mg intravitreally once every 8 weeks (2 months) per affected eye; however, Eylea may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly)

  • Additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (approximately monthly) dosing after the first 12 weeks (3 months).

Patients may also be treated with one dose every 12 weeks after one year of effective therapy

Macular Edema following RVO

2 mg intravitreally once every 4 weeks (approximately every 25 days, monthly) per affected eye

Diabetic macular edema & Diabetic retinopathy

Initiation:

2 mg intravitreally once every 4 weeks (approximately every 28 days, monthly) per affected eye for the first 5 injections

Maintenance:

2 mg intravitreally once every 8 weeks (2 months) per affected eye; however, Eylea may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly)

  • Additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).
  1. Billing Code/Availability Information

Jcode:

J0178 – Injection, aflibercept, 1 mg; 1 billable unit = 1 mg

NDC:

Eylea 2 mg/0.05 mL Solution for Injection, single-use vial or pre-filled syringe: 61755-0005-xx

  1. References
  1. Eylea [package insert].  Tarrytown, NY; Regeneron Pharmaceuticals, Inc.; August 2019. Accessed September 2019.
  2. Solomon SD, Chew E, Duh EJ, et al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418.
  3. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Update 2017. Nov 2017.
  4. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Update 2017. Nov 2017.
  5. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP – Update 2017. Nov 2017.
  6. Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – July 2015. Accessed at https://www.rcophth.ac.uk/standards-publications-research/clinical-guidelines.
  7. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology 2016;123(6):1351-9. doi.org/10.1016/j.ophtha.2016.02.022
  8. National Government Services, Inc. Local Coverage Article for Ranibizumab (e.g., Lucentis™) and Aflibercept (e.g., Eylea™) – Related to LCD L33394 (A52451). Centers for Medicare & Medicaid Services, Inc. Updated on 06/21/2019 with effective date of 07/01/2019. Accessed September 2019.
  9. First Coast Service Options, Inc. Local CoverageArticle: Billing and Coding: Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Diseases (A56716). Centers for Medicare & Medicaid Services, Inc. Updated on 7/17/2019 with effective date of 10/03/2018. Accessed September 2019.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

E08.3211

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye

E08.3212

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, left eye

E08.3213

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, bilateral

E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E08.3311

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E08.3312

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E08.3313

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E08.3411

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye

E08.3412

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye

E08.3413

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral

E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E08.3511

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye

E08.3512

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye

E08.3513

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral

E08.3519

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye

E08.37X1

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, right eye

E08.37X2

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, left eye

E08.37X3

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, bilateral

E08.37X9

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, unspecified eye

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

E09.3211

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

E09.3212

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

E09.3213

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E09.3311

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E09.3312

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E09.3313

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E09.3411

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

E09.3412

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

E09.3413

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E09.3511

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

E09.3512

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

E09.3513

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

E09.3519

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E09.37X1

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E09.37X2

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E09.37X3

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E09.37X9

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

 E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.3211

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

E10.3212

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

E10.3213

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

E10.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E10.3311

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E10.3312

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E10.3313

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E10.3411

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

E10.3412

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

E10.3413

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E10.3511

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

E10.3512

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

E10.3513

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

E10.3519

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E10.37X1

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E10.37X2

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E10.37X3

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E10.37X9

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

 E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.3211

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

E11.3212

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

E11.3213

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E11.3311

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E11.3312

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E11.3313

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E11.3411

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

E11.3412

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

E11.3413

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E11.3511

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

E11.3512

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

E11.3513

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

E11.3519

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E11.37X1

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E11.37X2

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E11.37X3

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E11.37X9

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

 E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.3211

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

E13.3212

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

E13.3213

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3311

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E13.3312

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E13.3313

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3411

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

E13.3412

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

E13.3413

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3511

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

E13.3512

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

E13.3513

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

E13.3519

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E13.37X1

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E13.37X2

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E13.37X3

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E13.37X9

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

H34.8110

Central retinal vein occlusion, right eye, with macular edema

H34.8111

Central retinal vein occlusion, right eye, with retinal neovascularization

H34.8112

Central retinal vein occlusion, right eye, stable

H34.8120

Central retinal vein occlusion, left eye, with macular edema

H34.8121

Central retinal vein occlusion, left eye, with retinal neovascularization

H34.8122

Central retinal vein occlusion, left eye, stable

H34.8130

Central retinal vein occlusion, bilateral, with macular edema

H34.8131

Central retinal vein occlusion, bilateral, with retinal neovascularization

H34.8132

Central retinal vein occlusion, bilateral, stable

H34.8190

Central retinal vein occlusion, unspecified eye, with macular edema

H34.8191

Central retinal vein occlusion, unspecified eye, with retinal neovascularization

H34.8192

Central retinal vein occlusion, unspecified eye, stable

H34.8310

Tributary (branch) retinal vein occlusion, right eye, with macular edema

H34.8311

Tributary (branch) retinal vein occlusion, right eye, with retinal neovascularization

H34.8312

Tributary (branch) retinal vein occlusion, right eye, stable

H34.8320

Tributary (branch) retinal vein occlusion, left eye, with macular edema

H34.8321

Tributary (branch) retinal vein occlusion, left eye, with retinal neovascularization

H34.8322

Tributary (branch) retinal vein occlusion, left eye, stable

H34.8330

Tributary (branch) retinal vein occlusion, bilateral, with macular edema

H34.8331

Tributary (branch) retinal vein occlusion, bilateral, with retinal neovascularization

H34.8332

Tributary (branch) retinal vein occlusion, bilateral, stable

H34.8390

Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema

H34.8391

Tributary (branch) retinal vein occlusion, unspecified eye, with retinal neovascularization

H34.8392

Tributary (branch) retinal vein occlusion, unspecified eye, stable

H35.3210

Exudative age-related macular degeneration, right eye, stage unspecified

H35.3211

Exudative age-related macular degeneration, right eye, with active choroidal neovascularization

H35.3212

Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization

H35.3213

Exudative age-related macular degeneration, right eye, with inactive scar

H35.3220

Exudative age-related macular degeneration, left eye, stage unspecified

H35.3221

Exudative age-related macular degeneration, left eye, with active choroidal neovascularization

H35.3222

Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization

H35.3223

Exudative age-related macular degeneration, left eye, with inactive scar

H35.3230

Exudative age-related macular degeneration, bilateral, stage unspecified

H35.3231

Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization

H35.3232

Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization

H35.3233

Exudative age-related macular degeneration, bilateral, with inactive scar

H35.3290

Exudative age-related macular degeneration, unspecified eye, stage unspecified

H35.3291

Exudative age-related macular degeneration, unspecified eye, with active choroidal neovascularization

H35.3292

Exudative age-related macular degeneration, unspecified eye, with inactive choroidal neovascularization

H35.3293

Exudative age-related macular degeneration, unspecified eye, with inactive scar

H35.81

Retinal edema

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52451

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A52451&bc=gAAAAAAAAAAA

Jurisdiction(s): N (9)

NCD/LCD Document (s): A56716

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A56716&bc=gAAAAAAAAAAA&

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

EYLEA® (aflibercept) Prior Auth Criteria
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