Ocular Angiogenesis Inhibitor Agents
Restricted Product(s):
- brolucizumab-dbll (Beovu® ) intravitreal injection for administration by a healthcare professional
- aflibercept (Eylea® ) intravitreal injection for administration by a healthcare professional
- aflibercept (Eylea® HD) intravitreal injection for administration by a healthcare professional
- ranibizumab-nuna (Byooviz™) intravitreal injection for administration by a healthcare professional
- ranibizumab-eqrn (Cimerli™) intravitreal injection for administration by a healthcare professional
- ranibizumab (Lucentis® ) intravitreal injection for administration by a healthcare professional
- ranibizumab (Susvimo™) intravitreal implant for administration by a healthcare professional
- faricimab-svoa (Vabysmo® ) intravitreal injection for administration by a healthcare professional
FDA Approved Use:
- Brolucizumab-dbll (Beovu® )
- For treatment of neovascular (wet) age-related macular degeneration (AMD)
- For treatment of diabetic macular edema (DME)
- Aflibercept (Eylea® )
- For treatment of neovascular (wet) age-related macular degeneration (AMD)
- For treatment of macular edema following retinal vein occlusion (RVO)
- For treatment of diabetic macular edema (DME)
- For treatment of diabetic retinopathy (DR)
- For treatment of retinopathy of prematurity (ROP)
- Aflibercept (Eylea® HD)
- For treatment of neovascular (wet) age-related macular degeneration (AMD)
- For treatment of diabetic macular edema (DME)
- For treatment of diabetic retinopathy (DR)
- Ranibizumab (Lucentis® )
- For treatment of neovascular (wet) age-related macular degeneration (AMD)
- For treatment of macular edema following retinal vein occlusion (RVO)
- For treatment of diabetic macular edema (DME)
- For treatment of diabetic retinopathy (DR)
- For treatment of myopic choroidal neovascularization (mCNV)
- Ranibizumab-nuna (Byooviz™)
- For treatment of neovascular (Wet) age-related macular degeneration (AMD)
- For treatment of macular edema following retinal vein occlusion (RVO)
- For treatment of myopic choroidal neovascularization (mCNV)
- Ranibizumab-eqrn (Cimerli™)
- For treatment of neovascular (wet) age-related macular degeneration (AMD)
- For treatment of macular edema following retinal vein occlusion (RVO)
- For treatment of diabetic macular edema (DME)
- For treatment of diabetic retinopathy (DR)
- For treatment of myopic choroidal neovascularization (mCNV)
- Ranibizumab (Susvimo™)
- For treatment of neovascular (wet) age-related macular degeneration (AMD) in patients who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor
NOTE: On October 18, 2022, Susvimo was voluntarily withdrawn from the market by the manufacturer due to safety concerns related to the septum of the ocular implant. The manufacturer plans to make adjustments to the manufacturing process to resolve safety concerns. Susvimo will be unavailable for new implantation, but continued refill procedures may occur in eligible patients with existing implants.
- Faricimab-svoa (Vabysmo® )
- For treatment of neovascular (wet) age-related macular degeneration (AMD)
- For treatment of diabetic macular edema (DME)
- For treatment of macular edema following retinal vein occlusion (RVO)
Criteria for Medical Necessity:
The restricted product(s) may be considered medically necessary when the following criteria are met:
- The patient is currently being treated with the requested agent and has been stable on therapy for at least 180 days; OR
- The patient has been treated with the requested agent within the past 180 days AND is at risk if therapy is changed; OR
- The requested agent is brolucizumab-dbll (Beovu); AND
- The patient has ONE of the following diagnoses:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD); OR
- Diabetic Macular Edema (DME); AND
- BOTH of the following:
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; AND
- ONE of the following:
- The patient has tried and had an inadequate response to one of the following: aflibercept (Eylea), aflibercept (Eylea HD), ranibizumab (Lucentis), ranibizumab-nuna (Byooviz), ranibizumab-eqrn (Cimerli), faricimab-svoa (Vabysmo) [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all of the following: aflibercept (Eylea), aflibercept (Eylea HD), ranibizumab (Lucentis), ranibizumab-nuna (Byooviz), ranibizumab-eqrn (Cimerli), faricimab-svoa (Vabysmo) [medical record documentation required]; OR
- ONE of the following:
- The patient has ONE of the following diagnoses:
- The requested agent is aflibercept (Eylea); AND
- The patient has ONE of the following diagnoses:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD); OR
- Macular Edema following Retinal Vein Occlusion (RVO); OR
- Diabetic Macular Edema (DME); OR
- Diabetic Retinopathy (DR); OR
- Retinopathy of Prematurity (ROP); AND
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; OR
- The patient has ONE of the following diagnoses:
- The requested agent is aflibercept (Eylea HD); AND
- The patient has ONE of the following diagnoses:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD); OR
- Diabetic Macular Edema (DME); OR
- Diabetic Retinopathy (DR); AND
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; OR
- The patient has ONE of the following diagnoses:
- The requested agent is ranibizumab (Lucentis); AND
- The patient has a diagnosis of Myopic Choroidal Neovascularization (mCNV); OR
- BOTH of the following:
- The patient has ONE of the following diagnoses:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD); OR
- Macular Edema following Retinal Vein Occlusion (RVO); OR
- Diabetic Macular Edema (DME); OR
- Diabetic Retinopathy (DR); AND
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; OR
- The patient has ONE of the following diagnoses:
- The requested agent is ranibizumab-nuna (Byooviz); AND
- The patient has a diagnosis of Myopic Choroidal Neovascularization (mCNV); OR
- BOTH of the following:
- The patient has ONE of the following diagnoses:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD); OR
- Macular Edema following Retinal Vein Occlusion (RVO); OR
- Diabetic Macular Edema (DME); OR
- Diabetic Retinopathy (DR); AND
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; OR
- The patient has ONE of the following diagnoses:
- The requested agent is ranibizumab-eqrn (Cimerli); AND
- The patient has a diagnosis of Myopic Choroidal Neovascularization (mCNV); OR
- BOTH of the following:
- The patient has ONE of the following diagnoses:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD); OR
- Macular Edema following Retinal Vein Occlusion (RVO); OR
- Diabetic Macular Edema (DME); OR
- Diabetic Retinopathy (DR); AND
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; OR
- The patient has ONE of the following diagnoses:
- The requested agent is ranibizumab (Susvimo); AND
- The patient has a diagnosis of Neovascular (Wet) Age-Related Macular Degeneration (AMD); AND
- BOTH of the following:
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; AND
- ONE of the following:
- The patient has tried and had an inadequate response to a ranibizumab product (e.g., Byooviz, Cimerli, Lucentis) [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all other ranibizumab products (e.g., Byooviz, Cimerli, Lucentis) that is not anticipated with the requested product [medical record documentation required]; OR
- ONE of the following:
- The requested agent is faricimab-svoa (Vabysmo); AND
- The patient has ONE of the following diagnoses:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD); OR
- Diabetic Macular Edema (DME); OR
- Macular Edema following Retinal Vein Occlusion (RVO); AND
- ONE of the following:
- The patient has tried and had an inadequate response to bevacizumab intravitreal injection [medical record documentation required]; OR
- The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to all bevacizumab products [medical record documentation required]; AND
- The patient has ONE of the following diagnoses:
- The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).
Duration of Approval: 365 days (1 year)
FDA Label Reference
Medication | Indication | Dosing | HCPCS | Maximum Units* |
---|---|---|---|---|
brolucizumab-dbll (Beovu® ) intravitreal injection | Neovascular (Wet) AgeRelated Macular Degeneration (AMD)
Diabetic Macular Edema (DME) | AMD: DME: | J0179 | 48 (per treated eye) |
aflibercept (Eylea® ) intravitreal injection | Neovascular (Wet) AgeRelated Macular Degeneration (AMD)
Macular Edema following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR)
Retinopathy of Prematurity (ROP) | AMD: RVO: DME: DR: ROP: | J0178 | ROP: All other diagnoses: |
aflibercept (Eylea® HD) intravitreal injection | Neovascular (Wet) AgeRelated Macular Degeneration (AMD)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR) | AMD: DME: DR: | J0177 | 64 (per treated eye) |
ranibizumab-nuna (Byooviz™) intravitreal injection | Neovascular (Wet) AgeRelated Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR) Myopic Choroidal neovascularization (mCNV) | AMD: RVO: DME: DR: mCNV: | Q5124 | 65 (per treated eye) |
ranibizumab-eqrn (Cimerli™) intravitreal injection | Neovascular (Wet) AgeRelated Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR) Myopic Choroidal neovascularization (mCNV) | AMD: RVO: DME: DR: mCNV: | Q5128 | 65 (per treated eye) |
ranibizumab (Lucentis® ) intravitreal injection | Neovascular (Wet) AgeRelated Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME) Diabetic Retinopathy (DR)
Myopic Choroidal neovascularization (mCNV) | AMD: RVO: DME: DR: mCNV: | J2778 | 65 (per treated eye) |
ranibizumab (Susvimo™) intravitreal implant | Neovascular (Wet) AgeRelated Macular Degeneration (AMD) | AMD: 2 mg (0.02 mL) continuously administered by intravitreal implant with refills every 24 weeks (approximately every 6 months) | J2779 | 40 (per treated eye) |
faricimab-svoa (Vabysmo® ) intravitreal injection | Neovascular (Wet) AgeRelated Macular Degeneration (AMD)
Diabetic Macular Edema (DME)
Macular Edema Following Retinal Vein Occlusion (RVO) | AMD: DME:
RVO | J2777 | AMD: 540 DME: 780 |
*Maximum units allowed for duration of approval
**Non-specific assigned HCPCS codes, must submit requested product NDC
Other HCPCS codes that may be applicable: C9257
References:
all information referenced is from FDA package insert unless otherwise noted below.
- Cheung CMG, Arnold JJ, Holz FG, et al. American Academy of Ophthalmology. Myopic choroidal neovascularization: review, guidance, and consensus statement on management. Ophthalmology. 2017;124(11):1690-1711.
- Flaxel CJ, Adelman RA, Bailey ST, et al. American Academy of Ophthalmology. Age-related macular degeneration preferred practice pattern® . Ophthalmology. 2020 Jan;127(1):1-65.
- Flaxel CJ, Adelman RA, Bailey ST, et al. American Academy of Ophthalmology. Diabetic retinopathy preferred practice pattern® . Ophthalmology. 2020 Jan;127(1):66-145.
- Flaxel CJ, Adelman RA, Bailey ST, et al. American Academy of Ophthalmology. Retinal vein occlusions preferred practice pattern® . Ophthalmology. 2020 Feb;127(2):288-320.
- Ho AC, Scott IU, Kim SJ, et al. American Academy of Ophthalmology Ophthalmic Technology Assessment. Anti–vascular endothelial growth factor pharmacotherapy for diabetic macular edema: a report by the American Academy of Ophthalmology. Ophthalmology. 2012 Oct;119(10):2179-88.
Policy Implementation/Update Information:
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.
January 2025: Criteria change: For Beovu, added requirement for trial and failure of one of the following products: Eylea, Eylea HD, Lucentis, Byooviz, Cimerli, or Vabysmo. For Lucentis, removed requirement for trial and failure of Byooviz and Cimerli. Adjusted maximum units for Eylea, Lucentis, Byooviz, Cimerli, and Vabysmo for clarity according to FDA labeled dosing. Removed Macugen from policy due to market withdrawal and product discontinuation. Additional minor updates made to formatting throughout policy for clarity. Policy notification given 11/1/2024 for effective date 1/1/2025.
April 2024: Coding change: Added HCPCS code J0177 for Eylea HD to dosing reference table effective 4/1/2024; deleted C9161, J3490, and J3590 termed 3/31/2024.
January 2024: Criteria change (Vabysmo): Added new indication for Vabysmo for treatment of macular edema following retinal vein occlusion (RVO) with corresponding criteria and dosing table updates.
January 2024: Coding update: Added HCPCS code C9161 for Eyela HD to dosing reference table effective 1/1/2024; deleted C9399 termed 12/31/2023.
September 2023: Criteria update: Added newly approved Eylea HD to policy for treatment of AMD, DME, and DR, with the same criteria requirements as Eylea for the appropriate FDA labeled indications. Added associated dosing and maximum units, and HCPCS codes C9399, J3490, and J3590 to FDA label reference table.
April 2023: Coding update: Added HCPCS code Q5128 for Cimerli to dosing reference table effective 4/1/2023; deleted C9399, J3490, J3590 termed 3/31/2023.
March 2023: Criteria update: Added new indication for Eylea for treatment of retinopathy of prematurity (ROP) with corresponding criteria and dosing table updates.
October 2022: Criteria change: Added new to market product Cimerli to policy as a co-preferred ranibizumab product with corresponding criteria and dosing table updates. Added note indicating temporary voluntary market withdrawal of Susvimo.
October 2022: Coding update: Added HCPCS code J2777 for Vabysmo to dosing reference table and updated maximum units per code definition effective 10/1/2022; deleted C9097, J3490, and J3590 termed 9/30/2022. Adjusted dosing for Byooviz for DME and DR indications in dosing reference table.
August 2022: Criteria change: Added new indication for Beovu for treatment of diabetic macular edema (DME) with corresponding criteria and dosing table updates.
August 2022: Criteria change: For Lucentis requests, added requirement of a documented serious adverse event that required medical intervention to Byooviz that is not anticipated with Lucentis and a submitted MedWatch Adverse Event Reporting form. For Susvimo requests, changed trial and failure requirement to one ranibizumab product (e.g., Byooviz, Lucentis). Policy notification given 6/1/2022 for effective date 8/1/2022.
July 2022: Coding update: Added HCPCS code C9097 for Vabysmo and J2779 for Susvimo to dosing reference table and updated units for Susvimo per code definition effective 7/1/2022, deleted C9399 for Vabysmo and C9093, C9399, J3490, and J3590 for Susvimo termed 6/30/2022.
March 2022: Criteria change: Added new to market product Byooviz to policy with corresponding criteria and dosing table updates; added code C9093 for Susvimo
February 2022: Criteria change: Added newly approved Vabysmo to policy for treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME) with requirement of trial and failure of bevacizumab; added associated dosing and maximum units to FDA label reference table.
January 2022: Criteria change: Added newly approved Susvimo to policy for treatment of neovascular (wet) age-related macular degeneration (AMD) with requirement of trial and failure of bevacizumab and Lucentis; added associated dosing and maximum units to FDA label reference table.
October 2021: Criteria change: Added criteria for patients currently being treated with and stable on therapy with the requested agent for at least 180 days, or at risk if therapy is changed.
October 2021: Original medical policy criteria issued. Policy notification given 7/1/2021 for effective date 10/1/2021.
Disclosures:
BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. Blue Cross NC is an independent licensee of the Blue Cross and Blue Shield Association. All other marks are the property of their respective owners.
Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.
Information in other languages: Español 中文 Tiếng Việt 한국어 Français العَرَبِيَّة Hmoob ру́сский Tagalog ગુજરાતી ភាសាខ្មែរ Deutsch हिन्दी ລາວ 日本語
© 2025 Blue Cross and Blue Shield of North Carolina. ®, SM Marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. All other marks and names are property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association.