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ModifiedEmpire BluecrossPolicy CC-0072

Intravitreal VEGF inhibitors (clinical criteria and coverage)

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Clinical criteria, coverage stance, step therapy, and quantity limits for intravitreal vascular endothelial growth factor (VEGF) antagonist agents used to treat retinal diseases (e.g., neovascular AMD, DME, RVO, PDR) for Empire Bluecross members.

Policy Summary

PayerEmpire Bluecross

PolicyIntravitreal VEGF inhibitors (clinical criteria and coverage)

Policy CodePolicy CC-0072

Change TypeCoding updatesstep therapy and quantity limit clarifications

Effective DateJun 12, 2025

Last ReviewJun 12, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests with supporting diagnosis and dosing documentation per the indication-specific clinical criteria.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS Q5155 for Yesafili effective 10/1/25 and removed HCPCS NOC C9399 and J3590 for Yesafili effective 9/30/25.

Added Q5153 for Opuviz effective 7/1/25 and removed HCPCS NOC C9399 and J3590 for Opuviz effective 6/30/25.

Step therapy table updates performed on 04/01/2025 and 06/12/2025.

Clarified Eylea HD quantity limits to align with FDA label.

multiplelisted agents

indication-specificcoverage by indication

quantity limitsdosing limits

Commercial/Medicare/Medicaidbenefit distinctions

extensiverevision log

Coverage Criteria for Intravitreal VEGF Agents

Vabysmo indications

Covered when ONE of the following diagnosis criteria is met:

Vabysmo indications: Diabetic macular edema (DME), including DME with diabetic retinopathy of any severity; OR Established neovascular (wet) age-related macular degeneration; OR Macular edema following retinal vein occlusion (central or branch RVO).

Requests not meeting these will not be approved.

Bevacizumab and biosimilars indications

Covered when ONE of the following diagnosis criteria is met:

Avastin-class indications: Proliferative or moderate to severe non‑proliferative diabetic retinopathy (with or without DME); Diabetic macular edema (DME); Established neovascular (wet) age‑related macular degeneration; Macular edema from central or branch retinal vein occlusion; Neovascular glaucoma; Other rare causes of choroidal neovascularization (including myopic CNV, angioid streaks, choroiditis, trauma, radiation retinopathy); Retinopathy of prematurity.

Requests not meeting these will not be approved.

Policy Summary

PayerEmpire Bluecross

PolicyIntravitreal VEGF inhibitors (clinical criteria and coverage)

Policy CodePolicy CC-0072

Change TypeCoding updatesstep therapy and quantity limit clarifications

Effective DateJun 12, 2025

Last ReviewJun 12, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests with supporting diagnosis and dosing documentation per the indication-specific clinical criteria.

SourceLink

On This Page

Agent-specific quantity and frequency limits

Quantity limits and dosing frequency by agent and indication:

Aflibercept (Eylea, Eylea HD and biosimilars): Per‑eye dosing: aflibercept 2 mg per eye (various formulations); Eylea HD 8 mg per eye. Frequency: Eylea HD 8 mg every ~28 days (+/‑7 days) for the first three doses, then every 8–16 weeks (DR and nAMD frequency ranges specified).See agent‑specific dosing in source

Eylea HD quantity limits aligned to FDA label; see chunks 18 and 19.

Ranibizumab (Lucentis, Byooviz, Cimerli): Per‑eye dosing: ranibizumab 0.3 mg (DME/DR) or 0.5 mg (CNV/radiation retinopathy/myopic CNV) per eye. Frequency: as frequently as every 4 weeks for DME/DR and other specified indications.0.3 mg or 0.5 mg per eye; every 4 weeks as indicated

See chunks 18–19 for formulation‑specific limits.

Bevacizumab (Avastin and biosimilars): Per‑eye dosing when used ophthalmically: commonly 0.5 mg or 1.25 mg per eye. Frequency: each eye may be treated as frequently as every 4 weeks.0.5 mg or 1.25 mg per eye every 4 weeks

Formulation and vial sizes listed in chunks 18–19; ophthalmic dosing statements provided.

Brolucizumab (Beovu): Per‑eye dosing: 6 mg per vial/prefilled syringe. Initiation override options: for age‑related macular degeneration, one 6 mg dose per eye monthly for the first three doses (alternate initiation dosing options for DME noted).6 mg per eye; initiation: monthly x3 doses (override)

Beovu initiation override criteria described in chunk 20.

Faricimab (Vabysmo): Per‑eye dosing: 6 mg per vial/prefilled syringe; frequency and per‑indication statements included in quantity limit listings.6 mg per eye

Vabysmo dosing referenced in chunks 19–20.

Coding, Codes and Quantity Limits

Quantity limit product entriesmixed

Eylea 2 mg	Eylea (aflibercept) 2 mg vial Enzeevu (aflibercept-abzv) 2 mg vial & syringe; Pavblu (aflibercept-ayyh) 2 mg vial & syringe; Yesafili (aflibercept-jbvf) 2 mg vial; Ahzantive (aflibercept-mrbb) 2 mg vial; Opuviz (aflibercecpt-yszy) 2 mg
Eylea HD 8 mg	Eylea HD (aflibercept) 8 mg vial
Lucentis 0.3/0.5 mg	Lucentis (ranibizumab) 0.3 mg, 0.5 mg prefilled syringe
Byooviz 0.5 mg	Byooviz (ranibizumab-nuna) 0.5 mg vial
Cimerli 0.3/0.5 mg	Cimerli (ranibizumab-cqrn) 0.3 mg, 0.5 mg vial
Avastin 100 mg/400 mg	Avastin (bevacizumab) 100 mg; 400 mg vial (and biosimilars Alymsys, Mvasi, Vegzelma, Zirabev)
Beovu 6 mg	Beovu (brolucizumab) 6 mg vial & prefilled syringe
Vabysmo 6 mg	Vabysmo (faricimab-svoa) 6 mg vial & prefilled syringe

Bevacizumab HCPCS/Q-codesHCPCS

C9257	Injection, bevacizumab, 0.25 mg [Avastin]
J9035	Injection, bevacizumab, 10 mg [when specified as Avastin intravitreal]
Q5126	Injection, bevacizumab-maly, biosimilar; (Alymsys), 10 mg
Q5129	Injection, bevacizumab-adcd (Vegzelma), biosimilar; 10 mg
Q5107	Injection, bevacizumab-awwb, biosimilar; (Mvasi), 10 mg
Q5118	Q5118 (listed without description in source)

Ranibizumab HCPCS/Q-codesHCPCS

J2778	Injection, ranibizumab; 0.1 mg [Lucentis]
Q5124	Injection, ranibizumab-nuna, biosimilar; (Byooviz), 0.1 mg
Q5128	Injection, ranibizumab-eqrn (Cimerli); biosimilar; 0.1 mg

Aflibercept and brolucizumab HCPCSHCPCS

J0177	Injection, aflibercept HD, mg [Eylea HD]
J0178	Injection, aflibercept; 1 mg [Eylea]
J0179	Injection, brolucizumab-dbll; mg [Beovu]

CPT - Intravitreal injectionCPT

67028

Intravitreal injection of a pharmacologic agent

ICD-10 Diagnosis codes (retinal, diabetic, radiation retinopathy, AMD)ICD-10

E08.311-E08.3519	Diabetes mellitus due to underlying condition with diabetic retinopathy with macular edema / ranges as specified
E09.311-E09.3599	Drug or chemical induced diabetes mellitus with diabetic retinopathy (ranges)
E10.311-E10.3599	Type 1 diabetes mellitus with diabetic retinopathy (ranges)
E11.311-E11.3599	Type 2 diabetes mellitus with diabetic retinopathy (ranges)
E13.311-E13.3599	Other specified diabetes mellitus with diabetic retinopathy (ranges)
H34.8110-H34.8390	Central and branch retinal vein occlusion with macular edema
H35.3210-H35.3293	Exudative age-related macular degeneration
H21.1X1-H21.1X9	Other vascular disorders of iris and ciliary body (neovascularization)
H44.2A1-H44.2A9	Degenerative myopia with choroidal neovascularization

HCPCS — BeovuHCPCS

J0179

HCPCS (Injection, brolucizumab-dbll; mg [Beovu])

HCPCS — VabysmoHCPCS

J2777

HCPCS (Injection, faricimab-svoa, 0.1 mg [Vabysmo])

CPT Procedure CodesCPT

67028

CPT (Intravitreal injection of a pharmacologic agent)

ICD-10 Diagnosis Codes and RangesICD-10

E08.311-E08.3519	Diabetes mellitus due to underlying condition with diabetic retinopathy with macular edema (range)
E09.311-E09.3519	Drug- or chemical-induced diabetes mellitus with diabetic retinopathy with macular edema (ranges)
E10.311-E10.3519	Type 1 diabetes mellitus with diabetic retinopathy with macular edema (ranges)
E11.311-E11.3519	Type 2 diabetes mellitus with diabetic retinopathy with macular edema (ranges)
E13.311-E13.3519	Other specified diabetes mellitus with diabetic retinopathy with macular edema (ranges)
H35.3210-H35.3293	Exudative age-related macular degeneration
H34.8110-H34.8390	Central and branch retinal vein occlusion with macular edema (various laterality codes)

Recently added HCPCS codes (document history)HCPCS

Q5153	HCPCS added for Opuviz (document history)
Q5155	HCPCS added for Yesafili (document history)

inv-23: Dosing intervals — per-eye dose and minimum interval vary by agent (examples provided)

ScopePer-eye dose and minimum dosing interval vary by agent; quantity limits provided per agent and indication.

Examples — Lucentis (ranibizumab)0.3 mg per eye for DME/DR; each eye may be treated as frequently as every 4 weeks.

Examples — Eylea HD (aflibercept)8 mg per eye every 4 weeks for the first three doses (approx. 28 days +/-7), then every 8 to 16 weeks depending on indication.

Examples — Bevacizumab (Avastin)Ophthalmic dosing listed as 0.5 mg or 1.25 mg per eye; each eye may be treated as frequently as every 4 weeks.

Examples — Byooviz / Cimerli (ranibizumab biosimilars)0.3 mg or 0.5 mg per eye depending on indication; each eye may be treated as frequently as every 4 weeks.

inv-24: Per-eye dosing and minimum intervals — agent-specific dosing examples and minimum intervals

Aflibercept (Eylea; biosimilars)2 mg per eye (standard Eylea) with frequency limits by indication; Eylea HD: 8 mg per eye every 4 weeks x3 then 8–16 week maintenance (DR/DME/AMD specifics in policy).

Ranibizumab (Lucentis; Byooviz; Cimerli)0.3 mg per eye for diabetic macular edema/diabetic retinopathy (treat as frequently as every 4 weeks); 0.5 mg per eye for CNV/radiation retinopathy where indicated.

Bevacizumab (Avastin and biosimilars)When used ophthalmically: 0.5 mg per eye or 1.25 mg per eye; each eye may be treated as frequently as every 4 weeks.

Brolucizumab (Beovu)6 mg per eye vial/prefilled syringe; initiation override options include one 6 mg dose monthly for the first three doses for AMD (and other specified initiation options).

Faricimab (Vabysmo)6 mg per eye vial/prefilled syringe; per-eye dosing and frequency statements provided for retinal indications per policy dosing tables.

inv-25: Quantity limits aligning to FDA label — Eylea HD quantity limits revised to align with FDA label

Policy changeEylea HD quantity limits clarified to align with the FDA label (document history note).

Eylea HD limit (example)8 mg per eye every 4 weeks for first three doses then 8–16 week maintenance depending on indication (per policy quantity limits).

Document history entriesMultiple coding and quantity limit updates recorded (see 12/09/2024 clarification and subsequent coding updates in 2024–2025).

Provider Actions, Prior Authorization and Billing Guidance

Prior Authorization

Prior authorization varies by agent and market

Prior authorization requirements vary by agent and by market. Some intravitreal VEGF agents may require precertification or prior authorization depending on the member's benefit type and the state/market. Providers must verify the member's contract benefits at the time of service to determine whether prior authorization or precertification is required. Inclusion or exclusion of codes in this policy is informational only and does not guarantee coverage or reimbursement.

Precertification requirements differ by market and benefit (Commercial, Medicare, Medicaid).
Check member contract and payer-specific precertification portals before administration.
Coding lists in this document are informational only; do not assume authorization based on code presence.

Denial Risk

Avastin-class denial risk

Requests for Avastin (bevacizumab) or Avastin-class biosimilars may be denied when the diagnostic or clinical criteria are not met. In markets where precertification is required (for example, Florida), billing for Avastin ocular without required precertification may result in denial or payment delay.

Affected agents: Avastin (bevacizumab) and listed biosimilars (Alymsys, Mvasi, Vegzelma, Zirabev).
Markets requiring precertification for Avastin ocular include: FL (see precertification status).
Ensure documentation supports the listed clinical indications in the policy to reduce denial risk.

Step Therapy

Step therapy for non-preferred VEGF agents

Step therapy may apply to requests for non-preferred intravitreal VEGF antagonists. A non-preferred agent may be approved only after trial and inadequate response or intolerance to a preferred agent, or when other specified exceptions are met. Providers should document prior trials, reasons for failure or intolerance, or other exception criteria when requesting non-preferred agents.

Non-preferred agent approval criteria include documented trial and inadequate response or intolerance to at least one preferred agent.
Exceptions that can override step therapy include: current use of the requested agent, FDA-approved indication not available among preferred agents, unique clinical needs (e.g., Susvimo implant supplemental injections), or when Avastin is the sole preferred agent approvable for the diagnosis.
Preferred = agents deemed clinically comparable and preferred based on clinical evidence and cost-effectiveness.

Step Therapy

Step therapy updates

Step therapy tables and preferred/non-preferred categorizations are updated periodically. Providers should use the most recent step therapy table effective for the member's plan date of service; notable recent updates include changes effective 04/01/2025 and 06/12/2025 and upcoming preferred/non-preferred updates effective 07/01/2025.

04/01/2025 — Step therapy table updates.
06/12/2025 — Step therapy table updates.
07/01/2025 — Commercial and Medicare preferred/non-preferred lists updated (see policy for full agent lists and effective dates).

Background and Clinical Rationale

Overexpression of vascular endothelial growth factor (VEGF) is implicated in the pathogenesis of neovascular retinal conditions including neovascular (wet) age‑related macular degeneration (AMD), diabetic retinopathy and diabetic macular edema (DME), and macular edema from retinal vein occlusion (RVO). Intravitreal anti‑VEGF agents reduce pathologic neovascularization and vascular permeability, and are considered first‑line pharmacologic therapy for neovascular AMD and for macular edema related to diabetic retinopathy and RVO. Intravitreal injections carry procedure‑related risks (for example, endophthalmitis, retinal detachment, traumatic lens injury, and intraocular pressure elevations) that should be considered when selecting and administering therapy.

Definitions and Product Notes

inv-41: Bevacizumab (Avastin) and biosimilars — off-label ocular use and compounding note

Regulatory statusBevacizumab (Avastin) is not FDA‑approved for intravitreal ocular use but is widely used off‑label after compounding into single‑use units.

Compounding noteCompounding pharmacies often repackage Avastin into single‑use units; FDA and AAO warn to obtain repackaged Avastin from accredited compounding pharmacies to avoid contamination risks.

BiosimilarsFDA‑approved bevacizumab biosimilars (e.g., Alymsys, Mvasi, Vegzelma, Zirabev) exist but many have not been studied in ophthalmic indications; use may be extrapolated based on biosimilarity.

inv-42: Biosimilar / Interchangeable — definition and examples (Cimerli)

DefinitionBiosimilars are highly similar to a reference biologic with no clinically meaningful differences in safety, purity, and potency.

Interchangeable designationSome products (e.g., Cimerli) are FDA‑designated interchangeable to the reference product (Lucentis), meaning they are expected to produce the same clinical result and may be substituted per FDA guidance.

ExamplesFDA‑approved biosimilars include Alymsys, Mvasi, Zirabev, Vegzelma (bevacizumab biosimilars); Byooviz (ranibizumab biosimilar); Eylea biosimilars include Enzeevu, Pavblu, Ahzantive, Yesafili, Opuviz.

inv-43: Intravitreal dose limits — per-agent per-eye dose and minimum intervals examples

Per-agent dose examplesAflibercept (Eylea): 2 mg per eye (standard) and Eylea HD 8 mg per eye with specified initiation and maintenance intervals.

Ranibizumab examplesLucentis/Byooviz/Cimerli: 0.3 mg per eye for DME/DR (every 4 weeks) and 0.5 mg per eye where indicated (CNV/radiation retinopathy).

Beovu (brolucizumab)6 mg per eye; initiation options include one 6 mg dose monthly for the first three doses for AMD (override criteria noted).

Vabysmo (faricimab)6 mg per eye vial/prefilled syringe; per-eye dosing and frequency statements included in the policy quantity limits section.

inv-44: Vabysmo (faricimab-svoa) — product note and HCPCS linkage

Product noteVabysmo (faricimab‑svoa) is listed with HCPCS J2777 and indicated for exudative AMD, RVO‑related macular edema, and diabetic retinopathy with macular edema per ICD‑10 mappings.

HCPCS linkageHCPCS code J2777 is associated with faricimab (Vabysmo) for billing intravitreal administration.

Dosing formVabysmo is available as a 6 mg vial and prefilled syringe per the policy quantity limit entries.

inv-45: Beovu (brolucizumab-dbll) — product note and HCPCS linkage

Product noteBeovu (brolucizumab‑dbll) is listed with HCPCS J0179 and available as a 6 mg vial/prefilled syringe for intravitreal use.

HCPCS linkageHCPCS code J0179 is used to report brolucizumab (Beovu) for intravitreal injection billing.

Initiation guidancePolicy includes Beovu initiation override options (one 6 mg dose monthly for the first three doses for AMD) referenced in dosing sections.