Medical Benefit Drug Policy

Coverage Summary

UnitedHealthcare covers intravitreal administration of specified VEGF and dual VEGF/Ang‑2 inhibitors with criteria (coverage stance: covered_with_criteria) effective 2025-10-01. Coverage requires adherence to the General and Diagnosis‑Specific Requirements and limits intravitreal administrations to a maximum of 12 doses per year per eye.

Agent-specific Proven / Medically Necessary Indications

Agent-specific Coverage (Diagnosis-Specific Requirements)

Proven and medically necessary indications by product.

Avastin (bevacizumab)

Indication: Choroidal neovascularization secondary to pathologic myopia, angioid streaks/pseudoxanthoma elasticum, or ocular histoplasmosis syndrome (OHS)
Indication: Diabetic macular edema (DME)
Indication: Macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Indication: Neovascular age-related macular degeneration (nAMD)
Indication: Neovascular glaucoma
Indication: Neovascularization of the iris (NVI) (rubeosis iridis)
Indication: Proliferative diabetic retinopathy
Indication: Type I Retinopathy of Prematurity

Beovu (brolucizumab-dbll)

Indication: Neovascular age-related macular degeneration (nAMD)
Indication: Diabetic macular edema (DME)

Byooviz (ranibizumab-nuna)

Indication: Neovascular age-related macular degeneration (nAMD)
Indication: Macular edema following retinal vein occlusion (RVO)
Indication: Myopic choroidal neovascularization (mCNV)

Cimerli (ranibizumab-eqrn)

Indication: Myopic choroidal neovascularization (mCNV)
Indication: Diabetic macular edema (DME)
Indication: Diabetic retinopathy (DR)
Indication: Macular edema following retinal vein occlusion (RVO)
Indication: Neovascular age-related macular degeneration (nAMD)

Eylea (aflibercept)

Indication: Diabetic macular edema (DME)
Indication: Diabetic retinopathy (DR)
Indication: Macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Indication: Neovascular age-related macular degeneration (nAMD)
Indication: Retinopathy of prematurity (ROP)

Eylea HD (aflibercept)

Indication: Diabetic macular edema (DME)
Indication: Diabetic retinopathy (DR)
Indication: Neovascular age-related macular degeneration (nAMD)

Lucentis (ranibizumab)

Indication: Choroidal neovascularization secondary to pathologic myopia, angioid streaks/pseudoxanthoma elasticum, or ocular histoplasmosis syndrome (OHS)
Indication: Diabetic macular edema (DME)
Indication: Diabetic retinopathy (DR)
Indication: Macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Indication: Neovascular age-related macular degeneration (nAMD)

Pavblu (aflibercept-ayyh)

Indication: Diabetic macular edema (DME)
Indication: Diabetic retinopathy (DR)
Indication: Macular edema following retinal vein occlusion (RVO)
Indication: Neovascular age-related macular degeneration (nAMD)

Off‑label intravitreal Avastin (bevacizumab) is commonly provided as a compounded product (vial‑splitting/prefilled syringes). Providers sourcing or using compounded bevacizumab must follow the policy's compounding guidance and credentialing expectations for compounding pharmacies (USP <797> compliance and lot‑number tracking); compounding procedures themselves are described in the Provider Actions/Additional Information sections.

Continuation Therapy Criteria

Unproven / Exclusions

Certain agents are noted as typically excluded or subject to additional review: the policy states that Beovu (brolucizumab) and Byooviz (ranibizumab‑nuna) are typically excluded and may require medical necessity review or be managed via the excluded‑drug list; this exclusion note is operational and referenced under Provider Actions (prior authorization/medical necessity review).

Applicable Codes

HCPCS/J/Q codes referencedHCPCSCovered

J0177	Injection, aflibercept HD, 1 mg (Eylea HD)
J0178	Injection, aflibercept, 1 mg (Eylea)
J0179	Injection, brolucizumab-dbll, 1 mg (Beovu)
J2777	Injection, faricimab-svoa, 0.1 mg (Vabysmo)
J2778	Injection, ranibizumab, 0.1 mg (Lucentis)
J9035	Injection, bevacizumab, 10 mg (Avastin)
Q5124	Injection, ranibizumab-nuna (Byooviz), biosimilar, 0.1 mg
Q5128	Injection, ranibizumab-eqrn (Cimerli), biosimilar, 0.1 mg
Q5147	Injection, aflibercept-ayyh (Pavblu), biosimilar, 0.1 mg

Applicable ICD-10 diagnosis codes listedICD-10

E08.3311	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E08.3312	... left eye
E08.3313	... bilateral
E08.3391	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, right eye
E08.3392	... left eye
E08.3393	... bilateral
E08.3399	... unspecified eye
E08.3411	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye
E08.3412	... left eye
E08.3419	... unspecified eye

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Mapped ICD-10 diagnoses with applicable HCPCS codesmixedCovered

B39.5	Histoplasmosis duboisii - applicable to J9035
B39.9	Histoplasmosis unspecified - applicable to J9035
E08.311	Applies to J0177, J0178, Q5147, J0179, J2777, J2778, J9035
E08.319	Applies to J0177, J0178, Q5147, Q5128, J9035
E08.3211	Applies to J0177, J0178, Q5147, J0179, J2777, J2778, J9035
E08.3212	Applies to J0177, J0178, Q5147, J0179, J2777, J2778, J9035
E08.3213	Applies to J0177, J0178, Q5147, J0179, J2777, J2778, J9035

Providers must pair ICD-10 diagnosis codes with the appropriate HCPCS/J/Q code per the mapping. See Provider Actions for billing rules and dose-limit constraints.

Provider Actions / Prior Authorization & Billing

Prior Authorization

Medical necessity review required for excluded agents

Certain agents are excluded and require a medical necessity review prior to coverage determination. Submit clinical rationale and supporting documentation for review.

Affected codes: J0179, Q5124

Billing Rule

Dose limit billing constraint

Billing is constrained by an annual dose limit per eye. Claims exceeding the threshold may be denied or require additional documentation to justify medical necessity.

Threshold: <= 12 doses per year per eye
Affected HCPCS codes: J0177, J0178, J0179, J2777, J2778, J9035, Q5124, Q5128, Q5147

Clinical Evidence Summary

multiple RCTsKey trials referenced (VIEW, PULSAR, CATT, HAWK/HARRIER, TENAYA/LUCERNE, YOSEMITE/RHINE, KESTREL/KITE, BALATON/COMINO)

N up to 2412Largest trial populations cited (pooled AMD trials: VIEW1/VIEW2 N up to 2412)

~1891Largest DME trial population cited (YOSEMITE/RHINE N = 1891)

approx. 6-7Common mean injections reported in trials (e.g., CATT mean ~6.5-6.8 injections/year)

Key pivotal trials and high‑level conclusions summarized in the policy: CATT (bevacizumab vs ranibizumab) showed bevacizumab noninferior for BCVA at 1 year with similar safety; HAWK/HARRIER (brolucizumab vs aflibercept) demonstrated noninferiority and allowed extended q12w dosing for many patients; TENAYA/LUCERNE (faricimab vs aflibercept) showed faricimab noninferior with many patients achieving extended dosing intervals; YOSEMITE/RHINE (faricimab for DME) showed noninferiority to aflibercept with individualized extended dosing; ROP trials (BEAT‑ROP and others) demonstrated benefit of intravitreal bevacizumab in zone I ROP with reduced recurrence versus laser, though results vary by zone and longer‑term/systemic effects are less certain.

Background & Definitions

Background: intravitreal administration of anti‑VEGF and dual VEGF/Ang‑2 agents is a standard ophthalmic route to treat neovascular and edematous retinal diseases. The policy highlights agent‑specific indications and notes that bevacizumab is often vial‑split and compounded for ophthalmic use, which carries contamination risks and thus requires adherence to compounding standards and tracking.

Term	Definition
Type I Retinopathy of Prematurity (ROP)	Defined as any of: any stage ROP with plus disease in zone I; stage 3 ROP without plus disease in zone I; stage 2 or 3 ROP with plus disease in zone II.
CNV	Choroidal neovascularization
ROP	Retinopathy of prematurity
BCVA	Best corrected visual acuity
logMAR	Logarithm of the minimum angle of resolution

Revision History

2025-10-01material_changeLatest

Summary of Changes: updated Applicable ICD-10 diagnosis codes to reflect annual edits — added H40.841, H40.842, H40.843, and H40.849; Applicable Codes section and Supporting Information updated; archived prior policy version 2025D0042AN.

2025-10-01policy_archive

Archived previous policy version 2025D0042AN as noted in Policy History/Revision Information.

2025-10-01applicable_codes_update