Viva Health intravitreal aflibercept Coverage

Coverage Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

Bevacizumab step: Patient has a contraindication, intolerance, or failure to a bevacizumab product prior to consideration of another ophthalmic VEGF-inhibitor product

Step therapy requirement applies prior to use of aflibercept products

Age: Member is at least 18 years of age, unless otherwise specified

Exception: ROP criteria for premature infants specify gestational age/birth weight

Universal safety criteria: Member is free of ocular and/or peri-ocular infections; does not have active intraocular inflammation; will not receive concomitant ophthalmic VEGF inhibitors; and best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment (BCVA measurement not applicable to ROP)

Concomitant or alternating use with other ophthalmic VEGF inhibitors is generally not permitted and will be reviewed case-by-case

Definitive diagnosis: Member has a definitive diagnosis of one of: neovascular (wet) age-related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), or retinopathy of prematurity (ROP)

Eylea HD not applicable to ROP; indications flagged as FDA approved/compendia/orphan as noted in policy

Renewal Criteria and All Other Indications

Renewal criteria — Covered when ALL of the following are met:

Continued universal criteria: Member continues to meet the universal and indication-specific relevant criteria identified in the Initial Approval Criteria (Section III)

See Initial Approval Criteria for specifics

Toxicity absence: Absence of unacceptable toxicity from the drug (examples include endophthalmitis, retinal detachments, retinal vasculitis with or without occlusion, increased intraocular pressure, arterial thromboembolic events)

Document absence of these adverse events to support renewal

ROP activity and dosing interval: For Retinopathy of Prematurity (ROP): member still has active disease requiring treatment; at least 10 days have elapsed since initial treatment; and member has not exceeded a maximum of 3 total doses per each affected eyeAt least 10 days since initial treatment; maximum 3 doses per affected eye

ROP renewal rules are specific to infant dosing and limit total doses per eye

Concomitant intravitreal administration of two ophthalmic vascular endothelial growth factor (VEGF) inhibitors is generally not permitted. The policy requires that therapy "will not be used concomitantly with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors," and notes that use as part of an alternating treatment regimen with other ophthalmic VEGF inhibitors is normally disallowed and will be reviewed on a case‑by‑case basis. Documentation should clearly state the rationale if a provider requests concomitant or alternating VEGF‑inhibitor regimens so the case can be evaluated against the policy criteria.

This appendix is intended for non‑Medicare coverage determinations. When Medicare Part B applies, providers must follow the Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15, §50, and any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Compliance with NCD/LCD/LCA guidance is required for Medicare claims; use the CMS Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx) to identify relevant determinations. Where Medicare policies apply, they may supersede or modify the coverage rules in this appendix.

Use of aflibercept products as part of an alternating treatment regimen with other ophthalmic VEGF inhibitors is generally not permitted and may be denied. Requests that propose alternating agents should include clear documentation of medical necessity and will be reviewed on a case‑by‑case basis; absent compelling justification consistent with the policy's universal criteria, alternating regimens are not supported.

Coding and Diagnosis Lists

HCPCS CodesHCPCS

J0178	Injection, aflibercept, 1 mg; 1 billable unit = 1 mg (Eylea Only)
J0177	Injection, aflibercept hd, 1 mg; 1 billable unit = 1 mg (Eylea HD Only)
J3590	Unclassified biologics (Eydenzelt Only) (Discontinue use on 07/01/2026)
Q5147	Injection, aflibercept-ayyh (pavblu), biosimilar, 1 mg; 1 billable unit = 1 mg (Pavblu Only)
Q5149	Injection, aflibercept-abzv (enzeevu), biosimilar, 1 mg; 1 billable unit = 1 mg (Enzeevu Only)
Q5150	Injection, aflibercept-mrbb (ahzantive), biosimilar, 1 mg; 1 billable unit = 1 mg (Ahzantive Only)
Q5153	Injection, aflibercept-yszy (opuviz), biosimilar, 1 mg; 1 billable unit = 1 mg (Opuviz Only)
Q5155	Injection, aflibercept-jbvf (yesafili), biosimilar, 1 mg; 1 billable unit = 1 mg (Yesafili Only)
Q5170	Injection, aflibercept-boav (eydenzelt), biosimilar, 1 mg; 1 billable unit = 1 mg (Effective 07/01/2026)

NDCsNDC

61755-0005-xx	Eylea 2 mg/0.05 mL single-dose vial kit or pre-filled syringe
61755-0050-xx	Eylea HD 8 mg/0.07 mL single-dose vial kit
61755-0051-xx	Eylea HD 8 mg/0.07 mL single-dose vial
85006-8092-xx	Ahzantive 2 mg/0.05 mL pre-filled syringe
85006-2908-xx	Ahzantive 2 mg/0.05 mL single-dose vial
61314-0504-xx	Enzeevu 2 mg/0.05 mL single-dose vial kit or pre-filled syringe
72606-0026-xx	Eydenzelt 2 mg/0.05 mL single-dose vial kit or pre-filled syringe
64406-0028xx	Opuviz 2 mg/0.05 mL single-dose vial kit or single-dose vial
55513-0056-xx	Pavblu 2 mg/0.05 mL single-dose pre-filled syringe
55513-0065-xx	Pavblu 2 mg/0.05 mL single-dose vial

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Covered ICD-10 Codes (partial list shown in this extract)ICD-10Covered

E08.311	Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema.
E08.319	Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without 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.
E08.3291	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, right eye.
E08.3292	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, left eye.
E08.3293	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, bilateral.
E08.3299	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye.

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

E13.3219	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
E13.3291	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye
E13.3292	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye
E13.3293	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral
E13.3299	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without 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
E13.3391	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye

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Minimum interval since initial ROP treatment

Minimum intervalAt least 10 days must have elapsed since receiving initial ROP treatment

ContextApplies to dosing interval between injections into the same affected eye for Retinopathy of Prematurity (ROP)

Source noteRenewal criteria require this interval before additional ROP doses are considered

Maximum doses per affected eye for ROP

Maximum doses per affected eyeMaximum of 3 total doses per each affected eye for ROP

Scope

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization may be required and is applied based on the clinical indication and drug cost. PA validity is generally provided for 12 months (365 days) for initial approvals and renewals unless otherwise specified. Retinopathy of Prematurity (ROP) is an exception: initial PA validity is for a total of 2 doses (1 dose per eye) and renewals may be provided as retreatment for up to an additional 4 doses (2 doses per eye).

PA consideration based on indication and cost per NQTL findings
Standard PA validity: 12 months (365 days) initial and renewal
ROP exception: initial = 2 doses; renewal retreatment up to 4 additional doses

Documentation Required

Documentation Required for Medical Necessity

Document the medical necessity clearly with emphasis on the clinical indication and cost considerations that justified prior authorization. Include baseline and periodic best corrected visual acuity (BCVA) measurements (not applicable for ROP), a definitive diagnosis, and a dosing/treatment history. For cases where a bevacizumab step is required, document contraindication, intolerance, or treatment failure to bevacizumab prior to consideration of other ophthalmic VEGF‑inhibitor products.

Background

Aflibercept is available in standard intravitreal formulations and a high‑dose product (Eylea HD). The policy covers aflibercept products for FDA‑approved ophthalmic indications including neovascular (wet) age‑related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema/diabetic retinopathy, and retinopathy of prematurity (ROP). Dosing schedules vary by indication and formulation; Eylea HD provides a higher dose option and may require different maintenance intervals for some members. Note that the ROP indication is an orphan use with specific eligibility and dosing rules, and Eylea HD is not applicable to ROP.

Definitions

BCVA — Best Corrected Visual Acuity

DefinitionBest Corrected Visual Acuity (BCVA) — member's visual acuity measured with optimal refractive correction

Measurement timingBCVA is measured at baseline and periodically during treatment for applicable indications

ExceptionBCVA measurement is NOT applicable to members with Retinopathy of Prematurity (ROP)

ROP — Retinopathy of Prematurity

DefinitionRetinopathy of Prematurity (ROP) — retinal vascular disease of premature infants; included as an indication in this policy with special dosing and authorization rules

Patient criteriaApplicable to premature infants with maximum gestational age at birth of 32 weeks OR birth weight of ≥ 800 to 1500 g

OpenPayer

Intravitreal aflibercept (Eylea and biosimilars) — Coverage Criteria

Coverage Criteria

Coding and Diagnosis Lists

Provider Actions and Prior Authorization

Background

Definitions