CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Intravitreal aflibercept (Eylea/Eylea HD/Pavblu) coverage criteria

Policy governing coverage, dosing, and authorization requirements for intravitreal aflibercept products for Medicaid, Commercial, and Medicare‑Medicaid members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIntravitreal aflibercept (Eylea/Eylea HD/Pavblu) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with definitive diagnosis, baseline BCVA (when required), and documentation of prior therapy or contraindication as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsstandard initial authorization period

2 dosesinitial ROP coverage

3HCPCS codes listed

~180+ICD-10 codes in appendix

YesP&T reviewed

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Coverage Criteria for Intravitreal Aflibercept

Initial Approval - Universal Criteria

Covered when ALL of the following are met:

Universal and indication-specific criteria: Patient meets age requirement (≥18 years unless otherwise specified) AND prescribed by or in consultation with a retina specialist AND has a definitive diagnosis of an indicated condition (neovascular AMD; macular edema following retinal vein occlusion [RVO] — aflibercept only; diabetic macular edema [DME]; diabetic retinopathy [DR]; or retinopathy of prematurity [ROP] — aflibercept only) AND best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment when applicable (NOT applicable to ROP) AND patient is free of ocular and/or peri‑ocular infection AND patient does not have active intraocular inflammation AND aflibercept will not be used concurrently with other ophthalmic VEGF inhibitors.

Initial Approval - Step Therapy / Prior Treatment Requirements

AND one of the following indication‑specific prior therapy conditions must be met:

Indication-specific step requirements: ROP: premature infant with gestational age ≤32 weeks OR birth weight >800 to 1500 g AND inadequate response, intolerance, or contraindication to bevacizumab (aflibercept only). DR: inadequate response, intolerance, or contraindication to bevacizumab. AMD or RVO: inadequate response, intolerance, or contraindication to bevacizumab or Byooviz. DME with baseline VA 20/50 or worse: inadequate response, intolerance, or contraindication to bevacizumab or ranibizumab. DME with baseline VA better than 20/50: inadequate response, intolerance, or contraindication to bevacizumab.

For Eylea HD requests, patient must also have inadequate response, intolerance, or contraindication to Pavblu or Eylea.

Renewal Criteria

Renewal criteria — coverage may be renewed when ALL of the following are met:

Renewal conditions: Patient continues to meet the universal and indication-specific criteria AND there is absence of unacceptable toxicity from the drug (examples include endophthalmitis, retinal detachment, increased intraocular pressure, arterial thromboembolic events) AND for ROP: patient still has active ROP requiring treatment AND at least 10 days have elapsed since initial treatment; for all other indications: patient has had a beneficial response to therapy (e.g., improvement in baseline BCVA) and continued administration is necessary for maintenance treatment.

Authorization length: initial approvals generally provided for 6 months; ROP initial coverage commonly 2 doses (see dosing section) with potential re‑treatment per policy.

Dosage/Administration and Max Units

Dosing and max units by indication:

nAMD dosing: Aflibercept (standard): initiate 2 mg (0.05 mL) intravitreally per affected eye once every 4 weeks (≈28 days) for the first 12 weeks (3 doses), then maintenance 2 mg every 8 weeks; may dose every 4 weeks if insufficient response. Eylea HD: 8 mg (0.07 mL) intravitreal every 4 weeks for first 3 doses, then every 8–16 weeks.

Max units (HCPCS units): Aflibercept initial = 4 units every 28 days x3; maintenance = 4 units every 28–56 days. Eylea HD initial = 16 units every 28 days x3; maintenance = 16 units every 56–112 days.

RVO dosing (aflibercept only): Administer 2 mg intravitreally per affected eye once every 4 weeks (monthly) for macular edema following retinal vein occlusion.

Max units: initial and maintenance = 4 units per 28 days (HCPCS units). Eylea HD not indicated for RVO in this policy.

DME/DR dosing: Aflibercept initiation: 2 mg intravitreally per affected eye once every 4 weeks (≈28 days) for the first 5 injections; maintenance 2 mg every 8 weeks, with ability to dose every 4 weeks if inadequate response. Eylea HD: 8 mg every 4 weeks x3 then every 8–16 weeks.

Plan coverage criteria (general)

Covered when use aligns with FDA labeling, relevant literature, and applicable Medicare NCD/LCD/LCA (when present):

P&T-reviewed coverage criteria: Use must be consistent with FDA‑approved labeling and/or relevant clinical literature as adopted by the Neighborhood P&T committee. Where a Medicare NCD, LCD, or LCA applies, those criteria must be followed and supersede plan discretion. Neighborhood will consider cost‑effective options and give individual consideration to requests based on submitted clinical information.

Neighborhood reviews requests against FDA labeling, relevant literature, and applicable CMS coverage determinations.

Aflibercept therapy must not be used concurrently with other ophthalmic VEGF inhibitors (for example: brolucizumab-dbll, ranibizumab including implant formulations, pegaptanib, bevacizumab, faricimab-svoa, etc.). This exclusion is a requirement of the universal coverage criteria; members already receiving aflibercept may remain on therapy per the policy, but simultaneous administration of two ophthalmic anti‑VEGF agents is not permitted.

When a Medicare National Coverage Determination (NCD) or a Local Coverage Determination (LCD)/Local Coverage Article (LCA) exists for outpatient Part B drugs, providers and prior authorization reviewers must follow those CMS criteria; such determinations supersede plan discretion where applicable. The CMS coverage database is available at the provided CMS search site, and the plan may cover additional indications only at its discretion when no NCD/LCD/LCA applies.

Requests for aflibercept that do not meet the policy’s prior therapy (step) requirements or lack required documentation — including a definitive diagnosis and baseline/periodic best corrected visual acuity where applicable — may be considered not medically necessary. For certain indications (for example, ROP, DME, DR, AMD, and RVO) the policy specifies inadequate response, intolerance, or contraindication to specified alternatives (e.g., bevacizumab, ranibizumab or Byooviz) before aflibercept will be approved; failure to document these steps can trigger denial.

Use of aflibercept for indications that are not supported by FDA labeling, relevant clinical literature, or the plan’s adopted coverage criteria may be considered not medically necessary unless the prescriber submits sufficient clinical justification. The P&T Committee adopted these criteria to align use with FDA‑approved indications and evidence; prior authorization requests will be reviewed against those standards and may be denied for unsupported indications.

Coding and Diagnosis Appendices

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

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
E08.3491	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, right eye
E08.3492	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, left eye
E08.3493	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, bilateral
E08.3499	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without 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

1–10 of 64

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

E10.3291	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye
E10.3292	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye
E10.3293	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral
E10.3299	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without 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
E10.3391	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye
E10.3392	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye

1–10 of 32

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

E11.311	Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E11.319	Type 2 diabetes mellitus with unspecified diabetic retinopathy without 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
E11.3291	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye
E11.3292	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye
E11.3293	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral
E11.3299	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

1–10 of 37

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

E13.311	Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema
E13.319	Other specified diabetes mellitus with unspecified diabetic retinopathy without 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
E13.3291	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

1–10 of 26

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Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required where Neighborhood's clinical coverage criteria apply. Initial approvals are provided for 6 months (for Retinopathy of Prematurity [ROP] aflibercept: initial approval for 2 doses total — 1 dose per eye — with potential renewal per re‑treatment criteria). Requests will be reviewed against FDA labeling and the plan's criteria; prior authorization may be renewed if continuation criteria are met.

Initial authorization duration: 6 months (general).
ROP initial authorization: 2 doses total (1 dose per eye); may be renewed for up to 4 additional doses (2 doses per eye) per re‑treatment criteria.

Step Therapy

Step Therapy / Use of Cost‑Effective Alternatives

Step therapy applies for many indications. For most indications the patient must have an inadequate response, intolerance, or contraindication to bevacizumab before aflibercept is approved. Specific exceptions include: patients currently on aflibercept or members who received this medication within the past 365 days (not subject to step therapy), and indication‑specific alternatives (e.g., DME with baseline VA ≤20/50 may require prior use of ranibizumab). Eylea HD requests require prior inadequate response, intolerance, or contraindication to Pavblu or Eylea.

General step: trial of bevacizumab required (unless exception applies).
DME with baseline VA 20/50 or worse: trial of bevacizumab or ranibizumab may be required.
Eylea HD: trial of Pavblu or Eylea required.

Documentation Required

Clinical Justification Required

Prescribers must submit clinical justification and documentation to support the requested indication and prior medication use. Neighborhood will give individual consideration based on the information supplied.

Clinical justification should describe the indication, prior therapies tried (drug name, dates, response/intolerance), and rationale for aflibercept.
If requesting an exception to step therapy, include reason (intolerance, contraindication, or inadequate response) with supporting clinical details.

Documentation Required

Documentation Requirements

Required documentation must be included with the prior authorization request. At minimum, submit a definitive diagnosis, baseline and periodic best corrected visual acuity (BCVA) measurements (not applicable for ROP), retina specialist consultation notes when relevant, and documentation of prior therapies and their outcomes.

Definitive diagnosis using an appropriate ICD‑10 code from Appendix 1.
Baseline BCVA and periodic BCVA during treatment (except ROP).
Retina specialist prescriber or documented consultation.
Records of prior anti‑VEGF treatments, dates, and reason for discontinuation or inadequate response.

Billing Rule

Diagnosis Coding and Billing

Providers should include an appropriate ICD‑10 diagnosis code from the appendix on claims and prior authorization requests. Failure to include a covered diagnosis code that matches the requested indication may result in denial.

Use one of the Appendix 1 covered ICD‑10 codes (examples in appendix include E08.x–E13.x series, H34.x for RVO).
Claims lacking a listed covered diagnosis code for the indication (e.g., DME, DR, RVO, AMD, ROP) risk denial.

Denial Risk

Potential Denial Triggers

Requests may be denied if the prescriber does not provide required documentation or if the clinical scenario does not meet the plan's criteria. Common denial triggers include absence of a definitive diagnosis for an approved indication, missing baseline BCVA (when applicable), lack of documentation of prior required therapy or inadequate response/intolerance, and use of aflibercept concomitantly with other ophthalmic VEGF inhibitors.

No definitive diagnosis for an approved indication.
Missing baseline or follow‑up BCVA when required.
No documentation of prior required trial(s) (e.g., bevacizumab) or reason for exemption.
Concurrent use with other ophthalmic VEGF inhibitors (not allowed).

Definitions and Product Details

Eylea HD / Eylea / Pavblu (aflibercept products)

Products & formulationsEylea (aflibercept) 2 mg/0.05 mL; Eylea HD 8 mg/0.07 mL; Pavblu (aflibercept biosimilar) 1 mg per billable unit (Q5147 effective 4/1/25).

Standard aflibercept dosing (nAMD, RVO, DME/DR)2 mg intravitreal per affected eye: initiation varies by indication (nAMD: monthly x3; DME/DR: monthly x5), then maintenance typically every 8 weeks; may dose every 4 weeks if inadequate response.

Eylea HD dosing8 mg intravitreal: every 4 weeks for first 3 doses then every 8–16 weeks for maintenance (per labeling).

ROP noteAflibercept use for ROP is aflibercept-only dosing and vial restrictions apply (see ROP block).

Retinopathy of Prematurity (ROP) criteria

Eligible populationPremature infants with gestational age ≤32 weeks OR birth weight >800 to 1500 g for ROP treatment.

Prior therapy requirementCoverage only when there is inadequate response, intolerance, or contraindication to bevacizumab (required step before aflibercept for ROP).

Dosing and administration specificsAdminister 0.4 mg intravitreally per affected eye; may dose bilaterally same day; repeat dosing in same eye at least 10 days apart; use single-dose vial kit only (do NOT use pre-filled syringe for ROP).

Evidence supportRandomized clinical trial FIREFLEYE cited supporting aflibercept for ROP (Stahl et al., JAMA 2022).

Retinopathy of prematurity (ROP) — documentation & evidence

ROP is a listed covered diagnosisRetinopathy of prematurity appears in Appendix 1 as a covered diagnosis (ICD-10 H35.1 series).

Clinical trial referenceFIREFLEYE randomized clinical trial (Stahl et al., JAMA 2022) is cited in references as evidence for ROP treatment with aflibercept.

Policy placementROP referenced in both coverage criteria and appendix diagnosis lists to guide coding and authorization decisions.

ICD-10 diagnosis list for eligible retinal conditions (selected examples)

Diabetic retinopathy / DME codes (examples)E08.311, E08.3211, E08.3311, E10.3511, E11.3311 (and many E08–E13 series variants listed in Appendix 1).

Retinal vein occlusion codesH34.8110, H34.8120, H34.8130, H34.8190, H34.8310–H34.8330, H34.8390 (CRVO/BRVO with macular edema).

Retinopathy of prematurity codesH35.1, H35.10, H35.101–H35.169 (multiple stages and laterality included).

Age-related macular degeneration codesH35.3210–H35.3233, H35.3290–H35.3293 (exudative AMD codes included).

OpenPayer

Intravitreal aflibercept (Eylea/Eylea HD/Pavblu) coverage criteria

Coverage Criteria for Intravitreal Aflibercept

Coding and Diagnosis Appendices

Prior Authorization, Documentation, and Billing Actions

Background and Clinical Context

Definitions and Product Details