CurrentViva HealthPolicy IC-0026

Intravitreal aflibercept (Eylea and biosimilars) — coverage criteria

Prior authorization, dosing limits, approvals, and renewal criteria for intravitreal aflibercept products (Eylea, Eylea HD, biosimilars and branded variations) used for retinal conditions; applies to Viva Health members and providers submitting PA requests.

Policy Summary

PayerViva Health

PolicyIntravitreal aflibercept (Eylea and biosimilars) — coverage criteria

Policy CodePolicy IC-0026

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization (typically valid 12 months) and document bevacizumab contraindication, intolerance, or treatment failure before requesting alternate ophthalmic VEGF-inhibitor therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial PA validity (typical)

Max 3Max doses per eye (ROP)

2 mgStandard dose

8 mgEylea HD dose

Numerous ICD-10Covered diagnoses (sample)

Coverage Criteria for Intravitreal Aflibercept

Initial Approval

Covered when ALL of the following are met:

Initial approval core criteria: Patient must have a contraindication, intolerance, or failure to a bevacizumab product prior to consideration of another ophthalmic VEGF-inhibitor product; AND member is at least 18 years of age unless otherwise specified; AND member has a definitive diagnosis of one of the listed indications (neovascular AMD, macular edema following RVO, diabetic macular edema/diabetic retinopathy, or retinopathy of prematurity when applicable)

Defines primary step-therapy requirement and age/diagnosis prerequisites

Universal Criteria

Universal criteria (must also be met):

Universal safety and usage criteria: Member is free of ocular and/or peri-ocular infection; AND member does not have active intraocular inflammation; AND therapy will not be used concomitantly with other ophthalmic VEGF inhibitors; AND best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment (NOT applicable to ROP); AND when applicable for ROP, member meets gestational age or birth weight criteria (maximum gestational age at birth of 32 weeks OR birth weight of ≥ 800 to 1500 g)

Also notes alternating VEGF use generally not permitted; FDA-approved and compendia-recommended indications listed

Renewal Criteria

Renewal/Continuation coverage:

Renewal criteria: Member continues to meet the universal and indication-specific relevant criteria; AND there is absence of unacceptable toxicity from the drug (examples include endophthalmitis, retinal detachments, retinal vasculitis with or without occlusion, increased intraocular pressure, arterial thromboembolic events); AND when applicable, member still has active ROP requiring treatment; AND at least 10 days have elapsed since initial treatment; AND member has not exceeded a maximum of 3 total doses per each affected eyemax 3 doses per affected eye (ROP)

For other indications, continued beneficial response (e.g., BCVA improvement) supports renewal

Dosage/Indication-specific Coverage

Indication-specific dosing and coverage considerations (defines allowed dosing schedules):

Neovascular (Wet) AMD dosing: Eylea and listed biosimilars/brands: Initiation 2 mg intravitreally per affected eye once every 4 weeks x 3 doses (approximately every 28 days); maintenance 2 mg every 8 weeks with option to dose every 4 weeks for inadequate response; some members may be treated one dose every 12 weeks after one year of effective therapy. Eylea HD: initiation 8 mg intravitreally once every 4 weeks x 3 doses; maintenance 8 mg every 8 to 16 weeks (+/- 1 week) with potential extension to every 20 weeks after one year for selected members

Members not maintaining response with extended intervals may resume every-4-week dosing

Macular edema following RVO dosing: Eylea and listed biosimilars/brands: Administer 2 mg intravitreally per affected eye once every 4 weeks; Eylea HD: initiation 8 mg once every 4 weeks x 3–5 doses then maintenance 8 mg every 8 weeks (+/- 1 week); some patients may require every-4-week retreatment if response inadequate

Eylea HD maintenance intervals specified +/- 1 week

DME/DR dosing: Eylea and listed biosimilars/brands: Initiation 2 mg intravitreally per affected eye once every 4 weeks x 5 injections; maintenance 2 mg every 8 weeks with option for every-4-week dosing if inadequate response. Eylea HD: initiation 8 mg once every 4 weeks x 3 doses then maintenance 8 mg every 8–12 weeks (+/- 1 week); DR dosing parallels DME guidance

Maximum Units / Billing

Supplies / billing limits:

Max units per dose/time: HCPCS billing units correspond to mg: standard aflibercept product 2 mg = 4 HCPCS units per dose; Eylea HD 8 mg = 16 HCPCS units per dose. Dosing tables specify initial loading units and maintenance units by indication (see dosing schedules for per-dose unit assignment)see dosing tables for indication-specific unit limits

HCPCS unit conversions are provided to support billing; units reflect administration to each affected eye

For the indication of Retinopathy of Prematurity (ROP), treatment must use the single‑dose vial formulation. The policy explicitly states: “Treatment for this indication is ONLY applicable to the single‑dose vial. Do NOT use the pre‑filled syringe for the treatment of ROP.”

There are no additional explicit exclusion conditions listed in the exclusions section of this policy segment.

Medicare beneficiaries may be subject to separate requirements: Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) can impose additional conditions. The appendix notes that the preceding information is intended for non‑Medicare coverage determinations and that compliance with applicable CMS NCD/LCD/LCA guidance is required.

Use of aflibercept as part of an alternating regimen with other ophthalmic VEGF inhibitors is generally not permitted. Such alternating use will be reviewed on a case‑by‑case basis, consistent with the Universal Criteria statement that therapy should not be used concomitantly with other ophthalmic VEGF inhibitors.

Coding — HCPCS, NDC, and ICD-10 Codes

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

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Covered ICD-10 Diagnosis Codes (partial list shown)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.

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Covered ICD-10 CodesICD-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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Dose unit conversions / per-dose units

Standard aflibercept per-dose conversion2 mg = 4 HCPCS units (per affected eye, typical intravitreal dose)

Eylea HD per-dose conversion8 mg = 16 HCPCS units (per affected eye, higher‑dose formulation)

Typical initiation (AMD) unitsInitiation dosing for standard product: 4 units (4 mg) every 28 days x3 doses — corresponds to 2 mg per dose = 4 units as shown

Eylea HD initiation unitsInitiation dosing for Eylea HD: 16 units (16 mg) every ~25 days x3 doses — corresponds to 8 mg per dose = 16 units

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required and Validity

Prior authorization is required for these ophthalmic VEGF-inhibitor products. Initial authorizations are generally valid for 12 months (365 days) unless otherwise specified. For Retinopathy of Prematurity (ROP) an initial prior authorization is provided for a total of 2 doses (1 dose per eye); renewals for ROP may be provided as retreatment for up to an additional 4 doses (2 doses per eye) per retreatment authorization. Renewals for standard indications may be provided every 12 months (365 days) thereafter, unless otherwise specified.

Initial PA validity: 12 months (365 days) for most indications
ROP initial PA validity: total of 2 doses (1 dose per eye)
Renewal PA validity: may be renewed every 12 months (365 days) for most indications
ROP renewal/retreatment: may be renewed for up to 4 additional doses (2 doses per eye)

Prior Authorization

Prior Authorization Indicated (NQTL Summary)

Prior authorization will be indicated when utilization management factors warrant it for this drug/drug group. The plan considered indication and drug cost as reasons to apply PA; safety/efficacy and potential for misuse/abuse were not primary drivers. PA may be applied to ensure appropriate use (including step requirements) and cost-effective therapy selection.

NQTL conclusion: Indication and cost support consideration of PA
PA used to align utilization with clinical indications and cost-effectiveness

Denial Risk

Prior Authorization Denial Triggers

Prior authorization may be denied if documentation does not show a contraindication, intolerance, or failure to bevacizumab when such a step-failure is required by the policy prior to coverage of alternative ophthalmic VEGF-inhibitors. Additional prior authorization requirements or coverage criteria may be specified elsewhere in the policy and must be met.

Denial trigger: Lack of documented bevacizumab contraindication/intolerance/failure when required
Other PA requirements or criteria elsewhere in the policy must also be satisfied

Documentation Required

Required Clinical Documentation

Clinical documentation must support the requested therapy and includes baseline and periodic best corrected visual acuity (BCVA) measurements for members (BCVA requirement not applicable to ROP). Documentation should also confirm absence of ocular/peri-ocular infection and absence of active intraocular inflammation, and that therapy will not be used concomitantly with other ophthalmic VEGF inhibitors unless otherwise authorized.

BCVA: baseline and periodic measurements required for non-ROP members
Clinical status: documentation of no active ocular/peri-ocular infection or intraocular inflammation
Concomitant therapy: documentation that therapy will not be used with other ophthalmic VEGF inhibitors

Documentation Required

NQTL Documentation and Rationale

When designing and applying prior authorization, the NQTL considerations included the indication being treated and the drug cost as reasons to require PA; safety/efficacy evidence and potential for misuse/abuse were not primary justifications. The NQTL was applied to be no more restrictive for MH/SUD benefits than for M/S benefits.

NQTL factors considered: indication (yes), cost (yes), safety/efficacy (no), misuse/abuse potential (no)
NQTL application: applied comparably across MH/SUD and M/S medical benefit prescription drugs

Note

CMS and Medicare Part B References

Medicare (Part B) coverage determinations differ from this non‑Medicare policy. Providers must follow CMS guidance, applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) where relevant. Search the Medicare Coverage Database for applicable documents and ensure claims comply with any Medicare contractor guidance.

Medicare Part B guidance: Medicare Benefit Policy Manual, Pub. 100-2, Chapter 15, §50
Check NCD/LCD/LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx
Compliance: NCDs/LCDs/LCAs apply where applicable and must be followed for Medicare claims

Definitions and Key Terms

BCVA (Best Corrected Visual Acuity)

DefinitionBest corrected visual acuity (BCVA) must be measured at baseline and periodically during treatment.

Applicability noteBCVA monitoring requirement is NOT applicable to members with Retinopathy of Prematurity (ROP).

Use in documentationBCVA measurement is required as part of clinical documentation to support continuation/renewal decisions where applicable.

ROP eligibility (Retinopathy of Prematurity)

Eligibility definitionPremature infant with maximum gestational age at birth of 32 weeks OR a birth weight of ≥ 800 to 1500 g.

Formulation restrictionROP treatment applies to the single‑dose vial only; pre‑filled syringe is NOT permitted for ROP.

Dosing specificsAdminister 0.4 mg intravitreally per affected eye; injections may be bilateral the same day; repeat interval at least 10 days with maximum of 3 total doses per affected eye.

NQTL (Non‑Quantitative Treatment Limitations)

DefinitionNon‑Quantitative Treatment Limitations (NQTLs) are methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan (e.g., utilization review or prior authorization).

Design considerationsNQTL factors include indication, safety/efficacy, potential for misuse/abuse, and drug cost; these were considered when designing prior authorization for this drug group.

Parity statementThe utilization management NQTL applies comparably, and not more stringently, to MH/SUD and M/S medical benefit prescription drugs.

Covered Diagnosis Codes (ICD‑10) — representative examples

Example ICD-10: H35.1Retinopathy of prematurity.

Example ICD-10: H35.3211Exudative age-related macular degeneration, right eye, with active choroidal neovascularization.

Example ICD-10: E13.3311Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye.

Example ICD-10: H34.8110Central retinal vein occlusion, right eye, with macular edema.

CMS / MAC references and Medicare Part B guidance

Medicare guidance referenceMedicare Part B coverage for outpatient drugs is governed by the Medicare Benefit Policy Manual (Pub. 100‑02), Chapter 15, §50; NCDs and LCDs may apply and must be followed where applicable.

Search toolCMS Medicare Coverage Database can be searched for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx.

MAC jurisdictions noteAppendix lists Medicare Part B Administrative Contractor (MAC) jurisdictions and contractors by jurisdiction (examples include Palmetto GBA for J/M and M (NC) jurisdictions, Noridian, NGS, Novitas, etc.).

OpenPayer

Intravitreal aflibercept (Eylea and biosimilars) — coverage criteria

Coverage Criteria for Intravitreal Aflibercept

Coding — HCPCS, NDC, and ICD-10 Codes

Provider Actions, Prior Authorization, and Documentation

Background on Aflibercept and Indications

Definitions and Key Terms