Neighborhood Health Plan RI aflibercept Coverage

Coverage Criteria for Intravitreal Aflibercept

Initial Approval Criteria

Covered when ALL of the following are met

Universal and prescriber criteria: Patient is at least 18 years of age unless otherwise specified; prescribed by or in consultation with a retina specialist; definitive diagnosis of a listed indication (nAMD, RVO, DME, DR, or ROP when aflibercept only); BCVA measured at baseline and periodically during treatment (not applicable to ROP); patient is free of ocular and/or peri-ocular infection and has no active intraocular inflammation; therapy will not be used concurrently with other ophthalmic VEGF inhibitors; patients currently on aflibercept or MMP members who received the medication within the past 365 days are not subject to Step Therapy.

Includes eligibility exemptions for current treatment

Indication-specific comparator requirement: Patient has an inadequate treatment response, intolerance, or contraindication to specified alternatives as follows: for ROP and DR — bevacizumab; for AMD and RVO — bevacizumab or Byooviz; for DME with baseline VA ≤20/50 — bevacizumab or ranibizumab (Lucentis); for DME with baseline VA better than 20/50 — bevacizumab; for Eylea HD requests — inadequate response/intolerance/contraindication to Pavblu or Eylea.

Step therapy rules apply

Renewal Criteria

Renewal is allowed when ALL of the following are met

General renewal criteria: Patient continues to meet the universal and indication-specific criteria in section IV; AND there is absence of unacceptable toxicity from the drug (examples include endophthalmitis, retinal detachments, increased intraocular pressure, arterial thromboembolic events).

Examples of unacceptable toxicity listed in policy

ROP renewal criteria (aflibercept only): For ROP, patient still has active ROP requiring treatment; AND at least 10 days have elapsed since receiving initial treatment.At least 10 days between doses injected into the same eye

ROP-specific renewal differs from other indications

Other indications renewal: 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 of the condition.

Continued clinical benefit required

Dosage / Administration Rules

Dosing and administration rules

Aflibercept dosing for nAMD: Initiation: Administer 2 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days) for the first 12 weeks (3 doses). Maintenance: 2 mg every 8 weeks; may be dosed as frequently as every 4 weeks if inadequate response. Some patients may be treated every 12 weeks after one year.

Eylea HD dosing for nAMD: Recommended dose is 8 mg intravitreally every 4 weeks for the first three doses, followed by 8 mg once every 8 to 16 weeks (+/- 1 week).

Aflibercept for RVO: Administer 2 mg intravitreally per affected eye once every 4 weeks (approximately monthly).

DME/DR dosing (Aflibercept): Initiation: Administer 2 mg intravitreally per affected eye once every 4 weeks for the first 5 injections. Maintenance: 2 mg every 8 weeks; may dose as frequently as every 4 weeks if needed.

General Coverage Criteria

Covered when consistent with FDA labeling, relevant clinical literature, and applicable Medicare NCD/LCD/LCA

General coverage conditions: Use must align with FDA-approved labeling and/or relevant clinical literature; plan criteria prioritize medically accepted indications and cost-effective options first. Compliance with applicable Medicare NCDs, LCDs, and LCAs is required; for INTEGRITY members these criteria apply only in the absence of an applicable NCD or LCD. Neighborhood will give individual consideration to requests based on prescriber-submitted information.

Neighborhood P&T Committee adopted these criteria; individual consideration given based on prescriber-submitted information.

Therapy must not be administered concurrently with other ophthalmic VEGF inhibitors (examples: brolucizumab-dbll, ranibizumab or ranibizumab implant, pegaptanib, bevacizumab, faricimab-svoa). This concurrent-use exclusion is a universal criterion and applies to all aflibercept product requests unless otherwise specified in the policy.

Members who are already receiving aflibercept at the time of policy application may remain on therapy; similarly, MMP members who received aflibercept within the prior 365 days are not subject to step therapy requirements per the universal criteria.

Where applicable, coverage decisions must comply with existing Medicare guidance. Neighborhood references National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) for Medicare Part B drugs and will follow those requirements when they apply.

For INTEGRITY (Medicare‑Medicaid Plan) members, the plan’s aflibercept criteria apply only in the absence of an applicable NCD/LCD; when an NCD or LCD exists, the Medicare determination takes precedence and Neighborhood will follow that guidance while continuing to give individual consideration to prescriber-submitted information.

Requests that fail to meet the policy’s universal or indication‑specific requirements — for example, lacking required prior therapy trials where specified (inadequate response/intolerance/contraindication to listed comparators), missing documentation of diagnosis, or evidence of active ocular infection or intraocular inflammation — may be denied as not meeting medical necessity.

Prescriber-submitted clinical information will be reviewed and Neighborhood will give individual consideration, but absence of the required documentation (e.g., BCVA baseline/serial measurements for non‑ROP indications, or evidence of prior bevacizumab trial when required) increases the risk of denial.

Neighborhood ensures aflibercept is used for medically accepted indications by aligning coverage with FDA‑approved labeling and relevant clinical literature. Uses not supported by FDA labeling, the clinical evidence cited in the policy rationale, or the plan’s coverage criteria may be considered not medically necessary and denied.

The policy is intended to both safeguard patients (by minimizing adverse effects through restrictions such as exclusion of concurrent VEGF inhibitors and infection/inflammation screening) and to promote more cost‑effective treatment sequencing where clinically appropriate.

Coding and Diagnosis Lists

Covered HCPCS CodesHCPCSCovered

J0178	Injection, aflibercept, 1 mg; 1 billable unit = 1 mg (Eylea Only)
J0177	Injection, afibercept hd, 1mg; 1 billable unit = 1 mg (Eylea HD Only)
Q5147	Injection, aflibercept-ayyh (pavblu), biosimilar, 1 mg (Effective 4/1/25)

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

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

Covered ICD-10 Diagnosis Codes (sample — Appendix 1 is extensive)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 Diagnosis CodesICD-10Covered

H34.8310	Tributary (branch) retinal vein occlusion, right eye, with macular edema.
H34.8320	Tributary (branch) retinal vein occlusion, left eye, with macular edema.
H34.8330	Tributary (branch) retinal vein occlusion, bilateral, with macular edema.
H34.8390	Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema.
H35.1	Retinopathy of prematurity.
H35.10	Retinopathy of prematurity, unspecified.
H35.101	Retinopathy of prematurity, unspecified, right eye.
H35.102	Retinopathy of prematurity, unspecified, left eye.
H35.103	Retinopathy of prematurity, unspecified, bilateral.
H35.109	Retinopathy of prematurity, unspecified, unspecified eye.

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Referenced CMS coverage documents / NCD/LCD identifiersmixed

A52451	CMS NCA/LCD reference (keyword A52451) applicable to Medicare coverage listings.
A53387	CMS NCA/LCD reference (keyword A53387) applicable to Medicare coverage listings.

Retreatment interval for ROP — minimum interval between doses

Minimum intervalAt least 10 days between doses injected into the same eye for ROP treatment

Dose frequency noteInjections may be given bilaterally on the same day

Vial restrictionROP treatment applicable only to single-dose vial kit; do NOT use pre-filled syringe

Medicare applicability — apply existing NCD/LCD/LCA where applicable

Apply Medicare guidanceApply existing National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) where applicable

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required when requesting intravitreal aflibercept products. Requests must include clinical information demonstrating that the member meets the Universal and indication‑specific criteria (diagnosis, BCVA documentation, prior treatment response/intolerance/contraindication where applicable).

Applies to Eylea, Pavblu, Eylea HD, and aflibercept formulations administered intravitreally.
Members currently on aflibercept or who received it within the past 365 days may be exempt from Step Therapy requirements per policy.

Note

Prior Authorization — Process Not Specified Here

Prior authorization process details are not specified in this section. Providers should follow the payer's standard authorization submission processes and include the clinical documentation described in this section and the Appendix diagnosis codes.

Background and Clinical Context

Aflibercept (marketed as Eylea, Pavblu, and Eylea HD) is an intravitreal vascular endothelial growth factor (VEGF) inhibitor used to treat neovascular age‑related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema due to retinal vein occlusion (RVO). Clinical trial data and guideline reviews demonstrate improvements in visual acuity and retinal anatomy for these conditions.

The policy reflects differences in product formulations and dosing: standard aflibercept regimens (2 mg intravitreal dosing with induction and maintenance schedules) and higher‑dose Eylea HD regimens have been evaluated across indications; ROP is a special, off‑label orphan indication for which aflibercept dosing and vial‑use restrictions differ and prior bevacizumab trial is required for coverage under the policy.

Definitions and Key Terms

BCVA — Best corrected visual acuity measurement requirement

BCVA requirementBest corrected visual acuity (BCVA) must be measured at baseline and periodically during treatment for non‑ROP indications

ROP exceptionBCVA measurement requirement does NOT apply to patients with Retinopathy of Prematurity (ROP)

Documentation useBCVA measures support prior authorization and renewal determinations for continued benefit

Retinopathy of Prematurity (ROP) criteria — gestational age, birth weight, and prior therapies

Gestational age / birth weightPremature infants with maximum gestational age at birth ≤32 weeks OR birth weight >800 to 1500 g

Prior therapy requirement

OpenPayer

Intravitreal aflibercept (Eylea, Pavblu, Eylea HD) — Coverage Criteria

Coverage Criteria for Intravitreal Aflibercept

Coding and Diagnosis Lists

Provider Actions, Prior Authorization, and Documentation

Background and Clinical Context

Definitions and Key Terms