CurrentCareSourcePolicy N/A

Ophthalmology — Aflibercept Products (Eylea, Eylea HD, Pavblu) Utilization Management

Policy governs prior authorization, dosing, and coverage criteria for intravitreal aflibercept products (Eylea, Eylea HD, and Pavblu) for ophthalmic indications and affects providers requesting medical-benefit coverage from CareSource.

Policy Summary

PayerCareSource

PolicyOphthalmology — Aflibercept Products (Eylea, Eylea HD, Pavblu) Utilization Management

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 30, 2024

Key ActionSubmit prior authorization requests demonstrating the patient meets the policy's indication, dosing, and prescriber requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3aflibercept products covered

≥1 yrtypical authorization duration

25 daysmin interval (2 mg)

10 daysmin interval (ROP 0.4 mg)

8 mgEylea HD dose (adult)

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Coverage for Eylea and Pavblu (2 mg) - FDA-Approved and supported indications

Covered when ALL of the following are met for each listed indication:

Indication: Patient has one of the policy-listed indications: diabetic macular edema OR diabetic retinopathy OR neovascular (wet) age-related macular degeneration OR macular edema following retinal vein occlusion OR other neovascular diseases of the eye OR retinopathy of prematurity (Eylea only).

Examples of other neovascular diseases include neovascular glaucoma, sickle cell neovascularization, and choroidal neovascular conditions.

Dose is 2 mg administered by intravitreal injection for each eye being treated (except for retinopathy of prematurity where the dose is 0.4 mg).2 mg (standard); 0.4 mg for ROP

Interval: Dosing interval meets the policy limits for the indication: generally not more frequent than once every 25 days for 2 mg indications; for retinopathy of prematurity (0.4 mg) not more frequent than once every 10 days.25 days (2 mg); 10 days (0.4 mg)

Prescriber: Medication is administered by or under the supervision of an ophthalmologist (or appropriate specialist).

Approvals require ophthalmologist involvement.

Duration: Approvals are generally provided for up to 1 year when criteria are met; extended approvals may be allowed if the patient continues to meet criteria.1 year

Coverage for Eylea HD (8 mg)

Covered when ALL of the following are met for each listed indication:

Indication: Patient has an FDA-approved indication listed for Eylea HD such as diabetic macular edema, diabetic retinopathy, or neovascular (wet) age-related macular degeneration.

Dose is 8 mg administered by intravitreal injection for each eye being treated.8 mg

Initial dosing interval: Initial dosing meets the policy-specified interval: not more frequent than once every 21 days for the first three doses; thereafter dosing as indicated (generally every 7–16 weeks depending on indication and labeling).21 days for initial three doses; then 7–16 weeks per indication

Policy notes recommended once-every-4-weeks (~28 days ±7) for first three doses in labeling with specific follow-up intervals by indication.

Coverage of intravitreal aflibercept products (Eylea, Eylea HD, Pavblu) is not recommended for circumstances that are not listed in the policy's Recommended Authorization Criteria. The policy criteria will be updated as new published data become available; requests falling outside the enumerated indications and conditions should be considered unsupported by this policy and are generally not recommended for approval.

Use of intravitreal aflibercept for indications or dosing regimens that are not specified in this policy is not recommended for approval and may be considered not medically necessary. Requests for nonstandard indications or dosing should be reviewed against the policy criteria and supporting literature; absence from the Recommended Authorization Criteria is a basis for denial.

Billing, Codes, and Dosing Limits

Referenced codesmixed

NDCs/HCPCS not explicitly listed

Document references prescribing information but does not list specific NDC or HCPCS codes in text.

Minimum dosing intervals — intravitreal aflibercept products (policy limits)

2 mg indications (typical)Dosing interval not more frequent than once every 25 days for each eye being treated (applies to 2 mg indications such as DME, DR, wet AMD, macular edema following RVO).

ROP (retinopathy of prematurity)Dose 0.4 mg intravitreal; dosing interval not more frequent than once every 10 days for each eye treated.

Eylea HD initial dosing (8 mg)Initial three doses: dosing interval not more frequent than once every 21 days for the first three doses; thereafter interval per indication as specified (7–16 weeks range).

Prior Authorization, Prescribing, and Administrative Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for intravitreal aflibercept products (Eylea, Eylea HD, Pavblu). Approval is recommended when patients meet the Recommended Authorization Criteria and Dosing for the listed indications. Extended approvals may be granted if the patient continues to meet the Criteria and Dosing. Requests for doses outside the established dosing in this policy will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist) and may be denied.

Step Therapy

No formal step therapy (i.e., no required trial of an alternate agent prior to coverage) is specified in this policy. There are no explicit step therapy requirements for intravitreal aflibercept products.

Documentation Required

Prescriber / Administration Requirement

Medication must be prescribed by and administered by or under the supervision of an ophthalmologist. Approvals require that the prescribing clinician be an ophthalmologist or in consultation with a physician who specializes in the condition being treated. Approvals are for the durations specified in the Recommended Authorization Criteria (typically 1 year) when dosing and administration requirements are met.

Denial Risk

Coverage Not Recommended When Criteria Not Met

Requests that do not meet the Recommended Authorization Criteria are not recommended for approval. Coverage is not recommended for indications or circumstances not listed in the Recommended Authorization Criteria; criteria will be updated as new data become available.

Denial Risk

Nonstandard Dosing

Requests for doses outside the established dosing documented in this policy (including dosing frequency more frequent than once every 25 days or dose other than 2 mg intravitreal per eye) will be considered on a case-by-case basis and may be denied.

Drug Definitions and Formulations

Pavblu — product definition

DefinitionPavblu is a biosimilar intravitreal aflibercept product to Eylea.

Therapeutic classVascular endothelial growth factor (VEGF) inhibitor administered via intravitreal injection for neovascular ophthalmic conditions.

Indications (shared with Eylea)Diabetic macular edema, diabetic retinopathy, neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion.

Eylea HD — high‑dose aflibercept (8 mg)

DefinitionEylea HD is a high‑dose aflibercept formulation indicated for certain ophthalmic conditions with an 8 mg dosing regimen.

Adult indications (examples)Diabetic retinopathy and neovascular (wet) age‑related macular degeneration are listed indications for Eylea HD.

Recommended dosing overviewTypical dosing: 8 mg intravitreal injection every 4 weeks (~28 days ±7) for the first three doses; thereafter dosing intervals vary by indication (commonly every 8–12 or 8–16 weeks as noted).

OpenPayer

Ophthalmology — Aflibercept Products (Eylea, Eylea HD, Pavblu) Utilization Management

Coverage and Medical Necessity Criteria

Billing, Codes, and Dosing Limits

Prior Authorization, Prescribing, and Administrative Requirements

Drug Definitions and Formulations

Clinical and Policy Background