Aflibercept (Eylea) for Retinopathy of Prematurity — Prior Authorization Coverage Criteria
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Prior authorization form and clinical criteria for coverage of Eylea (aflibercept J0177) for treatment of Retinopathy of Prematurity (ROP) in premature infants; intended for AvMed providers requesting outpatient drug approval.
No material clinical or coverage changes in this revision.
Coverage Criteria for Aflibercept (Eylea) — Retinopathy of Prematurity
Initial Authorization Criteria
Covered when ALL of the following are met
Include Zone and Stage (or AP-ROP) as reported on the form
Reauthorization Criteria
Reauthorization covered when ALL of the following are met
Specify improvement status and provide documentation
The policy specifies that treatment for this indication is ONLY applicable to the single-dose vial kit (NDC: 61755-0005-02). Do NOT use the pre-filled syringe for the treatment of Retinopathy of Prematurity (ROP).
Infants with advanced disease are not eligible for coverage under these criteria. Specifically, the infant must NOT have ROP stage 4 or 5 for approval.
Billing Codes, NDCs, and Injection Limits
| J0177 | Aflibercept injectable — Eylea (aflibercept) for Retinopathy of Prematurity (ROP) (Medical) |
| NDC: 61755-0005-02 | Single-dose vial kit — only applicable formulation for ROP; do NOT use the pre-filled syringe for the treatment of ROP |
Provider Requirements and Submission Guidance
Prior authorization required for Eylea (J0177)
Prior authorization is required for Eylea (aflibercept) for Retinopathy of Prematurity (J0177). Complete and submit the medical prior authorization request form with the required clinical criteria and supporting documentation for approval.
- Submit the completed Medical Prior Authorization/Step-Edit Request form (prescribing physician signature required).
- Indicate drug requested: Eylea (aflibercept) — ROP (J0177).
- Check all applicable clinical criteria on the form for initial authorization or reauthorization.
Samples do not meet preauthorization/step criteria
Use of samples to start therapy does not satisfy step-edit or preauthorization requirements; AvMed will verify prior therapies through pharmacy paid claims or submitted chart notes.
- Do not rely on samples to meet prior authorization or step therapy edits.
- Provide documentation of prior treatments (pharmacy claims or chart notes) when applicable.
Submit supporting clinical documentation
Provider must submit documentation supporting each checked clinical criterion on the form; include lab results, diagnostic tests, and chart notes. For ROP, include infant ophthalmology notes and ROP imaging and the infant ROP location & classification per International Classification of ROP (2005) where available.
- Include infant ROP location & classification (Zone and Stage or AP-ROP) and any relevant imaging.
- Attach lab results, diagnostic reports, and chart notes that substantiate each checked criterion.
Incomplete or illegible submissions risk delay or denial
Authorization may be delayed or denied if the submission is incomplete, incorrect, or illegible; missing required information such as diagnosis, gestational age, or weight can prevent approval.
- Ensure all required fields (diagnosis, ICD code if applicable, weight and date weight obtained, dosing schedule) are completed and legible.
- Incomplete or missing documentation (lab results, diagnostics, chart notes) may result in denial or processing delays.
Background — Retinopathy of Prematurity (ROP)
Retinopathy of Prematurity (ROP) is a disease of premature infants characterized by abnormal retinal vascular development that can progress through defined zones and stages. Management may require intravitreal anti-VEGF injections such as aflibercept; the form references the International Classification of ROP (2005) for documenting Zone and Stage (including Aggressive Posterior ROP (AP-ROP)). The recommended intravitreal dosage referenced is 0.4 mg per injection, injections may be given bilaterally the same day, and the minimum interval between doses in the same eye is 10 days.
Definitions and Key Terms
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