aflibercept
Marketed as EYLEA HD.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA761355 | EYLEA HD | 2023-08-18 | REGENERON PHARMACEUTICALS |
Manufacturers
REGENERON PHARMACEUTICALS
Common denial patterns
- Step therapy requiring bevacizumab (Avastin off-label) first per UnitedHealthcare/Aetna policies
- Quantity limit on injections per eye per year
- High-dose Eylea HD denied (8mg formulation)
- Site-of-care reduction
Specific notes
Brand: Eylea. Anti-VEGF for wet AMD, DME, DR, RVO. Eylea HD (8mg, FDA-approved August 2023) enables longer dosing intervals. Biosimilars Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) launched 2024.
EylEA4U: https://www.eylea.us/eylea-4u
Frequently asked questions
Why does insurance commonly deny aflibercept?
Step therapy requiring bevacizumab (Avastin off-label) first per UnitedHealthcare/Aetna policies; Quantity limit on injections per eye per year; High-dose Eylea HD denied (8mg formulation); Site-of-care reduction.
When was aflibercept FDA approved?
Earliest FDA approval on record: 2023-08-18.
What brand names are sold as aflibercept?
EYLEA HD.
Is there a patient assistance program for aflibercept?
Yes — EylEA4U at https://www.eylea.us/eylea-4u.
What's specific to aflibercept?
Brand: Eylea. Anti-VEGF for wet AMD, DME, DR, RVO. Eylea HD (8mg, FDA-approved August 2023) enables longer dosing intervals. Biosimilars Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) launched 2024.
Sources
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