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As of October 6, 2025

INDICATIONS

EYLEA HD® (aflibercept) Injection 8 mg is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

EYLEA® (aflibercept) Injection 2 mg is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

IMPORTANT SAFETY INFORMATION FOR EYLEA HD AND EYLEA

CONTRAINDICATIONS

  • EYLEA HD and EYLEA are contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA HD or EYLEA.

Please see additional Important Safety Information below.

EYLEA HD Coverage and Access

100% of eligible patients with Medicare Fee-for-Service (FFS) have first-line access to EYLEA HD with no prior authorization or step edit required1
• 84% of Medicare FFS patients have supplemental plans to help cover out-of-pocket costs2

For an up-to-date payer coverage report for national and regional payers, click here

Please be sure to clear your browser cache and history to view the latest payer coverage report via the link above.

* Individual plan policies may vary, and the information presented herein does not replace a benefit verification. All formulary data and other access criteria are provided by Managed Markets Insight & Technology, LLC database as of January 2025 and EYLEA HD imputed sales as of November 2024.
† Prior authorization may still be required.

Medicare in Focus

Our Medicare in Focus initiative provides patients with information and education on the differences between Original Medicare and Medicare Advantage to support their selection of the most appropriate coverage based on their needs.

You can visit and direct your patients to medicareinfocus.com to access helpful resources and videos, including:

  • Information about how and when to switch between Medicare Advantage and Original Medicare (with or without a Medigap plan)
  • A side-by-side cost comparison of Medicare Advantage versus Original Medicare with Medigap, including a cost comparison worksheet patients can fill in themselves
  • An overview of affordability options for Medicare patients

Don’t forget to remind your patients! Medicare Open Enrollment runs from October 15 – December 7 each year.

NEW!

Navigating Insurance: A Guide to Patient Affordability

A guide for HCPs and office staff to understand different payer channels, out-of-pocket considerations, and support services available for patients being treated with EYLEA HD.

Please reach out to your RBM to learn more.

Annual Reverification: Be prepared for 2026!

Annual reverification (AR) helps ensure your patients continue receiving EYLEA4U® support. Below are important dates and timelines for the EYLEA4U reverification process for your patients receiving EYLEA HD and EYLEA:

AR dashboard opens

Access your AR list via the new EYLEA4U ePortal at www.E4Ueportal.com

Last day to submit

eligible patients for
AR 2026

During this period, EYLEA4U cannot commit to releasing AR 2026 benefits

If you need a statement of benefits between January 1, 2026, and January 7, 2026, you must contact the payer directly

Start of benefits return*

EYLEA4U will begin distributing the scheduled, date-specific statement of benefits 

*You may receive the statement of benefits sooner than scheduled based on payer availability.

For more information, please reach out to your RBM for details!

Navigating Payer Challenges (NPC)

The NPC resource contains information for HCPs and office administrators that may facilitate how to access, submit claims, and seek reimbursement to support their patients’ access to EYLEA.
You can also visit NavigatingPayerChallenges.com to:
  • Download updated state, US territory, or ancillary NPC flash cards
  • Review Payer Reimbursement Time Frames and Penalties that plans must adhere to for reimbursing for services rendered by health care providers within the 50 states, US territories, ERISA, and Medicare Advantage
  • Find information about the status of state and federal Gold Card Act legislation, which is legislation that allows prequalified providers with a specific prior approval rate to bypass the prior authorization process for certain procedures over a defined period4
We recommend bookmarking the website for your convenience. Updates to the site will be made on a regular basis.

Reimbursement Information for EYLEA HD5

Vial kit with injection components

  • One EYLEA HD 8 mg (0.07 mL of a 114.3 mg/mL solution), single-dose glass vial
  • One 18-gauge x 11/2-inch, 5-micron filter needle for withdrawal of the vial contents
  • One 30-gauge x 1/2-inch injection needle for intravitreal injection
  • One 1-mL syringe for administration
  • One Prescribing Information

NDC

  • 6175505001
  • 61755005001

Note: The product’s NDC has been “zero-filled” to ensure creation of an 11-digit code that meets general billing standards. The zero-fill location is indicated in bold.

Ask your RBM about the EYLEA HD Comprehensive Product Acquisition Brochure, which includes more information on how you can acquire EYLEA HD for your practice.

Permanent J-code for EYLEA HD6

  • J0177, Injection, aflibercept hd, 1 mg, is effective for dates of service on or after April 1, 2024
  • With the permanent J-code, billing units for EYLEA HD must be reported based on the unit value for the assigned permanent code. EYLEA HD is reported with “8” units of J0177 per treatment

Modifiers required on Medicare FFS claims for EYLEA HD and EYLEA

As of October 1, 2023, claims for drugs from single-dose containers that do not use the required modifiers (JZ and JW) may be returned.7

Reminder: HCPs are required to report the JZ modifier when submitting Medicare FFS claims from all outpatient settings. The JZ modifier is used to attest that no amount of drug was discarded and eligible for payment and that no JW modifier amount is reported (a JW modifier, required since July 1, 2023, is used when indicating that the discarded drug was not administered to a patient). Like the JW modifier, the JZ modifier should only be used for claims that bill for single-dose container drugs as approved by the FDA.

Click here to learn more.

Payment Terms, WAC Discount, and ASP Information for EYLEA HD

Payment terms for EYLEA HD: Effective as of August 18, 2023

Physician payment terms will be 120 days, subject to distributor qualification.*†

Discount for EYLEA HD: Effective as of October 1, 2025

The wholesale acquisition cost (WAC) discount is 13.20% on EYLEA HD for community-based physicians in solo or group practices who are treating patients on an outpatient basis (if ordered through authorized distributors).‡

* These payment terms are subject to change. Regeneron worked with its authorized distributors of record to apply these terms for EYLEA HD.
† Subject to distributor qualification. Please verify with your distributor the timing and specific dating terms that apply to your office.
‡ This discount applies only to eligible purchasers ordering from authorized distributors. See EYLEAHDhcp.us for additional discount terms. The EYLEA HD WAC discount is subject to change.
§ WAC serves as the list price for EYLEA HD. It does not necessarily reflect the end price paid by purchasers.
∥ Rebates are subject to additional terms and conditions, including eligibility criteria. Please contact your Regeneron Ophthalmology Account Director for additional information.
  The discount and rebates described herein are intended to constitute a discount as such term is defined in 42 U.S.C. § 1320a-7b(b)(3) and 42 C.F.R. § 1001.952(h). As such, participating physicians have an obligation to comply with all retention, disclosure, and reporting requirements regarding the value of any discounts or rebates paid or received, including those described herein, pursuant to 42 U.S.C. § 1320a-7b(b)(3) and 42 C.F.R. § 1001.952(h) and all other applicable federal and state laws and regulations.
  The EYLEA HD WAC discount is an independent and non-contingent offering specific to EYLEA HD.

Participating GPOs and Authorized Specialty Distributors

GPOs:
Acuity; AllyRetina; IPN; Onmark; Matrix

Specialty Distributors:
Besse Medical; BioCareSD; CuraScript SD Specialty Distribution; McKesson Specialty Health; McKesson Plasma & Biologics for Hospitals; Metro Medical (A Cardinal Health Company); and Cardinal Health Specialty Pharmaceutical Distribution for Hospitals

Contact one of our authorized distributors and receive EYLEA HD on the next business day. Orders received prior to 7 PM Eastern Time Monday–Thursday are typically processed on the same day and scheduled for delivery the next business day. Orders received on Friday will typically be delivered the following Monday.

Regeneron does not recommend the use of a particular authorized distributor or GPO. 

GPO and specialty distributor added as of October 1, 2024.

ASP for EYLEA HD

Effective as of October 1, 2025, the ASP for EYLEA HD in Q4 2025 is $2,350.05.

Access News Roundup

Access-related news affecting the retina care landscape

A CMS claims system issue is causing denials for Medicare and Medicare Advantage claims related to treating Wet AMD and geographic atrophy (GA) when both treatments are given within 25-28 days. The first treatment is typically reimbursed, but the second drug and injection code are being denied.

ASRS and AAO are working with CMS to remove the edit, and retina practices are encouraged to appeal, arguing that Wet AMD and GA are distinct diseases treated with different drugs, all following FDA guidelines.8

Congress passed a bill that includes a 2.5% increase in Medicare physician payments for 2026, with no changes to payment levels through 2025 or after 2026. Starting in 2027, the bill introduces significant changes to Medicaid eligibility and low-income subsidies, though physician reimbursement under Medicaid remains unchanged.9

  • Unlike traditional Medicare, nearly all Medicare Advantage enrollees (99%) must obtain prior authorization for certain higher-cost treatments and services10

    • In 2023, Medicare Advantage plans made nearly 50 million prior authorization determinations—up from 42 million in 2022
    • 3.2 million of these requests were partially or fully denied, and 11.7% of the requests were appealed
    • However, ~82% of appeals resulted in overturning the initial prior authorization denial

  • Despite coverage complexities, most beneficiaries didn’t compare plan options during open enrollment11

    • 69% of Medicare beneficiaries overall and 65% of Medicare Advantage enrollees did not explore other coverage options for 2022, even though plan changes could impact access to care
    • Certain subgroups were even less likely to compare coverage: 82% of those aged 85 years and older, 79% of Hispanic individuals, and 77% of those making <$10,000 annually compared coverage during open enrollment

Reform for Medicare Advantage Policies

CMS released its 2025 Medicare Advantage and Part D plan year final rule, which includes a requirement that Medicare Advantage plans incorporate health equity experts into their utilization management committees and conduct annual health equity assessments of prior authorization policies.12

Educational Opportunities

Practice Administrator Educational Programs

There are several speaker programs available to educate practice administrators and staff on specific topics related to EYLEA HD and EYLEA. 

Topics include:

  • Access and reimbursement information
  • Understanding market access dynamics within your account
  • Helpful tips when reviewing payer contracts and documentation
  • Processes for benefit verification, prior authorization, medical exceptions, and appeals

Click here to connect with your Regeneron RBM for more information about these speaker programs.

Helpful Documentation Considerations Resource

The Helpful Documentation Considerations guide is available for office use. It provides tips to help ensure proper documentation and a checklist to confirm that the necessary EYLEA HD clinical information is included in all appropriate paperwork to be submitted to payers. It is distributed by RBMs to help physicians facilitate payer coverage and reduce prior authorization denials.

EYLEA4U Information

The EYLEA4U Patient Support Program can provide you with benefit verification support for your patients. All programs within EYLEA4U are available for both EYLEA HD and EYLEA. EYLEA4U forms include both EYLEA and EYLEA HD, which can help streamline the process of enrolling patients who require treatment with EYLEA HD, including those transitioning from EYLEA to EYLEA HD in the EYLEA4U Commercial Copay Card Program or Patient Assistance Program (PAP).

Please note: To receive payments for EYLEA HD through the EYLEA4U Commercial Copay Card Program, you must complete (one-time only) an EYLEA4U Healthcare Provider Representation Form.

 

If you haven’t completed this form, please contact your RBM or call EYLEA4U at 1-855-EYLEA4U (1-855-395-3248), Option 4, Monday–Friday, 9 am–8 pm Eastern Time to receive a form today.  

Annual Reverification

Be prepared for 2026: Annual reverification helps ensure your patients continue receiving support from EYLEA4U.

The EYLEA4U ePortal has moved to a new platform! Visit E4Ueportal.com to learn more.

EYLEA4U Online Via Tablet-Based Technology*

Tablet-based technology that interfaces with electronic medical record, practice management, and inventory management system technology and can connect patients to all EYLEA4U support services.

  • Electronic signature capture for tablet enrollment† 
  • Electronic submissions in real time 
  • Electronic enrollment solutions can offer benefit verification accuracy

Contact your Reimbursement Business Manager if you are interested in utilizing the tablet.

* Requires the use of a tablet provided by Regeneron’s third-party technology source and a license paid for by the HCP office.
† For tablet only; portal enrollment requires patient signature to be filed.

CMS Policy Pulse13,14

Responding to criticisms of the current prior authorization (PA) process, CMS has issued a new rule requiring health plans to send PA decisions within three days for urgent requests and within seven days for standard requests.

The new rule, effective in 2026, also requires payers to provide an explanation for every denial of a PA and publicly report their PA metrics.

By 2027, payers will have to implement a PA application programming interface (API) to improve the electronic exchange of health information and automation of the PA process. 

CMS estimates the new rule will save approximately $15 billion over 10 years by reducing the administrative burden of PAs and improving patient outcomes.

Stay up-to-date with the latest information on audits from CMS

Current MAC Medical Review List

MAC EYLEA J0178 Medical Review Links
CGS J15 Part B TPE review Link
Palmetto JJ Part B TPE review Link
Palmetto JM Part B TPE review Link

As of June 2025.

Product Support

Click here for a list of authorized specialty distributors and specialty pharmacy providers for EYLEA HD and EYLEA.

Regeneron does not recommend the use of any particular authorized distributor or specialty pharmacy.

Product return procedure

If EYLEA HD or EYLEA is rendered unusable after purchase, it may be returned to Regeneron and replaced, under certain circumstances. Returns are subject to adherence to Regeneron policies and procedures regarding the return of product and Regeneron’s right, at its sole discretion, to deny replacement when misuse is suspected.

For more information about product returns, click here.

Resources

Your dedicated RBM can provide support to help your eligible patients access EYLEA HD and EYLEA. They provide support in areas including access and reimbursement, financial assistance, and health plan policy, and can provide you with various educational tools and resources.

Contact your RBM to learn more about the latest tools and resources available for EYLEA HD and EYLEA:

  • EYLEA HD and EYLEA Payer Policy Portal
  • Enables your practice administrators and office staff to access certain payer policy information for EYLEA HD and EYLEA
  • Navigating Insurance: A Guide to Patient Affordability
  • Provides guidance for HCPs and office staff to understand different payer channels, out-of-pocket considerations, and support services available for patients being treated with EYLEA HD
  • FormTrak Coverage Flash Cards
  • Provides coverage status for EYLEA HD and EYLEA by health plan, channel, and location
  • Helpful Documentation Considerations Guide

  • Provides your office staff with tips and a checklist to ensure proper documentation for EYLEA HD coverage

  • Medicare in Focus
  • Provides patients with information and education on the differences between Original Medicare and Medicare Advantage to support their selection of the most appropriate coverage based on their needs

Visit the Resource Center at the EYLEA HD HCP website to download information about EYLEA HD, including:

  • Prior Authorization Checklist Flash Card
  • Billing and Coding Brochure
  • Appeals Letter Overview Brochure
  • EYLEA4U Annotated Enrollment Form Brochure
  • EYLEA4U Overview Brochure for HCPs

The EYLEA4U Practice Administrator Speaker Program is designed to educate practice administrators and their staff on specific topics related to EYLEA HD and EYLEA. Contact your RBM for the Practice Administrator Speaker Program (RAP) Overview Flash Card to see the wide variety of topics covered through this program.

IMPORTANT SAFETY INFORMATION FOR EYLEA HD AND EYLEA (cont’d)

WARNINGS AND PRECAUTIONS

  • Intravitreal injections, including those with aflibercept, have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be used when administering EYLEA HD or EYLEA. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
  • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA HD and EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
  • There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA HD and EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
    • EYLEA HD: The incidence of reported thromboembolic events in the wet AMD study (PULSAR) from baseline through week 48 was 0.4% (3 out of 673) in the combined group of patients treated with EYLEA HD compared with 1.5% (5 out of 336) in patients treated with EYLEA 2 mg. The incidence in the DME study (PHOTON) from baseline to week 48 was 3.1% (15 out of 491) in the combined group of patients treated with EYLEA HD compared with 3.6% (6 out of 167) in patients treated with EYLEA 2 mg.
    • EYLEA: The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.

ADVERSE REACTIONS

  • EYLEA HD:
    • The most common adverse reactions (≥3%) reported in patients receiving EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
  • EYLEA:
    • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment.
    • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
  • Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD or EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

Please see full Prescribing Information for EYLEA HD and EYLEA.

AMD = age-related macular degeneration; AAO = American Academy of Ophthalmology; ASP = average sales price; ASRS = American Society of Retina Specialists; CMS = Centers for Medicare & Medicaid Services; DME = diabetic macular edema; DR = diabetic retinopathy; ERISA = Employee Retirement Income Security Act; FDA = US Food and Drug Administration; HCP = health care provider; GPO = group purchasing organization; MAC = Medicare Administrative Contractor; NDC = National Drug Code; RBM = Reimbursement Business Manager.

References: 1. Centers for Medicare & Medicaid Services. Medicare Benefit Policy Manual, Chapter 15: Covered medical and other health services. Revised April 11, 2025. Accessed August 25, 2025. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf 2. Tarazi W, Welch P, Nguyen N, et al. Medicare beneficiary enrollment trends and demographic characteristics. March 2, 2022. Accessed September 4, 2025. https://aspe.hhs.gov/reports/medicare-enrollment 3. Data on file. Regeneron Pharmaceuticals, Inc. 4. Robeznieks A. New physician “gold card” law will cut prior authorization delays. American Medical Association. September 15, 2021. Accessed August 25, 2025. https://www.ama-assn.org/practice-management/prior-authorization/new-physician-gold-card-law-will-cut-prior-authorization 5. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. October 2024. 6. Centers for Medicare & Medicaid Services. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) application summaries and coding recommendations: fourth quarter, 2023 HCPCS coding cycle. Accessed August 25, 2025. https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-4-2023-drugs-and-biologicals-updated-04/25/2024.pdf 7. Medicare program: discarded drugs and biologicals—JW modifier and JZ modifier policy frequently asked questions. Accessed August 25, 2025. https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf 8. American Society of Retina Specialists. ASRS seeks to remove CMS edit for billing Wet and Dry AMD treatments in the same month. February 18, 2025. Accessed August 25, 2025. https://www.asrs.org/advocacy/updates/10407/asrs-seeks-to-remove-cms-edit-for-billing-wet-and-dry-amd-treatments-in-the-same-month 9. American Society of Retina Specialists. Physician payment update enacted in Republican agenda bill. July 8, 2025. Accessed July 30, 2025. https://www.asrs.org/advocacy/updates/10436/physician-payment-update-enacted-in-republican-agenda-bill 10. Biniek JF, Sroczynski N, Freed M, Neuman T. Medicare Advantage insurers made nearly 50 million prior authorization determinations in 2023. Published January 28, 2025. Accessed August 25, 2025. https://www.kff.org/medicare/issue-brief/nearly-50-million-prior-authorization-requests-were-sent-to-medicare-advantage-insurers-in-2023/ 11. Ochieng N, Cubanski J, Freed M, Neuman T. Nearly 7 in 10 Medicare beneficiaries did not compare plans during Medicare’s open enrollment period. KFF. Published September 26, 2024. Accessed August 25, 2025. https://www.kff.org/medicare/issue-brief/nearly-7-in-10-medicare-beneficiaries-did-not-compare-plans-during-medicares-open-enrollment-period/ 12. Centers for Medicare & Medicaid Services. Contract year 2025 Medicare Advantage and Part D final rule (CMS-4205-F). Accessed August 25, 2025. https://www.cms.gov/newsroom/fact-sheets/contract-year-2025-medicare-advantage-and-part-d-final-rule-cms-4205-f 13. CMS finalizes rule to expand access to health information and improve the prior authorization process. News release. Centers for Medicare & Medicaid Services. January 17, 2024. Accessed August 25, 2025. https://www.cms.gov/newsroom/press-releases/cms-finalizes-rule-expand-access-health-information-and-improve-prior-authorization-process 14. Tong N. CMS finalizes rule setting prior authorization deadlines for payers. January 17, 2024. Accessed August 25, 2025. https://www.fiercehealthcare.com/payers/cms-introduce-prior-authorization-deadlines-payers

EYLEA HD, EYLEA, and EYLEA4U are registered trademarks of Regeneron Pharmaceuticals, Inc.
All other trademarks are property of their respective owners.

IMPORTANT SAFETY INFORMATION FOR EYLEA HD AND EYLEA +
CONTRAINDICATIONS
• EYLEA HD and EYLEA are contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA HD or EYLEA.