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As of July 2024
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 patients with Medicare Fee-for-Service (FFS) have first-line access to EYLEA HD with no prior authorization or step edit required1

* MMIT medical lives as of Q2 2024. 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 June 2024.
† National coverage reflects channel mix for patients using branded anti-VEGF agents.

EYLEA HD National Access Spotlight

Medicare Fee-For-Service (FFS)
• Unrestricted access for 100% of patients with Medicare FFS. No prior authorization or step edit required for patients with Medicare FFS1
United Healthcare Medicare Advantage, Managed Medicaid
• DME/DR: single step edit through EYLEA
• Wet AMD: double step edit through bevacizumab and EYLEA
BCBS Federal Employee Program Commercial
• First-line access, no step edit required
Humana Commercial and Medicare Advantage
•  Step edit with bevacizumab
Cigna Commercial and Medicare Advantage
• DME with vision worse than 20/50: first-line access, no step edit required
• Step edit with bevacizumab
Department of Veterans Affairs (VA)
• First-line access, no step edit required
Department of Defense (DoD) Government
• First-line access, no step edit required

Contact your RBM to learn more about regional payer policies

EYLEA HD and EYLEA Payer Policy Portal

For more information about payer coverage for EYLEA HD and EYLEA, contact your RBM or click here to visit the EYLEA HD and EYLEA Payer Policy Portal to access certain payer policy information.

  • Find health plan coverage for EYLEA HD and EYLEA for each state through different channels and indications

  • Check the coverage status for various health plans, including step edits and prior authorization requirements

This information is provided for informational purposes only, is subject to change, and should not be construed as legal or medical advice. This information may not apply to all patients or to all health plans and providers should exercise independent judgment when submitting claims.

Reimbursement information for EYLEA HD3

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 HD4

  • 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.5

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 August 18, 2023

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

Discount for EYLEA HD: Effective September 16, 2024

The wholesale acquisition cost (WAC) discount is 3.50% 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. 3.50% discount effective September 16, 2024. 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.

ASP for EYLEA HD

Effective July 1, 2024, reimbursement for EYLEA HD will transition to the ASP. The ASP for EYLEA HD in Q4 2024 is $2,518.46

Access News Roundup

Access-related news affecting the retina care landscape

Developments in Tracking Social Determinants of Health (SDOH)

Senators Address Physician Payment Concerns

On May 17, 2024, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a white paper highlighting concerns about Medicare physician payment rates not keeping pace with inflation, while Senators Sheldon Whitehouse (D-RI) and Bill Cassidy, MD (R-LA) introduced the “Pay PCPs Act” aimed at increasing Medicare reimbursement for primary care providers by creating a capitation option that would be in addition to existing fee-for-service payments.8

Proposed Reform for Medicare Advantage Policies

CMS released its 2025 Medicare Advantage and Part D plan year proposed 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.9

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).

The EYLEA HD Provider Representation Form must be completed (one time only) in order to receive payments for EYLEA HD through the EYLEA4U Commercial Copay Card Program.

2024 annual reverification

More than 350,000 patient benefits were reverified this year! Thank you and congratulations for your efforts in helping streamline patient access to EYLEA HD and EYLEA.

Click here for the EYLEA4U Provider Portal.

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.

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 secure 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 period10
We recommend bookmarking the website for your convenience. Updates to the site will be made on a regular basis.

Ask your RBM for a Payer Business Review for your specific location.

Your RBM can provide a local review of your payer landscape and answer questions related to coverage of EYLEA HD in your specific location. Your RBM can also provide state-specific information and an overview resource of several laws and regulations that may apply to patient insurance and payer issues.

CMS Policy Pulse11,12

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 prior authorization 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 Pending TPE review Link
Novitas JH Part B TPE review Link
Novitas JL Part B TPE review Link
Palmetto JJ Part B TPE review Link
Palmetto JM Part B TPE review Link

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.

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
  • Payer Access Business Review
  • Provides high-level national, state, and individualized office data to analyze EYLEA HD coverage trends and aggregate data from EYLEA4U, our patient support program, for your overall organization and individual offices
  • FormTrak Coverage Landscape Tool
  • Provides coverage status for EYLEA HD and EYLEA by health plan, channel, and location
  • Know Your Medical and Pharmacy Directors Flash Card
  • Helps your practice understand the importance of having a rapport with medical and pharmacy directors at health plans and how advocating can lead to successful appeals and influence medical policy

  • Regional Payer Coverage Flash Cards

  • Provide regional coverage status for EYLEA HD specific to one or multiple plans

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

  • Prior Authorization Checklist Flashcard
  • 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 EYLEA4U 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
CONTRAINDICATIONS (cont’d)
• 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.
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.
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).
Please see full Prescribing Information for EYLEA HD and EYLEA.

AMD = age-related macular degeneration; ASP = average sales price; BCBS = Blue Cross Blue Shield; 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; HCPCS = healthcare common procedure coding system; GPO = group purchasing organization; NDC = National Drug Code; PCP = primary care physician; VEGF = vascular endothelial growth factor.

References: 1. Centers for Medicare & Medicaid Services. Medicare Benefit Policy Manual, Chapter 15: Covered medical and other health services. March 7, 2024. Accessed July 8, 2024. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf 2. Data on file. Regeneron Pharmaceuticals, Inc. 3. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 4. 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 July 5, 2024. https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-4-2023-drugs-and-biologicals-updated-04/25/2024.pdf 5. Medicare program: discarded drugs and biologicals—JW modifier and JZ modifier policy frequently asked questions. Accessed January 5, 2024. https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf 6. Gallegos A. New SDOH reporting requirements expected to impact HI workflow, staffing. J AHIMA . February 23, 2024. Accessed May 28, 2024. https://journal.ahima.org/page/new-sdoh-reporting-requirements-expected-to-impact-hi-workflow-staffing 7. Nicoletti B. HCPCS code G0136 for assessment social determinants of health (SDoH). CodingIntel. Revised February 12, 2024. Accessed May 28, 2024. https://codingintel.com/screening-for-social-determinants-of-health-sdoh/ 8. American Society of Retina Specialists. Physician payment reform draws bipartisan attention on the hill. ASRS. Accessed May 28, 2024. https://www.asrs.org/clinical/clinical-updates/10375/physician-payment-reform-draws-bipartisan-attention-on-the-hill 9. CMS proposes MA plans’ prior authorization policies are subject to equity assessments. ASRS. Accessed May 28, 2024. https://www.asrs.org/advocacy/updates/10352/cms-proposes-ma-plans-prior-authorization-policies-are-subject-to-equity-assessments 10. Robeznieks A. New physician “gold card” law will cut prior authorization delays. American Medical Association. Accessed February 13, 2024. https://www.ama-assn.org/practice-management/prior-authorization/new-physician-gold-card-law-will-cut-prior-authorization 11. CMS finalizes rule to expand access to health information and improve the prior authorization process. News release. Centers for Medicare & Medicaid Services. Accessed February 13, 2024. https://www.cms.gov/newsroom/press-releases/cms-finalizes-rule-expand-access-health-information-and-improve-prior-authorization-process 12. Tong N. CMS finalizes rule setting prior authorization deadlines for payers. Accessed February 13, 2024. https://www.fiercehealthcare.com/payers/cms-introduce-prior-authorization-deadlines-payers
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.