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Q1 2024
IMPORTANT SAFETY INFORMATION FOR EYLEA HD AND EYLEA
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).
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.

News

New J-Code for EYLEA HD, J1077
The EYLEA HD permanent J-code—J0177, Injection, aflibercept hd, 1 mg—is effective for dates of service on or after April 1, 2024.1
  • The new J-code can help streamline medical claims for reimbursement
  • Bill 8 units per 8-mg administered dose of EYLEA HD
  • Update billing software and EMRs and adjust billing protocols to include the permanent J-code
EYLEA HD Coverage

All Medicare Administrative Contractor (MAC) jurisdictions and many private payers have confirmed reimbursement for EYLEA HD.2 To learn more, contact your Regeneron Reimbursement Business Manager (RBM).

* MMIT medical lives as of Q4 2023. National coverage reflects channel mix for patients using branded anti-VEGF agents.
† Individual plan policies may vary, and the information presented herein does not replace a benefit verification. A prior authorization may be required.

EYLEA HD National and Regional Access Spotlight

National plans

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 FFS3
Elevance Health Commercial, Medicare, Managed Medicaid
• First-line access, no step edit required
BCBS Federal Employee Plan 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 20/40: first-line access, no step edit required
• Wet AMD, DME, or DR: 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

Select regional plans

Blue Shield of California Commercial and Medicare Advantage
• First-line access, no step edit required
EmblemHealth Medicare Advantage, Commercial, and Managed Medicaid
• Medicare Advantage: first-line access, no step edit required
• Commercial, Managed Medicaid: single step edit with bevacizumab
BCBS of Massachusetts Commercial
• Step edit with bevacizumab
BCBS of Tennessee Commercial and Medicare Advantage
• First-line access, no step edit required
Florida Blue
• Commercial: first-line access, no step edit required
• Medicare Advantage: step edit with bevacizumab
Independence Blue Cross Commercial and Medicare Advantage
• Step edit with bevacizumab
BCBS of Michigan Commercial and Medicare Advantage
• DME with vision ≤20/50: first-line access, no step edit required
• Wet AMD, DME, or DR: step edit with bevacizumab

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.

Useful Tips

Reimbursement information for EYLEA HD4

Vial kit with injection components

NDC

  • 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
  • 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 HD1

  • 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.

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).

Reminder: Complete and return the EYLEA HD Provider Representation Form (one time only) as soon as possible 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.

EYLEA Access

For information about payer coverage information for EYLEA, contact your RBM or visit the EYLEA Payer Policy Portal.

State-by-State Reimbursement

Navigating Payer Challenges (NPC) resource

The NPC resource contains information for HCPs and office administrators that may facilitate how to access, submit claims, and seek reimbursement in order to secure their patients’ access to EYLEA. Flash cards on specific state, US territory, and other ancillary insurance laws, rules, and regulations have been updated.
In addition to obtaining these flash cards from your RBM, you can also visit NavigatingPayerChallenges.com, a website where you can:
  • Download any state, US territory, or ancillary NPC flash card
  • Review payer reimbursement time frames and penalties that payers must follow for reimbursing services rendered by HCPs within the 50 states, US territories, ERISA, and Medicare Advantage
  • Find information about the status of state and federal Gold Card Act legislation, laws that allow HCPs who have consistently met PA requirements and prior approval rates within a specific period to bypass the PA process for certain procedures6
We suggest you bookmark the website for your convenience. We will update the information 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 Pulse7,8

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 and EYLEA 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

Visit the Resource Center at the EYLEA HD HCP website to download information about EYLEA HD and EYLEA, 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
• 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; BCBS = Blue Cross Blue Shield; CMS = Centers for Medicare & Medicaid Services; DME = diabetic macular edema; DR = diabetic retinopathy; EMRs = electronic medical records; ERISA = Employee Retirement Income Security Act; FDA = US Food and Drug Administration; HCP = health care provider; NDC = National Drug Code; VEGF = vascular endothelial growth factor.
References: 1. 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 February 13, 2024. https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-4-2023-drugs-and-biologicals-updated-02/05/2024.pdf 2. Data on file. Regeneron Pharmaceuticals, Inc. 3. Centers for Medicare & Medicaid Services. Medicare benefit policy manual 2023: chapter 15: covered medical and other health services. Accessed February 8, 2024. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf 4. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023.5. 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. 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 7. 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 8. 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.