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Q2 2023
IMPORTANT SAFETY INFORMATION AND INDICATIONS
INDICATIONS
EYLEA® (aflibercept) Injection 2 mg (0.05 mL) 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), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg [0.01 mL]).
CONTRAINDICATIONS
• EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
Please see additional Important Safety Information below.

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News and Best Practices

The 2023 EYLEA Market Access National Webcast is available for download
Click here to listen to the webcast, which provides a review of the EYLEA® (aflibercept) Injection market access landscape, an overview of EYLEA4U® support, and an update on health care policy relevant to the anti-VEGF category.
The 2022/2023 EYLEA annual reverification is complete!
In 2023, almost 55,000 EYLEA4U patients had changes to their health insurance benefits:
  • 78% had modifications to their out-of-pocket costs
  • 46% had benefit changes that affected EYLEA coverage
  • 23% had adjustments to their deductibles
  • 15% shifted from one payer type to another
Thank you for your participation in the reverification process and helping to ensure a seamless continuation of EYLEA treatment for your patients.
Navigating Payer Challenges (NPC) refresh
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 Reimbursement Business Manager (RBM), you can also visit NavigatingPayerChallenges.com, a new 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 procedures1
We suggest you bookmark the website for your convenience. We will update the information on a regular basis.
JZ modifier to be required on Medicare Part B claims for EYLEA
Beginning July 1, 2023, HCPs will be required to report the JZ modifier when submitting Medicare Part B claims from all outpatient settings. The JZ modifier is an HCPCS Level II modifier reported on a claim that 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 is required 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. As of October 1, 2023, claims for drugs from single-dose containers that do not use the JW and JZ modifiers appropriately may be returned.2
Click here to learn more.
In other news…
UnitedHealthcare 2023 changes
For Medicare Advantage patients:
  • EYLEA is now designated as the only preferred branded product for UnitedHealthcare Medicare Advantage and must be used before any branded or biosimilar agent for all its indications3
  • For DME, DR, and MEfRVO, UnitedHealthcare will cover EYLEA as the preferred brand with no step edit3 (EYLEA is the only branded agent that can be used first line)
  • For Wet AMD, only EYLEA can be used after 3 injections of compounded bevacizumab3
  • These policies apply to treatment-naïve patients only3
For commercial patients:
  • In 2023, UnitedHealthcare is continuing to cover EYLEA first line for commercial patients for all FDA-approved indications4

EYLEA4U® Updates

  Commercial Copay Program
 
• The Commercial Copay Program now covers up to $1,000 in assistance per rolling year eligibility toward administration-specific (67028) copay, coinsurance, and deductibles for EYLEA treatment.* This is in addition to up to $20,000 in assistance per rolling year eligibility toward product-specific (J0178) copay, coinsurance, and deductibles for EYLEA treatments.† Go to eyleahcp.us or contact your RBM for more information
• You can now enroll in Electronic Funds Transfer (EFT) Reimbursement for the EYLEA Commercial Copay Card Program. To receive payments via EFT, your practice will need to complete and submit an authorization form to EYLEA4U. Funds are typically disbursed within 2 business days of review/approval. Contact your RBM for the authorization form and more information
  Patient Assistance Program (PAP) Updates
 
• EYLEA4U now offers both Proactive (up-front) and Reactive (replacement) product fulfillment for approved PAP patients
• Your practice must complete and submit a current Product Request Form to EYLEA4U before any shipments are sent, including the initial shipment for newly approved PAP patients
• For the Reactive (replacement) option, a Product Request Form must be submitted within 120 days of your patient’s treatment date
• Click here for the current Product Request Form, which replaced the previous form on October 1, 2022
• For additional information, contact your RBM or call EYLEA4U at 1-855-EYLEA4U (1-855-395-3248), Option 4, Monday–Friday, 9 AM–8 PM Eastern Time
* As of December 19, 2022, all patients enrolled in the EYLEA Commercial Copay Card Program will have a product benefit cap of $20,000 (up from the current $15,000 max annual benefit per Program enrollee) for J0178 through their eligibility end date. Additionally, starting December 19, 2022, patients enrolled in the Program will have an administration benefit cap of $1,000 for 67028 in association with their EYLEA treatment through their eligibility end date.
† Not an insurance or debit card program. This program is not valid for prescriptions covered by or submitted for reimbursement under Medicaid, Medicare, Veterans Affairs, Department of Defense, TRICARE, or similar federal or state programs. This program does not cover or provide support for supplies for EYLEA. This program is not valid where prohibited by law, taxed, or restricted. Patients who are residents of Massachusetts or Rhode Island are not eligible for EYLEA administration assistance. EYLEA4U reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Additional program conditions apply. See EYLEA.com.

National Access Spotlight

Preferred Access
EYLEA is now the preferred branded anti-VEGF agent for UnitedHealthcare Medicare Advantage patients and continues to be a preferred agent for Anthem Commercial and Medicare Advantage patients.

UnitedHealthcare Medicare Advantage
(DME, DR, MEfRVO indications)

75% of all covered lives will have first-line access to EYLEA with no step edits.5

Unrestricted Access to EYLEA
No PA or step edit required.

Medicare Part B Fee-for-Service (FFS)

Parity Access to Bevacizumab
EYLEA is covered without a step edit for UnitedHealthcare Commercial.‡

Step Edit Policies
Step edit policies are in place for these select health plans.‡

UnitedHealthcare Medicare Advantage
(Step edit is for Wet AMD indication only)
For Wet AMD, EYLEA is the only preferred branded agent after a trial of 3 doses of bevacizumab. For DME, DR, and MEfRVO, EYLEA is the only preferred branded agent and will be covered without a step edit.
Cigna Commercial and Medicare Advantage

Patients in plans with step edits make up 25% of all patients receiving EYLEA nationally. Of health plans that require step edits, 88% of them allow EYLEA to be used after 1 injection of bevacizumab.5

UnitedHealthcare PA Portal Update
Click here for information about a PA update on UnitedHealthcare’s medical benefit specialty injectable drug programs and PA tools

Health Plans That Partner With Availity

Local Access

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 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.

‡ Individual patient coverage may vary by health plan. Contact the patient’s health plan for the most current coverage information.

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.

CMS Policy Pulse

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

Current Medicare Administrative Contractor (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.

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. 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:
 
• EYLEA Payer Policy Portal
 
– Enables your practice administrators and office staff to access certain payer policy information for EYLEA
• Payer Access Business Review
 
– Provides high-level national, state, and individualized office data to analyze 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 by health plan, channel, and location
• Know Your Medical and Pharmacy Director 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
• EYLEA4U PA Checklist Flashcard
 
– Click here to find tips for submitting a PA for EYLEA and how to avoid common causes of PA denials
Click here for the EYLEA4U Provider Portal.
  New resources for Retinopathy of Prematurity (ROP) indication
 
• EYLEA4U ROP Enrollment Form
 
– EYLEA4U Enrollment Form used solely for patients who are prescribed EYLEA for ROP
• Product Fact Sheet
 
– Product information needed for ordering and obtaining EYLEA for ROP (including dosage and administration, as well as the J-code, 10- and 11-digit NDCs, and a list of authorized specialty distributors)
• EYLEA4U ROP Billing and Coding Guide
 
– Potential ICD-10-CM codes that may be used for billing for ROP and guidance for filling out CMS-1500 and CMS-1450 claim forms
   
IMPORTANT SAFETY INFORMATION AND INDICATIONS
CONTRAINDICATIONS
• EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
WARNINGS AND PRECAUTIONS
• Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
• Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with 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.
• In infants with ROP, reactivation of abnormal angiogenesis and tortuosity may occur following treatment with EYLEA. Infants should be monitored closely after injection with EYLEA until retinal vascularization has completed or until the examiner is assured that reactivation of ROP will not occur. Treatment with EYLEA will necessitate extended periods of ROP monitoring and additional EYLEA injections and/or laser treatments may be necessary.
• There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). 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
• 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.
• In pre-term infants with ROP receiving EYLEA the most common adverse reactions (≥4%) reported were retinal detachment, conjunctival hemorrhage, and intraocular pressure increased. Adverse reactions established for adult indications are considered applicable to pre-term infants with ROP, though not all were observed in the clinical studies.
• Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.
INDICATIONS
EYLEA® (aflibercept) Injection 2 mg (0.05 mL) 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), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg [0.01 mL]).
Please see the full Prescribing Information for EYLEA.
AMD = age-related macular degeneration; 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; ICD-10-CM = International Classification of Diseases, Tenth Revision, Clinical Modification; MEfRVO = macular edema following retinal vein occlusion; NDC = National Drug Code; PA = prior authorization; RBM = Reimbursement Business Manager; TPE = Targeted Probe and Educate; VEGF = vascular endothelial growth factor.
For Colorado Prescribers — Click Here for Pricing Information
References
1. Robeznieks A. New physician “gold card” law will cut prior authorization delays. American Medical Association. Published September 15, 2021. Accessed April 1, 2023. https://www.ama-assn.org/practice-management/prior-authorization/new-physician-gold-card-law-will-cut-prior-authorization 2. Medicare program: discarded drugs and biologicals—JW modifier and JZ modifier policy. Frequently asked questions. Accessed March 22, 2023. https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf 3. Medicare Part B Step Therapy Programs. UnitedHealthcare. Effective March 22, 2023. Accessed March 22, 2023. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-coverage-sum/medicare-part-b-step-therapy-programs.pdf 4. Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors. UnitedHealthcare Commercial Medical Benefit Drug Policy. UnitedHealthcare. Effective December 1, 2022. Accessed March 22, 2023. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/ophthalmologic-vegf-inhibitors.pdf 5. Data on file. Regeneron Pharmaceuticals, Inc.
04/2023   EYL.23.02.0177
IMPORTANT SAFETY INFORMATION AND INDICATIONS +
CONTRAINDICATIONS
• EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.