EYLEA® HD (aflibercept) Injection 8 mg

Dear ,

We are excited to share that as of March 1st, EYLEA HD is now a preferred anti-VEGF product for eligible Medicare Advantage patients.

EYLEA HD Has Very Strong Access Across UnitedHealthcare Commercial and Medicare Advantage Plans

Use EYLEA HD for your eligible UnitedHealthcare patients


Commercial Wet AMD, DME, DR: First-line access, no step edit*	Medicare Advantage DME and DR: First-line access, no step edit* Wet AMD: Single agent step through bevacizumab*

*A prior authorization may be required.

This information is provided for informational purposes only, is subject to change, and should not be construed as legal or medical advice. Providers should confirm a patient's coverage criteria with their health plan.

For additional information about UnitedHealthcare's coverage policies, please visit uhcprovider.com.

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
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 for EYLEA HD and EYLEA below.

EYLEA HD Coverage Spotlight

Be sure to request all insurance cards from your patients. Insurance coverage can be confirmed by enrolling patients in EYLEA4U^®.

EYLEA4U is a patient support program that offers patient access, reimbursement, and product support for your eligible patients who are prescribed EYLEA HD. Enrollment is the first step to accessing support for benefit verifications, prior authorizations, claims, and appeals.

For more information, contact your Regeneron RBM.

Talk to your dedicated RBM or call EYLEA4U at 1‑855‑EYLEA4U (1‑855‑395‑3248), Option 4, Monday–Friday, 9 AM–8 PM Eastern Time.

IMPORTANT SAFETY INFORMATION

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).

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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.

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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:

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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.

If you have questions about this email, contact the Regeneron Market Access Strategy team at oph.marketaccess@regeneron.com.

This material 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; providers should exercise independent judgment when submitting claims.

AMD = age-related macular degeneration; DME = diabetic macular edema; DR = diabetic retinopathy; FFS = fee-for-service; RBM = Reimbursement Business Manager; VEGF = vascular endothelial growth factor.

References: 1. Data on file. Regeneron Pharmaceuticals, Inc. 2. Centers for Medicare & Medicaid Services. Medicare benefit policy manual, Chapter 15: covered medical and other health services. Revised October 4, 2024. Accessed October 21, 2024. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf

^†	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 August 2024 and EYLEA HD imputed sales as of April 2024.

For Colorado Prescribers – Click Here for Pricing Information for EYLEA HD

For Colorado Prescribers – Click Here for Pricing Information for EYLEA

For Connecticut Prescribers – Click Here for Pricing Information for EYLEA HD

For Connecticut Prescribers – Click Here for Pricing Information for EYLEA

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