Announcing the approval of EYLEA® HD (aflibercept) Injection 8 MG (8/18/23) – 9/7/23

Announcing the approval of EYLEA® HD (aflibercept) Injection 8 MG

Effective August 18th, 2023

EYLEA® HD (aflibercept) Injection 8 MG

has been approved as a new single source drug by the FDA

Suggested Billing and Coding for EYLEA HD**

HCPCS CODES

EYLEA HD NDC*

PACKAGE DESCRIPTION

WAC Per Package

J3490:

Unclassified drugs


J3950:

Unclassified Biologicals

61755-0050-01

xxxxxxxxxxxxxxxxxxxxx

Vial kit containing one EYLEA HD 8 mg (0.07 mL of a 114.3 mg/mL solution) single-dose glass vial, one 18-gauge x 1½-inch, 5-micron, filter needle for withdrawal of the vial contents, one 30-guage x ½-inch injection needle for intravitreal injection and one 1-mL syringe for administration, one Prescribing Information

$2625.00

*Note that 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. 


**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 clinical judgment when selecting codes and submitting claims.

EYLEA HD is not the same product as EYLEA® (aflibercept) Injection 2 mg

EYLEA HD should NOT be billed using HCPCS Code J0178

 

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. 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 or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA HD and EYLEA.


  • 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) 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) 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 click here for full Prescribing Information for EYLEA HD and EYLEA.

References

1. EYLEA® HD (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August, 2023.

 

© 2023, Regeneron Pharmaceuticals, Inc. All Rights Reserved.

777 Old Saw Mill River Road, Tarrytown, NY 10591

08/2023 EHD.23.08.0102