Product Information
EYLEA HD is available as a vial kit with injection components (filter needle, syringe, and injection needle). Each vial is for single eye use only. Discard unused portion.1
Effective April 1, 2024: EYLEA HD J-Code J01772
Ensure claims processing systems are updated for dates of service on or after April 1, 2024
Effective for dates of service on or after April 1, 2024: EYLEA HD J-code J0177
Description: Injection, aflibercept hd, 1 mg
Note: The J-code for EYLEA HD has a 1-mg descriptor. “8” billing units should be indicated on claim forms for each EYLEA HD 8-mg injection.
Please ensure that policies and systems are updated to reflect EYLEA HD.
| Product specifications | |
|---|---|
| Dosage form and strength1 | EYLEA HD is a clear to slightly opalescent, colorless to pale yellow solution available as:
|
| NDC number1 | 61755005001* |
| EYLEA HD J-code2 | J0177 |
| How supplied1 | Vial kit with injection components
|
| Storage and handling1 | Refrigerate EYLEA HD at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light. |
| WAC3 | $2,625 |
| Product specifications |
|---|
| Dosage form and strength1
EYLEA HD is a clear to slightly opalescent, colorless to pale yellow solution available as:
|
| NDC number1 61755005001* |
|
EYLEA HD J-code2 |
| How supplied1
Vial kit with injection components
|
| Storage and handling1
Refrigerate EYLEA HD at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light. |
| WAC3 $2,625 |
| WAC as of August 2023 per Regeneron Pharmaceuticals media statement. WAC is the list price and does not necessarily reflect the end price paid by customers. | |
| * | 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. |
| † | NDC = National Drug Code; WAC = wholesale acquisition cost. |
- 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.
- 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.
- 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.
References: 1. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 2. 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 3. Regeneron Pharmaceuticals, Inc. Information for EYLEA HD (aflibercept) Injection 8 mg U.S. list price. Press release. Regeneron; August 18, 2023. Accessed August 18, 2023. https://investor.regeneron.com/static-files/146d7101-2db1-4d35-b6d0-b9b94b11c6fb
03/2024
US.EHD.24.02.0203
