Estimated Costs

Methodology for Calculating Year 1 Anti-VEGF Treatment Costs for Wet AMD and DME

Cost calculations for EYLEA^® (aflibercept) 2 mg, EYLEA HD, faricimab-svoa, ranibizumab, ranibizumab-nuna (Byooviz^™), and ranibizumab-eqrn (Cimerli^™) are based on procedure and drug list prices (WAC) as of August 2023 and FDA-recommended dosing. Per-injection costs were included in this comparison.

The calculations do not take into account discounts, rebates, reimbursement rates, or management of AEs. Dosing and cost variances do not imply differences in safety or efficacy.

August 2023 drug list prices (WAC): EYLEA HD 8 mg, Wet AMD, DME, and DR, $2,625; EYLEA 2 mg, Wet AMD and DME, $1,850; faricimab-svoa 6 mg, Wet AMD and DME, $2,190; ranibizumab 0.5 mg, Wet AMD, $1,950; ranibizumab 0.3 mg, DME, $1,170; ranibizumab-nuna 0.5 mg, Wet AMD, $1,130; ranibizumab-eqrn 0.5 mg, Wet AMD, $1,360; ranibizumab-eqrn, 0.3 mg, DME, $816.^1,2

2023 procedure costs: CPT 67028, Intravitreal Injection, $114; CPT 92014, Physician Visit, $127; CPT 92134, Optical Coherence Tomography, $41.³

Fundus photographs (2 per year) and fluorescein angiography (2 per year) are also used in the treatment of Wet AMD; however, these costs are the same whether the patient uses EYLEA HD, EYLEA 2 mg, faricimab-svoa, ranibizumab, ranibizumab-nuna, or ranibizumab-eqrn, regardless of the number of treatments. Therefore, costs associated with fundus photographs and fluorescein angiography were excluded.

AEs = adverse events; AMD = age-related macular degeneration; CPT = Common Procedural Terminology; DME = diabetic macular edema; FDA = US Food and Drug Administration; VEGF = vascular endothelial growth factor; WAC = wholesale acquisition cost.

All trademarks are property of their respective owners.

References: 1. Red Book Online. IBM Micromedex. Accessed August 18, 2023. www.micromedexsolutions.com 2. 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-b9b94b11c6 3. CMS Physician Fee Schedule 2023. Centers for Medicare & Medicaid Services. Accessed August 18, 2023. www.cms.gov/medicare/physician-fee-schedule/search

For Patients With DME, the Estimated Year 1 Cost of EYLEA HD Is Similar to the Estimated Cost of Other FDA-Approved Anti-VEGF Treatments

DME year 1 estimated cost based on an average of FDA-recommended dosing, procedure costs, and drug list prices^1-10

EYLEA HD

3 initial monthly injections followed by³:

Q16W dosing, year 1: 5 injections, or
Q12W dosing, year 1: 6 injections

Faricimab-svoa

Varying dosing regimens⁵

Year 1: Average 8 injections^6,7†

EYLEA 2 mg Q8W⁴*:

Year 1: 8 injections (5 initial monthly injections followed by every-other-month dosing)

Ranibizumab, ranibizumab-eqrn (Cimerli™):

Once-monthly dosing^8-9

Year 1: 12 injections

EYLEA HD

3 initial monthly injections followed by³:

Q16W dosing, year 1: 5 injections, or
Q12W dosing, year 1: 6 injections

EYLEA 2 mg Q8W⁴*:

Year 1: 8 injections (5 initial monthly injections followed by every-other-month dosing)

Faricimab-svoa

Varying dosing regimens⁵

Year 1: Average 8 injections^6,7†

Ranibizumab, ranibizumab-eqrn (Cimerli™):

Once-monthly dosing^8-9

Year 1: 12 injections

For patients with DME, the cost of EYLEA HD is at parity with EYLEA 2 mg for the first year of treatment^6‡

*	Some patients may need Q4W (monthly) dosing after the first 20 weeks (5 months).
^†	Based on the analysis of dosing intervals in the clinical trial setting and under the unvalidated PTI dose criteria, an average of 8 injections of faricimab-svoa was administered to patients for treatment of DME in year 1.
^‡	In the EYLEA HD groups in PULSAR and PHOTON, patients could be treated as frequently as every 8 weeks based on protocol-defined visual and anatomic criteria, starting at week 16 (17% Q8W, 7% Q8W all EYLEA HD PULSAR and PHOTON, respectively). The estimated total treatment cost of EYLEA HD for Wet AMD, DME, or DR with a Q8W dosing regimen following 3 initial monthly doses through year 1 is $20,349.
	DME = diabetic macular edema; FDA = US Food and Drug Administration; PTI = personalized treatment interval; Q8W = every 8 weeks; Q12W = every 12 weeks; Q16W = every 16 weeks; VEGF = vascular endothelial growth factor; WAC = wholesale acquisition cost. All trademarks are property of their respective owners.
	References: 1. Red Book Online. IBM Micromedex. Accessed August 18, 2023. www.micromedexsolutions.com 2. CMS Physician Fee Schedule 2023. Centers for Medicare & Medicaid Services. Accessed March 16, 2023. https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/PFSlookup 3. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 4. EYLEA full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 5. Vabysmo® (faricimab-svoa) injection full U.S. Prescribing Information. Genentech, Inc. January 2023. 6. Data on file. Regeneron Pharmaceuticals, Inc. 7. US Food and Drug Administration. Biologics License Application 761235. Accessed May 25, 2023. https://www.accessdata.fda.gov/ drugsatfda_docs/ nda/2022/761235Orig1s000StatR.pdf 8. Lucentis® (ranibizumab injection) full U.S. Prescribing Information. Genentech, Inc. March 2018. 9. Cimerli™ (ranibizumab-eqrn) full U.S. Prescribing Information. Coherus BioSciences, Inc. August 2022. 10. Regeneron Pharmaceuticals, Inc. Information for EYLEA HD (aflibercept) Injection 8 mg U.S. list price. Press release. Regeneron; December 18, 2023. Accessed August 18, 2023. https://investor.regeneron.com/static-files/ 146d7101-2db1-4d35-b6d0-b9b94b11c6fb

For Patients With Wet AMD, the Estimated Year 1 Cost of EYLEA HD Is Similar to the Estimated Cost of Other FDA-Approved Anti-VEGF Treatments

Wet AMD Year 1 estimated cost based on an average of FDA-recommended dosing, procedure costs, and drug list prices^1-11

EYLEA HD

3 initial monthly injections followed by³:

Q16W dosing, year 1: 5 injections, or
Q12W dosing, year 1: 6 injections

Faricimab-svoa

Varying dosing regimens⁵

Year 1: Average 7 injections^6,7†

EYLEA 2 mg Q8W⁴*:

Year 1: 7 injections (3 initial monthly injections followed by every-other-month dosing)

Ranibizumab, ranibizumab-eqrn (Cimerli™), and ranibizumab-nuna (Byooviz™):

Once-monthly dosing^8-10

Year 1: 12 injections

EYLEA HD

3 initial monthly injections followed by³:

Q16W dosing, year 1: 5 injections, or
Q12W dosing, year 1: 6 injections

EYLEA 2 mg Q8W⁴*:

Year 1: 7 injections (3 initial monthly injections followed by every-other-month dosing)

Faricimab-svoa

Varying dosing regimens⁵

Year 1: Average 7 injections^6,7†

Ranibizumab, ranibizumab-eqrn (Cimerli^™), and ranibizumab-nuna (Byooviz^™):

Once-monthly dosing^8-10

Year 1: 12 injections

For patients with Wet AMD, the cost of EYLEA HD is at parity with EYLEA 2 mg for the first year of treatment^6‡

*	Some patients with Wet AMD may need every-4-week (monthly) dosing after the first 3 months. Additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks.
^†	Based on the analysis of dosing intervals in the clinical trial setting and under the unvalidated PTI dose criteria, an average of 7 injections of faricimab-svoa was administered to patients for treatment of Wet AMD in year 1.
^‡	In the EYLEA HD groups in PULSAR and PHOTON, patients could be treated as frequently as every 8 weeks based on protocol-defined visual and anatomic criteria, starting at week 16 (17% Q8W, 7% Q8W all EYLEA HD PULSAR and PHOTON, respectively). The estimated total treatment cost of EYLEA HD for Wet AMD, DME, or DR with a Q8W dosing regimen following 3 initial monthly doses through year 1 is $20,349.

IMPORTANT SAFETY INFORMATION FOR EYLEA HD AND EYLEA (aflibercept) Injection 2 mg

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; FDA = US Food and Drug Administration; PTI = personalized treatment interval; Q8W = every 8 weeks; Q12W = every 12 weeks; Q16W = every 16 weeks; VEGF = vascular endothelial growth factor; WAC = wholesale acquisition cost.

All trademarks are property of their respective owners.

References: 1. Red Book Online. IBM Micromedex. Accessed August 18, 2023. www.micromedexsolutions.com 2. CMS Physician Fee Schedule 2023. Centers for Medicare & Medicaid Services. Accessed March 16, 2023. https://www.cms.gov/
Medicare/Medicare-Fee-for-Service-Payment/PFSlookup 3. EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 4. EYLEA full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 5. Vabysmo® (faricimab-svoa) injection full U.S. Prescribing Information. Genentech, Inc. January 2023. 6. Data on file. Regeneron Pharmaceuticals, Inc. 7. US Food and Drug Administration. Biologics License Application 761235. Accessed May 25, 2023. https://www.accessdata.fda.gov/
drugsatfda_docs/nda/2022/761235
Orig1s000StatR.pdf 8. Lucentis® (ranibizumab injection) full U.S. Prescribing Information. Genentech, Inc. March 2018. 9. Cimerli™ (ranibizumab-eqrn) full U.S. Prescribing Information. Coherus BioSciences, Inc. August 2022. 10. Byooviz™️ (ranibizumab-nuna) injection full U.S. Prescribing Information. Biogen Inc. June 2022. 11. 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

01/2024
US.EHD.23.12.0055

Estimated Costs

Methodology for Calculating Year 1 Anti-VEGF Treatment Costs for Wet AMD and DME

For Patients With DME, the Estimated Year 1 Cost of EYLEA HD Is Similar to the Estimated Cost of Other FDA-Approved Anti-VEGF Treatments

DME year 1 estimated cost based on an average of FDA-recommended dosing, procedure costs, and drug list prices1-10

For Patients With Wet AMD, the Estimated Year 1 Cost of EYLEA HD Is Similar to the Estimated Cost of Other FDA-Approved Anti-VEGF Treatments

Wet AMD Year 1 estimated cost based on an average of FDA-recommended dosing, procedure costs, and drug list prices1-11

Welcome to the Market Access Website for EYLEA HD

DME year 1 estimated cost based on an average of FDA-recommended dosing, procedure costs, and drug list prices^1-10

Wet AMD Year 1 estimated cost based on an average of FDA-recommended dosing, procedure costs, and drug list prices^1-11