Active Ingredient: Aflibercept

Strength: 2 mg (0.05 mL)

Dosage Form: Injection (intravitreal)

Mechanism of Action: VEGF-A and PlGF inhibitors

First Approval: US (18 Nov 2011), EU (27 Nov 2012)

Revenue¹

EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in the United States and Bayer records net product sales of EYLEA outside the United States. With $9.2Bn in sales in 2021, Regeneron and Bayer’s Eylea ranked among the top 10 best-selling drugs in the world. Let’s investigate how the revenue of Eylea has changed over the last five years.

Approved Indication of Eylea²

Eylea is indicated for adults in the treatment of:

• Neovascular (wet) age-related macular degeneration (AMD) 

• Visual impairment due to Macular Edema secondary to retinal vein occlusion (branch RVO or central RVO) 

• Visual impairment due to Diabetic Macular Edema (DME) 

• Visual impairment due to myopic choroidal neovascularisation (myopic CNV) 

Clinical Trials Analysis³

Eylea has a total of 492 trials, including 307 industry trials of which 255 are interventional, 51 observational & 1 expanded access trial. The analysis of clinical trials through a representation is shown below (Trials are taken as of 12 Sep 2022)

*Active trials include Recruiting; Active, Not Recruiting; Enrolling by Invitation, and suspended

*Inactive trials include Terminated; Withdrawn; Unknown Status

EYLEA4U⁴

Patient assistance programs (PAPs) are most often sponsored by pharmaceutical companies that provide free or discounted medicines and co-pay programs to uninsured and under-insured people who meet specific guidelines. EYLEA4U is the patient assistance program by Regeneron and Bayer.

Program eligibility 

• Patient’s insurance company must cover EYLEA for an approved use 
• EYLEA co-pay must be more than $5 for each treatment 
• The patient must be a resident of the United States or its territories or possessions

The patients can enrol in the EYLEA4U program through the EYLEA4U portal or just by calling 1-855-395-3248 and pressing Option 4. The timings are from Monday to Friday from 9 am to 8 pm Eastern Time. Through this, an EYLEA4U Support Specialist will be allotted to the patient for guiding through the enrolment process. EYLEA4U Support Specialist can provide information to help patients to apply for assistance with their chosen foundation.

Once EYLEA4U receives the patient’s application, the support specialist: 

• Verifies that patient meets the program requirements
• Sends a confirmation letter about the patient’s enrolment to the concerned doctor’s office upon approval 
• Makes sure that EYLEA® (aflibercept) Injection gets shipped to the patient’s doctor’s office

Eylea Co-Pay Card Program⁵

The Co-Pay Card Program eligible patients who have commercial insurance not

funded through a government healthcare program.

Eligible patients may pay: 

• As little as a $0 co-pay for each EYLEA treatment. Subject to annual assistance limit

The program covers: 

• Up to $15,000 in assistance per year toward product-specific copay, coinsurance, and insurance deductibles for EYLEA treatments.
• The patients may pay any additional copay costs that exceed the annual assistance limit.

Obtaining Co-Pay Assistance Through the EYLEA Co-Pay Card Program

• The patient is responsible for the first $5 and any additional out-of-pocket co-pay costs that exceed the program assistance limit
• The office submits an EYLEA4U Co-Pay Expenditure Form and documentation that reflects the charges for the EYLEA purchase as well as any reimbursements from the payer

• W-9 Form (one time only)
• EYLEA4U Healthcare Provider Representation Form (one time only)
• CMS 1500 or CMS 1450 Form
• Itemized explanation of benefits (EOB) from the patient’s insurer
• Patient’s authorization to use and disclose health information (on file)

• EYLEA Co-Pay Card Program will disburse funds within 7 to 14 business days of review/approval
• All requests for reimbursement must be submitted within 90 days of the Date of Service

Eyelea Pipeline Analysis⁶

Eylea is currently being studied in various indications and formulations. This can be categorized as follows:

Eylea Patents⁷

Eylea’s patent life running out in the 2025 to 2027 timeframe. The patent expiration can be a threat to it due to duking competition from other drugs. The following table describes some of the U.S. patents, European patents, and Japanese patents of Eylea:

Competitor Products of Eylea⁸

Eylea is the top-selling drug of Regeneron and Bayer. It faces tough competition from various other top-selling drugs for Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, mCNV, and ROP. The following table provides an overview of the current competitive landscape for Eylea.

Biosimilars of Eylea⁹

Regeneron’s Eylea is one of the top-selling biologicals with $9.2B in sales in 2021. Eylea is facing competition from biosimilars in the US and other countries. Some of its biosimilars are presented in the table below:

References:

1. Regeneron 10-K and Bayer 10-K
2. Eylea Prescribing Information
3. ClinicalTrials.gov
4. EYLEA4U
5. Eylea Co-Pay Card Program
6. Regeneron Pipeline and ClinicalTrials.gov
7. Google Patents
8. Regeneron 10-K
9. Biosimilars of Eylea

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