This letter provides an example of the types of information that may be provided when responding to a
request from a patient’s insurance company to provide a letter of medical necessity for
EYLEA® (aflibercept) Injection treatment. A copy of the full Prescribing Information for EYLEA is available
for download on www.EYLEA.com
EXAMPLE
[Date]
[Contact Name]
[Insurance Company]
[Insurance Address]
[Insurance City, State Zip]
Re:[Patient First Name] [Patient Last Name]
[Policy Number]
[Group Number]
[Diagnosis]
Dear [Name or Contact]:
I am writing on behalf of [Patient First Name] [Patient Last Name] to document the medical necessity for
administering EYLEA® (aflibercept) Injection. [Patient First Name] [Patient Last Name], has been under
treatment for [Diagnosis] since [Date of Onset]. This letter provides information about the patient’s medical
history and diagnosis, a statement summarizing my treatment rationale, and other documents that support my
use of EYLEA in this clinical case.
Product Description
EYLEA is approved by the FDA for the treatment of Diabetic Retinopathy (DR) in patients with Diabetic Macular
Edema (DME). EYLEA is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2
extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for
intravitreal administration. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth
factor (PlGF) and thereby can inhibit them from binding to and activating cognate VEGF receptors. Vascular
endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of
angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial
cells.
Clinical History
[Name of patient] is a [age] year-old [male/female] who has Diabetic Retinopathy (DR) with Diabetic Macular
Edema (DME). The patient was initially diagnosed with Diabetic Retinopathy (DR) with Diabetic Macular
Edema (DME) by [name of referring physician], but has been in my care since [date]. The diagnosis of Diabetic
Retinopathy (DR) with Diabetic Macular Edema (DME) for this patient was based on [provide details regarding
the patient’s diagnostic workup, history and prior treatments]. Currently the patient [discuss the patient’s
current condition, including any loss of visual acuity, or other signs of disease progression, highlighting those
factors leading you to recommend the use of EYLEA].
Treatment Plan
EYLEA [was/will be] administered to [patient name] by intravitreal injection on a dosing regimen of 2 mg (0.05
mL) every 4 weeks (monthly) for the first 5 injections, followed by 2 mg (0.05 mL) via intravitreal injection once
every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly),
additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
Based upon the patient’s clinical condition and a review of the supporting documentation, I am confident you
will agree that EYLEA is medically necessary for this patient. I would appreciate prompt review of this case
and approval of my use of EYLEA for this patient. Please contact me at [physician’s telephone number] if I can
provide additional information about this case. Thank you in advance for your immediate attention to this very
important matter.
[Physician’s name, M.D.]
Enclosures [suggested]:
EYLEA FDA approval letter
EYLEA full Prescribing Information
Clinic notes, OCT/FA images
Use of the information in this letter does not guarantee the insurance company will provide reimbursement for EYLEA
and is not intended to be a substitute for or an influence on the independent medical judgment of the physician.
© 2015, Regeneron Pharmaceuticals, Inc.
E4U-0450B
All Rights Reserved
03/15