61755-0005-XX Eylea 2 MG/0.05ML SOLN (REGENERON PHARMACEUTICALS)
Aflibercept 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. 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.
VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability. Aflibercept is a dimeric glycoprotein which acts as a soluble decoy receptor that binds VEGF-A and PlGF, and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Aflibercept for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Neovascular age-related macular degeneration (AMD)
Macular edema following retinal vein occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic retinopathy (DR) associated with diabetic macular edema (DME)
Aflibercept for the treatment of other conditions/diseases is considered investigational.
Aflibercept is considered medically appropriate if ALL of the following criteria are met:
Individual is free from ocular and/or peri-ocular infections
Individual does not have active intraocular inflammation
Individual has a definitive diagnosis of ANY ONE of the following:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME) and an inadequate response to ANY ONE of the following, or contraindication or intolerance to both.*
Diabetic retinopathy (DR) associated with diabetic macular edema (DME) and an inadequate response to ANY ONE of the following; or contraindication or intolerance to both.*
*NOTE: Treatment naïve (new to therapy – commercial line of business only)
Individual must have an inadequate response to an adequate trial of bevacizumab AND/OR ranibizumab prior to initiating treatment with aflibercept.
An adequate trial is defined as a minimum of 3 injections per affected eye of bevacizumab AND/OR ranibizumab. The trial period must be completed within 168 days of initiation of therapy.
Inadequate response is defined as one of the following:
After 3 injections of bevacizumab AND/OR ranibizumab, Spectrum-Domain Optical Coherence Tomography (SD-OCT) central thickness reading of >350 μm OR visual acuity is equal to or worse than 20/50**; OR
After 6 injections of bevacizumab AND/OR ranibizumab, visual acuity is worse than 20/20 AND SD-OCT reading of >250 μm. The 6 injections must be completed within 1 year of initiation of therapy**; OR
Treatment with Aflibercept may be initiated if the patient has a documented contraindication or severe intolerance to BOTH bevacizumab AND/OR ranibizumab.
**Optical Coherence Tomography (OCT) and VA testing must be completed within 56 days after the last injection of bevacizumab and/or ranibizumab when requesting Aflibercept. We recommend specialists ensure patients have received a proper exam of their eyes by a qualified provider within the appropriate time frames to ensure individuals BCVA is optimal.
Aflibercept is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug such as endophthalmitis and retinal detachments; increase in intraocular pressure; arterial thromboembolic events
Continued administration is necessary for the maintenance treatment of the condition
DOSAGE & ADMINISTRATION
2 mg intravitreally once every 4 weeks (monthly) per affected
eye for the first 3 months
2 mg once every 8 weeks (2 months) per affected eye; however Aflibercept may be dosed as frequently as 2 mg every 4 weeks (monthly)
Additional efficacy was not demonstrated in most patients when Aflibercept was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).
Macular Edema following RVO
2 mg intravitreally once every 4 weeks (monthly) per affected eye
Diabetic macular edema and diabetic retinopathy in individuals with diabetic macular edema
2 mg intravitreally once every 4 weeks (monthly) per eye for the first 5 injections
2 mg once every 8 weeks (2 months); however Aflibercept may be dosed as frequently as 2 mg every 4 weeks (monthly)Additional efficacy was not demonstrated in most patients when Aflibercept was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).
LENGTH OF AUTHORIZATION
Coverage will be provided annually and may be renewed.
Click here to view DOSAGE LIMITS
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validates the use of aflibercept for the treatment of other conditions or diseases.
Lexicomp Online. (2016). AHFS DI. Aflibercept. Retrieved December 12, 2016 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Aflibercept. Retrieved December 12, 2016 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2016, October). Center for Drug Evaluation and Research. Eylea® (aflibercept) injection. Retrieved December 12, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s052lbl.pdf.
Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012;119:789–801. doi.org/10.1016/j.ophtha.2011.12.039.
Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology 2016;123 (6):1351-9. doi.org/10.1016/j.ophtha.2016.02.022.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 2/16/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit
(Max units are based on administration to both eyes)