DESCRIPTION
Aflibercept is a recombinant fusion protein consisting of portions of human vascular endothelial growth factor (VEGF) receptors 1 and 2 that binds all forms of VEGF- A along with the related placental growth factor (PlGF). It is a specific and highly potent blocker of these growth factors. Aflibercept is purified and contains iso-osmotic buffer concentrations, which allows for intravitreal administration.
An example of a preparation of aflibercept is Eylea™.
REFER TO DECISION SUPPORT TREE
POLICY
Aflibercept for the treatment of age-related macular degeneration (AMD) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Aflibercept for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Aflibercept for the treatment of wet (neovascular) age-related macular degeneration is considered medically appropriate.
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.
IMPORTANT REMINDER
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.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
SOURCES
U. S. Food and Drug Administration. (2011, November). Center for Drug Evaluation and Research. Eylea™ (aflibercept) injection for intravitreal injection. Retrieved December 1, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125359lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/2/2011
MOST RECENT REVIEW DATE: 12/2/2011
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.
Pharmaceutical Decision Support Tree
Does the individual have a diagnosis of age-related macular degeneration (AMD)?
If yes, go to question #2
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the agent being used for the treatment of wet (neovascular) age-related macular degeneration?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.