BlueCross BlueShield of Tennessee Medical Policy Manual

Ziv-Aflibercept

NDC CODE(S)

00024-5840-XX - Zaltrap 100 MG/4ML SOLN (SANOFI-AVENTIS U.S.)

 

00024-5841-XX - Zaltrap 200 MG/8ML SOLN (SANOFI-AVENTIS U.S.)

DESCRIPTION

Ziv-aflibercept is a recombinant fusion protein which consists of the binding portions of vascular endothelial growth factor (VEGF) from VEGF receptors 1 and 2 fused to the Fc (crystallizable fragment) portion of immunoglobulin G1 (IgG1).  VEGF receptor 1 (VEGFR-1) and VEGFR-2 are tyrosine kinases present on the surface of endothelial cells.  Ziv-aflibercept acts as a soluble receptor that binds to three VEGF family members: VEGF-A, VEGF-B and placental growth factor (PlGF). VEGF proteins are markedly expressed in most human tumors and if activated by binding to their natural receptors, tumor growth is accelerated through neovascularization and increased vascular permeability.  Ziv-aflibercept acts as a decoy by binding to VEGF-A,-B and PlGF and stops their activation, inhibiting tumor growth.

Ziv-aflibercept contains the same drug, aflibercept, as the intravitreal preparation, Eylea®, used in the treatment of macular degeneration.  To prevent potential medication errors the FDA required the addition of the prefix “ziv” to the generic name of the intravenous agent, ziv-aflibercept.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Colorectal cancer

4 mg/ kg as an intravenous (IV) infusion over 1 hour every two weeks

LENGTH OF AUTHORIZATION

Coverage is provided for six months 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.

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 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 validate the use of ziv-aflibercept in the treatment/prevention of any other conditions/diseases.

SOURCES

Lexi-Comp Online. (2017). AHFS DI. Ziv-aflibercept. Retrieved October 23, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, October). Ziv-aflibercept. Retrieved October 23, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Ziv-aflibercept. Retrieved October 23, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, June). Center for Drug Evaluation and Research. Zaltrap® (ziv-aflibercept). Retrieved October 23, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125418s039lbl.pdf.

ORIGINAL EFFECTIVE DATE:  8/13/2012

MOST RECENT REVIEW DATE:  1/9/2018

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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.

This document has been classified as public information.

 

 



DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Diagnosis

MAXIMUM UNITS/DOSE

Colorectal cancer

500 billable units every 14 days