BlueCross BlueShield of Tennessee Medical Policy Manual

Bendamustine HCl (Bendeka®)

NDC CODE(S)

63459-0348-XX Bendeka 100 MG/4ML SOLN (CEPHALON)

DESCRIPTION

Bendamustine, classified as a bifunctional alkylating agent, is a nitrogen mustard analogue.  It is an antineoplastic agent whose exact mechanism of action is unknown.  As an alkylating agent it interferes with DNA replication and the transcription of RNA which ultimately disrupts nucleic acid function.  In this respect, bendamustine has produced more DNA double-strand breaks than other alkylating agents.  It may also activate apoptosis by inhibiting mitosis, with DNA-damaged cells undergoing a premature form of necrotic cell death known as mitotic catastrophe.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
NHL Up to 120mg/m² on days 1 and 2 of a 21 day cycle, up to 8 cycles
HL Up to 120 mg/m² on days 1 and 2 of a 28-day cycle, up to 6 cycles
All other indications Up to 100mg/m² on days 1 and 2 of a 28 day cycle, up to 6 cycles

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may NOT 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 bendamustine HCl (Bendeka®) for the treatment of other conditions or diseases.

SOURCES 

Lexi-Comp Online. (2017, March). AHFS DI. Bendamustine hydrochloride. Retrieved March 24, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, March). Bendamustine. Retrieved March 24, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Bendamustine hydrochloride. Retrieved March 28, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, February). Center for Drug Evaluation and Research. Bendeka® bendamustine hydrochloride. Retrieved March 28, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208194s005lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/12/2009

MOST RECENT REVIEW DATE:  4/10/2018

ID_MRx

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  1 billable unit = 1 mg

DIAGNOSIS

MAXIMUM UNITS

NHL

600 billable units every 21 days

HL

600 billable units every 28 days

All  other indications

500 billable units every 28 days