BlueCross BlueShield of Tennessee Medical Policy Manual

Bendamustine

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.

An example of a preparation of bendamustine is Treanda®.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

* Evidence-based treatment regimens for individualized therapy and specific agent combinations should be based on recognized compendia, e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) which is published by the National Comprehensive Cancer Network®.

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).

No additional published literature was found that validates the use of bendamustine in the treatment of any other conditions/diseases.

SOURCES

Lexi-Comp Online. (2013). AHFS DI. Bendamustine hydrochloride. Retrieved October 16, 2013 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2013, October). Bendamustine. Retrieved October 16, 2013 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2013). NCCN Drugs & Biologics Compendium™. Bendamustine hydrochloride. Retrieved October 17, 2013 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2013, September). Center for Drug Evaluation and Research. Treanda® bendamustine hydrochloride. Retrieved October 16, 2013 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s015lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/12/2009

MOST RECENT REVIEW DATE: 2/12/2014

ID_BT

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

Bendamustine (Treanda®)

  1. Is the requested medication being used to treat chronic lymphocytic leukemia (CLL)?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #2

  1. Does the individual have a diagnosis of classical Hodgkin lymphoma?

If yes, go to question #15

If no, go to question #3

  1. Does the individual have a diagnosis of lymphocyte-predominant Hodgkin lymphoma?

If yes, go to question #15

If no, go to question #4

  1. Does the individual have a diagnosis of metastatic breast cancer?

If yes, go to question #15

If no, go to question #5

  1. Does the individual have a diagnosis of multiple myeloma, including solitary plasmacytoma and smoldering multiple myeloma?

If yes, go to question #15

If no, go to question #6

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is AIDS-related B-cell lymphoma?

If yes, go to question #15

If no, go to question #7

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is small lymphocytic lymphoma?

If yes, go to question #15

If no, go to question #8

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is diffuse large B-cell lymphoma?

If yes, go to question #15

If no, go to question #9

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is follicular lymphoma or nodal marginal zone lymphoma?

If yes, go to question #15

If no, go to question #10

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is MALT lymphoma, gastric or nongastric?

If yes, go to question #15

If no, go to question #11

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is Mantle cell lymphoma?

If yes, go to question #15

If no, go to question #12

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is primary cutaneous B-cell lymphoma?

If yes, go to question #15

If no, go to question #13

  1. Does the individual have a diagnosis of non-Hodgkin lymphoma that is splenic marginal zone lymphoma?

If yes, go to question #15

If no, go to question #14

  1. Does the individual have a diagnosis of Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma?

If yes, go to question #15

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the requested treatment regimen based on recognized compendia, e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), for individualized therapy and specific agent combinations?

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.