BlueCross BlueShield of Tennessee Medical Policy Manual

Bendamustine Hydrochloride

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.

Examples of preparations of bendamustine are Bendeka™ and Treanda®.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

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.

The National Comprehensive Cancer Network (NCCN) published at the foot of its NCCN Drugs & Biologics Compendium™ entry in the NCCN Recommended Use column for bendamustine an additional notation/warning, “Risk of stem cell toxicity and/or transformation with this agent unknown".

SOURCES

Lexi-Comp Online. (2015, April). AHFS DI. Bendamustine hydrochloride. Retrieved July 29, 2015 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2015, June). Bendamustine. Retrieved July 29, 2015 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2015). NCCN Drugs & Biologics Compendium™. Bendamustine hydrochloride. Retrieved July 29, 2015 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, December). Center for Drug Evaluation and Research. Bendeka™ bendamustine hydrochloride. Retrieved January 27, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf.

U. S. Food and Drug Administration. (2015, November). Center for Drug Evaluation and Research. Treanda® bendamustine hydrochloride. Retrieved January 27, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s020lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/12/2009

MOST RECENT REVIEW DATE:  8/17/2016

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 Hydrochloride (Bendeka ™, Treanda ®)

  1. Does the individual have a diagnosis of ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #2

  1. Does the individual have a diagnosis of Hodgkin lymphoma further diagnosed as classical Hodgkin lymphoma requesting treatment as a single agent for refractory or relapsed disease?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #3

  1. Does the individual have a diagnosis of multiple myeloma that was previously treated but disease is relapsed, refractory or progressive and requesting treatment as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #4

  1. Does the individual have a diagnosed form of non-Hodgkin lymphoma?

If yes, go to question #5

If no, go to question #18

  1. Is the diagnosis adult T-cell leukemia/lymphoma for use in a nonresponder to first-line therapy for ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #6

  1. Is the diagnosis AIDS-related B-cell lymphoma for use as second-line or subsequent therapy with or without rituximab for ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #7

  1. Is the diagnosis diffuse large B-cell lymphoma as second-line or subsequent therapy with or without rituximab for relapsed or refractory disease in a noncandidate for high-dose therapy?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #8

  1. Is the diagnosis follicular lymphoma / or nodal marginal zone lymphoma for use as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #9

  1. Is the diagnosis gastric MALT lymphoma for use as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #10

  1. Is the diagnosis mantle cell lymphoma for use as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #11

  1. Is the diagnosis mycosis fungoides (MF)/Sézary syndrome (SS) with treatment as single-agent therapy for tumors with histologic evidence of large cell transformation and aggressive growth rate for ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #12

  1. Is the diagnosis nongastric MALT lymphoma with treatment as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #13

  1. Is the diagnosis peripheral T-cell lymphoma with treatment as second-line or subsequent therapy for relapsed or refractory disease further classified as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #14

  1. Is the diagnosis primary cutaneous B-cell lymphoma further diagnosed as primary cutaneous marginal zone or follicle center lymphoma for treatment used in combination with rituximab for ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #15

  1. Is the diagnosis primary cutaneous B-cell lymphoma further diagnosed as primary cutaneous diffuse large B-cell lymphoma, leg type for second-line or subsequent therapy for relapsed or refractory disease in a noncandidate for high-dose therapy?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #16

  1. Is the diagnosis a primary cutaneous CD30+ T-cell lymphoproliferative disorder to be used as single agent therapy for ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, go to question #17

  1. Is the diagnosis splenic marginal zone lymphoma for treatment as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

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

  1. Does the individual have a diagnosis of Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma with treatment requesting treatment as ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

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

This document has been classified as public information.