BlueCross BlueShield of Tennessee Medical Policy Manual

Bendamustine HCl (Treanda®)

NDC CODE(S)

Treanda 100mg lyophilized powder for injection: 63459-0391-xx (Cephalon)

 

Treanda 25mg lyophilized powder for injection: 63459-0390-xx (Cephalon)

 

Treanda 45 mg/0.5mL solution for injection: 63459-0395-xx (Cephalon)

 

Treanda 180 mg/2mL solution for injection: 63459-0396-xx (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.

REFER TO DECISION SUPPORT TREE

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
All other indications Up to 100mg/m² on days 1 and 2 of a 28 day cycle up to 6 cycles

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 (Treanda®) for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, July). AHFS DI. Bendamustine hydrochloride. Retrieved September 20, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, August). Bendamustine. Retrieved September 2o, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Bendamustine hydrochloride. Retrieved September 20, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, November). Center for Drug Evaluation and Research. Treanda® bendamustine hydrochloride. Retrieved September 20, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s020lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/12/2009

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Bendamustine (Treanda®)

1.     Is the requested medication being used to treat Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Waldenström’s Macroglobulinemia / Lymphoplasmacytic Lymphoma?

If yes, go to question #11

If no, go to question #2

2.     Does the individual have a diagnosis of Classical Hodgkin Lymphoma and is requesting treatment as a single agent for refractory or relapsed disease?

If yes, go to question #11

If no, go to question #3

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

If yes, go to question #11

If no, go to question #4

4.     Does the individual have a diagnosis of Non-Hodgkin Lymphoma (NHL) further diagnosed as ANY ONE of the following and is requesting therapy as second-line or subsequent?

If yes, go to question #11

If no, go to question #5

5.     Does the individual have a diagnosis of NHL further diagnosed as ANY ONE of the following requesting treatment for first-line therapy  in combination with rituximab OR second-line or subsequent therapy as a single agent OR in combination with rituximab?

If yes, go to question #11

If no, go to question #6

6.     Does the individual have a diagnosis of NHL further diagnosed as AIDS-Related B-Cell Lymphoma as second-line or subsequent therapy in noncandidates for high-dose therapy?

If yes, go to question #11

If no, go to question #7

7.     Does the individual have a diagnosis of NHL further diagnosed as Diffuse Large B-Cell Lymphoma as second-line or subsequent therapy in a noncandidate for high-dose therapy?

If yes, go to question #11

If no, go to question #8

8.     Does the individual have a diagnosis of NHL further diagnosed as Mycosis Fungoides (MF)/Sézary Syndrome (SS) requesting treatment as single-agent therapy?

If yes, go to question #11

If no, go to question #9

9.     Does the individual have a diagnosis of NHL further diagnosed as Peripheral T-Cell Lymphoma requesting second-line or subsequent therapy for relapsed or refractory disease?

If yes, go to question #11

If no, go to question #10

10.  Does the individual have a diagnosis of NHL further diagnosed as Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorder requesting treatment as single agent therapy only for relapsed or refractory disease?

If yes, go to question #11

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

11.  Is the request for 600 billable units or less every 21 days for NHL diagnoses or 500 billable units or less every 28 days for all other indications for six months ONLY?

If yes, go to question #12

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

12.  Is the dosage requested ANY ONE of the following?

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.