Bendamustine HCl (Treanda®)
63459-0390-XX Treanda 25 MG SOLR (CEPHALON)
63459-0391-XX Treanda 100 MG SOLR (CEPHALON)
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.
Bendamustine HCl (Treanda®) for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Waldenström’s Macroglobulinemia / Lymphoplasmacytic Lymphoma
Multiple myeloma, including solitary plasmacytoma, smoldering multiple myeloma
Non-Hodgkin lymphoma (NHL)
Bendamustine HCl (Treanda®) for the treatment of other conditions/diseases is considered investigational.
Bendamustine HCl (Treanda®) is considered medically appropriate if ALL of the following criteria are met:
Individual must not have received prior treatment with bendamustine
Individual must be 18 years of age or older
Request is for a diagnosis of ANY ONE of the following:
Non-Hodgkin lymphoma further diagnosed as ANY ONE of the following:
B-Cell Lymphomas as ANY ONE of the following:
Used as second line or subsequent therapy
Used as first line therapy in combination with rituximab for ANY ONE of the following:
Non-Gastric MALT Lymphoma
Gastric MALT Lymphoma
Splenic Marginal Zone Lymphoma
Nodal Marginal Zone Lymphoma
Mantle Cell Lymphoma;
Used as first line therapy in combination with rituximab or obinutuzumab for Follicular Lymphoma
T-Cell Lymphomas as ANY ONE of the following:
Adult T-cell leukemia/lymphoma as a single agent for second line or subsequent therapy
Mycosis Fungoides (MF)/Sézary Syndrome (SS) used as systemic therapy with or without skin-directed or radiation therapy
Peripheral T-cell lymphoma used as second-line or subsequent therapy
Primary cutaneous CD30+ T-cell lymphoproliferative disorders as single agent for relapsed or refractory disease
Chronic lymphocytic leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Waldenström’s macroglobulinemia/Lymphoplasmacytic lymphoma as ANY ONE of the following:
Used as a single agent
Used in combination with rituximab
Hodgkin lymphoma if ALL of the following:
Used as single agent
For refractory or relapsed disease
Multiple myeloma in relapsed or progressive disease as ANY ONE of the following:
Used as Single agent
Used in combination therapy with lenalidomide and dexamethasone or bortezomib and dexamethasone
Bendamustine HCl (Treanda®) is NOT considered medically appropriate for renewal.
|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.
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.
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 validates the use of bendamustine HCl (Treanda®) for the treatment of other conditions or diseases.
Lexi-Comp Online. (2018, February). AHFS DI. Bendamustine hydrochloride. Retrieved March 09, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, March). Bendamustine. Retrieved March 09, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Bendamustine hydrochloride. Retrieved March 09, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, December). Center for Drug Evaluation and Research. Treanda® bendamustine hydrochloride. Retrieved March 09, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022249s022lbl.pdf.
ORIGINAL EFFECTIVE DATE: 3/12/2009
MOST RECENT REVIEW DATE: 4/10/2018
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.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 1 mg