DESCRIPTION
Bendamustine is a type of alkylating agent and a type of antimetabolite. It appears to act primarily as an alkylator. The exact mechanism of action of bendamustine is unknown. It is thought bendamustine damages the DNA in cancer cells leading to cell death via several pathways.
An example of a preparation of bendamustine is Treanda®.
REFER TO DECISION SUPPORT TREE
POLICY
Bendamustine for the treatment of chronic lymphocytic leukemia (CLL) is considered medically necessary.
Bendamustine for the treatment of non-Hodgkin’s lymphoma (NHL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Bendamustine for the treatment of other conditions/diseases is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)
MEDICAL APPROPRIATENESS
Bendamustine for the treatment of non-Hodgkin’s lymphoma is considered medically appropriate with ANY ONE of the following criteria:
For indolent B-cell non-Hodgkin’s lymphoma when the disease has progressed during or within six months of treatment with rituximab or a rituximab containing regimen
For mantle cell lymphoma (NHL), if the individual has relapsed, refractory, or progressive disease
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
Drugdex recognizes the use of bendamustine in the treatment of:
Salvage therapy for multiple myeloma
Hodgkin’s disease
The NCCN Drugs & Biologics Compendium recognizes additional uses for bendamustine beyond the FDA-approved labeling in the treatment of the following conditions: (Refer to the NCCN Drugs & Biologics Compendium or NCCN Clinical Practice Guidelines for detailed recommendations):
Non-Hodgkin’s lymphoma (NHL) - Follicular lymphoma
NHL - Nodal marginal zone lymphoma
NHL - MALT lymphoma (gastric or nongastric)
NHL - Primary cutaneous B-cell lymphoma
Waldenström's macroglobulinemia / Lymphoplasmacytic lymphoma
A published multicenter Phase III trial recognizes the use of bendamustine in the treatment of metastatic breast cancer.
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).
There is insufficient evidence supporting the use of bendamustine for the treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2011). AHFS DI. Bendamustine hydrochloride. Retrieved March 29, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, January). Bendamustine. Retrieved March 29, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Bendamustine hydrochloride. Retrieved March 29, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2010, February). Center for Drug Evaluation and Research. Approval Letter. Treanda® (bendamustine). Retrieved March 29, 2011 fromhttp://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s006ltr.pdf.
U. S. Food and Drug Administration. (2010, February). Center for Drug Evaluation and Research. Label and Approval History. Treanda®. Retrieved March 29, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s006lbl.pdf.
von Minckwitz, G., Chernozemsky, I., Sirakova, L., Chilingirov, P., Souchon, R., Marschner, N., et.al. (2005, September). Bendamustine prolongs progression-free survival in metastatic breast cancer (MBC): a phase III prospective, randomized, multicenter trial of bendamustine hydrochloride, methotrexate and 5-fluorouracil (BMF) versus cyclophosphamide, methotrexate and 5-fluorouracil (CMF) as first-line treatment of MBC. Anti-Cancer Drugs, 16 (8), 871-877. (Level II Evidence - Industry sponsored)
ORIGINAL EFFECTIVE DATE: 3/12/2009
MOST RECENT REVIEW DATE: 8/13/2011
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®)
Does the individual have a diagnosis of chronic lymphocytic leukemia (CLL)?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of non-Hodgkin’s lymphoma with ANY ONE of the following?
Indolent B-cell non-Hodgkin’s lymphoma when the disease has progressed during or within six months of treatment with rituximab or a rituximab containing regimen
Mantle cell lymphoma (NHL) if the individual has relapsed, refractory, or progressive disease
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.