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Clinical Policy Bulletin:
Bendamustine (Treanda)
Number: 0875


Policy

Bendamustine (Treanda) is considered medically necessary for the following indications (see appendix for selection criteria):

  1. Classical Hodgkin's lymphoma
  2. Lymphocyte-predominent Hodgkin's lymphoma
  3. Multiple myeloma
  4. AIDS-related B-cell lymphoma
  5. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma
  6. Diffuse large B-cell lymphoma
  7. Follicular lymphoma
  8. Gastric MALT lymphoma
  9. Mantle cell lymphoma
  10. Non-gastric MALT lymphoma
  11. Primary cutaneous B-cell lymphoma
  12. Splenic marginal zone lymphoma
  13. Waldenstrom's macroglobulinemia/Lymphocytoplasmic lymphoma.

Bendamustine is considered experimental and investigational for all other indications.



Background

Bendamustine (Treanda) is a alkylatic agent used in the treatment of chronic lymphocytic leukemia and non-Hodgkin lymphomas. Bendamustine was approved by the U.S. Food and Drug Administration in March 2008 for the treatment of chronic lymphocytic leukemia, and in October 2008, for treatment of indolent B-cell non-Hodgkin's lymphomas that have progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Appendix

Bendamustine is considered medically necessary for the following indicaitons (based upon current guidelines from the National Comprehensive Cancer Network (NCCN, 2013)):

  • Classical Hodgkin Lymphoma -  Second-line or salvage therapy as a single agent with or without radiation therapy prior to autologous stem cell rescue for progressive disease or for relapsed disease
  • Lymphocyte-predominant Hodgkin Lymphoma (LPHL) - Second-line therapy as a single agent or in combination with rituximab for symptomatic progressive or relapsed disease
  • Multiple myeloma - Salvage therapy on or off clinical trials for disease relapse or for progressive or refractory disease
     
    • as a single agent
    • in combination with lenalidomide and dexamethasone
       
  • AIDS-Related B-Cell Lymphoma - Second-line therapy with or without rituximab for relapsed disease in noncandidates for high-dose therapy
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - Treatment for CLL without del(17p) or with or without del(11q)
     
    • as first-line therapy with or without rituximab for stage II-IV disease
    • with or without rituximab for relapsed or refractory disease
       
  • Diffuse Large B-Cell Lymphoma - Second-line therapy with or without rituximab for relapsed or refractory disease in noncandidates for high-dose therapy
  • Follicular Lymphoma - Used in patients with the indications for treatment as
     
    • first-line therapy in combination with rituximab
    • second-line or subsequent therapy as a single agent or in combination with rituximab
       
  • Gastric MALT Lymphoma - Used in patients with the indications for treatment as
     
    • first-line therapy in combination with rituximab
    • second-line therapy for recurrent or progressive disease as a single agent or in combination with rituximab
       
  • Mantle Cell Lymphoma -- Used as
    • less aggressive induction therapy with rituximab
    • second-line therapy with or without rituximab for relapsed, refractory, or progressive disease
  • Nongastric MALT Lymphoma - Used in patients with the indications for treatment as
     
    • first-line therapy for stage III-IV disease in combination with rituximab
    • second-line therapy for recurrent stage I-II disease or for progressive disease as a single agent or in combination with rituximab
       
  • Primary Cutaneous B-Cell Lymphoma
     
    • Therapy for primary cutaneous marginal zone or follicle center lymphoma as 
       
      • first-line therapy for newly diagnosed generalized extracutaneous disease in combination with rituximab
      • second-line therapy for refractory generalized cutaneous disease or relapsed generalized extracutaneous disease as a single agent, in combination with rituximab, or as a component of BVR (bendamustine, bortezomib, and rituximab) regimen
         
    • Second-line therapy with or without rituximab for relapsed or refractory primary cutaneous diffuse large B-cell lymphoma, leg type in noncandidates for high-dose therapy
       
  • Splenic Marginal Zone Lymphoma - Used in patients with the indications for treatment as
     
    • first-line therapy in combination with rituximab for disease progression following initial treatment for splenomegaly
    • second-line therapy for progressive disease as a single agent or in combination with rituximab
       
  • Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma
     
    • Used with or without rituximab as
       
      • primary therapy
      • salvage therapy for disease that does not respond to primary therapy or for progressive or relapsed disease
         
    • Risk of stem cell toxicity and/or transformation with this agent unknown
 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96413
96415
HCPCS codes covered if selection criteria are met:
J9033 Injection, bendamustine HCL, 1 mg
ICD-9 codes covered if selection criteria are met:
200.10 - 200.18 Lymphosarcoma [Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)]
200.30 - 200.38 Marginal zone lymphoma [Follicular Lymphoma, Gastric MALT Lymphoma, Nongastric MALT Lymphoma, Splenic Marginal Zone Lymphoma]
200.40 - 200.48 Mantle cell lymphoma [Mantle Cell Lymphoma]
200.70 - 200.78 Large cell lymphoma [Diffuse Large B-Cell Lymphoma
200.80 - 200.88 Other named variants [Primary Cutaneous B-Cell Lymphoma [Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma]
201.40 - 201.48 Lymphocytic-histiocytic predominance [Lymphocyte-predominant Hodgkin Lymphoma (LPHL)]
201.50 - 201.58 Nodular sclerosis [Classical Hodgkin Lymphoma]
201.60 - 201.68 Mixed cellularity [Classical Hodgkin Lymphoma]
201.70 - 201.78 Lymphocytic depletion [Classical Hodgkin Lymphoma]
201.90 - 201.98 Hodgkin's disease, unspecified [Classical Hodgkin Lymphoma]
202.00 - 202.08 Nodular lymphoma [follicular lymphoma]
202.80 - 202.88 Other lymphomas [Diffuse Large B-Cell Lymphoma, Primary Cutaneous B-Cell Lymphoma]
203.00 Multiple myeloma without mention of having achieved remission failed remission
203.02 Multiple myeloma in relapse
203.10 Plasma cell leukemia without mention of having achieved remission failed remission [multiple myeloma]
203.12 Plasma cell leukemia in relapse [multiple myeloma]
203.80 Other immunoproliferative neoplasms without mention of having achieved remission failed remission [multiple myeloma]
203.82 Other immunoproliferative neoplasms in relapse [multiple myeloma]
204.10 Chronic lymphoid leukemia, without mention of having achieved remission [Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)]
204.12 Chronic lymphoid leukemia, in relapse [Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)]
238.6 Chronic lymphoid leukemia, in relapse [Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)]
273.3 Macroglobulinemia [Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma]
Other ICD-9 codes related to the CPB:
042 Human immunodeficiency virus [HIV] disease [with Large cell lymphoma, Other malignant lymphomas, Other lymphatic and hematopoietic neoplasms]
V10.72 Hodgkin's disease [Classical Hodgkin Lymphoma, Lymphocyte-predominant Hodgkin Lymphoma (LPHL)]
V10.79 Other lymphatic and hematopoietic neoplasms [Multiple Myeloma, Diffuse Large B-Cell Lymphoma, Gastric MALT Lymphoma, Mantle Cell Lymphoma, Nongastric MALT Lymphoma, Primary Cutaneous B-Cell Lymphoma, Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma]


The above policy is based on the following references:
  1. Treanda prescribing information, Cephalon, 7/2010.
  2. Bendamustine (Treanda) for CLL and NHL, Medical Letter, vol 50, issue 299, November 17, 2008
  3. Bendamustine, NCCN Drugs and Biologics Compendium, http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=311 (accessed 04/16/12)
  4. Bendamustine, AHFS Formulary Monographs, Wolters Kluwer, November 2009. 
  5. Chronic Lymphocytic Leukemia (PDQ), National Cancer Institute,  National Institutes of Health, http://www.cancer.gov/cancertopics/pdq/treatment/CLL (accessed 04/16/2012)
  6. NCCN Clinical Practice Gudielines: Non-Hodgkins Lymphomas. V.2.2012. Accessed 04/16/2012 at http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf
  7. National Comprehensive Cancer Network (NCCN). Compendium listing for Treanda. Accessed 08/28/13.
  8. Treanda, DrugDex. Micromedex Website. http://www.thomsonhc.com/micromedex2/ Accessed 4/16/12.
  9. Treanda. Clinical Pharmacology Website. www.clinicalpharmacology.com. Accessed 4/16/12.
  10. Treanda. AHFS Drug Information. Ovid website. http://ovidsp.tx.ovid.com. Accessed. 4/16/12


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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