Overview

This document addresses the use of bendamustine agents (Bendeka, Treanda, Belrapzo). Bendamustine is an alkylating agent primarily used to treat types of blood cancers such as leukemias and lymphomas. The FDA approved indications for bendamustine include first line treatment of chronic lymphocytic leukemia (CLL) as well as indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed on treatment including rituximab. Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are different manifestations of the same disease and are managed in much the same way. The National Comprehensive Cancer Network® (NCCN) provides additional recommendations with a category 2A level of evidence for the use of bendamustine. These recommendations include the use alone or in combination for previously treated multiple myeloma for relapse or progressive disease; as well as second-line, subsequent, or palliative therapy for classic Hodgkin lymphoma. NCCN also recommends bendamustine alone or in combination for primary, previously treated, progressive, or relapsed waldenstrom’s macroglobulinemia. Bendamustine is recommended by NCCN for other types of non-Hodgkin’s lymphoma (NHL) which is a group of blood cancers that includes all types of lymphoma except Hodgkin’s lymphoma. NCCN recommends bendamustine in the following types of NHL:

• B-Cell lymphomas:
  • AIDS-related B-cell lymphoma
  • Diffuse large B-cell lymphoma
  • Follicular lymphoma
  • Gastric MALT lymphoma
  • High-Grade B-Cell Lymphomas
  • Mantle cell lymphoma
  • Nodal marginal zone lymphoma
  • Nongastric MALT lymphoma
  • Post-transplant lymphoproliferative disorders
  • Splenic marginal zone lymphoma
• T-Cell lymphomas:
  • Adult T-cell leukemia/lymphoma
  • Peripheral T-cell lymphomas
  • Breast Implant-associated Anaplastic Large Cell Lymphoma (ALCL)
  • Hepatosplenic T-cell lymphoma

Definitions and Measures

Multiple myeloma: A type of cancer that begins in plasma cells (white blood cells that produce antibodies). Non-Hodgkin Lymphoma (NHL): A heterogeneous group of lymphoproliferative disorders originating from B lymphocytes, T lymphocytes, or natural killer (NK) cells. Refractory Disease: Illness or disease that does not respond to treatment. Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Bendamustine Agents (Belrapzo, Bendeka, Treanda, Vivimusta)

Requests for bendamustine agents (Belrapzo, Bendeka, Treanda, Vivimusta) may be approved if the following criteria are met:

1. Individual has a diagnosis of one of the following:
   1. Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL); OR
   2. Relapsed or refractory classical Hodgkin lymphoma (NCCN 2A); OR
   3. Non-Hodgkin lymphoma (NHL); OR
   4. Relapsed or progressive Multiple myeloma (NCCN 2A); OR
   5. Relapsed or refractory systemic light chain amyloidosis; OR
   6. Waldenstrom’s macroglobulinemia (NCCN 2A); OR
   7. Cold agglutinin disease (DP BIIa; Jager 2020).

Requests for bendamustine agents (Belrapzo, Bendeka, Treanda, Vivimusta) may not be approved for the following:

• Treatment of metastatic breast cancer; OR
• Treatment of small cell lung cancer (SCLC); OR
• When the above criteria are not met and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• J9036 Injection, bendamustine HCL (Belrapzo), 1mg (Effective 7/1/2019)
• J9033 Injection, bendamustine HCL (Treanda), 1 mg
• J9034 Injection, bendamustine HCL (Bendeka), 1 mg
• J9056 Injection, bendamustine hydrochloride (vivimusta), 1 mg
• J9058 Injection, bendamustine hydrochloride (apotex), 1 mg
• J9059 Injection, bendamustine hydrochloride (baxter), 1 mg

ICD-10 Diagnosis

• C81.10-C81.99 Classical/unspecified Hodgkin lymphoma
• C82.00-C86.6 Non-Hodgkin lymphoma
• C88.0 Waldenstrӧm’s macroglobulinemia
• C88.4 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma]
• C90.00-C90.32 Multiple myeloma and malignant plasma cell neoplasms
• C91.10-C91.12 Chronic lymphocytic leukemia of B-cell type
• C91.50-C91.52 Adult T-cell lymphoma/leukemia (HTLV-1 associated)
• E85.81 Light chain (AL) amyloidosis

Document History

Revised: 02/24/2023