CurrentCareSourcePolicy N/A

Bendamustine (injectable) utilization management

Defines prior authorization and medical necessity criteria for medical-benefit coverage of bendamustine injectable products for oncology indications for CareSource members and providers.

Policy Summary

PayerCareSource

PolicyBendamustine (injectable) utilization management

Policy CodePolicy N/A

Change TypeMaterial revisions and additions

Effective Date

Next Review DateJul 17, 2024

Key ActionObtain prior authorization and ensure bendamustine is prescribed by or in consultation with an oncologist; approvals are issued for specified durations by indication.

SourceLink

POLICY UPDATE CHANGES

B-Cell Non-Hodgkin Lymphoma: clarified note to remove MALT (gastric and nongastric) phrasing and explicitly list extranodal marginal zone lymphoma of the stomach and nongastric sites.

Multiple Myeloma: changed prior requirement to 'Patient has been treated with more than 3 prior regimens' (removing earlier wording about relapsed or refractory disease).

Vivimusta (bendamustine from Slayback/Latina) was added to the list of covered bendamustine products.

Mycosis Fungoides/Sezary Syndrome was added as a new condition of approval.

6 monthsTypical approval duration

1 monthHCT conditioning approval

Up to 120 mg/m2Common dosing per infusion

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Coverage Criteria for Bendamustine (Injectable)

FDA-Approved Indications

Covered when ALL of the following are met for each listed FDA-approved indication (approval duration commonly 6 months unless specified):

B-Cell Non-Hodgkin Lymphoma: A) Patient is >= 18 years of age; AND B) Bendamustine is prescribed by or in consultation with an oncologist; AND C) Dosing: approve up to 120 mg/m2 IV administered no more frequently than twice in each 21-day cycleage >=18

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A) Patient is >= 18 years of age; AND B) Bendamustine is prescribed by or in consultation with an oncologist; AND C) Dosing: approve up to 100 mg/m2 IV administered no more frequently than twice in each 28-day cycleage >=18

Guideline-supported Indications

Covered when ALL of the following are met for each listed non-FDA but guideline-supported indication:

Hematopoietic Cell Transplantation (conditioning): A) Bendamustine is used as conditioning prior to autologous hematopoietic cell transplantation; AND B) Patient has non-Hodgkin lymphoma without central nervous system disease OR Hodgkin lymphoma; AND C) Bendamustine is prescribed by or in consultation with a physician who specializes in hematopoietic cell transplantation; AND D) Dosing: approve up to 200 mg/m2 IV administered no more frequently than twice prior to autologous HCT

Hodgkin Lymphoma (second-line or subsequent): A) Bendamustine is used as second-line or subsequent therapy; AND B) Bendamustine is prescribed by or in consultation with an oncologist; AND C) Dosing: approve up to 120 mg/m2 IV administered no more frequently than twice in each 21- or 28-day cycle

Multiple Myeloma (late relapsed/progressive): A) Patient is >= 18 years of age; AND B) Patient has been treated with more than 3 prior regimens; AND C) Bendamustine is prescribed by or in consultation with an oncologist; AND D) Dosing: approve up to 150 mg/m2 IV administered no more frequently than twice in each 28-day cycleage >=18; prior regimens >3

Mycosis Fungoides/Sezary Syndrome:

Coverage is not recommended for circumstances that are not specifically listed in the Recommended Authorization Criteria. The policy will be updated as new published data become available; until then, requests falling outside the enumerated indications and criteria should be denied as not recommended for approval.

Use of bendamustine for indications outside those listed in the Recommended Authorization Criteria is considered not recommended for approval. Providers seeking coverage for off‑label or non‑listed uses should be aware that such requests do not meet the policy’s medical necessity criteria.

Permitted Regimens and Combinations

Regimen	Indication / Setting	Coverage status
Bendamustine monotherapy
Bendamustine + rituximab
Bendamustine + obinutuzumab
Bendamustine + polatuzumab vedotin

Regimen	Indication / Setting	Coverage status
Bendamustine + gemcitabine + vinorelbine
Bendamustine + brentuximab vedotin (Adcetris)
Bendamustine + carboplatin + etoposide

Product Identifiers, Dosing Frequency, and Related Coding

Relevant product identifiers (manufacturers/products)NDC

NDC (various)

Bendamustine product NDCs per manufacturer prescribing information (products listed: Bendeka, Belrapzo, Treanda, Vivimusta, others)

inv-06: Dosing frequency — No more frequently than twice per cycle (21- or 28-day cycles depending on indication); specific mg/m2 per infusion varies by indication.

Frequency restrictionNo more frequently than twice per treatment cycle (apply to 21- or 28-day cycles depending on indication).

B-Cell Non-Hodgkin Lymphoma dosingApprove up to 120 mg administered IV no more frequently than twice in each 21-day cycle.

Chronic Lymphocytic Leukemia dosingApprove up to 100 mg administered IV no more frequently than twice in each 28-day cycle.

Hodgkin lymphoma dosingApprove up to 120 mg administered IV no more frequently than twice in each 21- or 28-day cycle.

Hematopoietic cell transplantation conditioning dosingApprove up to 200 mg/m2 administered IV no more frequently than twice prior to autologous HCT.

Multiple myeloma dosing

Provider Requirements, Prior Authorization, and Denial Conditions

Prior Authorization

Prior Authorization and Approval Durations

Prior Authorization is recommended for medical benefit coverage of bendamustine. Approvals are recommended only when the patient meets the applicable indication-specific criteria and dosing described in the policy. All approvals are issued for the duration specified by indication (commonly 6 months for most indications; 1 month when used as conditioning for hematopoietic cell transplantation). When approvals are authorized in months, 1 month equals 30 days. Requests for doses or regimens outside those documented in this policy will be considered on a case-by-case basis by a clinician (for example, a Medical Director or Pharmacist). Bendamustine must be prescribed by or in consultation with an oncologist or a physician who specializes in hematopoietic cell transplantation, as appropriate for the indication.

Prior authorization recommended for bendamustine (medical benefit).
Standard approval durations: commonly 6 months for listed indications; 1 month for hematopoietic cell transplantation conditioning (1 month = 30 days).
Requests for dosing/regimens outside the policy are reviewed case-by-case by a clinician (Medical Director or Pharmacist).
Bendamustine must be prescribed by or in consultation with an oncologist or a physician who specializes in hematopoietic cell transplantation.

Line-of-Therapy Criteria

first-line

First-line use: Bendamustine in combination with rituximab or obinutuzumab is recommended for first-line treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who do not have del(17p)/TP53 mutation and who have indications for treatment (not recommended for frail patients); bendamustine prescribed by or in consultation with an oncologistabsence of del(17p)/TP53 per guideline note

second-line

Second-line use: Hodgkin lymphoma: bendamustine is recommended for recurrent or refractory disease and as second-line or subsequent therapy per guidelines (including pediatric salvage settings); bendamustine prescribed by or in consultation with an oncologist

Background and Drug Overview

Bendamustine is an alkylating agent used across multiple hematologic malignancies, including B‑cell non‑Hodgkin lymphomas, chronic lymphocytic leukemia/small lymphocytic lymphoma, Hodgkin lymphoma, select T‑cell lymphomas, multiple myeloma, and systemic light‑chain amyloidosis. National Comprehensive Cancer Network (NCCN) guidance supports bendamustine in various monotherapy and combination regimens depending on disease subtype and prior therapies. Prior authorization is recommended and coverage is allowed only when the patient meets the specific authorization criteria listed in this policy; uses not meeting those criteria are not recommended for approval.

Definitions and Terminology

inv-12: Bendamustine — definition and clinical context.

Drug class and general indicationBendamustine is an alkylating agent indicated for use alone or with rituximab/rituximab-containing regimens in specified hematologic malignancies.

Clinical scopeUsed across multiple hematologic malignancies including B-cell lymphomas, chronic lymphocytic leukemia/small lymphocytic lymphoma, Hodgkin lymphoma, select T-cell lymphomas, multiple myeloma, and systemic light chain amyloidosis.

Prescriber requirementBendamustine must be prescribed by or in consultation with an oncologist (or a physician who specializes in hematopoietic cell transplantation when used for HCT conditioning).

Guideline contextNCCN guidelines recommend bendamustine as monotherapy or in combination (e.g., with rituximab, obinutuzumab, polatuzumab-vedotin) depending on lymphoma subtype and prior therapies.

Typical approval durationsApproval durations vary by indication (commonly 6 months for many indications; 1 month for HCT conditioning).

Policy Revision History

2024-07-17additionLatest

Mycosis Fungoides/Sezary Syndrome added as a new condition of approval for bendamustine use.

2023-07-12revised

B-Cell Non-Hodgkin Lymphoma note clarified: removed 'gastric and nongastric MALT' phrasing and explicitly listed extranodal marginal zone lymphoma of the stomach and nongastric sites.

2023-07-12revised