CareSource bendamustine Prior Auth Policy Update

Recommended Authorization Criteria

Recommended Authorization Criteria (by indication)

Covered when ALL of the following are met for the specified indication groups

B-Cell Non-Hodgkin Lymphoma (FDA-Approved): A) Patient is >= 18 years of age; AND B) Bendamustine is prescribed by or in consultation with an oncologist.Approve for 6 months; dosing: up to 120 mg/m2 IV administered no more frequently than twice in each 21-day cycle.

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.Approve for 6 months; dosing: up to 100 mg/m2 IV administered no more frequently than twice in each 28-day cycle.

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 an oncologist or an HCT specialist.Approve for 1 month; dosing: up to 200 mg/m2 IV administered by infusion 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.Approve for 6 months; dosing: 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.Approve for 6 months; dosing: up to 150 mg/m2 IV administered no more frequently than twice in each 28-day cycle.

Mycosis Fungoides/Sezary Syndrome: A) Patient is >= 18 years of age; AND B) Bendamustine is used in combination with brentuximab vedotin (Adcetris); AND C) Bendamustine is prescribed by or in consultation with an oncologist.Approve for 6 months; dosing: up to 120 mg/m2 IV administered no more frequently than twice in each 21-day cycle.

Systemic Light Chain Amyloidosis: A) Patient is >= 18 years of age; AND B) Patient has relapsed or refractory disease; AND C) Bendamustine is used in combination with dexamethasone; AND D) Bendamustine is prescribed by or in consultation with an oncologist.Approve for 6 months; dosing: up to 100 mg/m2 IV administered no more frequently than twice in each 28-day cycle.

T-Cell Lymphoma (relapsed/refractory): A) Patient is >= 18 years of age; AND B) Bendamustine is used as single agent; AND C) Bendamustine is prescribed by or in consultation with an oncologist.Approve for 6 months; dosing: up to 120 mg/m2 IV administered no more frequently than twice in each 21-day cycle.

Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma: A) Patient is >= 18 years of age; AND B) Bendamustine is prescribed by or in consultation with an oncologist.Approve for 6 months; dosing: up to 90 mg/m2 IV administered no more frequently than twice in each 28-day cycle.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. The criteria will be updated as new published data become available, and requests outside the listed indications are not routinely approved.

Use of bendamustine for indications or clinical circumstances that are not explicitly listed in the Recommended Authorization Criteria is not recommended for approval and may be considered not medically necessary.

Approved Regimens and Combinations

Regimen	Indication	Coverage
Bendamustine + gemcitabine + vinorelbine
Hodgkin lymphoma salvage therapy (second-line or subsequent); approve for 6 months; dosing: up to 120 mg/m2 IV no more frequently than twice in each 21- or 28-day cycle.
Bendamustine + brentuximab vedotin (Adcetris)
Hodgkin lymphoma salvage therapy (second-line or subsequent); approve for 6 months; dosing: up to 120 mg/m2 IV no more frequently than twice in each 21- or 28-day cycle.
Bendamustine + carboplatin + etoposide
Hodgkin lymphoma salvage therapy (third-line or subsequent); approve for 6 months; dosing: up to 120 mg/m2 IV no more frequently than twice in each 21- or 28-day cycle.
Bendamustine (single agent)
Hodgkin lymphoma later-line therapy; approve for 6 months when used as second-line or subsequent therapy; dosing: up to 120 mg/m2 IV no more frequently than twice in each 21- or 28-day cycle.

Regimen	Indication	Coverage
Bendamustine + brentuximab vedotin (Adcetris)
Primary cutaneous lymphomas: CD30+ mycosis fungoides stage IVA2, mycosis fungoides/Sezary syndrome stage IVB, generalized cutaneous or extracutaneous lesions with large cell transformation; also subsequent treatment of stage IIB–IV.
Approval: Approve for 6 months when criteria met; dosing: up to 120 mg/m2 IV no more frequently than twice in each 21-day cycle.

Regimen	Indication	Coverage
Bendamustine (single agent)
Multiple myeloma — late relapsed or progressive disease in patients who have been treated with >3 prior regimens.
Approve for 6 months when criteria met; dosing: up to 150 mg/m2 IV no more frequently than twice in each 28-day cycle.
Bendamustine + dexamethasone + lenalidomide
Multiple myeloma — late relapsed or progressive disease (patient has received >3 therapies).
Approve for 6 months when criteria met; dosing: up to 150 mg/m2 IV no more frequently than twice in each 28-day cycle.
Bendamustine + dexamethasone + bortezomib
Multiple myeloma — late relapsed or progressive disease (patient has received >3 therapies).
Approve for 6 months when criteria met; dosing: up to 150 mg/m2 IV no more frequently than twice in each 28-day cycle.
Bendamustine + dexamethasone + carfilzomib (Kyprolis)
Multiple myeloma — late relapsed or progressive disease (patient has received >3 therapies).
Approve for 6 months when criteria met; dosing: up to 150 mg/m2 IV no more frequently than twice in each 28-day cycle.

Coding and Dose Limits

Coding not providedmixed

No CPT/HCPCS/ICD codes listed in the document; dosing and schedule provided but billing codes not specified.

Dose limits per administration and cycle — examples

B-Cell NHL (typical per-dose limit)Up to 120 mg/m2 IV administered no more frequently than twice in each 21-day cycle.

Chronic Lymphocytic Leukemia (CLL/SLL)Up to 100 mg/m2 IV administered no more frequently than twice in each 28-day cycle.

Hematopoietic Cell Transplantation conditioningUp to 200 mg/m2 IV administered by infusion no more frequently than twice prior to autologous HCT (approve duration: 1 month).

Multiple Myeloma (late relapsed/progressive)Up to 150 mg/m2 IV administered no more frequently than twice in each 28-day cycle.

Systemic Light Chain AmyloidosisUp to 100 mg/m2 IV administered no more frequently than twice in each 28-day cycle.

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for medical benefit coverage of bendamustine. Approvals are provided for specified durations and dosing per indication; extended approvals may be allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the documented dosing in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). All approvals are provided for the duration noted in the criteria (when months are used, 1 month = 30 days). Bendamustine must be prescribed by or in consultation with a physician who specializes in the condition treated (for example, an oncologist or a physician who specializes in hematopoietic cell transplantation). Automation: None.

Prior authorization recommended for medical benefit coverage
Approvals provided for specified durations and dosing per indication; extended approvals allowed if criteria continue to be met
Dose exceptions considered case-by-case by clinician (Medical Director or Pharmacist)
Approval duration units: 1 month = 30 days
Must be prescribed by or in consultation with a specialist (oncologist or transplant specialist)

Line of Therapy Specifications

first-line

First-line context where recommended by guidelines

CLL first-line context: Bendamustine in combination with rituximab or obinutuzumab is recommended for first-line treatment of patients without del(17p)/TP53 mutation who have indications for treatment (not recommended for frail patients).

second-line | subsequent

Second-line or subsequent therapy contexts

Hodgkin lymphoma: Bendamustine recommended for recurrent or refractory Hodgkin lymphoma and as second-line or subsequent therapy in adults; used in combinations for salvage or later lines.

salvage

Salvage therapy / late-line context

Background and Definitions

Bendamustine is an alkylating chemotherapy agent used across multiple hematologic malignancies including B‑cell non‑Hodgkin lymphomas, chronic lymphocytic leukemia, Hodgkin lymphoma (recurrent/refractory), multiple myeloma in later lines, systemic light‑chain amyloidosis, T‑cell lymphomas, and Waldenstrom macroglobulinemia. It is referenced in NCCN guidelines for various lymphoma subtypes and may be used as conditioning for autologous hematopoietic cell transplantation.

Bendamustine — definition and guideline context

DefinitionBendamustine: an alkylating chemotherapy agent indicated for chronic lymphocytic leukemia and multiple lymphoma and plasma cell malignancies as described in NCCN guidelines and product prescribing information.

NCCN guideline contextRecommended for various B-cell lymphomas (eg, follicular, extranodal marginal zone, transformed indolent to DLBCL, mantle cell, DLBCL, high-grade B-cell) as monotherapy or in combination with anti-CD20 antibodies depending on type and prior therapy.

CLL useRecommended in combination with rituximab or obinutuzumab for first-line treatment in patients without del(17p)/TP53 mutation who have indications for treatment; also recommended for relapsed/refractory disease without del(17p)/TP53 mutation.

Hodgkin lymphoma and salvage regimens

Policy Changes and Revision History

2024-07-17Annual revisionLatest

Mycosis fungoides/Sezary syndrome was added as a condition of approval.

2023-07-12Annual revision

B‑Cell Non‑Hodgkin Lymphoma note revised: MALT lymphoma (gastric and nongastric) removed and extranodal marginal zone lymphoma of the stomach and nongastric sites added; Multiple myeloma eligibility changed to require more than 3 prior regimens (replacing 'relapsed or refractory').

2023-07-12Administrative update

OpenPayer

Oncology (Injectable) Bendamustine Products Utilization Management Medical Policy