CurrentCareSourcePolicy N/A

Bendamustine (injectable) utilization management

Defines prior authorization, coverage criteria, dosing limits, and approved indications for bendamustine products for oncology-related indications affecting providers requesting medical-benefit coverage.

Policy Summary

PayerCareSource

PolicyBendamustine (injectable) utilization management

Policy CodePolicy N/A

Change TypeAnnual revision (material changes)

Effective Date

Next Review DateJul 17, 2024

Key ActionSubmit prior authorization with documentation that patient meets indication-specific criteria and dosing limits; approvals are typically 6 months (1 month for HCT conditioning).

SourceLink

POLICY UPDATE CHANGES

Extranodal marginal zone lymphoma of the stomach and extranodal marginal zone lymphoma of nongastric sites were added to the B‑cell Non‑Hodgkin lymphoma note; MALT lymphoma wording removed.

Multiple myeloma criteria changed: 'relapsed or refractory disease' removed and replaced with requirement 'patient has been treated with more than 3 prior regimens'.

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

6 monthsTypical approval duration

120 mg/m2Common dosing limit

~10Approved indications

1 month

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Recommended Authorization Criteria

Coverage is not recommended for circumstances that are not listed in the Recommended Authorization Criteria. Requests for bendamustine for indications or dosing outside the covered criteria will generally be declined; the criteria will be updated as new published data become available.

Indication	Regimen / Combinations	Coverage status
B‑cell lymphomas (including follicular, extranodal marginal zone including stomach and nongastric sites, transformed indolent to DLBCL, mantle cell, DLBCL, high‑grade B‑cell lymphoma, HIV‑related B‑cell lymphoma, post‑transplant lymphoproliferative disorder)	Bendamustine as single agent or in combination with rituximab (e.g., Rituxan), obinutuzumab (Gazyva), polatuzumab vedotin (Polivy), or brentuximab vedotin (Adcetris) depending on lymphoma type and prior therapy per NCCN guidance	Covered

Indication	Regimen / Combinations	Coverage status
Hodgkin lymphoma (recurrent/refractory; second‑line or subsequent therapy)	Bendamustine combined with gemcitabine and vinorelbine, or in combination with brentuximab vedotin (Adcetris); for later lines, combinations with carboplatin and etoposide may be used per guidelines	Covered

Indication	Regimen / Combinations	Coverage status
Multiple myeloma (late relapsed/progressive; patient has received >3 prior regimens)	Bendamustine as a single agent or in combination regimens with dexamethasone, lenalidomide, bortezomib, or carfilzomib (Kyprolis) as described in NCCN/Multiple Myeloma guidance	Covered

Line-of-Therapy Criteria

second-line

Hodgkin lymphoma line: Bendamustine used as second‑line or subsequent therapy

Policy approves bendamustine for second‑line or later Hodgkin lymphoma

first-line

CLL/SLL line: Bendamustine in combination with rituximab or obinutuzumab is recommended for first‑line treatment in selected patients without del(17p)/TP53 mutation (patients with indications for treatment; not recommended for frail patients).

Policy lists CLL/SLL as an approved first‑line indication with specialist prescribing

salvage

HCT conditioning line: Bendamustine used in combination with etoposide, cytarabine, and melphalan as conditioning for autologous hematopoietic cell transplantation for NHL or Hodgkin lymphoma (no CNS disease for NHL).

Approved as conditioning per policy (1 month authorization)

Prior Authorization & Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical benefit coverage of bendamustine. Approvals are granted for specified durations (commonly 6 months for most indications; 1 month for hematopoietic cell transplantation conditioning). All approvals are provided for the duration noted; when authorized in months, 1 month = 30 dosing days. Prior authorization requests for doses outside the dosing documented in this policy will be considered case-by-case by a clinician (Medical Director or Pharmacist). Automation: None.

All requests: Bendamustine must be prescribed by or in consultation with an oncologist or a physician who specializes in the condition being treated (e.g., hematopoietic cell transplantation).
Duration: Typical approvals – 6 months for FDA-approved and supported indications; 1 month when used as conditioning prior to autologous hematopoietic cell transplantation.
Dosing deviations: Requests for doses outside the policy dosing will be reviewed on a case-by-case basis.
Documentation: Include specialist consultation notes and indication-specific supporting documentation with the PA request.

Step Therapy

Age & Administrative Coding Notes

inv-03: Age — Patient is ≥ 18 years of age for most listed indications

Age requirementPatient is ≥ 18 years of age for most listed indications (e.g., B‑cell NHL, CLL/SLL, multiple myeloma, mycosis fungoides/Sezary, systemic light chain amyloidosis, T‑cell lymphoma, Waldenstrom)

Hematopoietic cell transplantation exceptionHCT conditioning: age criterion applies within conditioning context but primary criteria focus on conditioning use and transplant indication (approve for 1 month)

Prescriber requirement linked to age criteriaFor indications requiring age ≥ 18, bendamustine must be prescribed by or in consultation with an oncologist

Multiple myeloma noteMultiple myeloma: patient must be ≥ 18 and have been treated with more than 3 prior regimens

Coverage duration tied to age-based indicationsMost age‑based indications are approved for 6 months when criteria (including age ≥ 18) are met

Dosing and Cycle Limits

inv-09: Dosing cycle limits — maximum mg/m2 dosing and frequency

Common cycle maximum (many indications)Approve up to 120 mg/m2 IV administered no more frequently than twice per 21‑ or 28‑day cycle

Chronic lymphocytic leukemia dosingApprove up to 100 mg/m2 IV no more frequently than twice per 28‑day cycle

Multiple myeloma dosingApprove up to 150 mg/m2 IV no more frequently than twice per 28‑day cycle

HCT conditioning dosingApprove up to 200 mg/m2 IV administered no more frequently than twice for conditioning (approved for 1 month)

Systemic light chain amyloidosis dosingApprove up to 100 mg/m2 IV no more frequently than twice per 28‑day cycle

Regimens and Combinations

Indication	Regimen / Combinations	Coverage status
B‑cell lymphomas (various histologies as detailed in guidelines)	Bendamustine as single agent or combined with rituximab, obinutuzumab, polatuzumab vedotin, or brentuximab vedotin according to lymphoma subtype and prior treatments per NCCN	Covered

Indication	Regimen / Combinations	Coverage status
Hodgkin lymphoma (second‑line or subsequent therapy)	Bendamustine in combination with gemcitabine and vinorelbine, or with brentuximab vedotin; for third‑line or later may be used with carboplatin and etoposide per guideline recommendations	Covered

Indication	Regimen / Combinations	Coverage status
Multiple myeloma (patients treated with >3 prior regimens)	Bendamustine as single agent or combined with dexamethasone, lenalidomide, bortezomib, or carfilzomib consistent with NCCN Multiple Myeloma guidance	Covered

Clinical Background

Bendamustine is an alkylating agent used in the treatment of multiple hematologic malignancies and as conditioning for hematopoietic cell transplantation. National guideline sources (NCCN) support its use as monotherapy or in combination with agents such as rituximab or brentuximab vedotin depending on disease type and prior therapies; the policy references guideline-supported uses across B‑cell lymphomas, chronic lymphocytic leukemia/small lymphocytic lymphoma, Hodgkin lymphoma (salvage), hematopoietic cell transplantation conditioning, multiple myeloma for heavily pretreated patients, systemic light‑chain (AL) amyloidosis, T‑cell lymphomas, primary cutaneous lymphomas (mycosis fungoides/Sezary syndrome), and Waldenstrom macroglobulinemia.

Document History

2024-07-17annual_revisionLatest

Annual revision: Extranodal marginal zone lymphoma of the stomach and extranodal marginal zone lymphoma of nongastric sites were added to the B‑cell Non‑Hodgkin lymphoma note and MALT lymphoma wording was removed; Multiple myeloma criteria updated to require >3 prior regimens; Vivimusta added to the list of bendamustine products; Mycosis Fungoides/Sezary Syndrome added as a condition of approval.

2023-07-12annual_revision

Annual revision (07/12/2023): Gastric and nongastric mucosa‑associated lymphoid tissue (MALT) lymphoma wording removed from the B‑Cell Non‑Hodgkin Lymphoma note and extranodal marginal zone lymphoma sites were added; multiple myeloma requirement was revised to require treatment with more than 3 prior regimens (relapsed/refractory wording removed in later 2024 update).