CurrentAnthemPolicy CC-0116

Bendamustine agents (Belrapzo, Bendeka, Treanda, Vivimusta) — Clinical coverage criteria

Clinical coverage criteria for bendamustine agents for specified hematologic malignancies and select non-malignant indications when billed under the medical benefit and prior authorization is requested.

Policy Summary

PayerAnthem

PolicyBendamustine agents — Clinical coverage criteria

Policy CodePolicy CC-0116

Change TypeRevised (11/14/2025)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the patient is under 19 years of age OR has one of the listed approved diagnoses to support approval.

SourceLink

POLICY UPDATE CHANGES

Add nodular lymphocyte-predominant Hodgkin lymphoma per NCCN 2A.

Administrative update for age (includes criteria for individuals under 19 years).

Updated HCPCS coding description for J9036 and added/removed various ICD-10 codes.

8+Approved clinical indications

4Brand agents named

4HCPCS codes

multipleICD-10 codes

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Coverage Criteria for Bendamustine Agents

Initial Approval Criteria

Requests for bendamustine agents may be approved if ANY of the following are met:

Approval conditions

Pediatric: Individual is under 19 years of age
Diagnoses: Chronic lymphocytic leukemia/small lymphocytic lymphoma; relapsed/refractory or progressive classical Hodgkin lymphoma; Non-Hodgkin lymphoma; progressive/relapsed/refractory nodular lymphocyte-predominant Hodgkin lymphoma; relapsed/refractory/progressive multiple myeloma; relapsed/refractory systemic light chain amyloidosis; Waldenstrom's macroglobulinemia; cold agglutinin disease
NCCN category 2A cited for many indications; cold agglutinin disease reference Jager 2020.

Requests for bendamustine agents are explicitly not approved when used for the treatment of metastatic breast cancer or for the treatment of small cell lung cancer (SCLC). These two indications are listed as exclusions in the coverage criteria and will not meet medical necessity under this policy.

Use of bendamustine agents for any indication that does not meet the listed approval criteria is considered not approved under this document and therefore not medically necessary for those uses. Requests that do not satisfy the policy’s pediatric age provision or one of the specified diagnoses (e.g., CLL/SLL, relapsed/refractory Hodgkin lymphoma, NHL subtypes, relapsed/refractory multiple myeloma, systemic light chain amyloidosis, Waldenström’s macroglobulinemia, cold agglutinin disease) should be denied as not meeting criteria.

Permitted Regimens and Combinations

Regimen / Setting	Notes
Bendamustine alone
Used as monotherapy for approved and NCCN-recommended hematologic malignancies (e.g., first‑line CLL; indolent B‑cell NHL after progression on prior therapy). Specific dosing/regimens not enumerated in this policy.

Relevant Billing and Diagnosis Codes

HCPCSHCPCS

J9033	Injection, bendamustine hydrochloride (Treanda), 1 mg.
J9034	Injection, bendamustine hcl (Bendeka), 1 mg.
J9036	Injection, bendamustine hydrochloride (Belrapzo/bendamustine), 1mg.
J9056	Injection, bendamustine hydrochloride (Vivimusta), 1 mg

ICD-10 DiagnosisICD-10

C81.00-C81.99	Hodgkin lymphoma (range included/adjusted as described in document).
C82.00-C82.99	Follicular lymphoma.
C83.00-C83.09	Small cell B-cell lymphoma.
C83.10-C83.19	Mantle cell lymphoma.
C83.30-C83.38	Diffuse large B-cell lymphoma.
C83.398	Diffuse large B-cell lymphoma of other extranodal and solid organ sites.
C83.80-C83.89	Other non-follicular lymphoma.
C83.90-C83.99	Non-follicular (diffuse) lymphoma, unspecified.
C84.40-C84.49	Peripheral T-cell lymphoma, not elsewhere classified.
C84.60-C84.69	Anaplastic large cell lymphoma, ALK-positive.

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Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for bendamustine agents (Belrapzo, Bendeka, Treanda, Vivimusta). Requests will be reviewed for medical necessity and may be approved only when the patient meets the clinical criteria specified in the policy (see Clinical Criteria).

Affected products: Belrapzo, Bendeka, Treanda, Vivimusta
Prior authorization required for medical benefit coverage

Step Therapy

There is no step therapy requirement or mandated trial/failure of a specific prior systemic therapy stated in this policy. Requests are evaluated against the listed medical necessity criteria rather than a step-therapy algorithm.

Line of Therapy (First-line, Second-line, Salvage)

first-line | second-line | salvage

Line of therapy notes: Includes FDA-approved first-line CLL and NCCN-supported uses as first-line, second-line, subsequent, or palliative therapy depending on disease (document cites NCCN 2A recommendations for many indications).

Specific line (first-line vs second-line) is not rigidly specified in coverage criteria except where FDA/NCCN indicate; approval is tied to diagnosis rather than mandatory prior-line failure requirements in this document.

Definitions and Key Terms

Multiple myeloma — definition

TermMultiple myeloma

DefinitionA cancer originating in plasma cells (white blood cells that produce antibodies).

ContextListed as an indication for bendamustine use for relapsed or progressive disease per NCCN recommendations referenced in the policy.

Refractory Disease — definition

TermRefractory disease

DefinitionIllness or disease that does not respond to treatment.

ContextUsed in criteria to describe relapsed/refractory indications for bendamustine in hematologic malignancies.

Background and Clinical Context

Bendamustine is an alkylating agent used primarily in the treatment of leukemias and lymphomas. FDA labeling and guideline citations in this policy support its use in conditions such as chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and various indolent B‑cell non‑Hodgkin lymphomas; the document also references broader NCCN 2A recommendations for multiple hematologic malignancies and select non‑malignant hematologic conditions. Prior authorization is required and approval is contingent on meeting the policy’s clinical criteria (pediatric age criterion OR one of the listed diagnoses).

Policy Revision History

2025-11-14annual_reviewLatest

Added nodular lymphocyte-predominant Hodgkin lymphoma per NCCN 2A; updated HCPCS J9036 description and revised multiple ICD-10-CM code ranges; administrative wording clarified for age criteria (includes individuals under 19 years).

2025-01-22coding_update

Revised coding descriptions and split ICD-10-CM coding ranges C82.00-C86.61.

2024-11-15annual_review