CurrentViva HealthPolicy IC-0130

Bendamustine (Intravenous) Coverage Policy

This policy governs prior authorization, coverage criteria, dosing, and billing for intravenous bendamustine (Belrapzo, Bendeka, Treanda, Vivimusta) for members of Viva Health in North Carolina.

Policy Summary

PayerViva Health

PolicyBendamustine (Intravenous) Coverage Policy

Policy CodePolicy IC-0130

Change TypeNo material changes

Effective Date

Next Review DateSep 4, 2025

Key ActionObtain prior authorization before administering bendamustine; initial authorizations are valid up to 6 months (8 months for multiple myeloma) and renewals are not permitted.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4HCPCS J-codes listed

6mo / 8moPrior authorization validity

18+Minimum age (years)

8Max cycles (some indications)

NCMedicare MAC jurisdiction

Coverage Criteria for Bendamustine (IV)

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inv-01: Initial Approval Criteria

Covered when ALL of the following are met

General eligibility: Patient is at least 18 years of age; Patient must not have received bendamustine in a previous line of therapy unless otherwise specified

See pediatric Hodgkin section for patients ≤18 (AYA up to 39 may be applicable)

NHL (B-cell) uses: Prior authorization provided for B-cell lymphomas when used as subsequent therapy as a single agent for indolent lymphoma OR in combination with rituximab or obinutuzumab for listed histologies OR in combination with polatuzumab (with or without rituximab) for specified aggressive B-cell histologies; may also be used as first-line in combination with rituximab for classic follicular lymphoma

Eligible histologies include classic follicular lymphoma, extranodal marginal zone lymphoma (stomach & nongastric noncutaneous), mantle cell lymphoma, nodal and splenic marginal zone lymphoma, DLBCL, histologic transformation to DLBCL, high-grade B-cell lymphomas, monomorphic PTLD (B-cell), HIV-related DLBCL and plasmablastic lymphoma (per restrictions)

NHL (T-cell) uses: Prior authorization provided for specific T-cell lymphomas when used as a single agent per the listed line-of-therapy rules

Includes adult T-cell leukemia/lymphoma, breast implant–associated ALCL, hepatosplenic T-cell lymphoma, peripheral T-cell lymphomas (ALCL, PTCL-NOS, AITL, EATL, MEITL, nodal TFH/FTCL), and T-cell prolymphocytic leukemia with indicated single-agent and line restrictions

CLL/SLL: Used as first-line therapy as a single agent or with rituximab/obinutuzumab for disease without del(17p)/TP53 mutations (excluding frail patients); OR used as subsequent therapy for relapsed/refractory disease after BTK- and venetoclax-based regimens with combination requirements for certain patients

Specific age (<65) and comorbidity considerations apply for some combination uses

WM/LPL: Used as a single agent or in combination with rituximab for primary therapy, for relapse if previously effective, as an alternative for previously treated disease with persistent symptoms, for progressive/relapsed disease, or for management of symptomatic Bing-Neel syndrome

Adult Hodgkin lymphoma: Patient has classic Hodgkin lymphoma and bendamustine is used as second-line or subsequent therapy (or as subsequent therapy if not used second-line), in combination with gemcitabine+vinorelbine or brentuximab vedotin, or as single agent or with carboplatin+etoposide for refractory disease; NLPHL may be used as subsequent therapy with rituximab

Also allowed as palliative therapy for relapsed/refractory disease per listed combinations

Pediatric Hodgkin lymphoma: Patient is ≤18 years of age (AYA up to 39 may be considered); used in combination with brentuximab vedotin or with nivolumab+brentuximab vedotin for relapsed/refractory disease with additional criteria for heavy pretreatment or cardiac concerns; may be used as re-induction with involved-site radiation therapy in select patients

Eligibility details and recommendations to avoid ASCR in selected patients provided

Multiple myeloma and related plasma cell disorders: Used for CNS disease as part of multimodality therapy OR for relapsed/refractory disease after three prior therapies as single agent or with dexamethasone plus either bortezomib, carfilzomib, or lenalidomide; may also be used for POEMS, MIDD, and MGRS

Systemic light chain amyloidosis: Patient has relapsed or refractory light-chain (AL) amyloidosis and bendamustine is used in combination with dexamethasone

Hematopoietic cell transplant conditioning: Used as conditioning for autologous transplant in combination with etoposide, cytarabine and melphalan (BEAM); patient must have Non-Hodgkin Lymphoma without CNS disease or Hodgkin Lymphoma

BEAM combination requirement and exclusion of CNS disease for NHL apply

inv-02: Indication-specific dosing coverage

Covered when dosing and indication match documented regimen limits

Dose/Indication matching: Bendamustine is covered when administered at doses and cycles consistent with the listed indications: Non-Hodgkin Lymphoma up to 120 mg/m² IV days 1 and 2 of a 21-day cycle up to 8 cycles; CLL/SLL & systemic light-chain amyloidosis up to 100 mg/m² IV days 1 and 2 of a 28-day cycle up to 6 cycles; Waldenström macroglobulinemia/lymphoplasmacytic lymphoma up to 90 mg/m² IV days 1 and 2 of a 28-day cycle up to 6 cycles; Hodgkin lymphoma up to 120 mg/m² IV days 1 and 2 of a 28-day cycle up to 6 cycles; Multiple myeloma up to 100 mg/m² IV days 1 and 2 of a 28-day cycle up to 8 cycles; HSCT conditioning up to 200 mg/m² IV on days -7 and -6 prior to transplant.see dose values

Operators indicate all listed dose/indication combinations as separate covered scenarios

inv-03: Coverage by listed diagnosis codes

Covered when the diagnosis is one of the ICD-10 codes listed in Appendix 1

Diagnosis listed: Member has an ICD-10 diagnosis code exactly matching one of the codes enumerated in Appendix 1

Appendix 1 contains an extensive list of lymphoma, plasma cell, leukemia, amyloidosis, and transplant-related codes (see Appendix 1)

Use of bendamustine as part of hematopoietic cell transplant conditioning is restricted. Conditioning with bendamustine must be given in combination with etoposide, cytarabine, and melphalan (BEAM) and is covered only when used for autologous transplant in patients with Non‑Hodgkin lymphoma without CNS disease or Hodgkin lymphoma.

When billing or documenting product NDCs, note that several presentations are listed and some are designated as no longer commercially available. Certain branded or follow‑on formulations are approved under 505(b)(2) NDAs and are considered single‑source products (not rated therapeutically equivalent in the FDA Orange Book), which may affect substitution and procurement decisions; the Orange Book should be consulted for the current list of approved 505(b)(2) products.

For Medicare members, applicable CMS policies may supersede or modify the non‑Medicare coverage statements in this document. Compliance with relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) is required where they apply; use the CMS coverage database to identify any applicable documents. Noncompliance with applicable Medicare coverage policies may result in claim denial.

Coding, Units, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9033	Injection, bendamustine hydrochloride, 1 mg; 1 billable unit = 1 mg
J9034	Injection, bendamustine hcl (bendeka), 1 mg; 1 billable unit = 1 mg
J9036	Injection, bendamustine hydrochloride, (belrapzo/bendamustine), 1 mg; 1 billable unit = 1 mg
J9056	Injection, bendamustine hydrochloride (vivimusta), 1 mg; 1 billable unit = 1 mg

HCPCS J-codesHCPCSCovered

J9033	Injection, bendamustine hydrochloride, 1 mg; 1 billable unit = 1 mg
J9034	Injection, bendamustine hcl (bendeka), 1 mg; 1 billable unit = 1 mg
J9036	Injection, bendamustine hydrochloride, (belrapzo/bendamustine), 1 mg; 1 billable unit = 1 mg
J9056	Injection, bendamustine hydrochloride (vivimusta), 1 mg; 1 billable unit = 1 mg

NDCsNDC

63459-0391-xx	Treanda 100 mg lyophilized powder in a single-dose vial for reconstitution
63459-0390-xx	Treanda 25 mg lyophilized powder in a single-dose vial for reconstitution
63459-0395-xx	Treanda 45 mg/0.5 mL solution in a single-dose vial
63459-0396-xx	Treanda 180 mg/2 mL solution in a single-dose vial
63459-0348-xx	Bendeka 100 mg/4 mL ready-to-dilute solution in a multi-dose vial
42367-0521-xx	Belrapzo 100 mg/4 mL ready-to-dilute solution in a multi-dose vial
24338-0270-xx	Vivimusta 100 mg/4 mL solution in a multi-dose vial

Covered ICD-10 diagnosis codes (partial list shown)ICD-10Covered

C81.00	Nodular lymphocyte predominant Hodgkin lymphoma, unspecified site
C81.01	Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of head, face, and neck
C81.02	Nodular lymphocyte predominant Hodgkin lymphoma, intrathoracic lymph nodes
C81.03	Nodular lymphocyte predominant Hodgkin lymphoma, intra-abdominal lymph nodes
C81.04	Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of axilla and upper limb
C81.05	Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of inguinal region and lower limb
C81.06	Nodular lymphocyte predominant Hodgkin lymphoma, intrapelvic lymph nodes
C81.07	Nodular lymphocyte predominant Hodgkin lymphoma, spleen
C81.08	Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of multiple sites
C81.09	Nodular lymphocyte predominant Hodgkin lymphoma, extranodal and solid organ sites

Covered ICD-10 Diagnosis Codes (partial list shown)ICD-10Covered

C82.31	Follicular lymphoma grade IIIa, lymph nodes of head, face and neck
C82.32	Follicular lymphoma, grade IIIa, intrathoracic lymph nodes
C82.33	Follicular lymphoma grade IIIa, intra-abdominal lymph nodes
C82.34	Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb
C82.35	Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb
C82.36	Follicular lymphoma grade IIIa, intrapelvic lymph nodes
C82.37	Follicular lymphoma grade IIIa, spleen
C82.38	Follicular lymphoma grade IIIa, lymph nodes of multiple sites
C82.39	Follicular lymphoma grade IIIa, extranodal and solid organ sites
C82.40	Follicular lymphoma grade IIIb, unspecified site

Billable units per indication/interval

Non-Hodgkin Lymphoma (NHL)600 billable units every 21 days

Waldenström macroglobulinemia / Lymphoplasmacytic lymphoma (WM/LPL)450 billable units every 28 days

Hodgkin lymphoma600 billable units every 28 days

CLL/SLL, Systemic light-chain (AL) amyloidosis & Multiple myeloma500 billable units every 28 days

HSCT conditioning500 billable units for 2 doses

Dose — indication-specific dosing examples and limits

Non-Hodgkin Lymphoma (NHL)Up to 120 mg/m² IV on days 1 and 2 of a 21-day cycle, up to 8 cycles

CLL/SLL & Systemic light-chain amyloidosisUp to 100 mg/m² IV on days 1 and 2 of a 28-day cycle, up to 6 cycles

Waldenström macroglobulinemia / Lymphoplasmacytic lymphomaUp to 90 mg/m² IV on days 1 and 2 of a 28-day cycle, up to 6 cycles

Hodgkin lymphomaUp to 120 mg/m² IV on days 1 and 2 of a 28-day cycle, up to 6 cycles

Multiple myelomaUp to 100 mg/m² IV on days 1 and 2 of a 28-day cycle, up to 8 cycles

HSCT conditioningUp to 200 mg/m² IV on days -7 and -6 prior to transplant

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial approvals. Initial authorizations are typically valid for up to 6 months. For Multiple Myeloma, initial prior authorization may be provided for up to 8 months (maximum 16 doses). Prior authorizations may NOT be renewed; a new request is required for continuation beyond the initial authorization period.

Initial PA validity: up to 6 months (8 months / 16 doses for Multiple Myeloma).
Renewals: prior authorization validity may NOT be renewed.

Prior Authorization

Prior Authorization May Be Considered (NQTL)

Prior authorization may be applied based on the Non-Quantitative Treatment Limitations (NQTL) assessment. The NQTL checklist identified drug cost as a factor supporting consideration of PA. Providers should request prior authorization when clinically appropriate and when indicated by payer procedures.

NQTL consideration: Cost of drug = Yes (Consider for PA).
Providers: submit PA when utilization management or coverage rules apply.

Documentation Required

Indication and Line‑of‑Therapy Documentation

Document the specific indication and line of therapy in the prior authorization request and medical record. Requests must support whether the drug is being used as first-line or subsequent therapy and include disease-specific details (e.g., histology, prior therapies, relapsed/refractory status) per the clinical criteria.

Include clinical indication (diagnosis) and whether use is first-line or subsequent therapy.
Document prior lines of therapy and reasons for discontinuation or relapse as applicable.

Billing Rule

Billing Documentation

Charge and billing documentation must include the appropriate HCPCS J‑code and NDC when applicable, and clearly state dosing, units administered, and dates of service. Use the listed J‑codes for billing and include NDC(s) for the specific product used when required by payer billing policy.

Bill using HCPCS J9033 / J9034 / J9036 / J9056 as applicable (1 unit = 1 mg).
Include NDC when payer requires product‑level identification (see Appendix for product NDCs).
Document dose (mg), number of units, date of administration, and route.

Step Therapy

Therapy Sequencing and Combination Regimens

Therapy sequencing and combination regimens must be documented to match the clinical criteria. Indicate whether therapy is given as single-agent or in combination (for example, with rituximab, obinutuzumab, polatuzumab, dexamethasone, bortezomib, carfilzomib, or lenalidomide) and for which specific lymphoma or plasma cell indications the combination is being used.

Document if used as first‑line or subsequent therapy and the specific combination regimen (e.g., with rituximab for follicular lymphoma).
For Multiple Myeloma, document combination with dexamethasone and either bortezomib, carfilzomib, or lenalidomide when applicable.

Note

CMS Policy Applicability (Medicare)

Medicare policies may apply for beneficiaries. Where applicable, providers must comply with Medicare Benefit Policy Manual guidance and any relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Use the CMS coverage database to identify applicable Medicare guidance for Part B drugs.

Medicare Part B guidance: see Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 Drugs and Biologicals.
Search for NCD/LCD/LCA documents: https://www.cms.gov/medicare-coveragedatabase/search.aspx
When an NCD/LCD/LCA exists, comply with that Medicare policy for claims of Medicare beneficiaries.

Regimens and Combinations Supported

Regimen / Combination	Indication / Setting	Notes
Bendamustine (single-agent)	Indolent Non-Hodgkin lymphoma; also used in other NHL subtypes and select relapsed/refractory settings	Used as single agent for indolent lymphoma; dosage per indication (e.g., NHL up to 120 mg/m² IV days 1–2 q21d)
Bendamustine + rituximab (BR)	Classic follicular lymphoma (first-line in combination), mantle cell, nodal/splenic/extranodal marginal zone lymphoma, other B‑cell NHL	Supported for use in listed B‑cell histologies; BR is referenced in guideline and trial evidence (see NCCN and Rummel trial)
Bendamustine + obinutuzumab	Classic follicular lymphoma and marginal zone lymphoma (B‑cell NHL)	Permitted combination for listed histologies; supported by trial data referenced in policy (GADOLIN)
Bendamustine + polatuzumab (with or without rituximab)	Aggressive B‑cell histologies including DLBCL, transformed lymphoma, high‑grade B‑cell lymphoma, select HIV‑related DLBCL and plasmablastic lymphoma (non‑transplant candidates)	Allowed for specified aggressive B‑cell disease; policy notes use with or without rituximab depending on indication
Bendamustine + gemcitabine + vinorelbine	Relapsed/refractory classic Hodgkin lymphoma (as induction before autologous SCT)	Cited as effective induction regimen prior to autologous stem‑cell transplantation (phase II study)
Bendamustine + brentuximab vedotin	Relapsed or refractory classic Hodgkin lymphoma	Supported by phase 1–2 trial evidence for relapsed/refractory HL
Bendamustine + carboplatin + etoposide	Relapsed/refractory Hodgkin lymphoma (subsequent therapy)	Permitted combination for subsequent or refractory HL per policy
Bendamustine as part of BEAM (with etoposide, cytarabine, melphalan) for HSCT conditioning	Autologous hematopoietic cell transplant conditioning for NHL without CNS disease or Hodgkin lymphoma	Policy specifies use as conditioning for autologous transplant in combination with etoposide, cytarabine and melphalan (BEAM); HSCT conditioning dosing up to 200 mg/m² on days -7 and -6

Combination Regimen	Evidence / Source	Comments
Bendamustine + rituximab (BR)	Rummel et al., Lancet 2013; NCCN B‑Cell Lymphomas Guidelines (referenced)	Randomized trials comparing BR to CHOP‑R and other regimens support BR in indolent and mantle‑cell lymphomas; listed in NCCN compendium
Bendamustine + gemcitabine + vinorelbine	Santoro et al., J Clin Oncol 2016 (multicenter phase II)	Cited as effective induction chemotherapy before autologous SCT for relapsed/refractory Hodgkin lymphoma
Bendamustine + brentuximab vedotin	O'Connor et al., Lancet Oncology 2018 (phase 1–2)	Supported by international multicenter single‑arm trial for relapsed/refractory Hodgkin lymphoma
Bendamustine + rituximab + etoposide + carboplatin (T(R)EC)	Budde et al., Br J Haematol 2018 (phase 1/2)	Studied in relapsed/refractory aggressive lymphoma; referenced in policy literature list
Bendamustine + bortezomib ± dexamethasone	Ludwig et al., Blood 2014; other phase studies referenced	Active and tolerated regimen in relapsed/refractory multiple myeloma; combination regimens listed in references
Bendamustine + lenalidomide + dexamethasone (BLD)	Lentzsch et al., Blood 2012 (phase 1/2)	Feasible and effective in relapsed/refractory multiple myeloma per cited study

Line of Therapy Requirements

inv-30: mixed — 1 top-level node describing line-of-therapy rules

Line-of-therapy rules: Policy specifies line-of-therapy restrictions: bendamustine may be used as first-line in defined situations (e.g., CLL/SLL single agent or with anti‑CD20 for disease without del(17p)/TP53; BR first-line for classic follicular lymphoma) and is frequently authorized as subsequent therapy for many NHL and Hodgkin lymphoma subtypes; specific prior therapy requirements apply for relapsed/refractory indications (e.g., multiple myeloma after ≥3 prior therapies)

Line-of-therapy determination must be documented in the medical record per policy documentation requirements

inv-31: mixed — 1 top-level node describing additional line-of-therapy rules

Additional line-of-therapy rules: For T-cell lymphomas and certain pediatric/adolescent Hodgkin scenarios, bendamustine is limited to single-agent use and to specified lines (e.g., subsequent therapy for adult T‑cell leukemia/lymphoma, subsequent single‑agent use for breast implant–associated ALCL, hepatosplenic T‑cell lymphoma after two prior regimens); pediatric indications include combination regimens for relapsed/refractory disease with defined pretreatment and cardiac considerations

Document prior therapies and line of therapy in the request to support authorization

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