Viva Health bendamustine Coverage & Prior Auth

Coverage Criteria

Initial Approval Criteria

Covered when ALL of the following are met, specific to each disease indication:

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

General requirement

Non-Hodgkin B-cell lymphomas: Authorization provided when used as subsequent therapy (single agent for indolent lymphoma) OR in combination with rituximab for cFL, EMZL (stomach & non-gastric noncutaneous), mantle cell lymphoma (including as part of RBAC500), nodal MZL, splenic MZL OR in combination with obinutuzumab for cFL, EMZL, nodal MZL, splenic MZL OR in combination with polatuzumab (with or without rituximab) for DLBCL, transformed disease, high-grade B-cell lymphoma, HIV-related DLBCL/plasmablastic lymphoma, or monomorphic post-transplant B-cell PTLD OR used as first-line therapy in combination with a rituximab-based regimen for classic follicular lymphoma

Includes CAR T-cell bridging therapy use when specified

T-cell lymphomas: Authorization provided for adult T-cell leukemia/lymphoma as single agent for non-responders to first-line therapy; breast implant–associated ALCL as single agent for relapsed/refractory disease; hepatosplenic T-cell lymphoma as single agent for refractory disease after two first-line regimens; peripheral T-cell lymphomas as single agent for initial palliative intent or for relapsed/refractory disease; and T-cell prolymphocytic leukemia as single agent for symptomatic disease

CLL/SLL: Used as first-line therapy as single agent OR in combination with rituximab or obinutuzumab for disease without del(17p)/TP53 (excluding frail patients) OR used as subsequent therapy for patients with relapsed/refractory disease after prior BTK- and venetoclax-based regimens when given with rituximab for select younger patients without significant comorbidities

Waldenström Macroglobulinemia/LPL: Used as single agent or in combination with rituximab for primary therapy, for relapse if previously effective and tolerated, as alternative therapy for previously treated symptomatic disease, for progressive or relapsed disease, or for symptomatic Bing-Neel syndrome

Hodgkin Lymphoma (adult and pediatric): Adult cHL: used as second-line or subsequent therapy (if not used second-line) in combination with gemcitabine+vinorelbine or brentuximab vedotin, or as subsequent single-agent therapy for disease refractory to ≥3 prior lines, or as palliative single-agent therapy. NLPHL: subsequent therapy in combination with rituximab. Pediatric cHL (≤18 years, AYA up to 39 as noted): used with brentuximab vedotin ± nivolumab for relapsed/refractory disease with additional re-induction criteria as specified

Multiple Myeloma: Used for CNS disease as part of multimodality therapy OR for relapsed/refractory disease after 3 prior therapies, as single agent or combined with dexamethasone and either bortezomib, carfilzomib, or lenalidomide; may also be used for POEMS, MIDD, and MGRS per policy note

Systemic Light Chain Amyloidosis: Patient has relapsed or refractory systemic light chain (AL) amyloidosis AND bendamustine is used in combination with dexamethasone

Hematopoietic Cell Transplantation conditioning: Used as conditioning for autologous transplant AND used in combination with etoposide, cytarabine and melphalan (BEAM) AND patient has NHL without CNS disease or Hodgkin lymphoma

Renewal Criteria

Renewal criteria

Renewal: Duration of authorization has not been exceeded (refer to Section I)

Policy indicates duration limits in Section I and that renewals are constrained by those limits

Coverage contingent on listed diagnosis codes

Covered when the patient has an ICD-10 diagnosis listed in Appendix 1

Appendix1_code_match: Patient diagnosis must match one of the ICD-10 codes enumerated in Appendix 1

Codes include multiple lymphoma subtypes, plasma cell disorders, amyloidosis, PTLD, and transplant status.

Patients younger than 18 years are generally excluded from coverage under this policy. The policy requires the patient to be at least 18 years of age unless a specific indication section explicitly allows pediatric use (for example, the Pediatric Hodgkin Lymphoma criteria where pediatric is defined as ≤18). Ensure the member meets the age requirement documented in the request before submitting prior authorization.

Some product presentations and NDCs are noted with availability designations in the policy. Items marked with "-*" are no longer commercially available. Several formulations are noted as generically available (§) while others are approved as 505(b)(2) NDAs and are considered single-source products (Ψ). When billing or sourcing the drug, verify the exact NDC and product status listed in the policy (e.g., Treanda, Bendeka, Belrapzo, Vivimusta) and document the vial/NDC on the claim as appropriate.

Medicare coverage rules may supersede this non‑Medicare policy. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) can apply to Medicare Part B drug coverage and affect whether a request is payable for Medicare members. Providers must follow applicable Medicare NCD/LCD/LCA requirements; failure to comply with those determinations may result in denials for Medicare beneficiaries.

Prior authorization is required and initial approvals are time‑limited. The standard initial authorization is provided for 6 months, unless the policy specifies otherwise. For multiple myeloma the initial authorization period is extended to a maximum of 8 months (16 doses). Per policy, prior authorizations may not be renewed; requests that would extend coverage beyond the specified initial duration are not supported as renewals and require documentation demonstrating the request meets the renewal criteria and applicable limits.

Coding and Billing (Codes & Units)

Covered HCPCS CodesHCPCSCovered

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

NDCs (product-specific)NDC

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 (selected from Appendix 1)ICD-10Covered

C81.70	Other Hodgkin lymphoma unspecified site
C81.71	Other Hodgkin lymphoma lymph nodes of head, face, and neck
C81.72	Other Hodgkin lymphoma intrathoracic lymph nodes
C81.73	Other Hodgkin lymphoma intra-abdominal lymph nodes
C81.74	Other Hodgkin lymphoma lymph nodes of axilla and upper limb
C81.75	Other Hodgkin lymphoma lymph nodes of inguinal region and lower limb
C81.76	Other Hodgkin lymphoma intrapelvic lymph nodes
C81.77	Other Hodgkin lymphoma spleen
C81.78	Other Hodgkin lymphoma lymph nodes of multiple sites
C81.79	Other Hodgkin lymphoma extranodal and solid organ sites

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Per-cycle billable units by indication

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 Amyloidosis & Multiple Myeloma500 billable units every 28 days

HSCT Conditioning500 billable units for 2 doses

HSCT conditioning dose

HSCT conditioning doseUp to 200 mg/m² intravenously on days -7 and -6 (2 doses)

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage. Initial PA validity: 6 months for most indications; for Multiple Myeloma, initial PA validity is up to 8 months (16 doses). Prior authorizations may NOT be renewed. When requesting authorization, providers must specify the indication and the planned duration of therapy on the PA request.

Prior authorization required — initial validity: 6 months (standard)
Multiple Myeloma: initial validity up to 8 months (16 doses)
PA renewal: not permitted — include planned duration on initial request
On PA requests, specify the exact indication being treated

Note

PA Consideration — drug cost (NQTL)

Prior authorization may be implemented primarily because of drug cost considerations as documented in the plan's NQTL assessment. Use of PA for this drug reflects cost-based utilization management and should be applied comparably across benefit types.

Line-of-Therapy Requirements

first-line | second-line | salvage

First-line: Used as first-line therapy in combination with a rituximab-based regimen for classic follicular lymphoma

Subsequent therapy: Used as subsequent therapy (single agent or in combinations) across multiple lymphoma and hematologic malignancy subtypes per indication-specific criteria (includes relapsed/refractory use, combinations with rituximab/obinutuzumab/polatuzumab, and CAR T-cell bridging in select settings)

Includes adult Hodgkin as subsequent therapy and T-cell lymphoma subsequent indications

mixed

Mixed line/regimen use: Dosing and line-of-therapy are mixed per indication: specific dose, schedule, and maximum cycles vary by diagnosis (e.g., NHL up to 120 mg/m² days 1–2 q21d up to 8 cycles; CLL/SLL & systemic AL up to 100 mg/m² days 1–2 q28d up to 6 cycles; Waldenström up to 90 mg/m² days 1–2 q28d up to 6 cycles; Hodgkin up to 120 mg/m² days 1–2 q28d up to 6 cycles; Multiple Myeloma up to 100 mg/m² days 1–2 q28d up to 8 cycles; HSCT conditioning up to 200 mg/m² on days -7 and -6)

Covered Regimens and Dosing

Example regimen / combination	Supported indications / context
Bendamustine + rituximab	Classic follicular lymphoma (first-line with rituximab; also subsequent therapy), nodal/extranodal/splenic marginal zone lymphoma, mantle cell lymphoma; component of RBAC500 in select settings
Bendamustine + obinutuzumab	Classic follicular lymphoma, extranodal marginal zone lymphoma, nodal marginal zone lymphoma, splenic marginal zone lymphoma (as combination therapy)
Bendamustine + polatuzumab (± rituximab)	DLBCL and related entities including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL, histologic transformation to DLBCL, high-grade B‑cell lymphomas, monomorphic PTLD (B‑cell)
Bendamustine + gemcitabine + vinorelbine	Adult classic Hodgkin lymphoma as second-line or subsequent therapy (combination regimens for relapsed/refractory disease)
Bendamustine + brentuximab vedotin	Adult and pediatric Hodgkin lymphoma (relapsed/refractory) in combination regimens or as part of re-induction strategies; pediatric use described with additional criteria
BEAM conditioning: bendamustine + etoposide + cytarabine + melphalan	Autologous hematopoietic cell transplantation conditioning for NHL (without CNS disease) or Hodgkin lymphoma

Diagnosis / indication	Dosing (mg/m²), schedule, maximum cycles
Non-Hodgkin lymphoma (NHL)	Up to 120 mg/m² IV on days 1 and 2 of a 21‑day cycle; up to 8 cycles
Chronic lymphocytic leukemia / Small lymphocytic lymphoma (CLL/SLL)	Up to 100 mg/m² IV on days 1 and 2 of a 28‑day cycle; up to 6 cycles
Systemic light chain (AL) amyloidosis	Up to 100 mg/m² IV on days 1 and 2 of a 28‑day cycle; up to 6 cycles (used in combination with dexamethasone)
Waldenström macroglobulinemia / Lymphoplasmacytic lymphoma (WM/LPL)	Up to 90 mg/m² IV on days 1 and 2 of a 28‑day cycle; up to 6 cycles
Hodgkin lymphoma (adult and pediatric)	Up to 120 mg/m² IV on days 1 and 2 of a 28‑day cycle; up to 6 cycles (used in combination regimens for relapsed/refractory disease)
Multiple myeloma	Up to 100 mg/m² IV on days 1 and 2 of a 28‑day cycle; up to 8 cycles (used for CNS disease or relapsed/refractory disease per policy)
Hematopoietic stem cell transplant (HSCT) conditioning — BEAM	Up to 200 mg/m² IV on days -7 and -6 prior to transplant (part of BEAM regimen with etoposide, cytarabine, melphalan)

Definitions

Hematopoietic cell transplant conditioning (BEAM)

Regimen nameBEAM (bendamustine + etoposide + cytarabine + melphalan)

IndicationUsed as conditioning for autologous hematopoietic cell transplantation for NHL (without CNS disease) or Hodgkin lymphoma

Combination requirementBendamustine administered in combination with etoposide, cytarabine and melphalan per BEAM regimen

HSCT Conditioning — dosing details

NHL dosingUp to 120 mg/m² IV on days 1 and 2 of a 21-day cycle (up to 8 cycles)

CLL/SLL & Systemic Light Chain Amyloidosis dosingUp to 100 mg/m² IV on days 1 and 2 of a 28-day cycle (up to 6 cycles)

Background

Bendamustine is an intravenous alkylating chemotherapy agent used across a broad range of hematologic malignancies and transplant conditioning. The policy documents use of bendamustine for multiple B‑ and T‑cell lymphomas, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL), Hodgkin lymphoma (including pediatric criteria where specified), multiple myeloma (including CNS disease), systemic light‑chain (AL) amyloidosis, and as part of BEAM conditioning for autologous hematopoietic cell transplantation. Indication‑specific dosing, combinations, and line‑of‑therapy requirements are specified elsewhere in the policy and must be met to support authorization.

OpenPayer

Bendamustine (intravenous) coverage