CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Bendamustine (Treanda/Bendeka/Belrapzo/Vivimusta) indications and limits

Defines accepted oncologic indications, dosing/duration limits, contraindications, coding, and prior authorization expectations for bendamustine products for Neighborhood Health Plan of Rhode Island members processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBendamustine (Treanda/Bendeka/Belrapzo/Vivimusta) indications and limits

Policy CodePolicy N/A

Change TypeClinical and operational updates

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required and requests must be supported by FDA labeling, CMS compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Added new product 'Vivimusta' to policy.

Updated indication section.

4branded bendamustine products listed

J9033–J9056HCPCS codes for bendamustine products

6 cyclesmax duration (CLL)

8 cyclesmax duration (NHL)

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Coverage Criteria for Bendamustine

CLL/SLL - Initial or subsequent therapy

Covered when ALL of the following are met for CLL/SLL

CLL/SLL coverage: Bendamustine may be used in combination with rituximab/rituximab biosimilar as initial or subsequent therapy for members with CLL/SLL.

Supports initial or subsequent therapy.

NHL - Indications and combinations

Covered when ALL of the following are met for Indolent B-cell NHL and other specified NHL subtypes

Indolent B-cell NHL: Bendamustine in combination with rituximab/rituximab biosimilar may be used for primary or subsequent therapy for follicular lymphoma, nodal/extra-nodal/gastric/non-gastric MALT, and splenic marginal zone lymphoma.

Diffuse large B-cell lymphoma (DLBCL): Bendamustine may be used as subsequent therapy for relapsed or refractory DLBCL in combination with polatuzumab with or without rituximab/rituximab biosimilar.

Subsequent therapy only.

Mantle cell lymphoma: Bendamustine may be used as initial or subsequent therapy in combination with rituximab/rituximab biosimilar.

Authorization requests for bendamustine will be excluded (denied) when any of the following operational criteria are met: the member has documented disease progression while on bendamustine; the proposed dosing exceeds the single-dose limits of 100 mg/m2 for CLL or 120 mg/m2 for NHL; or the proposed treatment duration exceeds the policy maximum of 6 cycles for CLL or 8 cycles for NHL. Requests for investigational or off-label indications that lack sufficient evidence or are not generally accepted by the medical community will also be excluded.

Bendamustine products (Treanda/Bendeka/Belrapzo/Vivimusta) are not supported by this policy for the treatment of relapsed or refractory small cell lung cancer (SCLC). This position is based on the lack of Level 1 evidence (randomized clinical trials and/or meta-analyses) demonstrating superior outcomes compared with Evolent-recommended regimens; therefore use in relapsed/refractory SCLC is considered not approvable under the policy.

Regimens and Combinations Supported

Regimen	Indication	Coverage
Bendamustine + rituximab or rituximab biosimilar	Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) — initial or subsequent therapy	Covered
Support/notes	May be used in combination with rituximab/rituximab biosimilar as initial or subsequent therapy for members with CLL/SLL.

Regimen	Indication	Coverage
Bendamustine + rituximab or rituximab biosimilar	Indolent B‑cell Non‑Hodgkin lymphomas (including follicular, nodal/extra‑nodal/gastric/non‑gastric MALT, splenic marginal zone) — primary or subsequent therapy	Covered
Support/notes	May be used in combination with rituximab/rituximab biosimilar for primary or subsequent therapy of specified indolent B‑cell NHL subtypes.

Regimen	Indication	Coverage
Bendamustine + polatuzumab (with or without rituximab/rituximab biosimilar)	Diffuse large B‑cell lymphoma (DLBCL) — relapsed or refractory; subsequent therapy	Covered
Support/notes	May be used as subsequent therapy for relapsed or refractory DLBCL in combination with polatuzumab with or without rituximab/rituximab biosimilar.

Regimen	Indication	Coverage
Bendamustine products (Treanda/Bendeka/Belrapzo/Vivimusta)	Relapsed/refractory small cell lung cancer (SCLC)	Not supported
Support/notes	Bendamustine products are not supported for the treatment of relapsed/refractory SCLC due to lack of Level 1 evidence demonstrating superior outcomes compared to recommended regimens.

Billing and Coding

Bendamustine 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

inv-06: Single dose limit — 100 mg/m2 for CLL; 120 mg/m2 for NHL

Single-dose limit (CLL)100 mg/m2 per administration

Single-dose limit (NHL)120 mg/m2 per administration

ApplicabilityLimits apply to Treanda/Bendeka/Belrapzo/Vivimusta (bendamustine) per EXCLUSION CRITERIA

inv-07: Maximum number of cycles — 6 cycles for CLL; 8 cycles for NHL

Maximum cycles (CLL)6 cycles total

Maximum cycles (NHL)8 cycles total

Trigger for denial

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Treanda/Bendeka/Belrapzo/Vivimusta (bendamustine). Requests must be supported by FDA approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Prior authorization required and documentation must reference one of: FDA labeling; CMS compendia; NCCN or ASCO guidance; or qualifying peer‑reviewed literature.

Documentation Required

Supporting documentation and continuation rules

Authorization requests must include supporting documentation that demonstrates the request meets coverage criteria and is consistent with accepted references. Continuation (renewal) requests are eligible only when all of the following are met: the member has not experienced disease progression while on bendamustine; the medication was used within the last year with no gap greater than 30 days since the prior active authorization; and no additional medications are being added to the continuation request. Continuation requests for medications deemed not approvable by Evolent are exempt from initial-therapy requirements when these conditions are satisfied.

Line of Therapy Positions

first-line

Covered when ALL of the following are met for first-line use

First-line CLL/SLL: Bendamustine used in combination with rituximab/rituximab biosimilar as initial (first-line) therapy for members with CLL/SLL.

salvage

Covered when ALL of the following are met for salvage (subsequent) therapy

Salvage DLBCL: Bendamustine may be used as subsequent (salvage) therapy for relapsed or refractory DLBCL in combination with polatuzumab with or without rituximab/rituximab biosimilar.

Subsequent therapy only.

Definitions and Supported Combinations

inv-13: Combination regimens — Policy supports bendamustine in combination with rituximab/rituximab biosimilars for CLL/SLL and multiple indolent and mantle cell NHL series

Supported combinations (general)Bendamustine in combination with rituximab or rituximab biosimilars is supported for CLL/SLL and multiple indolent and mantle cell NHL settings

DLBCL (relapsed/refractory)Bendamustine supported in combination with polatuzumab (Polivy) with or without rituximab/rituximab biosimilar as subsequent therapy

Indolent B-cell NHL examplesIncludes follicular lymphoma, nodal/extra-nodal/gastric/non-gastric MALT, and splenic marginal zone lymphoma when given with rituximab/rituximab biosimilar

Mantle cell lymphomaBendamustine plus rituximab/rituximab biosimilar may be used as initial or subsequent therapy

Background

Bendamustine (branded as Treanda, Bendeka, Belrapzo, and Vivimusta) is an alkylating chemotherapeutic agent used in the management of several B-cell malignancies. Within this policy, bendamustine is described for use primarily in combination with rituximab or rituximab biosimilars for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and multiple indolent B‑cell non‑Hodgkin lymphomas, and—when indicated—as part of subsequent therapy regimens (for example, with polatuzumab with or without rituximab) for relapsed/refractory diffuse large B‑cell lymphoma (DLBCL). The policy list of supported products was updated to include Vivimusta in addition to the other branded bendamustine preparations.