CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1215

Bendamustine (Treanda/Bendeka/Belrapzo/Vivimusta) drug policy — coverage and utilization management criteria

Coverage and utilization management criteria for bendamustine (brand and biosimilar products) for oncology indications; applies to prior authorization and medication requests processed by the UM program for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBendamustine (Treanda/Bendeka/Belrapzo/Vivimusta) drug policy

Policy CodePolicy UM ONC_1215

Change TypeNo material clinical or coverage changes

Effective DateAug 30, 2024

Next Review Date

Key ActionSubmit prior authorization through the UM program; continuation requests may be exempt if the medication was used within the last year and the member has not experienced disease progression or intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8 cyclesmax duration (NHL)

6 cyclesmax duration (CLL)

100 mg/m2single dose (CLL)

120 mg/m2single dose (NHL)

2024-08-30

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Coverage and Indications

Covered Indications (CLL and NHL)

Covered when ALL of the following are met for the specific indication

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

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

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

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

Use of bendamustine (Treanda/Bendeka/Belrapzo/Vivimusta) for relapsed or refractory small cell lung cancer (SCLC) is not supported by this policy. The exclusion is based on an absence of Level 1 evidence (randomized clinical trials or meta-analyses) demonstrating superior outcomes compared with Evolent-recommended regimens. Providers should expect denials when bendamustine is requested for relapsed/refractory SCLC because the clinical evidence does not meet the policy standard for accepted therapy.

Investigational or off‑label uses of bendamustine that are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature are considered not medically necessary. The policy requires that supporting evidence adequately represent the patient and regimen, report clinically meaningful outcomes (generally overall survival or progression‑free survival benefit of at least 3 months), and be derived from appropriate study designs. Case reports and meeting abstracts without a full peer‑reviewed publication are generally insufficient to establish medical necessity.

Initial Therapy Requirements

Initial therapy

Initial therapy is covered when at least ONE of the following clinical scenarios is met

Initial therapy: Bendamustine may be used as initial therapy in chronic lymphocytic leukemia (CLL) when given in combination with rituximab or a rituximab biosimilar

Initial therapy: Bendamustine may be used as initial therapy in mantle cell lymphoma when given in combination with rituximab or a rituximab biosimilar

Continuation and Renewal Criteria

Continuation requests

Continuation requests are exempt from policy review when ALL of the following are met

Continuation exemption: Requested medication was used within the last year AND member has not experienced disease progression AND member has not experienced intolerance to the medication

If all met, continuation request is exempt from policy review

Dose Limits and Quantity Rules

inv-04: Single dose limits — 100 mg/m2 for CLL; 120 mg/m2 for NHL

CLL single-dose limit100 mg/m2

NHL single-dose limit120 mg/m2

Unit of measuremg/m2 per single dose

inv-05: Maximum duration — 6 cycles for CLL; 8 cycles for NHL

Maximum duration for CLL6 cycles

Maximum duration for NHL8 cycles

ScopeTreatment course maximums per member

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required through the UM program for all requests for bendamustine (Treanda/Bendeka/Belrapzo/Vivimusta). Continuation requests for a medication that would otherwise be not approvable are exempt from this policy if: the requested medication was used within the last year; the member has not experienced disease progression; and the member has not had intolerance to the requested medication.

Prior authorization required for all initial requests.
Continuation exemption if medication used within last year, no disease progression, and no intolerance.

Note

Combination Therapy Expectations

Bendamustine is expected to be used in combination with rituximab or a rituximab biosimilar in many lymphoma and CLL indications (initial or subsequent therapy). For relapsed or refractory diffuse large B‑cell lymphoma, use in combination with polatuzumab (with or without rituximab/rituximab biosimilar) is an acceptable regimen per this policy.

Combination with rituximab/rituximab biosimilar expected for CLL, indolent B‑cell lymphomas, mantle cell lymphoma.

Preferred Regimens and Step Requirements

Step	Required prior therapy / preferred combination	Notes
1	Bendamustine in combination with rituximab or a rituximab biosimilar	Preferred combinational partner for indicated indolent B‑cell lymphomas and mantle cell lymphoma; also used with polatuzumab ± rituximab for relapsed/refractory DLBCL as subsequent therapy.

Administration and Site-of-Care Considerations

Note

Infusion center: follow FDA labeling for administration and monitoring

For infusion center administration, refer to the FDA prescribing information/label for details on administration, dosing, monitoring, and site‑of‑care considerations.

FDA labeling/packaging insert contains administration, dosing, monitoring and site‑of‑care details (chunk 7).

Biosimilar Use and Combinations

Billing Rule

Use with rituximab or rituximab biosimilars supported

Policy supports use of bendamustine in combination with rituximab or rituximab biosimilars for indicated CLL and B‑cell lymphoma settings.

CLL: bendamustine may be used with rituximab/rituximab biosimilar as initial or subsequent therapy (chunk 3).
Indolent B‑cell NHL and mantle cell lymphoma: bendamustine may be used with rituximab/rituximab biosimilar (chunk 4).

Definitions and Special Terms

inv-11: Continuation request exemption — exemption if medication used within last year and no disease progression

Exemption conditionRequested medication was used within the last year

Exemption conditionMember has not experienced disease progression

Exemption conditionMember has not experienced intolerance to the medication

Clinical Background

Bendamustine is an alkylating antineoplastic agent used primarily in hematologic malignancies. This policy addresses its use for chronic lymphocytic leukemia and various non‑Hodgkin B‑cell lymphomas (including follicular, marginal zone, MALT, splenic marginal zone, mantle cell lymphoma) and as subsequent therapy for relapsed/refractory diffuse large B‑cell lymphoma in combination with polatuzumab ± rituximab. Administration, dosing, monitoring and site‑of‑care considerations should follow the FDA labeling and institutional infusion center standards.

Quantity and Dose Constraints

inv-15: bendamustine — single dose limits 100 mg/m2 (CLL); 120 mg/m2 (NHL)

Drugbendamustine

CLL single-dose limit100 mg/m2

NHL single-dose limit120 mg/m2