WHA
 

Bendamustine Agents

Indications for Prior Authorization

Belrapzo
  • For diagnosis of Chronic Lymphocytic Leukemia (CLL)
    Indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

  • For diagnosis of Non-Hodgkin Lymphoma (NHL)
    Indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Bendamustine
  • For diagnosis of Chronic Lymphocytic Leukemia (CLL)
    Indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

  • For diagnosis of Non-Hodgkin Lymphoma (NHL)
    Indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Bendeka
  • For diagnosis of Chronic Lymphocytic Leukemia (CLL)
    Indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

  • For diagnosis of Non-Hodgkin Lymphoma (NHL)
    Indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Treanda
  • For diagnosis of Chronic Lymphocytic Leukemia (CLL)
    Indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

  • For diagnosis of Non-Hodgkin Lymphoma (NHL)
    Indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Vivimusta
  • For diagnosis of Chronic Lymphocytic Leukemia (CLL)
    Indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

  • For diagnosis of Non-Hodgkin Lymphoma (NHL)
    Indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Criteria

Bendeka, Belrapzo, Brand Bendamustine, Brand Treanda, Vivimusta

Prior Authorization

Length of Approval: 6 Month(s) [A, C]
For diagnosis of Chronic lymphocytic leukemia (CLL)

  • Diagnosis of chronic lymphocytic leukemia (CLL)
    • AND
  • One of the following:
    • Trial and failure, or intolerance to generic bendamustine
      • OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Bendeka, Belrapzo, Brand Bendamustine, Brand Treanda, Vivimusta

Prior Authorization

Length of Approval: 6 Month(s) [B, D]
For diagnosis of Non-Hodgkin lymphoma (NHL)

  • Diagnosis of indolent B-cell non-Hodgkin lymphoma (NHL)
    • AND
  • Disease has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen
    • AND
  • One of the following:
    • Trial and failure, or intolerance to generic bendamustine
      • OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Generic bendamustine

Prior Authorization

Length of Approval: 6 Month(s) [C]
For diagnosis of Chronic lymphocytic leukemia (CLL)

  • Diagnosis of chronic lymphocytic leukemia (CLL)
Generic bendamustine

Prior Authorization

Length of Approval: 6 Month(s) [D]
For diagnosis of Non-Hodgkin lymphoma (NHL)

  • Diagnosis of indolent B-cell non-Hodgkin lymphoma (NHL)
    • AND
  • Disease has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen

  • Guideline ID
    GL-484251

  • Formulary
    Premium

  • Effective date
    Feb 1, 2026

  • P&T approval date
    Sep 18, 2019

P & T Revisions

2025-12-24, 2025-12-18, 2025-12-18, 2024-09-12, 2024-08-07, 2024-06-26, 2023-06-18, 2023-05-04, 2023-02-23, 2023-01-04, 2022-06-16, 2021-12-30, 2021-09-10, 2021-05-20, 2020-07-25, 2020-04-01

  1. Belrapzo prescribing information. Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ. June 2022.
  2. Bendamustine prescribing information. Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ. May 2019.
  3. Bendeka prescribing information. Teva Pharmaceuticals USA, Inc. North Wales, PA. October 2021.
  4. Treanda prescribing information. Teva Pharmaceuticals USA, Inc. North Wales, PA. June 2021.
  5. Vivimusta prescribing information. Slayback Pharma LLC. Princeton, NJ. December 2022.
  1. For Bendeka: The recommended dose for chronic lymphocytic leukemia (CLL) is 100 mg/m2 administered intravenously over 10 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. [3]
  2. For Bendeka: The recommended dose for non-Hodgkin lymphoma (NHL) is 120 mg/m2 administered intravenously over 10 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles. [3]
  3. For Belrapzo, Bendamustine, Treanda: The recommended dose for chronic lymphocytic leukemia (CLL) is 100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. [1, 2, 4]
  4. For Belrapzo, Bendamustine, Treanda: The recommended dose for non-Hodgkin lymphoma (NHL) is 120 mg/m2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles. [1, 2, 4]
  5. For Vivimusta: The recommended dose for chronic lymphocytic leukemia (CLL) is 100 mg/m2 administered intravenously over 20 minutes on Days 1 and 2 of a 28-day cycle for up to 6 cycles. [5]
  6. For Vivimusta: The recommended dose for non-Hodgkin lymphoma (NHL) is 20 mg/m2 administered intravenously over 20 minutes on Days 1 and 2 of a 21-day cycle for up to 8 cycles. [5]
  • 2025-12-24: Remove EHB formulary from guideline.
  • 2025-12-18: No criteria change, bulk copy oRX-EHB
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2024-09-12: No changes to criteria. Added operational note.
  • 2024-08-07: update guideline
  • 2024-06-26: 2024 Annual Review.
  • 2023-06-18: 2023 Annual Review
  • 2023-05-04: update guideline
  • 2023-02-23: Added new 100mg/4mL formulation of bendamustine (MSC N) and generic Treanda to guideline.
  • 2023-01-04: Added Vivimusta to guideline
  • 2022-06-16: 2022 Annual Review
  • 2021-12-30: Updated to add NF criteria sections for Belrapzo, Bendamustine, and Treanda.
  • 2021-09-10: Updated references section.
  • 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-07-25: Updated references.
  • 2020-04-01: Updates to include embedded step for Belrapzo, Bendamustine, and Treanda; Background updates.