Brukinsa (zanubrutinib)
Indications for Prior Authorization
Brukinsa (zanubrutinib)
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For diagnosis of Mantle Cell Lymphoma
Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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For diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma [6] -
For diagnosis of Marginal Zone Lymphoma
Indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). -
For diagnosis of Follicular Lymphoma
Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Criteria
Brukinsa
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Mantle Cell Lymphoma
- Diagnosis of relapsed or refractory mantle cell lymphoma (MCL) AND
- Patient has received at least one prior therapy for MCL (e.g., chemotherapy) AND
- One of the following:
- Trial and failure, contraindication, or intolerance to one of the following:
- Calquence (acalabrutinib)
- Imbruvica (ibrutinib)
- For continuation of prior therapy
Brukinsa
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma
- Diagnosis of Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma [6] AND
- One of the following:
- Trial and failure, contraindication, or intolerance to one of the following:
- Calquence (acalabrutinib)
- Imbruvica (ibrutinib)
- For continuation of prior therapy
Brukinsa
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Marginal Zone Lymphoma (MZL)
- Diagnosis of Marginal Zone Lymphoma (MZL) AND
- Disease is relapsed or refractory AND
- Patient has received at least one anti-CD20-based regimen for MZL (e.g., rituximab, obinutuzumab) AND
- One of the following:
- Trial and failure, contraindication, or intolerance to one of the following:
- Calquence (acalabrutinib)
- Imbruvica (ibrutinib)
- For continuation of prior therapy
Brukinsa
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- Diagnosis of ONE of the following:
- Chronic Lymphocytic Leukemia (CLL)
- Small Lymphocytic Lymphoma (SLL)
- One of the following:
- Trial and failure, contraindication, or intolerance to one of the following:
- Calquence (acalabrutinib)
- Imbruvica (ibrutinib)
- For continuation of prior therapy
Brukinsa
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Follicular Lymphoma
- Diagnosis of follicular lymphoma (FL) AND
- Disease is relapsed or refractory AND
- Used in combination with Gazyva (obinutuzumab) AND
- Patient has received at least two prior lines of systemic therapy including both of the following:
- An anti-CD20 antibody [e.g., rituximab]
- An approved alkylator-based combination therapy [e.g., bendamustine in combination with obinutuzumab or rituximab, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)]
Brukinsa
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of All indications listed above
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2024-04-03, 2024-01-04, 2023-07-22, 2023-07-05, 2023-03-30, 2023-03-01, 2023-01-03, 2022-02-07, 2021-10-13, 2021-04-14, 2020-12-30, 2019-12-05
References
- Brukinsa Prescribing Information. BeiGene USA, Inc. San Mateo, CA. March 2024.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. B-Cell Lymphomas v4.2020. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. (Accessed March 26, 2024).
- ClinicalTrials.gov [Internet]. U.S. National Library of Medicine. Identifier NCT02343120. Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies; January 21, 2015. Available from: https://clinicaltrials.gov/ct2/show/NCT02343120.
- ClinicalTrials.gov [Internet]. U.S. National Library of Medicine. Identifier NCT03206970. Study of Evaluate Efficacy and Safety of BGB-3111 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL); July 2, 2017. Available from: https://clinicaltrials.gov/ct2/show/results/NCT03206970.
- Schulz H, Bohlius J, Trelle S et al. Immunochemotherapy With Rituximab and Overall Survival in Patients With Indolent or Mantle Cell Lymphoma: A Systematic Review and Meta-analysis. JNCI Journal of the National Cancer Institute. 2007;99(9):706-714. doi:10.1093/jnci/djk152.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Waldenström’s macroglobulinemia/Lymphoplasmacytic Lymphoma. V1.2022. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/waldenstroms.pdf. Accessed September 15, 2021.
- Tam CS, Opat S, D'Sa S, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038-2050. doi:10.1182/blood.2020006844
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. B-Cell Lymphomas. V1.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed Match 26, 2024.
End Notes
- Chemotherapy regimens may include bendamustine; cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP); cyclophosphamide, vincristine, prednisone (CVP); fludarabine, cyclophosphamide, mitoxantrone (FCM).
Revision History
- 2024-04-03: Addition of new indication for follicular lymphoma.
- 2024-01-04: Annual Review - no criteria changes
- 2023-07-22: July P & T update - Oncology UM Update Project - Removed specialist requirement from all indications eff 9/1/2023.
- 2023-07-05: Adding single step through Calquence or Imbruvica, COT will be allowed.
- 2023-03-30: T/f verbiage within MCL updated
- 2023-03-01: Addition of new indication for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
- 2023-01-03: Annual review - No criteria changes
- 2022-02-07: Annual Review - no criteria changes
- 2021-10-13: Updated guideline to include new indications
- 2021-04-14: Updated GPIs
- 2020-12-30: 2021 UM Annual Review.
- 2019-12-05: New Program. Pending Jan 2020 P&T decision.
HEALTHY LIVING