Pharmacy Prior Authorization Criteria

Gazyva (obinutuzumab)

Indications for Prior Authorization

Gazyva (obinutuzumab)

• For diagnosis of Chronic Lymphocytic Leukemia (CLL)
  Indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil.

• For diagnosis of Follicular Lymphoma (FL)
  1) Indicated in combination with bendamustine followed by Gazyva monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. 2) Indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma in combination with chemotherapy followed by Gazyva monotherapy in patients achieving at least a partial remission.

• Small Lymphocytic Lymphoma (SLL) [2]
  

Criteria

Gazyva

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Leukemia (SLL)

• One of the following:
• Diagnosis of chronic lymphocytic leukemia (CLL) and is previously untreated for CLL
• Diagnosis of small lymphocytic leukemia (SLL) and previously untreated for SLL [A]
AND
• Used in combination with chlorambucil [2,3]

Gazyva

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Follicular Lymphoma (FL)

• Diagnosis of follicular lymphoma (FL)
AND
• One of the following:
• All of the following:
• Relapsed or refractory to a rituximab-containing regimen [B]
AND
• Will be used in combination with bendamustine for six cycles prior to maintenance treatment with Gazyva monotherapy
OR
• All of the following:
• Diagnosis of stage II bulky, III or IV follicular lymphoma
AND
• Patient has not been treated with prior therapy
AND
• Both of the following:
• Used in combination with chemotherapy until at least partial remission has been achieved
• Followed by Gazyva monotherapy

Gazyva

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-03-25, 2023-07-03, 2023-04-04, 2022-04-05, 2021-09-27, 2021-05-19, 2021-04-02, 2020-03-30

References

1. Gazyva Prescribing Information, Genentech Inc. San Francisco, CA. July 2022.
2. NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed March 25, 2024.
3. National Comprehensive Cancer Network(NCCN) Practice Guidelines in Oncology. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma v2.2024. Available at: https://www.nccn.org/professionals/physician_gls/ pdf/cll.pdf. Accessed March 25, 2024.
4. Sharman JP, Banerji V, Fogliatto LM, et al. ELEVATE TN: Phase 3 study of acalabrutinib combined with obinutuzumab (O) or alone vs O plus chlorambucil (Clb) in patients (Pts) with treatment-naïve chronic lymphocytic leukemia (CLL). Blood. 2019;134 (Supplement_1):31.

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End Notes

1. The National Comprehensive Cancer Network (NCCN) guidelines support the use of obinutuzumab for the treatment of small lymphocytic leukemia (SLL). One clinical trial showed the combination of obinutuzumab plus chlorambucil resulted in significant improvement in the median progression free survival (PFS) compared to chlorambucil alone (26.7 months vs 11.1 months, respectively). [2]
2. NCCN supports use of obinutuzumab in the treatment of follicular lymphoma as maintenance therapy for rituximab refractory disease in patients with indications for treatment as second-line extended dosing. [2]

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Revision History

• 2024-03-25: 2024 Annual Review. Updated references.
• 2023-07-03: Removed specialist requirement
• 2023-04-04: Annual review - updated references.
• 2022-04-05: Annual review - combined reauth section for both indications as criteria is the same. Updated references.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-02: 2021 Annual Review
• 2020-03-30: Annual Review

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