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. -
For diagnosis of Lupus Nephritis (LN)
Indicated for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
Criteria
Gazyva
Prior Authorization (Initial Authorization)
Length of Approval: 8 Months [A]
For diagnosis of Lupus Nephritis (LN)
- Diagnosis of active lupus nephritis (LN) AND
- Currently receiving standard of care treatment for active lupus nephritis (e.g., corticosteroids [e.g., prednisone] with mycophenolate or cyclophosphamide) AND
- Prescribed by or in consultation with one of the following:
- Nephrologist
- Rheumatologist
Gazyva
Prior Authorization (Reauthorization)
Length of Approval: 12 Months [A]
For diagnosis of Lupus Nephritis (LN)
- Patient demonstrates positive clinical response to therapy (e.g., decrease or stabilization of symptoms, improvement in functional impairment, decrease of corticosteroid dose, decrease in pain medications)
Gazyva
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma (FL)
- One of the following:
- Both of the following:
- Prescribed medication is being used for one of the following Food and Drug Administration (FDA)-approved indications
- Chronic lymphocytic leukemia (CLL)
- Follicular lymphoma (FL)
- Both of the following labeling requirements have been confirmed:
- All components of the FDA approved indication are met (e.g., concomitant use, previous therapy requirements, age limitations, testing requirements, etc.) AND
- Prescribed medication will be used at a dose which is within FDA recommendations
- Meets the off-label administrative guideline criteria
P & T Revisions
2025-12-18, 2025-12-16, 2025-10-27, 2025-09-30, 2025-08-29, 2025-08-25, 2025-08-11, 2025-07-03, 2025-05-23, 2025-04-30, 2025-04-02, 2025-02-05, 2024-12-20, 2024-12-20, 2024-12-03, 2024-11-06, 2024-10-02, 2024-08-19, 2024-06-21, 2024-05-03, 2024-04-03, 2024-03-22, 2024-01-26, 2024-01-16, 2023-10-24, 2023-10-02, 2023-08-23, 2023-08-01, 2023-07-11, 2023-06-20, 2023-05-01, 2023-03-02, 2022-12-05, 2022-11-14, 2022-09-08, 2022-02-01, 2021-11-19, 2021-09-16, 2021-05-21, 2021-04-12, 2021-02-19, 2020-07-31, 2020-02-20, 2020-01-29
References
- Gazyva Prescribing Information. Genentech, Inc. South San Francisco, CA. October 2025.
End Notes
- Dosing for Gazyva requires an IV infusion at week 0, 2, 24, 26, then every 6 months. An initial approval of 8 months for lupus nephritis allows patients to receive all the loading doses. An approval duration of 12 months for reauthorization should allow for two doses of Gazyva.
Revision History
- 2025-12-18: Created drug-specific guideline due to new lupus nephritis indication. Criteria from the oncology injectable will still apply for CLL and FL.
- 2025-12-16: Created drug-specific guideline due to new lupus nephritis indication. Criteria from the oncology injectable will still apply for CLL and FL.
- 2025-10-27: Update Guideline to add Keytruda Qlex
- 2025-09-30: update guideline
- 2025-08-29: Addition of Rybrevant, Talvey, Trodelvy, and Zynlonta to first criteria bucket of guideline.
- 2025-08-25: Addition of Rybrevant, Talvey, Trodelvy, and Zynlonta to guideline.
- 2025-08-11: Update Guideline to include Zusduri and Lynozyfic. Added operational note.
- 2025-07-03: Addition of Emrelis
- 2025-05-23: Addition of Zynyz to guideline
- 2025-04-30: Addition of Vyloy 300mg strength and Opdualag
- 2025-04-02: Addition of Gazyva and Kimmtrak to guideline.
- 2025-02-05: Addition of Bizengri, Fyarro, and Opdivo Qvantig to guideline
- 2024-12-20: update guideline
- 2024-12-20: update guideline
- 2024-12-03: Addition of Vyloy, Imjudo, Tecvayli, Kyprolis to guideline.
- 2024-11-06: Addition of Tecentriq Hybreza and Sarclisa to guideline
- 2024-10-02: Addition of Elrexfio to guideline
- 2024-08-19: Addition of Columvi, Epkinly, Imfinzi, and Mylotarg to guideline.
- 2024-06-21: Addition of Brand and generic Halaven, Enhertu, Libtayo and Zaltrap.
- 2024-05-03: Addition of Bavencio and Besponsa
- 2024-04-03: Added Istodax and Romidepsin to guideline.
- 2024-03-22: 2024 Annual Review.
- 2024-01-26: update guideline
- 2024-01-16: Addition of Elahere to guideline
- 2023-10-24: Addition of Kadcyla and Tivdak to guideline
- 2023-10-02: Program Update
- 2023-08-23: 2023 Annual Review
- 2023-08-01: Addition of Zepzelca
- 2023-07-11: Removed prescriber requirement. Added Car-T cell products, Folotyn and Brand Pralatrexate to guideline.
- 2023-06-20: Addition of Polivy
- 2023-05-01: Program Update
- 2023-03-02: 2023 Annual Review
- 2022-12-05: Removal of Blenrep from guidelines
- 2022-11-14: Addition of Blenrep to guideline.
- 2022-09-08: Addition of Rylaze
- 2022-02-01: 2022 Annual Review
- 2021-11-19: Addition of Erbitux to guideline
- 2021-09-16: Addition of Opdivo 120mg/12ml strength
- 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
- 2021-04-12: GPI Replication. No change to clinical criteria.
- 2021-02-19: 2021 UM Annual Review.
- 2020-07-31: Added Cyramza to guideline
- 2020-02-20: 2020 UM Annual Review. No changes to criteria.
- 2020-01-29: Added Adcetris, Elzonris, and Lartruvo to guideline.
HEALTHY LIVING