Pharmacy Prior Authorization Criteria

Zydelig (idelalisib)

For diagnosis of Relapsed Chronic Lymphocytic Leukemia
Indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Limitation of Use: Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.

*This drug may require prior authorization.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Patient has relapsed on at least one prior therapy (e.g., purine analogues [fludarabine, pentostatin, cladribine], alkylating agents [chlorambucil, cyclophosphamide], or monoclonal antibodies [rituximab])

AND

AND

Patient is a candidate for Rituxan (rituximab) monotherapy due to presence of other comorbidities (e.g., coronary artery disease, peripheral vascular disease, diabetes mellitus, pulmonary disease [COPD], etc.)

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

2024-10-02, 2023-09-11, 2023-07-05, 2022-10-14, 2022-03-01, 2021-09-09, 2021-05-26, 2021-05-25, 2020-09-10, 2019-09-16

Zydelig Prescribing Information. Gilead Sciences, Inc. Foster City, CA. February 2022.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic lymphocytic leukemia/small lymphocytic lymphoma. v.3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed August 2, 2022.

2024-10-02: 2024 Annual Review - background updates
2023-09-11: 2023 Annual Review
2023-07-05: update guideline
2022-10-14: 2022 Annual Review - updated background
2022-03-01: Update to remove relapsed follicular lymphoma and relapsed small lymphocytic lymphoma criteria from guideline
2021-09-09: 2021 Annual Review.
2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
2020-09-10: 2020 Annual Review: updated reauthorization criteria
2019-09-16: 2019 Annual Review. No clinical criteria changes.