Pharmacy Prior Authorization Criteria

Inlyta (axitinib)

For diagnosis of Advanced Renal Cell Carcinoma
Indicated in combination with avelumab or pembrolizumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). It is also indicated as a single agent, for the treatment of advanced RCC after failure of one prior systemic therapy.

*This product may require prior authorization. ***Criterion is part of FDA-approved label

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Used as first-line treatment in combination with one of the following for clear cell renal cell carcinoma**: [2]

Used after failure of one prior systemic therapy (e.g., chemotherapy) for clear cell renal cell carcinoma** [2]

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

2024-07-30, 2023-07-06, 2023-05-04, 2023-03-21, 2022-07-22, 2022-04-11, 2021-09-27, 2021-06-18, 2021-05-19, 2021-04-07, 2020-06-29, 2019-07-19

Inlyta Prescribing Information. Pfizer Labs. New York, NY. July 2024.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Kidney Cancer. v.1.2025. Available at https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed July 30, 2024.

2024-07-30: Annual review: No criteria changes. Updated references.
2023-07-06: Updated criteria and removed specialist requirement
2023-05-04: Annual review: Updated criteria, operational notes, references.
2023-03-21: COT allowance to support formulary strategy for non-clear cell renal cell carcinoma.
2022-07-22: Update Guideline
2022-04-11: Annual review: Updated criteria and references.
2021-09-27: Annual Review: references updated
2021-06-18: Annual Review: references updated
2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
2021-04-07: Updated GPI'S
2020-06-29: Program Update: modified criteria to include expanded RCC indication
2019-07-19: P&T approved 7/17/19: AR No clinical criteria changes. Updated references and background.