Pharmacy Prior Authorization Criteria

Xospata (gilteritinib)

Indications for Prior Authorization

Xospata (gilteritinib) tablets

• For diagnosis of Relapsed or Refractory Acute Myeloid Leukemia
  Indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.

Criteria

Xospata

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of acute myeloid leukemia (AML)
AND
• Disease is relapsed or refractory
AND
• Patient has a FMS-like tyrosine kinase 3 (FLT3) mutation as determined by a U.S. Food and Drug Administration (FDA)-approved test (e.g., LeukoStrat CDx FLT3 Mutation Assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]

Xospata

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2025-01-03, 2024-01-05, 2023-11-16, 2023-06-26, 2023-02-15, 2022-01-07, 2021-04-09, 2021-01-25, 2019-12-13

References

1. Xospata prescribing information. Astellas Pharma US, Inc. Northbrook, IL. June 2022.
2. U.S. Food and Drug Administration: List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at: https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools. Accessed December 13, 2019.

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Revision History

• 2025-01-03: 2025 Annual Review.
• 2024-01-05: 2024 Annual Review
• 2023-11-16: Program update to standard reauthorization language. No changes to clinical intent
• 2023-06-26: Removed specialist requirement
• 2023-02-15: 2023 Annual Review
• 2022-01-07: 2022 Annual Review
• 2021-04-09: Updated GPIs
• 2021-01-25: 2021 Annual Review: updated reauthorization criteria
• 2019-12-13: 2020 Annual Review; updated references only

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