Pharmacy Prior Authorization Criteria

Idhifa (enasidenib)

Indications for Prior Authorization

Idhifa (enasidenib)

• For diagnosis of Relapsed or Refractory Acute Myeloid Leukemia (AML)
  Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

Criteria

Idhifa

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of acute myeloid leukemia (AML)
AND
• Disease is one of the following:
• Relapsed
• Refractory
AND
• Presence of isocitrate dehydrogenase-2 (IDH2) mutation as detected by a FDA-approved test or performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Idhifa

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2025-11-04, 2024-10-02, 2023-10-03, 2023-06-29, 2022-09-27, 2021-10-04, 2020-09-09, 2019-08-28

References

1. Idhifa Prescribing Information. Celgene Corporation. Summit, NJ. January 2025.

---

Revision History

• 2025-11-04: 2025 Annual Review: Updated language in genetic mutation criteria with no changes to clinical content. Updated references.
• 2024-10-02: 2024 Annual Review. Background updates only.
• 2023-10-03: Annual review - No criteria changes
• 2023-06-29: Removed specialist requirement
• 2022-09-27: Annual Review - No Criteria Changes
• 2021-10-04: Annual Review - no criteria changes
• 2020-09-09: Annual review no changes
• 2019-08-28: no updates to clinical criteria, references updated

---