Pharmacy Prior Authorization Criteria

Rezlidhia (olutasidenib) - PA, NF

Indications for Prior Authorization

Rezlidhia (olutasidenib)

• For diagnosis of Acute Myeloid Leukemia (AML)
  Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Criteria

Rezlidhia

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 a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., Abbott RealTime IDH1 assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to Tibsovo (ivosidenib)
OR
• For continuation of prior therapy

Rezlidhia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to Tibsovo (ivosidenib)
OR
• For continuation of prior therapy

Rezlidhia

Non Formulary

Length of Approval: 12 Month(s)

• Diagnosis of acute myeloid leukemia (AML)
AND
• Disease is one of the following:
• Relapsed
• Refractory
AND
• Presence of a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., Abbott RealTime IDH1 assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Tibsovo (ivosidenib)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2024-02-20, 2023-06-26, 2023-05-08, 2023-01-31

References

1. Rezlidhia Prescribing Information. Rigel Pharmaceuticals, Inc. South San Francisco, CA. December 2022.
2. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed on January 5, 2024.

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Revision History

• 2024-02-20: 2024 annual review: no criteria changes.
• 2023-06-26: Removed specialist requirement
• 2023-05-08: Added embedded ST through Tibsovo and added NF criteria.
• 2023-01-31: New program for Rezlidhia

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