Pharmacy Prior Authorization Criteria

Tibsovo (ivosidenib)

Indications for Prior Authorization

Tibsovo (ivosidenib)

• For diagnosis of Newly-Diagnosed Acute Myeloid Leukemia (AML)
  Indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

• 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 a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

• For diagnosis of Locally Advanced or Metastatic Cholangiocarcinoma
  Indicated for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

• For diagnosis of Relapsed or Refractory Myelodysplastic Syndromes (MDS)
  Indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Criteria

Tibsovo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Newly-Diagnosed Acute Myeloid Leukemia

• Diagnosis of newly-diagnosed acute myeloid leukemia (AML)
AND
• Patient has an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (e.g., Abbott RealTime IDH1 assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]
AND
• One of the following:
• Patient is greater than or equal to 75 years old
OR
• Patient has comorbidities that preclude use of intensive induction chemotherapy [A]

Tibsovo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Relapsed or Refractory Acute Myeloid Leukemia

• Diagnosis of acute myeloid leukemia (AML)
AND
• Disease is one of the following:
• Relapsed
• Refractory
AND
• Patient has an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (e.g., Abbott RealTime IDH1 assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]

Tibsovo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Locally Advanced or Metastatic Cholangiocarcinoma

• Diagnosis of cholangiocarcinoma
AND
• Disease is one of the following:
• Locally Advanced
• Metastatic
AND
• Patient has an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (e.g., Abbott RealTime IDH1 assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]
AND
• Patient has been previously treated

Tibsovo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Relapsed or Refractory Myelodysplastic Syndromes (MDS)

• Diagnosis of Myelodysplastic Syndromes (MDS)
AND
• Disease is one of the following:
• Relapsed
• Refractory
AND
• Patient has an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (e.g., Abbott RealTime IDH1 assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]

Tibsovo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

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

P & T Revisions

2024-06-04, 2023-11-29, 2023-06-23, 2022-07-03, 2021-09-17, 2021-06-02, 2020-06-25, 2019-07-29

References

1. Tibsovo prescribing information. Servier Pharmaceuticals LLC, Boston, MA. October 2023.
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/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm. Accessed June 15, 2022.
3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia. Version 2.2022. Accessed June 15, 2022.

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Revision History

• 2024-06-04: 2024 UM Annual Review. No changes
• 2023-11-29: Added criteria for new indication of relapsed or refractory myelodysplastic syndromes.
• 2023-06-23: 2023 UM Annual Review. Removal of specialist requirement
• 2022-07-03: Background updates.
• 2021-09-17: Added criteria for new indication of locally advanced or metastatic cholangiocarcinoma.
• 2021-06-02: 2021 UM Annual Review.
• 2020-06-25: Annual review
• 2019-07-29: corrected spelling of relapsed and refractory

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