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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End Notes

1. Examples of comorbid conditions are severe cardiac or pulmonary disease, baseline ECOG performance status greater than or equal to 2, hepatic impairment with bilirubin greater than 1.5 times the upper limit of normal, or creatinine clearance less than 45 mL/min. [1]

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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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