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DrugTibsovo® (ivosidenib) [Agios Pharmaceuticals, Inc.]

June 2019

Therapeutic area - Oncology, Oral

Initial approval criteria

  • Patient must be at least 18 years of age AND
  • A confirmed diagnosis of ONE of the following:
    • Relapsed or refractory acute myeloid leukemia (AML) OR
    • A condition listed in the FDA-approved label AND
  • ALL of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate:
    • A susceptible IDH1 mutation in the blood or bone marrow as detected by an FDA-approved test
    • Complete blood count with differential
    • Comprehensive metabolic panel
    • EKG AND
  • Patient does NOT have any of the following:
    • Severe renal impairment (eGFR < 30mL/min//1.73m2) OR
    • Renal impairment requiring dialysis OR
    • Moderate to severe hepatic impairment (total bilirubin ≥ 1.5X ULN and any value for AST) AND
  • Documentation that the prescriber has conducted a comprehensive review of all of patient’s current medications to ensure no significant drug interaction exists or dose modification if appropriate with:
    • Strong or moderate CYP3A4 inhibitors
    • Strong CYP3A4 inducers
    • Sensitive CYP3A4 substrates
    • QTc prolonging drugs
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the initial approval criteria AND
  • Patient has no evidence of disease progression as determined by prescriber AND
  • Patient does not have any unacceptable toxicity from the drug (e.g., development of Guillain-Barre syndrome, QTc prolongation with signs and symptoms of life-threatening arrhythmia, etc.)
  • Renewal approval is for 12 months

Quantity limits

  • 68 tablets per 34 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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