Tibsovo®

Drug - Tibsovo® (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

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

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