Tibsovo (ivosidenib) — Highmark

Initial criteria

• age ≥ 18 years
• disease is IDH1 mutation-positive as detected by an FDA-approved test
• member has one of the following: relapsed or refractory AML (ICD-10 C92) OR newly-diagnosed AML (ICD-10 C92) where Tibsovo is used as monotherapy or with azacitidine and one of the following: age ≥ 75 years, severe cardiac or pulmonary comorbidity, reduced renal function, hepatic impairment, or prescriber attests member is not a candidate for intensive induction therapy

Reauthorization criteria

• prescriber attests that the member is tolerating therapy and has experienced a therapeutic response defined as either disease improvement or delayed disease progression

Approval duration

12 months