Venetoclax (Venclexta)

CADTH recommends that Venclexta in combination with low-dose cytarabine (LDAC) should not be reimbursed by public drug plans for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. Evidence from 1 clinical trial demonstrated that treatment with Venclexta plus LDAC did not improve overall survival compared to treatment with LDAC alone. No conclusions could be drawn for other important outcomes including remission rates, transfusion independence, event-free survival, quality of life, and symptoms. Patients identified a need for treatments that can maintain remission, improve quality of life and symptoms (fatigue), and that have fewer side effects. It is unclear whether Venclexta plus LDAC meets these needs. Economic evidence suggests that Venclexta plus LDAC is not cost-effective at a willingness-to-pay threshold of $50,000 per quality-adjusted life-year (QALY), even at a 100% reduction in the price of Venclexta. Based on public list prices, the 3-year budget impact is $70,006,541. This estimate is larger than the value identified by drug plans as feasible for adoption.