WHAT IS THE REIMBURSEMENT RECOMMENDATION FOR TIBSOVO?: We recommend that Tibsovo in combination with azacitidine be reimbursed by public drug plans for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an mutation who are not eligible to receive intensive induction chemotherapy, if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Tibsovo in combination with azacitidine should only be covered to treat adult patients with newly diagnosed AML with an mutation who are considered ineligible for standard intensive induction chemotherapy and are aged at least 75 years; have an Eastern Cooperative Oncology Group (ECOG) performance status of 2; have severe organ dysfunction in the heart, lungs, kidneys, or liver; and/or have any other comorbidity judged to be incompatible with intensive induction chemotherapy. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Tibsovo in combination with azacitidine should only be reimbursed if prescribed by clinicians with expertise in managing patients with AML in a specialized hematology or oncology clinic, and the treatment should be supervised and delivered in institutions with expertise in systemic therapy delivery. The total drug cost of ivosidenib plus azacitidine should not exceed that of venetoclax plus azacitidine. Lastly, it must be feasible to test patients for mutations. WHY DID WE MAKE THIS RECOMMENDATION? • Evidence from 1 clinical trial demonstrated that treatment with Tibsovo plus azacitidine resulted in more patients living longer when compared to placebo plus azacitidine. • Tibsovo plus azacitidine meets patient needs as it improves disease control, prolongs survival, and offers an additional treatment option. • Based on our assessment of the health economic evidence, Tibsovo plus azacitidine does not represent good value to the health care system at the public list price. The committee determined that there is insufficient evidence to justify a greater cost for Tibsovo plus azacitidine compared with venetoclax plus azacitidine. ▪. Based on public list prices, Tibsovo is estimated to cost the public drug plans approximately $21 million over the next 3 years. However, the actual budget impact will depend on the proportion of patients with an mutation. ▪. Prior to initiating treatment with Tibsovo plus azacitidine, mutation status should be determined using next generation sequencing (NGS) or polymerase chain reaction (PCR) testing. This is currently not part of routine AML diagnostic testing for all jurisdictions across Canada. Implementation of testing may have substantial health system impacts.
WHAT IS AML? AML is a cancer of the blood and bone marrow that leads to a lower number of mature blood cells. This is 1 of the most aggressive forms of leukemia and is typically associated with a poor prognosis. Approximately 42% and 20% of patients are expected to be alive 1 year and 5 years after their initial diagnosis, respectively. In addition, 40% to 50% of patients with newly diagnosed AML are not suitable for intensive induction chemotherapy. In 2022, there were about 1,600 patients in Canada diagnosed with AML. UNMET NEEDS IN AML: There is a need for treatments that prolong life, reduce transfusion need, reduce symptoms, and improve patients’ quality of life. HOW MUCH DOES TIBSOVO COST? Treatment with Tibsovo in combination with azacitidine is expected to cost approximately $23,827 per 28-day cycle.
