Pharmacoeconomic Considerations for Tyrosine Kinase Inhibitors in the Treatment of Chronic Myeloid Leukemia

Abstract

The introduction and use of the tyrosine kinase inhibitor (TKI) drugs have markedly improved the overall survival and quality of life for patients with chronic myeloid leukemia (CML). There are currently five branded TKIs approved in the United States (US) and European Union (EU) for CML treatment, and one generic option (Gleevec’s generic, imatinib). Imatinib, a first-generation TKI, was the first treatment approved for CML by the European Medicines Agency and the Food and Drug Administration in 2001. Second-generation TKIs dasatinib, nilotinib, and bosutinib have since been approved in the US and EU for both patients who are resistant or intolerant to prior therapy (in 2006 and 2007) as well as those with newly diagnosed disease. Ponatinib is a highly active but more toxic third-generation TKI approved in 2012 as a last option or for patients with T315I-mutated CML patients. Internationally, many countries have added CML TKIs to their national formularies; however, despite their clinical benefits for patients, affordability of TKIs remains a significant concern in the US.