A budget impact analysis of gilteritinib for the treatment of relapsed or refractory acute myeloid leukemia in a US health plan.

Aims: To estimate the economic impact of the introduction of gilteritinib for the treatment of relapsed/refractory (R/R) mutation-positive ( ) acute myeloid leukemia (AML) from a US payer's perspective.

Methods: A budget impact model (BIM) was developed to evaluate the 3-year total budgetary impact of treating adults with R/R AML eligible for gilteritinib in a hypothetical US health plan. Total costs (drugs/administration, hospitalization, monitoring, adverse events, transfusions, subsequent hematopoietic stem cell transplantation, post-progression, and testing) were estimated before and after gilteritinib entry.

Characteristics of and trends in the late-stage biopharmaceutical pipeline.

Objective: To quantify and characterize biopharmaceutical agents and new indications in late-stage development in the United States as of May 2006.

Study Design: Review of drug development databases and other secondary sources.

Methods: Biopharmaceutical was defined as "any biology-based therapeutic that structurally mimics compounds found within the body.