Using an Iterative Approach to Economic Evaluation in the Drug Development Process

The pharmaceutical industry has a well-known and formally recognized process for drug development, consisting of four distinct phases of clinical assessment. Similar to this drug development process, there is a five-stage iterative process for economic evaluation, beginning with early indicative studies and progressing toward more rigorous assessment as data become available. This overview outlines the four phases of drug development and the five-stage iterative approach to economic evaluation. The commonalities of the two approaches are discussed, drawing parallels in support of the case for incorporating an iterative economic process into the drug development process. Both frameworks support a process of information gathering and reducing uncertainty in order to improve decision making. In the context of commercial and public funding for economic evaluation, it is more efficient and beneficial to invest in an iterative approach to economic evaluation throughout the drug or technology lifecycle rather than using a restrictive, one-off trial-based approach, which provides limited information on the true cost-effectiveness of the technology. Drug Dev Res 71 :470-477, 2010. (C) 2010 Wiley-Liss, Inc.