A variety of pragmatic issues can come up when developing budget-impact analyses. Some of these issues can have a substantial impact on drug budgets and can reverse the expected results. Therefore, payers and budget holders may require the consideration of some of these issues in the main analyses. In this chapter, we review three common pragmatic issues: (1) off-label drug use, (2) the impact of adherence and/or persistence, and (3) the importance of understanding the cost perspective. All of these issues should be carefully considered when developing budget-impact analyses for new drugs.
