Economic evaluation for devices and drugs--same or different?

Although the general methods of economic evaluation are well established [1,2], it is often their detailed application that raises methodological challenges. Most international guidelines for economic evaluation, although appearing to be generic, have been written with pharmaceuticals in mind [3]. For example, they typically assume that randomized controlled trials (RCTs) will be available for the assessment of relative treatment effect. In this article, we argue that the economic evaluation of devices raises additional challenges that international guidelines frequently overlook.