How good is good enough? Standards in policy decisions to cover new health technologies

Health technology coverage decisions require reasonable criteria, for example, the requirement that a technology be effective, efficient, legitimate in purpose, acceptable in its effects, safe and so on. The leap from such criteria to decisions requires not only evidence, but also standards. Decision-makers must specify their values, which apply in general, regarding what is "good enough" before they can judge any technology in particular. This paper will do the following: (1) describe the key analytic tasks involved in defining coverage criteria and their standards, (2) identify some of the policy applications of explicit standards to coverage decisions and (3) review the policy uses of such standards, including some challenges they pose. The problem of identifying cost-effectiveness standards will be used to illustrate key issues. It is argued that a precedent-based understanding of standards is relevant in the Canadian policy context, where fairness is crucial. Studies of actual decision-making that seek standards inductively have been misguided in their focus on central tendencies to the neglect of outliers (precedents), while deductive analyses and rules of thumb have been ungrounded in prevailing values.