The Pro's and Con's of Coverage Approaches

Current Coverage Approach +   Primarily technology assessments which leverage principles of critical thinking in experimental design and principles of evidence-based medicine+   Numerous US payors and tech assessment groups (govt/non-profit/commercial) “compete” for credibility and probably collate toward consensus over time+     Less than optimal understanding of how “incommensurate” factors are weighed (blinded RCT with large effect has high internal validity, but use of restricted test population limits external validity; versus a study with the opposite characteristics) +     Differences between “EBM” and “coverage decisions” not well articulated
Coverage Proposal 1: +   Use of focused guidelines, similar to FDA guidelines for narrow product categories+   Works well for FDA +   Maximizes predictability for industry+   Difficult-to-articulate factors may play variably large role, depending on coverage decision
Coverage Proposal 2: +   Produce book or thorough white paper of “case studies” of natural coverage decisions+   Raise visibility of issues for future work +   Other fields, such as judicial decision-making, have enormous literature of this type (e.g. Posner, 2008) +   A few examples exist (e.g. Giacommini, 2004)+   Unclear who would ever do this