Coverage with Evidence Development, Only in Research, Risk Sharing, or Patient Access Scheme? A Framework for Coverage Decisions

Background: Until recently, purchasers' options regarding whether to pay for the use of medical technologies have been binary in nature: a treatment is either covered or not. Policies, however, have emerged that expand the decision options, for example, linking coverage to evidence development, an option increasingly used for treatments with limited/uncertain evidence. There has been little effort to reconcile the features of technologies with the available decision options. Methods: We described a framework within which different decision options can be evaluated. We distinguished two sources of value in terms of health: the value of the technology per se and the value of reducing decision uncertainty. The costs of reversing decisions were also considered. Findings: Purchasers should weigh the expected benefits of coverage against the possibility that the decision may need to be reversed and the chance that adoption will hinder evidence generation. Based on the purchaser's range of authority over access, research, and price and on the characteristics of the technology with regard to reversibility and evidence, different decisions may be appropriate. The framework clarified the assessments needed to establish the appropriateness of different decisions. A taxonomy of coverage decisions was suggested. Conclusions: A range of decision options may facilitate paying for the use of promising medical technologies despite their uncertain evidence. It is important that the option be chosen on the basis of not only the expected value of a technology but also the value of further research, the anticipated effect of coverage on further research, and the costs associated with reversing the decision.