Coverage with evidence development, only in research, risk sharing or patient access scheme? A framework for coverage decisions

Context Until recently, purchasers’ options regarding whether to pay for the use of technologies have been binary in nature: a treatment is covered or not covered. However, policies have emerged which expand the options - for example, linking coverage to evidence development, an option increasingly used for new treatments with limited/uncertain evidence. There has been little effort to reconcile the features of technologies with the available options in a way that reflects purchasers’ ranges of authority. Methods We developed a framework within which different 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 are also considered. Findings Purchasers should weigh the expected benefits of coverage against the possibility the decision may need to be reversed and the possibility adoption will hinder/prevent evidence generation. Based on the purchaser’s range of authority and the features of the technology different decisions may be appropriate. The framework clarifies the assessments needed to establish the appropriateness of different decisions. A taxonomy of coverage decisions consistent with the framework is suggested. Conclusions A range of coverage options permit paying for use of promising medical technologies despite their limited/uncertain evidence bases. It is important that the option chosen be based upon 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.