An ethical analysis of coverage with evidence development

Sometimes a government or other payer is called on to fund a new health technology even when the evidence leaves a lot of uncertainty. One way to manage this problem is for the payer to provisionally fund the technology and reduce uncertainty by developing evidence. This is referred to as coverage with evidence development (CED). When the payer funds the technology only for patients who participate in the evidence development, the coverage is known as only-in-research. This type of CED raises the sharpest questions of coercion and inducement. Is the patient coerced or induced into participating in the evidence development? If so, under what circumstances, if any, is this ethically justified? Building on work by Miller and Pearson, we argue that patients have a right to funding for a technology only when the payer can be confident that the technology provides reasonable value for money. This means that patients have no right to technologies under a CED arrangement, since technologies are candidates for CED precisely because serious questions remain about value for money. It is for this reason that CED induces rather than coerces. The separate question of whether the inducement is ethically justified remains. We argue that CED does pose risks to patients, and the worse these risks are, the more difficult it is to justify the inducement. Finally, we propose conditions under which the inducement could be ethically justified, as well as means of avoiding inducement altogether. All of this has major bearings on the types of CED that are ethically justified and the governance structures that need to be in place. To develop our argument, we draw on the Australian context, so our conclusions apply most directly to comparable contexts, where the payer is a government that provides universal coverage with a regard for cost effectiveness that is prominent and fairly clearly defined.Drew Carter, Tracy Merlin, David Hunte