An Ethical Analysis of Coverage With Evidence Development.

ABSTRACT

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 option is for the payer to provisionally fund the technology and reduce uncertainty by developing evidence. This is called coverage with evidence development (CED). Only-in-research CED, when the payer funds the technology only for patients who participate in the evidence development, raises the sharpest ethical questions. Is the patient coerced or induced into participating? 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. Technologies are candidates for CED precisely because serious questions remain about value for money, and therefore patients have no right to technologies under a CED arrangement. This is why 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 harder it is to justify the inducement. Finally, we propose conditions under which the inducement could be ethically justified and means of avoiding inducement altogether. We draw on the Australian context, and 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.