In healthcare priority settings, early access to treatment before reimbursement decisions gives rise to problems of whether negative decisions for cost‐effectiveness reasons should result in withdrawing treatment, already accessed by patients. Among professionals there seems to be a strong attitude to distinguish between withdrawing and withholding treatment, viewing the former as ethically worse. In this article the distinction between withdrawing and withholding treatment for reasons of cost effectiveness is explored by analysing the doing/allowing distinction, different theories of justice, consequentialist and (...) virtue perspectives. The authors do not find any strong reasons for an intrinsic difference, but do find some reasons for a consequentialist difference, given present attitudes. However, overall, such a difference does not, all things considered, provide a convincing reason against withdrawal, given the greater consequentialist gain of using cost‐effective treatment. As a result, patients should be properly informed when given early access to treatment, that such treatment can be later withdrawn following a negative reimbursement decision. (shrink)

When considering the introduction of a new intervention in a budget constrained healthcare system, priority setting based on fair principles is fundamental. In many jurisdictions, a multi-criteria approach with several different considerations is employed, including severity and cost-effectiveness. Such multi-criteria approaches raise questions about how to balance different considerations against each other, and how to understand the logical or normative relations between them. For example, some jurisdictions make explicit reference to a large patient benefit as such a consideration. However, since (...) patient benefit is part of a cost-effectiveness assessment it is not clear how to balance considerations of greater patient benefit against considerations of severity and cost-effectiveness. The aim of this paper is to explore the role of a large patient benefit as an independent criterion for priority setting in a healthcare system also considering severity and cost-effectiveness. By taking the opportunity cost of new interventions (i.e., the health forgone in patients already receiving treatment) into account, we argue that patient benefit has a complex relationship to priority setting. More specifically, it cannot be reasonably concluded that large patient benefits should be given priority if severity, cost-effectiveness, and opportunity costs are held constant. Since we cannot find general support for taking patient benefit into account as an independent criterion from any of the most discussed theories about distributive justice: utilitarianism, prioritarianism, telic egalitarianism and sufficientarianism, it is reasonable to avoid doing so. Hence, given the complexity of the role of patient benefit, we conclude that in priority practice, a large patient benefit should not be considered as an independent criterion, on top of considerations of severity and cost-effectiveness. (shrink)

Background: Severity plays an essential role in healthcare priority setting. Still, severity is an under-theorised concept. One controversy concerns whether severity should be risk- and/or time-sensitive. The aim of this article is to provide a normative analysis of this question. Methods: A reflective equilibrium approach is used, where judgements and arguments concerning severity in preventive situations are related to overall normative judgements and background theories in priority-setting, aiming for consistency. Analysis, discussion, and conclusions: There is an argument for taking the (...) risk of developing a condition into account, and we do this when we consider the risk of dying in the severity assessment. If severity is discounted according to risk, this will ‘dilute’ severity, depending on how well we are able to delineate the population, which is dependent on the current level of knowledge. This will potentially have a more far-reaching effect when considering primary prevention, potentially the de-prioritisation of effective preventive treatments in relation to acute, less-effective treatments. The risk arguments are dependent on which population is being assessed. If we focus on the whole population at risk, with T 0 as the relevant population, this supports the risk argument. If we instead focus on the population of as-yet (at T 0 ) unidentified individuals who will develop the condition at T 1, risk will become irrelevant, and severity will not be risk sensitive. The strongest argument for time-sensitive severity (or for discounting future severity) is the future development of technology. On a short timescale, this will differ between different diagnoses, supporting individualised discounting. On a large timescale, a more general discounting might be acceptable. However, we need to also consider the systemic effects of allowing severity to be risk- and time-sensitive. (shrink)