In health care priority setting different criteria are used to reflect the relevant values that should guide decision-making. During recent years there has been a development of value frameworks implying the use of multiple criteria, a development that has not been accompanied by a structured conceptual and normative analysis of how different criteria relate to each other and to underlying normative considerations. Examples of such criteria are unmet need and severity. In this article these crucial criteria are conceptually clarified and (...) analyzed in relation to each other. We argue that disease-severity and condition-severity should be distinguished and we find the latter concept better reflects underlying normative values. We further argue that unmet need does not fulfil an independent and relevant role in relation to condition-severity except for in some limited situations when having to distinguish between conditions of equal severity. (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)

In the article Should rare diseases get special treatment? by Monica Q F de Magalhaes,1 it is argued that rarity is not a morally relevant feature to consider in prioritising treatment in healthcare, but severity is. A central conclusion in the article is that severity rather than prevalence should guide different cost-effectiveness thresholds. Hence, I take it, she answers no to the question in her own heading. I agree with all of this—and with most of her other arguments and conclusions (...) in the article—except for the clause ‘rather than prevalence’. For this reason, I find the article misses its’ mark. Let me explain by taking Sweden as an example. Sweden has a legally established ethics framework for priority setting in healthcare since 1997, comprising three principles: human-dignity principle, needs-solidarity principle and cost-effectiveness principle. The implication of these principles in practice is that the higher the severity—the higher the cost-effectiveness threshold acceptable.2 During the last 10 years or so, the highest accepted cost-effectiveness threshold for the most severe conditions have been in the order of €100 000/QALY. Until a few years ago rarity or prevalence was …. (shrink)

In recent years, the issue of accepting a higher cost per health improvement for orphan drugs has been the subject of discussion in health care policy agencies and the academic literature. This article aims to provide an analysis of broadly egalitarian arguments for and against accepting higher costs per health improvement. More specifically, we aim to investigate which arguments one should agree upon putting aside and where further explorations are needed. We identify three kinds of arguments in the literature: considerations (...) of substantial equality, formal equality, and opportunity cost. We argue that considerations of substantial equality do not support higher costs per health improvement orphan drugs, even if such considerations are considered valid. On the contrary, arguments of formal equality may support accepting a higher cost per health improvement for orphan drugs. However, in order to do so, a number of both normative and empirical issues must be resolved; these issues are identified in the article. For instance, it must be settled to what extent the opportunity cost in terms of foregone health for other patients is acceptable in order to uphold formal equality. We conclude that certain arguments can be set aside, and future focus should be put on the unresolved normative and empirical issues related to formal equality and opportunity cost. (shrink)

The Danish healthcare system must meet the need for easy and equal access to healthcare for every citizen. However, investigations have shown unfair prioritization of cancer patients and unfair prioritization of resources for expensive medicines over care. What is needed are principles for proper prioritization. This article investigates whether American ethicists Tom Beauchamp and James Childress’s principle of justice may be helpful as a conceptual framework for reflections on prioritization of expensive biological therapies in the Danish healthcare system. We present (...) an empirical study exploring the principles for prioritizing new expensive biological therapies. This study includes qualitative interviews with key Danish stakeholders experienced in antibody therapy and prioritizing resources for expensive medicines. Beauchamp and Childress’s model only covers government-funded primary and acute healthcare. Based on the interviews, this study indicates that to be helpful in a Danish context this model should include equal access for citizens to government-funded primary and acute healthcare, costly medicine, and other scarce treatments. We conclude that slightly modified, Beauchamp and Childress’s principle of justice might be useful as a conceptual framework for reflections on the prioritization of expensive biological therapies in the Danish healthcare system. (shrink)