Is a larger patient benefit always better in healthcare priority setting?

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.

Justification of principles for healthcare priority setting: the relevance and roles of empirical studies exploring public values.

How should scarce healthcare resources be distributed? This is a contentious issue that became especially pressing during the pandemic. It is often emphasised that studies exploring public views about this question provide valuable input to the issue of healthcare priority setting. While there has been a vast number of such studies it is rarely articulated, more specifically, what the results from these studies would mean for the justification of principles for priority setting. On the one hand, it seems unreasonable that public values would straightforwardly decide the ethical question of how resources should be distributed. On the other hand, in a democratic society, it seems equally unreasonable that they would be considered irrelevant for this question. In this paper we draw on the notion of reflective equilibrium and discuss the relevance and roles that empirical studies may plausibly have for justification in priority setting ethics. We develop a framework for analysing how different kinds of empirical results may have different kinds of implications for justification.

Should relational effects be considered in health care priority setting?

It is uncontroversial to claim that the extent to which health care interventions benefit patients is a relevant consideration for health care priority setting. However, when effects accrue to the individual patient, effects of a more indirect kind may accrue to other individuals as well, such as the patient's children, friends, or partner. If, and if so how, such relational effects should be considered relevant in priority setting is contentious. In this paper, we illustrate this question by using disease-modifying drugs for Alzheimer's disease as a case in point. The ethical analysis begins by sketching the so-called prima facie case for ascribing moral weight to relational effects and then moves on to consider a number of objections to it. We argue that, whereas one set of objections may be dismissed, there is another set of arguments that poses more serious challenges for including relational effects in priority setting.

Against tiebreaking arguments in priority setting.

Fair priority setting is based on morally sound criteria. Still, there will be cases when these criteria, our primary considerations, are tied and therefore do not help us in choosing one allocation over another. It is sometimes suggested that such cases can be handled by tiebreakers. In this paper, we discuss two versions of tiebreakers suggested in the literature. One version is to preserve fairness or impartiality by holding a lottery. The other version is to allow secondary considerations, considerations that are not part of our primary priority setting criteria, to be decisive. We argue that the argument for preserving impartiality by holding a lottery is sound, while the argument for using tiebreakers as secondary considerations is not. Finally, we argue that the instances where a tiebreaker seems necessary are precisely the situations where we have strong reasons for preferring a lottery. We conclude that factors that we consider valuable should all be included among the primary considerations, while ties should be settled by lotteries.

The Ethical Relevance of "Alternatives" in Health Care Priority Setting - The Case of Preexposure Prophylaxis (PrEP) of HIV.

Preexposure prophylaxis for HIV is a drug that reduces the risk for an HIV-negative person to acquire HIV if taken prior to sex. It has been suggested that it is important for resource allocation decisions that there are alternatives (such as abstinence, masturbation, etc.) for individuals potentially benefitted by this prophylaxis. In this paper we explore this idea from an ethical perspective in relation to three notions often discussed in priority setting ethics, namely responsibility, outcomes, and severity of disease. While the relevance of alternatives may be explained in terms by responsibility-sensitive priority setting, such a view comes with several challenges. We then discuss two other ways in which this intuition could be better explained: (a) in terms of total outcome of health, and (b) in terms of severity of the condition.

[Robotic-assisted pelvic and renal surgery - an overview]. / Robotassisterad bäcken- och njurkirurgi ­ en utvärdering.

Current studies indicate that robotic-assisted surgery is not inferior to laparoscopic or open surgery regarding oncologic or functional outcomes. An exception may be uterine cervix cancer, where the survival after minimal invasive surgery might not be as good as after open surgery. There is less bleeding and need for blood transfusion after robotic-assisted surgery, and postoperative complications are similar to open or laparoscopic surgery. Robotic-assisted surgery offers ergonomic advantages compared to laparoscopic surgery. The effect of the surgical learning curve is not sufficiently studied. Presently robotic-assisted surgery is not cost-effective due to high costs of investments. The operation is more time consuming than laparoscopic or open surgery with risks of delaying and cancellation of other operations.

Novel drug candidates targeting Alzheimer's disease: ethical challenges with identifying the relevant patient population.

Intensive research is carried out to develop a disease-modifying drug for Alzheimer's disease (AD). The development of drug candidates that reduce Aß or tau in the brain seems particularly promising. However, these drugs target people at risk for AD, who must be identified before they have any, or only moderate, symptoms associated with the disease. There are different strategies that may be used to identify these individuals (eg, population screening, cascade screening, etc). Each of these strategies raises different ethical challenges. In this paper, we analyse these challenges in relation to the risk stratification for AD necessary for using these drugs. We conclude that the new drugs must generate large health benefits for people at risk of developing AD to justify the ethical costs associated with current risk stratification methods, benefits much larger than current drug candidates have. This conclusion raises a new set of ethical questions that should be further discussed.

Should we accept a higher cost per health improvement for orphan drugs? A review and analysis of egalitarian arguments.

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.

Genetic testing for breast cancer risk, from BRCA1/2 to a seven gene panel: an ethical analysis.

BACKGROUND: Genetic testing is moving from targeted investigations of monogenetic diseases to broader testing that may provide more information. For example, recent health economic studies of genetic testing for an increased risk of breast cancer suggest that it is associated with higher cost-effectiveness to screen for pathogenic variants in a seven gene panel rather than the usual two gene test for variants in BRCA1 and BRCA2. However, irrespective of the extent to which the screening of the panel is cost-effective, there may be ethical reasons to not screen for pathogenic variants in a panel, or to revise the way in which testing and disclosing of results are carried out. MAIN TEXT: In this paper we discuss the ethical aspects of genetic testing for an increased risk of breast cancer with a special focus on the ethical differences between screening for pathogenic variants in BRCA1/2 and a seven gene panel. The paper identifies that the panel increases the number of secondary findings as well as the number of variants of uncertain significance as two specific issues that call for ethical reflection. CONCLUSIONS: We conclude that while the problem of handling secondary findings should not be overstated with regard to the panel, the fact that the panel also generate more variants of uncertain significance, give rise to a more complex set of problems that relate to the value of health as well as the value of autonomy. Therefore, it is insufficient to claim that the seven gene panel is preferable by only referring to the higher cost effectiveness of the panel.

Do not despair about severity-yet.

In a recent extended essay, philosopher Daniel Hausman goes a long way towards dismissing severity as a morally relevant attribute in the context of priority setting in healthcare. In this response, we argue that although Hausman certainly points to real problems with how severity is often interpreted and operationalised within the priority setting context, the conclusion that severity does not contain plausible ethical content is too hasty. Rather than abandonment, our proposal is to take severity seriously by carefully mapping the possibly multiple underlying accounts to well-established ethical theories, in a way that is both morally defensible and aligned with the term's colloquial uses.

Severity as a Priority Setting Criterion: Setting a Challenging Research Agenda.

Priority setting in health care is ubiquitous and health authorities are increasingly recognising the need for priority setting guidelines to ensure efficient, fair, and equitable resource allocation. While cost-effectiveness concerns seem to dominate many policies, the tension between utilitarian and deontological concerns is salient to many, and various severity criteria appear to fill this gap. Severity, then, must be subjected to rigorous ethical and philosophical analysis. Here we first give a brief history of the path to today's severity criteria in Norway and Sweden. The Scandinavian perspective on severity might be conducive to the international discussion, given its long-standing use as a priority setting criterion, despite having reached rather different conclusions so far. We then argue that severity can be viewed as a multidimensional concept, drawing on accounts of need, urgency, fairness, duty to save lives, and human dignity. Such concerns will often be relative to local mores, and the weighting placed on the various dimensions cannot be expected to be fixed. Thirdly, we present what we think are the most pertinent questions to answer about severity in order to facilitate decision making in the coming years of increased scarcity, and to further the understanding of underlying assumptions and values that go into these decisions. We conclude that severity is poorly understood, and that the topic needs substantial further inquiry; thus we hope this article may set a challenging and important research agenda.

Principles of Need and the Aggregation Thesis.

Principles of need are constantly referred to in health care priority setting. The common denominator for any principle of need is that it will ascribe some kind of special normative weight to people being worse off. However, this common ground does not answer the question how a plausible principle of need should relate to the aggregation of benefits across individuals. Principles of need are sometimes stated as being incompatible with aggregation and sometimes characterized as accepting aggregation in much the same way as utilitarians do. In this paper we argue that if one wants to take principles of need seriously both of these positions have unreasonable implications. We then characterize and defend a principle of need consisting of sufficientarian elements as well as prioritarian which avoids these unreasonable implications.

Patients with multiple needs for healthcare and priority to the worse off.

There is a growing body of literature which suggests that decisions about healthcare priority setting should take into account the extent to which patients are worse off. However, such decisions are often based on how badly off patients are with respect to the condition targeted by the treatment whose priority is under consideration (condition-specific severity). In this paper I argue that giving priority to the worse off in terms of condition-specific severity does not reflect the morally relevant sense of being worse off. I conclude that an account of giving priority to the worse off relevant for healthcare priority setting should take into account how badly off patients are when all of their conditions are considered (holistic severity).

The (Ir)relevance of Group Size in Health Care Priority Setting: A Reply to Juth.

How to handle orphan drugs for rare diseases is a pressing problem in current health-care. Due to the group size of patients affecting the cost of treatment, they risk being disadvantaged in relation to existing cost-effectiveness thresholds. In an article by Niklas Juth it has been argued that it is irrelevant to take indirectly operative factors like group size into account since such a compensation would risk discounting the use of cost, a relevant factor, altogether. In this article we analyze Juth's argument and observe that we already do compensate for indirectly operative factors, both outside and within cost-effectiveness evaluations, for formal equality reasons. Based on this we argue that we have reason to set cost-effectiveness thresholds to integrate equity concerns also including formal equality considerations. We find no reason not to compensate for group size to the extent we already compensate for other factors. Moreover, groups size implying a systematic disadvantage also on a global scale, i.e. taking different aspects of the health condition of patients suffering from rare diseases into account, will provide strong reason for why group size is indeed relevant to compensate for (if anything).

Individual responsibility as ground for priority setting in shared decision-making.

INTRODUCTION: Given healthcare resource constraints, voices are being raised to hold patients responsible for their health choices. In parallel, there is a growing trend towards shared decision-making, aiming to empower patients and give them more control over healthcare decisions. More power and control over decisions is usually taken to mean more responsibility for them. The trend of shared decision-making would therefore seem to strengthen the case for invoking individual responsibility in the healthcare priority setting. OBJECTIVE: To analyse whether the implementation of shared decision-making would strengthen the argument for invoking individual responsibility in the healthcare priority setting using normative analysis. RESULTS AND CONCLUSIONS: Shared decision-making does not constitute an independent argument in favour of employing individual responsibility since these notions rest on different underlying values. However, if a health system employs shared decision-making, individual responsibility may be used to limit resource implications of accommodating patient preferences outside professional standards and goals. If a healthcare system employs individual responsibility, high level dynamic shared decision-making implying a joint deliberation resulting in a decision where both parties are willing to revise initial standpoints may disarm common objections to the applicability of individual responsibility by virtue of making patients more likely to exercise adequate control of their own actions. However, if communication strategies applied in the shared decision-making are misaligned to the patient's initial capacities, arguments against individual responsibility might, on the other hand, gain strength.

Beyond the Black Box Approach to Ethics! Comment on "Expanded HTA: Enhancing Fairness and Legitimacy".

In the editorial published in this journal, Daniels and colleagues argue that his and Sabin's accountability for reasonableness (A4R) framework should be used to handle ethical issues in the health technology assessment (HTA)-process, especially concerning fairness. In contrast to this suggestion, it is argued that such an approach risks suffering from the irrrelevance or insufficiency they warn against. This is for a number of reasons: lack of comprehensiveness, lack of guidance for how to assess ethical issues within the "black box" of A4R as to issues covered, competence and legitimate arguments and finally seemingly accepting consensus as the final verdict on ethical issues. We argue that the HTA community is already in a position to move beyond this black box approach.

Health-care needs and shared decision-making in priority-setting.

In this paper we explore the relation between health-care needs and patients' desires within shared decision-making (SDM) in a context of priority setting in health care. We begin by outlining some general characteristics of the concept of health-care need as well as the notions of SDM and desire. Secondly we will discuss how to distinguish between needs and desires for health care. Thirdly we present three cases which all aim to bring out and discuss a number of queries which seem to arise due to the double focus on a patient's need and what that patient desires. These queries regard the following themes: the objectivity and moral force of needs, the prediction about what kind of patients which will appear on a micro level, implications for ranking in priority setting, difficulties regarding assessing and comparing benefits, and implications for evidence-based medicine.

From needs to health care needs.

One generally considered plausible way to allocate resources in health care is according to people's needs. In this paper I focus on a somewhat overlooked issue, that is the conceptual structure of health care needs. It is argued that what conceptual understanding of needs one has is decisive in the assessment of what qualifies as a health care need and what does not. The aim for this paper is a clarification of the concept of health care need with a starting point in the general philosophical discussion about needs. I outline three approaches to the concept of need and argue that they all share the same conceptual underpinnings. The concept of need is then analyzed in terms of a subject x needing some object y in order to achieve some goal z. I then discuss the relevant features of the object y and the goal z which make a given need qualify as a health care need and not just a need for anything.