The QALY at 50: One story many voices.

Research on quality adjusted life year (QALY) has been underway for just over 50 years, which seems like a suitable milestone to review its history. The purpose of this study is to provide a historical overview of why the QALY was developed, the key theoretical work undertaken by Torrance, Bush and Fanshel and how two seminal papers shaped its subsequent development. Moving the QALY forward - there are several historical and reflective exercises. The historical interplay between politics, policy and the challenges facing the National Health Service (NHS) in formulating the QALY concept in the UK has been explored in some depth already, whilst the conceptualization and development of the methodological framework is relatively underexplored. We address this gap by viewing the QALY through the lens of the methodological debates, reflecting upon two key papers underpinning the QALY methodology and how these methods have been developed over time. In part the changes in technology e.g. Google Scholar, and the availability of tools to search for early uses of the QALY allow us to better understand the historical context in which the theoretical development of the QALY has taken place. Here we celebrate two seminal papers that shaped early QALY development. The first section provides a history of these papers, summaries their contributions and explores the uptake of these papers over time. The second section reviews the methodological debates that have surrounded the QALY over the last 50 years and looks at how the QALY has moved to address these challenges. The third section presents the voices of diverse commentators representing the field of health economics who have contributed to the subsequent development of the QALY in both theoretical and empirical capacities and captures their thoughts about future research and policy use of QALYS.

Ambiguity preferences for health.

In most medical decisions, probabilities are ambiguous and not objectively known. Empirical evidence suggests that people's preferences are affected by ambiguity. Health economic analyses generally ignore ambiguity preferences and assume that they are the same as preferences under risk. We show how health preferences can be measured under ambiguity, and we compare them with health preferences under risk. We assume a general ambiguity model that includes many of the ambiguity models that have been proposed in the literature. For health gains, ambiguity preferences and risk preferences were indeed the same. For health losses, they differed with subjects being more pessimistic in decision under ambiguity. Utility and loss aversion were the same for risk and ambiguity. Our results imply that reducing the clinical ambiguity of health losses has more impact than reducing the ambiguity of health gains, that utilities elicited with known probabilities may not carry over to an ambiguous setting, and that ambiguity aversion may impact value of information analyses if losses are involved. These findings are highly relevant for medical decision making, because most medical interventions involve losses.

Treatment decisions under ambiguity.

Many health risks are ambiguous in the sense that reliable and credible information about these risks is unavailable. In health economics, ambiguity is usually handled through sensitivity analysis, which implicitly assumes that people are neutral towards ambiguity. However, empirical evidence suggests that people are averse to ambiguity and react strongly to it. This paper studies the effects of ambiguity aversion on two classical medical decision problems. If there is ambiguity regarding the diagnosis of a patient, ambiguity aversion increases the decision maker's propensity to opt for treatment. On the other hand, in the case of ambiguity regarding the effects of treatment, ambiguity aversion leads to a reduction in the propensity to choose treatment.

Capabilities as menus: a non-welfarist basis for QALY evaluation.

Quality-Adjusted Life Years (QALYs) are the most widely used measure of health in economic evaluations of health care. Within a welfarist framework QALYs are consistent with people's preferences under stringent assumptions. Several authors have argued that QALYs are a valid measure of health within an extra-welfarist framework. This paper studies the applicability of QALYs within the best-known extra-welfarist framework, Sen's capability approach. We propose a procedure to value capability sets and provide a foundation for QALYs within Sen's capability approach. We show that, under appropriate conditions, the ranking of capabilities can be represented locally by a QALY measure and that a willingness to pay for QALYs can be defined. The validity of QALYs as a general measure of health requires the same stringent conditions as in a welfarist framework.

A direct method for measuring discounting and QALYs more easily and reliably.

Time discounting and quality of life are two important factors in evaluations of medical interventions. The measurement of these two factors is complicated because they interact. Existing methods either simply assume one factor given, based on heuristic assumptions, or invoke complicating extraneous factors, such as risk, that generate extra biases. The authors introduce a method for measuring discounting (and then quality of life) that involves no extraneous factors and that avoids distorting interactions. Their method is considerably simpler and more realistic for subjects than existing methods. It is entirely choice based and thus can be founded on economic rationality requirements. An experiment demonstrates the feasibility of this method and its advantages over classical methods.

An experimental test of the concentration index.

The concentration index is widely used to measure income-related inequality in health. No insight exists, however, whether the concentration index connects with people's preferences about distributions of income and health and whether a reduction in the concentration index reflects an increase in social welfare. We explored this question by testing the central assumption underlying the concentration index and found that it was systematically violated. We also tested the validity of alternative health inequality measures that have been proposed in the literature. Our data showed that decreases in the spread of income and health were considered socially desirable, but decreases in the correlation between income and health not necessarily. Support for a condition implying that the inequality in the distribution of income and in the distribution of health can be considered separately was mixed.

How to aggregate health? Separability and the effect of framing.

BACKGROUND: Unweighted summation or quality-adjusted life year (QALY) utilitarianism is the most common way to aggregate health benefits in a cost-effectiveness analysis. A key qualitative principle underlying QALY utilitarianism is separability: those individuals unaffected by a policy choice should not influence the policy choice. Separability also underlies several of the alternatives for QALY utilitarianism that have been proposed. OBJECTIVES: To test separability and to test whether the support for separability is affected by the framing of the choice questions. METHODS: In 2 experiments, 345 student subjects (162 in the first experiment, and 183 in the second experiment) were asked to select 1 of 2 possible treatments, with each treatment resulting in a different distribution of health across individuals. The only aspect that varied across choice questions was the state of the patients whose health was unaffected by the act of choosing a policy. In each experiment, we used 2 frames. In the implicit frame, it was implied but not plainly expressed what outcomes the treatments had in common. In the explicit frame, common outcomes of the 2 treatments were directly stated. The 2 experiments differed in the way the explicit frame was presented (verbal v. numerical). RESULTS: The support for separability was significantly greater in the explicit frame. The proportion of violations in the implicit frame was 44% in Experiment 1 and 31% in Experiment 2, while in the explicit frame, the proportion of violations was 28% in Experiment 1 and 8% in Experiment 2. CONCLUSIONS: Framing affected the support for separability, raising issues as to whether it is possible to achieve a canonical representation of social choices.

When are person tradeoffs valid?

The person tradeoff (PTO) is commonly used in health economic applications. However, to date it has no theoretical basis. The purpose of this paper is to provide this basis from a set of assumptions that together justify the most common applications of the PTO method. Our analysis identifies the central assumptions in PTO measurements. We test these assumptions in an experiment, but find only limited support for the validity of the PTO.

Aversion to health inequalities and priority setting in health care.

Traditionally aversion to health inequality is modelled through a concave utility function over health outcomes. Bleichrodt et al. [Bleichrodt, H., Diecidue E., Quiggin J., 2004. Equity weights in the allocation of health care: the rank-dependent QALY model. Journal of Health Economics 23, 157-171] have suggested a "dual" approach based on the introduction of explicit equity weights. The purpose of this paper is to analyze how priorities in health care are determined in the framework of these two models. It turns out that policy implications are highly sensitive to the choice of the model that will represent aversion to health inequality.

New tests of QALYs when health varies over time.

This paper performs new tests of the QALY model when health varies over time. Our tests do not involve confounding assumptions and are robust to violations of expected utility. The results support the use of QALYs at the aggregate level, i.e. in economic evaluations of health care. At the individual level, there is less support for QALYs. The individual data are, however, largely consistent with a more general QALY-type model that remains tractable for applications.

A welfare economics foundation for health inequality measurement.

The empirical literature on the measurement of health inequalities is vast and rapidly expanding. To date, however, no foundation in welfare economics exists for the proposed measures of health inequality. This paper provides such a foundation for commonly used measures like the health concentration index, the Gini index, and the extended concentration index. Our results indicate that these measures require assumptions that appear restrictive. One way forward may be the development of multi-dimensional extensions.

Willingness to pay for reductions in health risks when probabilities are distorted.

We study the willingness to pay for reductions in health risks when people do not evaluate probabilities linearly, as is commonly assumed in elicitations of willingness to pay, but weight probabilities, as is commonly observed in empirical studies of decision under risk. We show that for the levels of baseline risk typically considered, probability weighting strongly affects willingness to pay estimates and may lead to unstable monetary valuations of health.

A nonparametric elicitation of the equity-efficiency trade-off in cost-utility analysis.

We performed an empirical elicitation of the equity-efficiency trade-off in cost-utility analysis using the rank-dependent quality-adjusted life-year (QALY) model, a model that includes as special cases many of the social welfare functions that have been proposed in the literature. Our elicitation method corrects for utility curvature and, therefore, our estimated equity weights are not affected by diminishing marginal utility. We observed a preference for equality in the allocation of health. The data suggest that the elicited equity weights were jointly determined by preferences for equality and by insensitivity to group size. A procedure is proposed to correct the equity weights for insensitivity to group size. Finally, we give an illustration how our method can be implemented in health policy.

The economic value of informal care: a study of informal caregivers' and patients' willingness to pay and willingness to accept for informal care.

We provide a new test of the feasibility of using contingent valuation to value informal care. We start with a theoretical model of informal caregiving and derive that willingness to pay depends positively on wealth and negatively on own health, whereas the effect of other's health is sign-ambiguous. These predictions are tested in two new data sets on patients' and caregivers' willingness to pay (WTP) and willingness to accept (WTA) for informal care. The data are generally consistent with the theoretical predictions: wealth generally has a positive impact and own health a negative impact. Other's health has a mixed effect. We find only small differences between WTP and WTA. Our findings suggest that contingent valuation may be a useful technique to value informal care in economic evaluations of health care.

Equity weights in the allocation of health care: the rank-dependent QALY model.

This paper introduces the rank-dependent quality-adjusted life-years (QALY) model, a new method to aggregate QALYs in economic evaluations of health care. The rank-dependent QALY model permits the formalization of influential concepts of equity in the allocation of health care, such as the fair innings approach, and it includes as special cases many of the social welfare functions that have been proposed in the literature. An important advantage of the rank-dependent QALY model is that it offers a straightforward procedure to estimate equity weights for QALYs. We characterize the rank-dependent QALY model and argue that its central condition has normative appeal.

A new and more robust test of QALYs.

Previous empirical tests of quality-adjusted life-years (QALYs), the most widely used outcome measure in economic evaluations of health care, generally yielded negative results. These tests were, however, for the most part based on expected utility, which is now widely acknowledged to be descriptively inaccurate. The observed violations might, therefore, have been caused by violations of expected utility. We performed a new test of QALYs, which is valid under expected utility and under the two most influential non-expected utility theories, rank-dependent utility and prospect theory, and found considerable support for the QALY model. Our findings suggest that QALYs may be valid if nonexpected utility formulas are used to compute health state utilities.

A consistency test of the time trade-off.

This paper tests the internal consistency of time trade-off utilities. We find significant violations of consistency in the direction predicted by loss aversion. The violations disappear for higher gauge durations. We show that loss aversion can also explain that for short gauge durations time trade-off utilities exceed standard gamble utilities. Our results suggest that time trade-off measurements that use relatively short gauge durations, like the widely used EuroQol algorithm, are affected by loss aversion and lead to utilities that are too high.

A new explanation for the difference between time trade-off utilities and standard gamble utilities.

This paper gives a new explanation for the systematic disparity between standard gamble (SG) utilities and time trade-off (TTO) utilities. The common explanation, which is based on expected utility, is that the disparity is caused by curvature of the utility function for duration. This explanation is, however, incomplete. People violate expected utility and these violations lead to biases in SG and TTO utilities. The paper analyzes the impact on SG and TTO utilities of three main reasons why people violate expected utility: probability weighting, loss aversion, and scale compatibility. In the SG, the combined effect of utility curvature, probability weighting, loss aversion, and scale compatibility is an upward bias. In the TTO these factors lead both to upward and to downward biases. This analysis can also explain the tentative empirical finding that the TTO better describes people's preferences for health than the SG.

A proposal to solve the comparability problem in cost-utility analysis.

In cost-utility analysis it is assumed that health state valuations are directly comparable across individuals. Instead, health state valuations may be relative and related to people's expectations and abilities. Then health state valuations are not fully comparable across people and, consequently, cost utility analysis cannot be applied in full. The present paper analyzes this comparability problem and proposes a method to solve it.