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Objectives This study aimed to investigate whether the profit margins of pharmaceuticals would influence the outcome of reimbursement decisions within the Dutch policy context. Methods We conducted a discrete choice experiment among 58 Dutch decision makers. In 20 choice sets, we asked respondents to indicate which of 2 pharmaceutical treatment options they would select for reimbursement. Options were described using 5 attributes (disease severity, incremental costs per quality-adjusted life-year, health gain, budget impact, and profit margin) with 3 levels each. Additionally, cognitive debriefing questions were presented, and for validation debriefing, interviews were conducted. Choice data were analyzed using mixed logit models, also to calculate marginal effects and choice probabilities. Results Results indicated that the specified levels of profit margins significantly influenced choices made. Decision makers were less likely to reimburse a product with a higher profit margin. The relative importance of profit margins was lower than that of the included traditional health technology assessment criteria, but not negligible. When asked directly, 61% of respondents indicated that profit margin should play a role in reimbursement decision making, although concerns about feasibility and the connection to price negotiations were voiced. Conclusions Our results suggest that if available to decision makers the profit margin of pharmaceutical products would influence reimbursement decisions within the Dutch policy context. Higher profit margins would reduce the likelihood of reimbursement. Whether adding profit margin as an additional, explicit criterion to the health technology assessment decision framework would be feasible and desirable is open to further exploration.

The COVID-19 pandemic highlights the need for effective infectious disease outbreak prevention. This could entail installing an integrated, international early warning system, aiming to contain and mitigate infectious diseases outbreaks. The amount of resources governments should spend on such preventive measures can be informed by the value citizens attach to such a system. This was already recognized in 2018, when a contingent valuation willingness to pay (WTP) experiment was fielded, eliciting the WTP for such a system in six European countries. We replicated that experiment in the spring of 2020 to test whether and how WTP had changed during an actual pandemic (COVID-19), taking into account differences in infection rates and stringency of measures by government between countries. Overall, we found significant increases in WTP between the two time points, with mean WTP for an early warning system increasing by about 50% (median 30%), from around €20 to €30 per month. However, there were marked differences between countries and subpopulations, and changes were only partially explained by COVID-19 burden. We discuss possible explanations for and implication of our findings. Supplementary Information The online version contains supplementary material available at 10.1007/s10198-021-01353-6.

Objectives The importance of economic evaluations of mental healthcare interventions is increasingly recognized. Despite the multitude of available quality of life instruments, concerns have been raised regarding the content validity of these instruments, and hence suitability for use in mental health. The aim of this paper, therefore, was to assess the content validity and the suitability of existing quality of life instruments for use in economic evaluations in mental health problems. Methods In order to identify available quality of life instruments used in people with mental health problems, a systematic review was performed using the Embase, Medline and PsycINFO databases (time period January 2012 to January 2018). Two reviewers independently assessed study eligibility and executed data extraction. The evaluation framework of Connell and colleagues was used to assess whether the identified quality of life instruments cover the dimensions valued highly by people with mental health problems. Two reviewers independently mapped the content of each identified instrument onto the evaluation framework and indicated the extent to which the instrument covered each of the dimensions of the evaluation framework. Results Searches of databases yielded a total of 5727 references. Following duplicate removal and double-independent screening, 949 studies were included in the qualitative synthesis. A total of 44 unique quality of life instruments were identified, of which 12 were adapted versions of original instruments. The best coverage of the dimensions of the evaluation framework of Connell and colleagues was by the WHOQOL-100, S-QoL, SQLS, EDQoL, QLI and the IMHQOL, but none fully covered all dimensions of the evaluation framework. Conclusions The results of this study highlight the multitude of available quality of life instruments used in people with mental health problems and indicate that none of the available quality of life instruments fully cover the dimensions previously found to be important in people with mental health problems. Future research should explore the possibilities of refining or expanding existing instruments as well as the development and testing of new quality of life instruments to ensure that all relevant quality of life dimensions for people with mental health problems are covered in evaluations.

Currently, reimbursement decisions based on health technology assessments (HTA) in the Netherlands mostly concern outpatient pharmaceuticals. The Dutch government aspires to broaden the systematic application of full HTA towards other types of health care in order to optimise the content of the basic benefit package. This paper identifies important challenges for broadening the scope of full HTA to other types of health care. Based on a description of the Dutch reimbursement decision-making process, five important characteristics of outpatient pharmaceuticals were identified, which are all relevant to the successful application of HTA: (i) closed reimbursement system, (ii) absence of alternative policy measures, (iii) existence of marketing authorisation, (iv) identifiable and accountable counterparty, and (v) product characteristics. For a selection of other types of health care, which may be subject to HTA more frequently in the future, deviations from these characteristics of outpatient pharmaceuticals are discussed. The implications of such deviations for performing HTA and the decision-making process are highlighted. It is concluded that broadening the application of HTA will require policy makers to meet both important policy-related and methodological challenges. These challenges differ per health care domain, which may inform policy makers which expansions of the current use of HTA are most feasible.

Background and Objective: The COVID-19 pandemic and the measures taken by governments to contain it have affected many aspects of the daily lives of citizens. This study aimed to describe changes in the productivity of paid work and time allocation to paid and unpaid work and leisure resulting from working at home during the pandemic. Methods: A sample of 851 people from the Netherlands who had paid work (≥ 24 h/week) and worked at least 4 hours per week extra at home because of lockdown measures completed a questionnaire during the first COVID-19 lockdown (April 2020). Respondents reported time spent on paid and unpaid work and leisure before and during the lockdown. Productivity was measured in terms of quantity and quality of paid work. Results: On average, respondents spent less time (14%) on paid work and productivity decreased 5.5%. Changes in productivity were associated with the age of children, net income and having a separate home office. Respondents spent more time on unpaid work (27%) and leisure (11%). Women spent more time on unpaid work in absolute but not in relative terms. People with a partner and with children spent more time on unpaid work and less time on leisure. Conclusions: Productivity of paid work decreased, and people reallocated time between paid and unpaid work and leisure during the first COVID-19 lockdown. Changes in time allocation and productivity differed across subgroups. If working at home becomes more common, future research should focus on the long-term impact on productivity and mental and physical health.

_Objectives:_ Decision-making frameworks that draw on economic evaluations increasingly use equity weights to facilitate a more equitable and fair allocation of healthcare resources. These weights can be attached to health gains or reflected in the monetary threshold against which the incremental cost-effectiveness ratios of (new) health technologies are evaluated. Currently applied weights are based on different definitions of disease severity and do not account for age-related preferences in society. However, age has been shown to be an important equity-relevant characteristic. This study examines the willingness to pay (WTP) for health-related quality of life (QOL) gains in relation to the disease severity and age of patients, and the outcome of the disease. _Methods:_ We obtained WTP estimates by applying contingent-valuation tasks in a representative sample of the public in The Netherlands (n = 2023). We applied random-effects generalized least squares regression models to estimate the effect of patients’ disease severity and age, size of QOL gains, disease outcome (full recovery/death 1 year after falling ill), and respondent characteristics on the WTP. _Results:_ Respondents’WTP was higher for more severely ill and younger patients and for larger-sized QOL gains, but lower for patients who died. However, the relations were nonlinear and context dependent. Respondents with a lower age, who were male, had a higher household income, and a higher QOL stated a higher WTP for QOL gains. _Conclusions:_ Our results suggest that—if the aim is to align resource-allocation decisions in healthcare with societal preferences—currently applied equity weights do not suffice.

SamenvattingHet stimuleren van gezond gedrag staat hoog op de politieke agenda. Overheidsmaatregelen op het gebied van gezonde voeding staan echter nog in de kinderschoenen. Onlangs pleitte de Raad voor Volksgezondheid en Samenleving dan ook voor meer overheidsmaatregelen om ongezond eetgedrag tegen te gaan. Het ontwerpen van zulke maatregelen op een zowel acceptabele als effectieve wijze is complex. We legden zevenhonderd Nederlanders vijf stellingen voor met betrekking tot overheidsingrijpen op het gebied van gezonde voeding. We vroegen hen welk effect ze voor zichzelf en voor anderen verwachten van de maatregelen die zijn gesuggereerd in het zogenaamde Nationaal Preventieakkoord en eveneens zijn aangehaald door de Raad voor Volksgezondheid en Samenleving.

Purpose The purpose of this study was to develop and psychometrically evaluate a new quality of life measure for use in people with mental health problems—the Mental Health Quality of Life questionnaire (MHQoL). Methods The MHQoL dimensions were based on prior research by Connell and colleagues, highlighting the seven most important quality of life dimensions in the context of mental health. Items were generated following a systematic review we performed and through inviting expert opinion. A focus group and an online qualitative study (N = 120) were carried out to assess the face and content validity of the MHQoL. The MHQoL was further tested for its internal consistency, convergent validity, known-group validity and test–retest reliability among mental healthcare service users (N = 479) and members of the general population (N = 110). Results The MHQoL consists of a descriptive system (MHQoL-7D), including s items covering seven dimensions (self-image, independence, mood, relationships, daily activities, physical health, future) and a visual analogue scale of general psychological well-being (MHQoL-VAS). Internal consistency was high (Cronbach's ∝ = 0.85) and correlations between MHQoL-7D scores and related measures (EQ-5D-5L, MANSA, ICECAP-A, and BSI) supported convergent validity. The intraclass correlation coefficient of the MHQoL-7D sum score for test–retest reliability was 0.85. Known-group validity was supported by the ability to detect significant differences in MHQoL-7D levels between service users and the general population, and between groups with different levels of psychological distress. Conclusion The MHQoL demonstrated favourable psychometric properties and showed promise as a simple and effective measure to assess quality of life in people with mental health problems.

Objectives Medical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization. Methods We conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years. Results We identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion. Conclusions CED programmes for devices with different characteristics exist in Europe. Decision-makers’ perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere.

BACKGROUND: When vaccines increase longevity, vaccinated people may experience costs and benefits during added life-years. These future benefits and costs may include increased productivity as well as medical and non-medical costs. Such impacts should be considered in cost-effectiveness analyses (CEA) of vaccines but are often omitted. Here, we illustrate the impact of including future costs on the cost-effectiveness of vaccination against pneumococcus disease. We emphasize the relevance of differentiating cost estimates between risk groups.METHODS: We updated an existing Dutch CEA of vaccination against pneumococcus disease with the 13-valent pneumococcal conjugate vaccine (PCV13) to include all future medical and non-medical costs. We linked costs by age and risk with survival information and estimates of cases prevented per vaccination strategy based on the original study to calculate the impact of inclusion. Future medical costs were adjusted for relevant risk groups.RESULTS: For the base-case strategy, the original incremental cost-effectiveness ratio (ICER) of PVC13 was €9,157 per quality adjusted life-year (QALY). Including all future medical costs increased the ICER to €28,540 per QALY. Also including future non-medical costs resulted in an ICER of €45,691 per QALY. The impact of future medical costs varied considerably per risk group and generally increased with age.DISCUSSION AND CONCLUSION: This study showed a substantial effect of the inclusion of future costs on the ICER of vaccinating with PCV13. Especially when lives of people with underlying health conditions are extended, the impact of future medical costs is large. This inclusion may make vaccination a less attractive option, especially in relation to low thresholds as often applied for prevention. Although this raises important questions, ignoring these real future costs may lead to an inefficient use of healthcare resources. Our results may imply that prices for some vaccines need to be lowered to be cost-effective.

People do not only care about maximizing health gains but also about their distribution. For example, they give more weight to younger patients than older patients. This pilot study aims to investigate if age weighting is reinforced by loss aversion if young people are falling behind one's perceived ‘normal’ quality of life (QoL), while older people do not. We apply a person trade-off method in a large representative sample (n = 990) to estimate age weighting factors. We also measure QoL levels that individuals regard as ‘normal’ for different ages, serving as reference points. We observe a considerable amount of age weighting, with 20-year-old patients on average receiving 1.7 times as much weight as 80-year-old patients. Perceived ‘normal’ QoL rapidly decreases with age of a patient. Older people are more optimistic about what constitutes ‘normal QoL’ than younger people, but they express a faster decline in normal QoL due to aging. Respondents who view all improvements to be gain enlarging show the least age weighting, but loss aversion cannot explain the results. Still, one's age-related reference level is an important predictor of age weights. Given the explorative nature of this study, further studies are called for to generate more robust evidence.

INTRODUCTION: Performance-based risk-sharing agreements (PBRSAs), between payers, health care providers, and technology manufacturers can be useful when there is uncertainty about the (cost-) effectiveness of a new technology or service. However, they can be challenging to design and implement. AREAS COVERED: A total of 18 performance-based agreements were identified through a literature review. All but two of the agreements identified were pay-for-performance schemes, agreed between providers and payers at the national level. No examples were found of agreements between health care providers and manufacturers at the local level. The potential for these local agreements was illustrated by hypothetical case studies of water quality management and an integrated chronic kidney disease program. EXPERT OPINION: Performance-based risk-sharing agreements can work to the advantage of patients, health care providers, payers, and technology manufacturers, particularly if they facilitate the introduction of technologies or systems of care that might not have been introduced otherwise. However, the design, conduct, and implementation of PBRSAs in renal care pose a number of challenges. Efforts should be made to overcome these challenges so that more renal care patients can benefit from technological advances and new models of care.

IntroductionMost collectively funded healthcare systems set limits to their benefit package. Doing so requires judgements which may involve economic evaluations. Performing such evaluations brings methodological challenges, which may be more pronounced in non-pharmaceutical interventions. For example, for medical devices, the validity of assessment results may be limited by learning effects, incremental innovation of the devices and the context-dependency of their outcomes.ObjectiveTo review the extent to which "learning effects", "incremental innovation" (related to outcomes) and "context-dependency" are included and/or discussed in peer reviewed economic evaluations on medical devices using Transcatheter Aortic Valve Implementation (TAVI) as an example.MethodsA systematic review was performed including full economic evaluations of TAVI for operable patients with aortic stenosis identified using the Pubmed database. Study characteristics, study results and text fragments concerning the aforementioned aspects were extracted. The quality of the studies was assessed using a quality checklist (CHEC-extended).ResultsWithin 207 screened records, 15 studies were identified. Two studies referred to all three aspects, four studies referred to none. "Learning effects" were discussed in five studies, one of which described a method to cope with this challenge. “Incremental innovation” was described in seven studies. Limitations in generalizability of results related to context of care provision were discussed in seven studies.ConclusionThe challenges related to economic evaluations of TAVI and their influence on the validity of reported results, are typically only partly discussed and rarely dealt within peer reviewed studies. It is important for better informed policy decisions that this improves.

One core assumption of standard economic theory is that an individual’s preferences are stable, irrespective of the method used to elicit them. This assumption may be violated if preference reversals are observed when comparing different methods to elicit people’s preferences. People may then prefer A over B using one method while preferring B over A using another. Such preference reversals pose a significant problem for theoretical and applied research. We used a sample of medical and economics students to investigate preference reversals in the health and financial domain when choosing patients/clients. We explored whether preference reversals are associated with domain-relevant training and tested whether using guided ‘choice list’ elicitation reduces reversals. Our findings suggest that preference reversals were more likely to occur for medical students, within the health domain, and for open-ended valuation questions. Familiarity with a domain reduced the likelihood of preference reversals in that domain. Although preference reversals occur less frequently within specialist domains, they remain a significant theoretical and practical problem. The use of clearer valuation procedures offers a promising approach to reduce preference reversals.

Background There is debate around the composition of life years gained from smoking elimination. The aim of this study was to conduct a systematic review of the literature to synthesize existing evidence on the effect of smoking status on health expectancy and to examine whether smoking elimination leads to compression of morbidity. Methods Five databases were systematically searched for peer-reviewed articles. Studies that presented quantitative estimates of health expectancy for smokers and non-/never-smokers were eligible for inclusion. Studies were searched, selected and reviewed by two reviewers who extracted the relevant data and assessed the risk of bias of the included articles independently. Results The search identified 2491 unique records, whereof 20 articles were eligible for inclusion (including 26 cohorts). The indicators used to measure health included disability/activity limitations (n=9), health-related quality of life (EQ-5D) (n=2), weighted disabilities (n=1), self-rated health (n=9), chronic diseases (n=6), cardiovascular diseases (n=4) and cognitive impairment (n=1). Available evidence showed consistently that non-/never-smokers experience more healthy life years throughout their lives than smokers. Findings were inconsistent on the effect of smoking on the absolute number of unhealthy life years. Findings concerning the time proportionally spent unhealthy were less heterogeneous: nearly all included articles reported that non-/never-smokers experience relatively less unhealthy life years (e.g. relative compression of morbidity). Conclusions Support for the relative compression of morbidity due to smoking elimination was evident. Further research is needed into the absolute compression of morbidity hypothesis since current evidence is mixed, and methodology of studies needs to be harmonized.

Purpose The CarerQol instrument has been designed and validated as an instrument able to measure both the positive and the negative impacts of caregiving on the quality of life of informal caregivers (CarerQol-7D), as well as their general happiness (CarerQol-VAS). The aim of this study was to assess the construct validity of the CarerQol in the Hungarian context. Methods The CarerQol was translated into Hungarian. Subsequently, in a cross-sectional online survey, representative for the general Hungarian population (N = 1000), informal caregivers were identified (N = 149, female 51.2%, mean age 53.2). Clinical, convergent and discriminant validity of the CarerQol were evaluated in relation to the caregivers’ and care recipients’ EQ-5D-5L health status, and caregiving situation characteristics. Results Average CarerQol-7D and CarerQol-VAS scores were 76.0 (SD 16.2) and 6.8 (SD 2.3), respectively. CarerQol-7D and CarerQol-VAS scores were significantly correlated with caregiving time (r = − 0.257; − 0.212), caregivers’ EQ-5D-5L scores (r = 0.453; 0.326) and the CarerQol-7D also with care recipients’ EQ-5D-5L scores (r = 0.247). CarerQol-7D scores differed significantly with relevant caregiving characteristics (e.g. nature and severity of care recipients’ health status, sharing household) and both the CarerQol-7D and CarerQol-VAS with the overall care experience. Conclusion Our findings confirmed the validity of the Hungarian language version of the CarerQol and support the cross-cultural validity of the instrument. CarerQol-7D scores performed better in distinguishing caregiving situation characteristics than the general happiness measure CarerQol-VAS. Care recipients’ health status was only weakly associated with informal caregivers’ care-related quality of life and happiness. Caregivers’ own health and caregiving circumstances were more strongly associated with these scores.

Standard gamble (SG) typically yields higher health state valuations than time trade‐off (TTO), which may be caused by biases affecting both methods. It has been suggested that TTO yields more accurate health state valuations, because TTO is subject to both upward and downward biases that may cancel out. Verifying this claim, however, would require a golden standard to test validity against. In this study, we attempted to provide a first direct test of the validity of health state valuation. A total of 119 students completed five TTO and SG tasks. Afterwards, their health state valuations elicited with TTO and SG were shown to them in an interactive graph. Respondents were asked to indicate which of the methods represented their valuation of a health state best. They could also adjust their valuation. Overall, we found that respondents indicated that TTO valuations better reflected health state valuations, a result that was more pronounced for more severe health states. When offered the opportunity, on average, respondents adjusted health state valuations downwards. These findings may have implications for future work on (bias correction in) health state valuations.

Background: The CarerQol instrument can be used in economic evaluations to measure the care-related quality of life of informal caregivers. Tariff sets are available for Australia, Germany, Sweden, the Netherlands, the UK, and the USA. Objective: Our objective was to develop tariff sets for the CarerQol instrument for Hungary, Poland and Slovenia and to compare these with the existing value sets. Methods: Discrete-choice experiments were carried out in Hungary, Poland and Slovenia. Data were collected through an online survey between November 2018 and January 2019, using representative samples of 1000 respondents per country. Tariffs were calculated from coefficient estimates from panel mixed multinomial logit models with random parameters. Results: All seven CarerQol domains contributed significantly to the utility associated with different caregiving situations. Attributes valued highest were ‘physical health’ (tariffs for no problems were 15.6–21.8), ‘mental health’ (18.1–18.9) and ‘fulfilment’ (16.3–22.9). Value sets were comparable across the countries, although in Poland ‘a lot of fulfilment’ was valued higher (22.9) than in Hungary (16.3) and Slovenia (17.1). Compared with existing value sets, in the three Central European countries, ‘fulfilment’ was more important, whereas ‘financial problems’ were less important. Conclusion: For the first time in the Central and Eastern European region, country-specific tariffs are now available for the Hungarian, Polish and Slovenian versions of the CarerQol instrument. This facilitates inclusion of the impact of informal care in economic evaluations. Our results can be used to develop and evaluate country-specific health policy strategies to support informal caregivers. The differences found in informal care preferences highlight the limited transferability of CarerQol tariffs across European regions.

Carer quality of life is increasingly considered alongside patient quality of life in economic evaluation. Important questions remain about how to value carer and patient quality of life effects alongside one another. In this study, we estimated the relative social value of two conceptualisations of carer quality of life (health-related and care-related) compared to patient quality of life. Relative valuations were estimated using a person trade-off (PTO) study with 990 representative members of the UK public. Participants chose between hypothetical services that improved the quality of life of carers and patients, iterating to a point of indifference. Overall 84% of participants completing the task were willing to trade patient and carer quality of life effects. Relative to a reference point of 1 for patient health-related quality of life, we estimated a social value of 0.74 for carer health-related quality of life effects and 0.69 for carer care-related quality of life effects. In conclusion, public preferences appear to support the inclusion of carer quality of life effects within economic evaluation. The results provide a means to value different carer quality of life outcomes in economic evaluation, where such values are needed and deemed appropriate.

Objectives This study aimed (1) to perform a systematic literature review of instruments for measuring productivity loss of paid and unpaid work and (2) to assess the suitability (in terms of identification, measurement, and valuation) of these instruments for use in health economic evaluations from a societal perspective. Methods Articles published from 2018 were sourced from PubMed/Medline, PsycInfo, Embase, and Econlit. Using 2 separate search strategies, eligible economic evaluations and validation studies were selected and unique measurement instruments identified. A data-extraction form was developed by studying previous literature and consulting an international panel of experts in the field of productivity costs. This data-extraction form was applied to assess the suitability of instruments for use in economic evaluations. Results A total of 5982 articles were retrieved from the databases, of which 99 economic evaluations and 9 validation studies were included in the review. A total of 42 unique measurement instruments were identified. Nine instruments provided quantified measures of absenteeism, presenteeism, and unpaid work. Five instruments supplied the necessary information to enable the use of at least 1 common valuation method. The Health and Labour Questionnaire-Short Form, Health and Labour Questionnaire, and Institute for Medical Technology Assessment Productivity Cost Questionnaire met both criteria. Nevertheless, the developers replaced the Health and Labour Questionnaire-Short Form and Health and Labour Questionnaire by the more recently developed Institute for Medical Technology Assessment Productivity Cost Questionnaire. Conclusions Although many instruments for measuring productivity loss were identified, most were not suitable for capturing productivity changes for economic evaluations from a societal perspective. Future research can benefit from this study by making an informed instrument choice for the measurement of productivity loss of paid and unpaid work.

Objectives: Cost-effectiveness analyses typically require measurement of health-related quality of life (HRQoL) to estimate quality-adjusted life-years. Challenges with measuring HRQoL arise in the context of episodic conditions if patients are less likely—or even unable—to complete surveys when having disease symptoms. This article explored whether HRQoL measured at regular time intervals adequately reflects the HRQoL of people with epilepsy (PWE). Methods: Follow-up data from the Epilepsy Support Dog Evaluation study on the (cost-)effectiveness of seizure dogs were used in which HRQoL is measured in 25 PWE with the EQ-5D at baseline and every 3 months thereafter. Seizure count is recorded daily using a seizure diary. Regression models were employed to explore whether PWE were more likely to complete the HRQoL survey on a good day (ie, when seizures are absent or low in frequency compared with other days) and to provide an estimate of the impact of reporting HRQoL on a good day on EQ-5D utility scores. Results: A total of 111 HRQoL measurements were included in the analyses. Regression analyses indicated that the day of reporting HRQoL was associated with a lower seizure count (P

Medical interventions that increase life expectancy of patients result in additional consumption of non-medical goods and services in 'added life years'. This paper focuses on the distributional consequences across socio-economic groups of including these costs in cost effectiveness analysis. In that context, it also highlights the role of remaining quality of life and household economies of scale. Data from a Dutch household spending survey was used to estimate non-medical consumption and household size by age and educational attainment. Estimates of non-medical consumption and household size were combined with life tables to estimate what the impact of including non-medical survivor costs would be on the incremental cost effectiveness ratio (ICER) of preventing a death at a certain age. Results show that including non-medical survivor costs increases estimated ICERs most strongly when interventions are targeted at the higher educated. Adjusting for household size (lower educated people less often live additional life years in multi-person households) and quality of life (lower educated people on average spend added life years in poorer health) mitigates this difference. Ignoring costs of non-medical consumption in economic evaluations implicitly favors interventions targeted at the higher educated and thus potentially amplifies socio-economic inequalities in health.

Background Early identification of patients with an anxiety disorder, obsessive-compulsive disorder (OCD), or post-traumatic stress disorder (PTSD) in need of highly specialized care could facilitate the selection of the optimal initial treatment in these patients. This paper describes the development and psychometric evaluation of the Decision Tool Anxiety Disorders, OCD and PTSD (DTAOP), which aims to aid clinicians in the early identification of patients with an anxiety disorder, OCD, or PTSD in need of highly specialized mental healthcare. Methods A systematic literature review and a concept mapping procedure were carried out to inform the development of the DTAOP. To evaluate the psychometric properties of the DTAOP, a cross-sectional study in 454 patients with a DSM-IV-TR anxiety disorder was carried out. Feasibility was evaluated by the completion time and the content clarity of the DTAOP. Inter-rater reliability was assessed in a subsample of 87 patients. Spearman’s rank correlation coefficients between the DTAOP and EuroQol five-dimensional questionnaire (EQ-5D-5L) scores were computed to examine the convergent validity. Criterion validity was assessed against independent clinical judgments made by clinicians. Results The average time required to complete the eight-item DTAOP was 4.6 min and the total DTAOP was evaluated as clear in the majority (93%) of the evaluations. Krippendorff’s alpha estimates ranged from 0.427 to 0.839. Based on the qualitative feedback, item wording and instructions were improved. As hypothesized, the DTAOP correlated negatively with EQ-5D-5L scores. The area under the curve was 0.826 and the cut-off score of ≥4 optimized sensitivity (70%) and specificity (71%). Conclusions The DTAOP demonstrated excellent feasibility and good validity, but weak inter-rater reliability. Based on the qualitative feedback and reliability estimates, revisions and refinements of the wording and instructions were made, resulting in the final version of the DTAOP.

In the evaluation of well-being, it is not only important what people have in absolute terms, but also how this compares to reference points in relative terms. We explore the relevance of relative comparisons by testing the effect of people's self-rated position on potential reference points for income and health on their subjective well-being. We used Multiple Discrepancies Theory as a framework to identify seven potentially relevant reference points for income and health. A representative sample (N = 550) of the Netherlands assessed their income and health relative to these reference points. In addition, we elicited monthly household income, health status (EQ-5D-5L), and subjective well-being (SWLS). In line with the literature, we found a negative convex relationship between subjective well-being and age and a positive relationship with being employed, income, and health. For income, subjective well-being was also associated with how current income compared to respondents' needs and progression over time, and for health especially with how current health compared to what they felt they deserved. Our findings suggest that income and health are important for subjective well-being both in absolute and relative terms. We found negative effects on life satisfaction if some of the domain specific reference points were not met.

Health gains are increasingly weighted in economic evaluations of new health technologies to guide resource-allocation decisions in healthcare. In Norway and the Netherlands weights are, for example, based on the disease severity of patients. In England and Wales, a higher weight is attached to quality-adjusted life-years (QALYs) gained from life-extending end-of-life (EOL) treatments. Societal preferences for QALY gains in EOL patients are increasingly examined. Although the available evidence suggests that gains in health-related quality of life (QOL) may be preferred to gains in life expectancy (LE), little is known about the influence of EOL patients’ age on these preferences. In this study, we examine the willingness to pay (WTP) for QOL and LE gains in EOL patients of different ages in a sample (n = 803) of the general public in the Netherlands. We found that WTP was relatively higher for QOL and LE gains in younger EOL patients. We further found indications suggesting that WTP may be relatively higher for QOL gains at the EOL, except for patients aged 20 for whom we observed a higher WTP for LE gains. Our results may inform discussions on attaching differential weights to QOL and LE gains in EOL patients of different ages with the objective to better align resource-allocation decisions with societal preferences.

Background Priority setting in healthcare can be guided by both efficiency and equity principles. The latter principle is often explicated in terms of disease severity and, for example, defined as absolute or proportional shortfall. These severity operationalizations do not explicitly consider patients' age, even though age may be inextricably related to severity and an equity-relevant characteristic. Objective This study examines the relative strength of societal preferences for severity and age for informing allocation decisions in healthcare. Methods We elicited preferences for severity and age in a representative sample of the public in The Netherlands (N = 1025) by applying choice tasks and person-trade-off tasks in a design in which severity levels and ages varied both separately and simultaneously between patient groups. We calculated person trade-off ratios and, in addition, applied ordinary least squares regression models to aid interpretation of the ratios when both severity and age varied. Results Respondents attached a higher weight (median of ratios: 2.46-3.50) to reimbursing treatment for relatively more severely ill and younger patients when preferences for both were elicited separately. When preferences were elicited simultaneously, respondents attached a higher weight (median of ratios: 1.98 and 2.42) to reimbursing treatment for relatively younger patients, irrespective of patients’ severity levels. Ratios varied depending on severity level and age and were generally higher when the difference in severity and age was larger between groups. Conclusions Our results suggest that severity operationalizations and equity weights based on severity alone may not align with societal preferences. Adjusting decision-making frameworks to reflect age-related societal preferences should be considered.

Background and Objectives Common health state valuation methodology, such as time tradeoff (TTO) and standard gamble (SG), is typically applied under several descriptively invalid assumptions, for example, related to linear quality-adjusted life years (QALYs) or expected utility (EU) theory. Hence, the current use of results from health state valuation exercises may lead to biased QALY weights, which may in turn affect decisions based on economic evaluations using such weights. Methods have been proposed to correct responses for the biases associated with different health state valuation techniques. In this article we outline the relevance of prospect theory (PT), which has become the dominant descriptive alternative to EU, for health state valuations and economic evaluations. Methods and Results We provide an overview of work in this field, which aims to remove biases from QALY weights. We label this “the corrective approach.” By quantifying PT parameters, such as loss aversion, probability weighting, and nonlinear utility, it may be possible to correct TTO and SG responses for biases in an attempt to produce more valid estimates of preferences for health states. Through straightforward examples, this article illustrates the effects of this corrective approach and discusses several unresolved issues that currently limit the relevance of corrected weights for policy. Conclusions Suggestions for research addressing these issues are provided. Nonetheless, if validly corrected health state valuations become available, we argue in favor of using these in economic evaluations.

Healthcare expenditures will continue to increase in the coming years, raising questions regarding the sustainability of the Dutch healthcare system and solidarity, but also about the optimal use of available resources. Given the issues in the oral care sector, attention for economic insights is appropriate there as well. Relevant issues in this regard are the design of the basic and supplementary health insurance schemes for oral care, the market structure and financing of oral care, questions regarding task shifting in oral care, as well as socio-economic inequalities in oral health. A closer cooperative relationship between oral care and the health economy can help in achieving an optimal and sustainable organisation of the Dutch oral care sector. In other words, an organisation contributing in an efficient and fair way to good oral care for all Dutch citizens.De zorguitgaven zullen de komende jaren blijven stijgen en daarmee dringen zich vragen op over de houdbaarheid van het Nederlandse zorgstelsel en de solidariteit, maar ook over het optimale gebruik van de beschikbare middelen. Gezien de vraagstukken binnen de mondzorg is ook daarin aandacht voor economische inzichten op zijn plaats. Hierbij valt te denken aan de vormgeving van de basisverzekering en de aanvullende mondzorgverzekering, de marktstructuur, de wijze van financiering, vragen omtrent taakherschikking in de mondzorg, en ook de sociaal-economische ongelijkheid in de mondgezondheid. Een hechtere samenwerking tussen mondzorg en gezondheidseconomie kan helpen om te komen tot een optimale, duurzame inrichting van de Nederlandse mondzorg. Dat wil zeggen, een inrichting die op een doelmatige en eerlijke manier bijdraagt aan een goede mondzorg voor alle Nederlanders.

Background In the context of priority setting, a differential cost-effectiveness threshold can be used to reflect a higher societal willingness to pay for quality-adjusted life-year gains in the worse off. However, uncertainty in the estimate of severity can lead to problems when evaluating the outcomes of cost-effectiveness analyses. Objectives This study standardizes the assessment of severity, integrates its uncertainty with the uncertainty in cost-effectiveness results and provides decision makers with a new estimate: the severity-adjusted probability of being cost effective. Methods Severity is expressed in proportional and absolute shortfall and estimated using life tables and country-specific EQ-5D values. We use the three severity-based cost-effectiveness thresholds (€20.000, €50.000 and €80.000, per QALY) adopted in The Netherlands. We exemplify procedures of integrating uncertainty with a stylized example of a hypothetical oncology treatment. Results Applying our methods, taking into account the uncertainty in the cost-effectiveness results and in the estimation of severity identifies the likelihood of an intervention being cost effective when there is uncertainty about the appropriate severity-based cost-effectiveness threshold. Conclusions Higher willingness-to-pay thresholds for severe diseases are implemented in countries to reflect societal concerns for an equitable distribution of resources. However, the estimates of severity are uncertain, patient populations are heterogeneous, and this can be accounted for with the severity-adjusted probability of being cost effective proposed in this study. The application to the Netherlands suggests that not adopting the new method could result in incorrect decisions in the reimbursement of new health technologies.

Healthcare interventions that improve the health of children with autism spectrum disorder (ASD) have the potential to affect the health of caregivers. This study compares the three-level EuroQoL-5 Dimension (EQ-5D-3L) and the Short Form-6 Dimension (SF-6D) in their ability to value such spillover effects in caregivers. Clinical data collected from two Autism Treatment Network (ATN) sites was combined with survey data of caregivers of children diagnosed with ASD. Caregivers completed instruments by proxy describing child health and completed the EQ-5D-3L and SF-6D preference-weighted instruments to describe their own health. There was a strong correlation between the health utility scores of the two preference-weighted instruments (ρ = 0.6172, p

Background Interventions in health care often not only have an efect on patients, but also on their informal caregivers.Caregiving can have a profound impact on the health and wellbeing of carers. Ignoring these spillovers in economic evaluations risks labelling interventions mistakenly as cost-efective, at the expense of informal caregivers.Objective This paper investigates willingness-to-accept (WTA) values for an hour of informal care, corrected for positiveand negative impacts of informal care, to facilitate the inclusion of informal care hours on the cost side of economic evaluations without double-counting spillover efects.Methods A discrete choice experiment (DCE) was conducted among a representative sample of the adult population in theNetherlands (n=552) in September 2011. An experimental design minimizing the D-error was used to construct choicesets with two unlabelled alternatives with the attributes ‘hours caregiving’, ‘monetary compensation for caregiving’ andseven impacts of caregiving. To operationalize the random utility model, we used a panel mixed multinomial logit (MMNL)parameter model. For calculation of WTA, we used both population-level parameters and individual-level parameters.Results The mean WTA for an additional hour of informal care, corrected for positive and negative impacts of informal care,was €14.57. The signs of the coefcients were all in the expected directions.Conclusions This study reports a preference-based monetary value for informal care, corrected for other impacts. This valuation facilitates the inclusion of informal care hours on the cost side in economic evaluations without double-counting anyspillover efects included on the efects side.

Background We aimed to investigate the burden of informal care in Hungary (HU), Poland (PL) and Slovenia (SI). Methods A cross-sectional online survey was performed involving representative samples of 1000 respondents per country. Caregiving situations were explored; health status of informal caregivers/care recipients and care-related quality of life were assessed using the EQ-5D-5L and CarerQol-7D. Results The proportion of caregivers was (HU/PL/SI) 14.9, 15.0 and 9.6%, respectively. Their mean age was 56.1, 45.6 and 48.0, and the average time spent on informal care was 27.6, 35.5 and 28.8 h/week. Chronic care was dominant (> 1 year: 78.5%, 72.0%, 74.0%) and care recipients were mainly (own/in-law) parents. Average EQ-5D-5L scores of care recipients were 0.53, 0.49 and 0.52. For Poland and Slovenia, EQ-5D-5L scores of informal care providers were signifcantly lower than of other respondents. Average CarerQol-7D scores were (HU/PL/SI) 76.0, 69.6 and 70.9, and CarerQol-VAS was 6.8, 6.4 and 6.6, respectively. Overall, 89, 87, and 84% of caregivers felt some or a lot fulflment related to caring. Problems with combining tasks with daily activities were most important in Hungary and Slovenia. Women had a higher probability of being a caregiver in Hungary. CarerQol-7D scores were signifcantly associated with caregivers’ EQ-5D-5L scores. In Hungary and Poland, living in a larger household was positively, while caring for patients with mental health problems was negatively associated with CarerQol-7D scores. Conclusions These frst results from the Central and Eastern European region using preference-based measures for the evaluation of informal care can serve as a valuable input for health economic analyses.

Background Risk communication is a key component of public health interventions during an outbreak. As the coronavirus pandemic unfolded in late 2019, the World Health Organization (WHO) was at the forefront in the development of risk communication strategies. The WHO introduced a range of activities with the purpose of enabling the public to avail verified and timely information on COVID-19 prevention behaviors. Given the various WHO activities to protect the public health during COVID-19, it is important to investigate the extent of familiarity and uptake of the WHO recommendations among the public during the first wave of the pandemic. Methods To do this, we conducted a large-scale Pan-European survey covering around 7500 individuals that are representative of populations from seven European countries, collected online during April 2-April 15, 2020. We use descriptive statistics including proportions and correlations and graphical representations such as bar charts to analyze and display the data. Results Our findings suggest that information from the WHO in the context of COVID-19 is well trusted and acted upon by the public. Overall familiarity and adherence were quite high in most countries. Adherence was higher for social distancing recommendations compared to hygiene measures. Familiarity and adherence were higher among older, female, and highly educated respondents. However, country level heterogeneities were observed in the level of trust in information from the WHO, with countries severely affected by the pandemic reporting lower levels of trust. Conclusion Our findings call for efforts from health authorities to get regular feedback from the public on their familiarity and compliance with recommendations for preventive measures at all stages of the pandemic, to further develop and adapt risk communication as the pandemic evolves.

Decisions on interventions or policy alternatives affecting health can be informed by economic evaluations, like cost‐benefit or cost‐utility analyses. In this context, there is a need for valid estimates of the monetary equivalent value of health (gains), which are often expressed in € per quality‐adjusted life years (QALYs). Obtaining such estimates remains methodologically challenging, with a recent addition to the health economists' toolbox, which is based on well‐being data: The well‐being valuation approach. Using general population panel data from Germany, we put this approach to the test by investigating several empirical and conceptual challenges, such as the appropriate functional specification of income utility, the choice of health utility tariffs, or the health state dependence of consumption utility. Depending on specification, the bulk of estimated € per QALY values ranged from €20,000–60,000, with certain specifications leading to more considerable deviations, underlining persistent practical challenges when applying the well‐being valuation methodology to health and QALYs. Based on our findings, we formulate recommendations for future research and applications.

To appropriately weight dimensions of quality of life instruments for health economic evaluations, population and patient preferences need to be elicited. Two commonly used elicitation methods for this purpose are discrete choice experiments (DCE) and case 2 best-worst scaling (BWS). These methods differ in terms of their cognitive burden, which is especially relevant when eliciting preferences among older people. Using a randomised experiment with respondents from an online panel, this paper examines the cognitive burden associated with colour-coded and level overlapped DCE, colour-coded BWS, and ‘standard’ BWS choice tasks in a complex health state valuation setting. Our sample included 469 individuals aged 65 and above. Based on both revealed and stated cognitive burden, we found that the DCE tasks were less cognitively burdensome than case 2 BWS. Colour coding case 2 BWS cannot be recommended as its effect on cognitive burden was less clear and the colour coding lead to undesired choice heuristics. Our results have implications for future health state valuations of complex quality of life instruments and at least serve as an example of assessing cognitive burden associated with different types of choice experiments.

Purpose Informal care constitutes an important part of the total care for people with dementia. Therefore, the impact of the syndrome on their caregivers as well as that of health and social care services for people with dementia should be considered. This study investigated the convergent and clinical validity of the CarerQol instrument, which measures and values the impact of providing informal care, in a multi-country sample of caregivers for people with dementia. Methods Cross-sectional data from a sample of 451 respondents in eight European countries, collected by the Actifcare project, were evaluated. Convergent validity was analysed with Spearman’s correlation coefficients and multivariate correlations between the CarerQol-7D utility score and dimension scores, and other similar quality of life measures such as CarerQol-VAS, ICECAP-O, and EQ-5D. Clinical validity was evaluated by bivariate and multivariate analyses of the degree to which the CarerQol instrument can differentiate between characteristics of caregivers, care receivers and caregiving situation. Country dummies were added to test CarerQol score differences between countries. Results The mean CarerQol utility score was 77.6 and varied across countries from 74.3 (Italy) to 82.3 (Norway). The scores showed moderate to strong positive correlations with the CarerQol-VAS, ICECAP-O, and EQ-5D health problems score of the caregiver. Multivariate regression analysis showed that various characteristics of the caregiver, care receiver and caregiving situation were associated with caregiver outcomes, but there was no evidence of a country-level effect. Conclusion This study demonstrates the convergent and clinical validity of the CarerQol instrument to evaluate the impact of providing informal care for people with dementia.

This study investigated the association of child, caregiver, and caregiving measurements with the quality of life (QoL) in 81 caregivers (mostly parents) of clinically referred children with autism spectrum disorder (ASD). We used the EuroQol five-dimensional (EQ-5D) questionnaire and the care-related QoL questionnaire (CarerQol) to respectively assess health-related QoL and care-related QoL. Health-related QoL was associated with the caregiver’s internalizing problems and adaptive coping, explaining 38% of the variance. Parenting stress and adaptive coping were associated with the care-related QoL and explained 60% of the variance. Child variables were not associated with the caregiver’s health- and care-related QoL if caregiver and caregiving variables were taken into account. Findings indicate the importance of the caregiver’s mental health, coping, and parenting stress in caring for children with ASD.

Background We aimed to investigate the acceptability of imperfect health states in relation to age in Hungary and analyse its determinants. Results are contrasted to age-matched actual population health scores and to findings from a previous study in The Netherlands. Methods A cross-sectional online survey was performed. The same survey questions were applied as in a previous study in The Netherlands in order to enable inter-country comparisons. The descriptive system of the EQ-5D-3L health status questionnaire was used to assess the acceptability of moderate and severe health problems at ages from 30 to 80 by 10-year age-groups. Descriptive statistics were performed and linear regression analysis was used to investigate the determinants of acceptability. Results Altogether 9281 (female 32.8%) were involved with mean age 36.0 years and EQ-5D-3L index score of 0.852 (SD 0.177). Acceptability of health problems increased with age, differed per health domain and with severity of the problems. Except for ‘Self-care’, moderate health problems were acceptable by the majority from age 70 and acceptability scores were lower than EQ-5D-3L population norms from that age. The lowest average acceptability age was found in the ‘Anxiety/depression’ and dimension the highest in the ‘Self-care’ dimension. Respondents’ age, current health, and lifestyle were significant determinants (R2: 0.041–0.130). With a few minor exceptions in some health dimensions, acceptability levels and patterns were strikingly similar to the Dutch findings. Conclusion In Hungary, acceptability of health problems increases with age and the majority found severe problems never acceptable. Views on acceptability of health problems seem to be fairly generalizable across European countries with different health and economic indicators.

__Objectives:__ The aim of this study was to assess the reliability, dimensionality and validity of the self-report questionnaire Health-Risk Attitude Scale (HRAS-13) in a sample of the general population and a patient population. __Methods:__ Sample 1 (_n_ = 930) was recruited from the general population aged 18–65 years in the Netherlands. Sample 2 (_n_ = 486) was recruited from the population of knee and hip osteoarthritis patients aged 45 and over, also from the Netherlands. Reliability was assessed using Cronbach’s alpha, average inter-item correlation and item-total correlations. Dimensionality was examined using confirmatory factor analysis (CFA), principal component analysis (PCA) and bifactor analysis. Validity was assessed by performing known-group analysis using ANOVA tests. __Results:__ Cronbach’s alphas of the HRAS-13 were 0.73 in sample 1 and 0.69 in sample 2. Reliability and dimensionality analyses differed slightly between the samples, and suggest that a short version of the HRAS may capture a general component of health-risk attitude. Validity assessment of known groups showed that the HRAS-13 and a likely HRAS-6 distinguished between subgroups of respondents based on most of the assessed characteristics, but not all. __Discussion:__ These findings are a preliminary indication that the HRAS-13 is a promising multidimensional instrument for measuring health-risk attitude. However, further research in various samples on decisions where health risks play a role is warranted to confirm the dimensionality of the HRAS-13 and the items to be retained in a full or a shorter version.

It was highlighted that in the original article [1] the graphs in Fig. 1 were duplicated. This Correction article shows the correct Fig. 1. The original article has been updated. Author details 1Erasmus University Rotterdam, Erasmus School of Health Policy & Management, P.O. Box 1738, 3000, DR, Rotterdam, the Netherlands. 2Erasmus University Rotterdam, Erasmus School of Economics, Rotterdam, The Netherlands.

Introduction: The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. Areas covered: The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. Expert opinion: Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage