Construct Validity, Reliability, and Responsiveness of the 10-Item Well-Being Instrument for Use in Economic Evaluation Studies.

OBJECTIVES: Economic evaluations of interventions in health and social care require outcome measures that capture their full benefits, including those beyond health. This study aimed to assess construct validity, test-retest reliability, and responsiveness of the newly developed 10-item Well-being instrument (WiX). METHODS: Data were gathered via an online survey in a representative sample of the adult general population in The Netherlands (N = 1045). Construct validity was assessed by inspecting convergent, structural, and discriminant validity, following the COnsensus-based Standards for the selection of health status Measurement INstruments methodology. Regression analyses of the WiX and its items on other validated measures of well-being were performed to assess the convergent validity of the instrument and the relevance of its items. Dimensionality of the WiX was assessed using exploratory factor analysis. To assess discriminant validity, several hypotheses in terms of well-being differences were assessed. Finally, a second survey was sent out 2 weeks after the initial survey (n = 563; 53.9% response rate) to assess the test-retest reliability and responsiveness of the WiX. RESULTS: The WiX showed to be correlated with alternative well-being measures as expected and able to sufficiently differentiate between relevant subgroups in the population. Moreover, the dimensionality analysis indicated that the WiX captures a broad array of elements relevant to well-being, including physical and mental health. The test-retest reliability was good, with an intraclass correlation coefficient of 0.82. CONCLUSIONS: The results regarding the WiX are favorable and indicate that this new instrument may be a promising alternative for existing measures of well-being for evaluating interventions in health and social care.

From Health to Well-Being: Toward a Monetary Valuation of a Well-Being-Adjusted Life-Year.

OBJECTIVES: Economic evaluations using broader measures to capture benefits beyond improved health can inform policy making, but only if the monetary value of gains measured using these instruments is understood. This study explored contingent valuation as a method to estimate the monetary value of a well-being-adjusted life-year (WALY) as measured by ICEpop Capability Measure for Adults (ICECAP-A). METHODS: In a large online survey of representative samples from 7 European countries, participants valued a change in the ICECAP-A from their current health state to a randomly assigned hypothetical state. Participants were instructed that an unspecified treatment could avoid a loss or produce a gain in well-being and were asked for their willingness to pay (WTP) for this treatment. WTP per WALY was calculated using an aggregated approach that used ICECAP-A tariffs from the United Kingdom. RESULTS: We analyzed a sample of 7428 observations, focusing on avoided losses (n = 6002) because the results for gains were not theoretically valid. Different cutoff points for a marginal change were explored. Depending on the definition of a marginal change, WTP per WALY averaged between €13 323.28 and €61 375.63 for avoided losses between [0, 0.5] and [0, 0.1], respectively, for 1 month. Mean WTP per WALY varied across the countries as follows: Denmark (€17 867.93-€88 634.14), France (€10 278.35-€45 581.28), Germany (€12 119.39-€54 566.56), Italy (€11 753.69-€52 161.25), The Netherlands (€14 612.88-€58 951.74), Spain (€11 904.12-€57 909.17), and United Kingdom (€13 133.75-€68 455.85). CONCLUSION: Despite the inherent limitations of our study, it offers valuable insights into methods for eliciting the WTP for changes in capability well-being as measured with ICECAP-A.

The role of budget impact and its relationship with cost-effectiveness in reimbursement decisions on health technologies in the Netherlands.

Health authorities using cost-effectiveness analysis (CEA) for informing reimbursement decisions on health technologies increasingly require economic evaluations encompassing both CEA and budget impact analysis (BIA). Good Research Practices advocate that the economic and clinical assumptions underlying these analyses are aligned and consistently applied. Nonetheless, CEAs and BIAs often are stand-alone analyses used in different stages of the decision-making process. This article used policy reports and Ministerial correspondence to discuss and elucidate the role of budget impact and its relationship with cost-effectiveness in reimbursement decisions in the Netherlands. The results indicate that CEAs and BIAs are both considered important for informing these decisions. While the requirements regarding CEAs-and application of the associated decision rule-are consistent across the different stages, the same does not hold for BIAs. Importantly, the definition of and evidence on budget impact differs between stages. Some important aspects (e.g. substitution and saving effects) typically are considered in the assessment and appraisal stages but are seemingly not considered in price negotiations and the final reimbursement decision. Further research is warranted to better understand why BIAs are not aligned with CEAs (e.g. in terms of underlying assumptions), vary in form and importance between stages, and do not have a clear relationship with the results of CEAs in the decision-making framework. Improving the understanding of the circumstances under which decision-makers attach a relatively larger or smaller weight to (different aspects of) budget impact may contribute to increasing the transparency, consistency, and optimality of reimbursement decisions in the Netherlands.

On spillovers in economic evaluations: definition, mapping review and research agenda.

An important issue in economic evaluations is determining whether all relevant impacts are considered, given the perspective chosen for the analysis. Acknowledging that patients are not isolated individuals has important implications in this context. Increasingly, the term "spillovers" is used to label consequences of health interventions on others. However, a clear definition of spillovers is lacking, and as a result, the scope of the concept remains unclear. In this study, we aim to clarify the concept of spillovers by proposing a definition applicable in health economic evaluations. To illustrate the implications of this definition, we highlight the diversity of potential spillovers through an expanded impact inventory and conduct a mapping review that outlines the evidence base for the different types of spillovers. In the context of economic evaluations of health interventions, we define spillovers as all impacts from an intervention on all parties or entities other than the users of the intervention under evaluation. This definition encompasses a broader range of potential costs and effects, beyond informal caregivers and family members. The expanded impact inventory enables a systematic approach to identifying broader impacts of health interventions. The mapping review shows that the relevance of different types of spillovers is context-specific. Some spillovers are regularly included in economic evaluations, although not always recognised as such, while others are not. A consistent use of the term "spillovers", improved measurement of these costs and effects, and increased transparency in reporting them are still necessary. To that end, we propose a research agenda.

Recommendations for Emerging Good Practice and Future Research in Relation to Family and Caregiver Health Spillovers in Health Economic Evaluations: A Report of the SHEER Task Force.

BACKGROUND: Omission of family and caregiver health spillovers from the economic evaluation of healthcare interventions remains common practice. When reported, a high degree of methodological inconsistency in incorporating spillovers has been observed. AIM: To promote emerging good practice, this paper from the Spillovers in Health Economic Evaluation and Research (SHEER) task force aims to provide guidance on the incorporation of family and caregiver health spillovers in cost-effectiveness and cost-utility analysis. SHEER also seeks to inform the basis for a spillover research agenda and future practice. METHODS: A modified nominal group technique was used to reach consensus on a set of recommendations, representative of the views of participating subject-matter experts. Through the structured discussions of the group, as well as on the basis of evidence identified during a review process, recommendations were proposed and voted upon, with voting being held over two rounds. RESULTS: This report describes 11 consensus recommendations for emerging good practice. SHEER advocates for the incorporation of health spillovers into analyses conducted from a healthcare/health payer perspective, and more generally inclusive perspectives such as a societal perspective. Where possible, spillovers related to displaced/foregone activities should be considered, as should the distributional consequences of inclusion. Time horizons ought to be sufficient to capture all relevant impacts. Currently, the collection of primary spillover data is preferred and clear justification should be provided when using secondary data. Transparency and consistency when reporting on the incorporation of health spillovers are crucial. In addition, given that the evidence base relating to health spillovers remains limited and requires much development, 12 avenues for future research are proposed. CONCLUSIONS: Consideration of health spillovers in economic evaluations has been called for by researchers and policymakers alike. Accordingly, it is hoped that the consensus recommendations of SHEER will motivate more widespread incorporation of health spillovers into analyses. The developing nature of spillover research necessitates that this guidance be viewed as an initial roadmap, rather than a strict checklist. Moreover, there is a need for balance between consistency in approach, where valuable in a decision making context, and variation in application, to reflect differing decision maker perspectives and to support innovation.

Estimating a Preference-Based Value Set for the Mental Health Quality of Life Questionnaire (MHQoL).

BACKGROUND: Health economic evaluations using common health-related quality of life measures may fall short in adequately measuring and valuing the benefits of mental health care interventions. The Mental Health Quality of Life questionnaire (MHQoL) is a standardized, self-administered mental health-related quality of life instrument covering 7 dimensions known to be relevant across and valued highly by people with mental health problems. The aim of this study was to derive a Dutch value set for the MHQoL to facilitate its use in cost-utility analyses. METHODS: The value set was estimated using a discrete choice experiment (DCE) with duration that accommodated nonlinear time preferences. The DCE was embedded in a web-based self-complete survey and administered to a representative sample (N = 1,308) of the Dutch adult population. The matched pairwise choice tasks were created using a Bayesian heterogeneous D-efficient design. The overall DCE design comprised 10 different subdesigns, with each subdesign containing 15 matched pairwise choice tasks. Each participant was asked to complete 1 of the subdesigns to which they were randomly assigned. RESULTS: The obtained coefficients indicated that "physical health,""mood," and "relationships" were the most important dimensions. All coefficients were in the expected direction and reflected the monotonic structure of the MHQoL, except for level 2 of the dimension "future." The predicted values for the MHQoL ranged from -0.741 for the worst state to 1 for the best state. CONCLUSIONS: This study derived a Dutch value set for the recently introduced MHQoL. This value set allows for the generation of an index value for all MHQoL states on a QALY scale and may hence be used in Dutch cost-utility analyses of mental healthcare interventions. HIGHLIGHTS: A discrete choice experiment was used to derive a Dutch value set for the MHQoL.This allows the use of the MHQoL in Dutch cost-utility analyses.The dimensions physical health, mood, and relationships were the most important.The utility values range from -0.741 for the worst state to 1 for the best state.

Obtaining preference scores for an abbreviated self-completion version of the Teen-Addiction Severity Index (ASC T-ASI) to value therapy outcomes of systemic family interventions: a discrete choice experiment.

BACKGROUND: Systemic family interventions for adolescents with problems of substance use and/or delinquency are increasingly focused subject of economic evaluations. Treatment effects go beyond improvements in commonly measured health-related quality of life (HRQOL). The Teen-Addiction Severity Index (T-ASI) was identified as capable of capturing these broad outcomes. However, it lacks preference-based scores. An abbreviated self-completion version (ASC T-ASI) was created and validated, covering the T-ASI domains substance use, school, work, family, social relationships, justice, and mental health. This study aimed to obtain societal preference scores for the ASC T-ASI. METHODS: Preferences were elicited in a sample of the Dutch general adult population (n = 1500), using a web-based Discrete Choice Experiment. Choice tasks included two unlabeled alternatives with attributes and levels corresponding to the domains and levels of the ASC T-ASI. A pilot study (n = 106) informed priors, optimal presentation, and number of choice tasks applied in the main study. Data were analyzed using a mixed multinomial logit model. RESULTS: Preference scores were logically ordered, with lower scores for worse ASC T-ASI states. Scores were most influenced by reductions in problems concerning the domains substance use, mental health, justice, and family. Tariffs were calculated for each ASC T-ASI state, ranging from 0 (worst situation) to 1 (best situation). CONCLUSIONS: The tariffs enable preference-based assessments of the broad effects of systemic family interventions for adolescents with problems of substance use and/or delinquency. The outcome reflects addiction-related rather than health-related utility and can be used next to generic HRQOL instruments in relevant economic evaluations. Given the source used for the preferences, interpretations and valuation of scores require attention.

Multiplier Effects and Compensation Mechanisms for Inclusion in Health Economic Evaluation: A Systematic Review.

BACKGROUND: Compensation mechanisms and multiplier effects may affect productivity losses due to illness, disability, or premature death of individuals. Hence, they are important in estimating productivity losses and productivity costs in the context of economic evaluations of health interventions. This paper presents a systematic literature review of papers focusing on compensation mechanisms and multiplier effects, as well as whether and how they are included in health economic evaluations. METHODS: The systematic literature search was performed covering EconLit and PubMed. A data-extraction form was developed focusing on compensation mechanisms and multiplier effects. RESULTS: A total of 26 studies were included. Of these, 15 were empirical studies, three studies were methodological studies, two studies combined methodological research with empirical research, four were critical reviews, one study was a critical review combined with methodological research, and one study was a cost-benefit analysis. No uniform definition of compensation mechanisms and multiplier effects was identified. The terminology used to describe compensation mechanisms and multiplier effects varied as well. While the included studies suggest that both multipliers as well as compensation mechanisms substantially impact productivity cost estimates, the available evidence is scarce. Moreover, the generalizability as well as validity of assumptions underlying the calculations are unclear. Available measurement methods for compensation mechanisms and multiplier effects differ in approaches and are hardly validated. CONCLUSION: While our review suggests that compensation mechanisms and multiplier effects may have a significant impact on productivity losses and costs, much remains unclear about their features, valid measurement, and correct valuation. This hampers their current inclusion in economic evaluation, and therefore, more research into both phenomena remains warranted.

The Value of Health in a Cost-Effectiveness Analysis: Theory Versus Practice.

A cost-effectiveness analysis has become an important method to inform allocation decisions and reimbursement of new technologies in healthcare. A cost-effectiveness analysis requires a threshold to which the cost effectiveness of a new intervention can be compared. In principle, the threshold ought to reflect opportunity costs of reimbursing a new technology. In this paper, we contrast the practical use of this threshold within a CEA with its theoretical underpinnings. We argue that several assumptions behind the theoretical models underlying this threshold are violated in practice. This implies that a simple application of the decision rules of CEA using a single estimate of the threshold does not necessarily improve population health or societal welfare. Conceptual differences regarding the interpretation of the threshold, widely varying estimates of its value, and an inconsistent use within and outside the healthcare sector are important challenges in informing policy makers on optimal reimbursement decision and setting appropriate healthcare budgets.

Production Losses due to Absenteeism and Presenteeism: The Influence of Compensation Mechanisms and Multiplier Effects.

BACKGROUND: Productivity costs can form a large and influential component of total costs in an economic evaluation taking a societal perspective. In calculating productivity costs, estimating productivity losses is a central element. Compensation mechanisms and multiplier effects may influence these losses but remain understudied. Compensation mechanisms could reduce productivity losses while multiplier effects may increase them. METHODS: Data on productivity losses were collected in 2015 using an online survey among a sample of persons aged 15-65 years in The Netherlands who worked at least 12 h per week and reported to have experienced absenteeism and/or presenteeism during the past 4 weeks. A total of 877 respondents completed the survey that contained questions on productivity losses, compensation mechanisms, and multiplier effects. RESULTS: We found that 45.5% of the respondents reported absenteeism (average 6.5 days) during the past 4 weeks, losing on average 48.7 working hours, while presenteeism was experienced by 75.9% of respondents, with an average loss of 10.7 working hours. Compensation mechanisms were reported by 76.9% of respondents, compensating almost 80% of their lost production, while multiplier effects were reported by 23.6% of respondents, reducing the productivity of 4.2 colleagues by 27.8% on average, implying a multiplier of 2.1 in that subgroup. CONCLUSIONS: This study highlights that compensation mechanisms and multiplier effects are common and may substantially affect production losses. Investigating these mechanisms and effects further, as well as their interactions, remains important. Translating these findings into productivity cost calculations in economic evaluations is not straightforward and requires attention, especially since compensation mechanisms may not be costless and, for multiplier effects, the value of hours of colleagues may not be similar to that of the person experiencing health problems.

An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations.

INTRODUCTION: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US). AREAS COVERED: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored. EXPERT OPINION: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers' evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

Reference-dependent age weighting of quality-adjusted life years.

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.

Do Health Technology Assessment organisations consider manufacturers' costs in relation to drug price? A study of reimbursement reports.

INTRODUCTION: Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, including those related to research and development (R&D) and manufacturing. Such considerations could enter the decision process in collectively financed health care systems. This paper investigates whether manufacturers' costs in relation to drug prices, or profit margins, are explicitly mentioned and considered by health technology assessment (HTA) organisations. METHOD: An analysis of reimbursement reports for cancer drugs was performed. All relevant Dutch HTA-reports, published between 2017 and 2019, were selected and matched with HTA-reports from three other jurisdictions (England, Canada, Australia). Information was extracted. Additionally, reimbursement reports for three cases of expensive non-oncolytic orphan drugs prominent in pricing debates in the Netherlands were investigated in depth to examine consideration of profit margins. RESULTS: A total of 66 HTA-reports concerning 15 cancer drugs were included. None of these reports contained information on manufacturer's costs or profit margins. Some reports contained general considerations of the HTA organisation which related prices to manufacturers' costs: six contained a statement on the lack of price setting transparency, one mentioned recouping R&D costs as a potential argument to justify a high price. For the case studies, 21 HTA-reports were selected. One contained a cost-based price justification provided by the manufacturer. None of the other reports contained information on manufacturer's costs or profit margins. Six reports contained a discussion about lack of transparency. Reports from two jurisdictions contained invitations to justify high prices by demonstrating high costs. CONCLUSION: Despite the attention given to manufacturers' costs in relation to price in public debates and in the literature, this issue does not seem to get explicit systematic consideration in the reimbursement reports of expensive drugs.

The Role of Perceived Utility of Full Health in Age Weighting.

OBJECTIVES: People often give different weights to quality-adjusted life-years (QALYs) gained by different socioeconomic groups. It is well known that QALY gains of younger patients generally get more weight than the same QALY gains accruing to older patients. This study aims to separate these age-related preferences into "pure age weighting" and age weighting caused by full health not perceived as being the same for the old as for the young. METHODS: We apply a person trade-off method in a large sample representative (N = 500) of the Dutch general adult population to estimate age weighting factors. We describe health as a percentage of what is considered full health for a given age, for which we obtain a proxy in a separate task. RESULTS: A high amount of age weighting is observed, with QALYs to 20-year-old patients receiving approximately 1.5 times as much weight as QALYs to 80-year-old patients. At the same time, we see that individuals do not perceive full health to be the same for young and older people. In fact, the age weighting disappears once we control for these differences in full health perceptions. CONCLUSIONS: Respondents had strong preferences for the young relative to the old, but these preferences were related to full health perceptions, that is, more weight being assigned to younger because full health is at a higher absolute level for them than for the old.

Estimating an anchored utility tariff for the well-being of older people measure (WOOP) for the Netherlands.

OBJECTIVE: Health economic evaluations using common health-related quality of life measures may fall short in adequately incorporating all relevant benefits of health and social care interventions targeted at older people. The Well-being of Older People measure (WOOP) is a broader well-being measure that comprises nine well-being domains. The objective of this study was to estimate a utility tariff for the WOOP, to facilitate its application in cost-utility analyses. METHODS: A discrete choice experiment (DCE) with duration approach was set up and fielded among 2,012 individuals from the Netherlands aged 65 years and above. Matched pairwise choice tasks, colour-coding and level overlap were used to reduce the cognitive burden of the DCE. The choice tasks were created using a Bayesian heterogeneous D-efficient design. The estimation procedure accommodated for nonlinear time preferences via an exponential discounting function. RESULTS: The estimation results showed that 'physical health', 'mental health', and 'making ends meet' were the most important well-being domains for older people, followed by 'independence' and 'living situation'. Of somewhat lesser importance were domains like 'social life', 'receiving support' and 'feeling useful'. The generated utility tariffs can be used to translate well-being states described with the WOOP to a utility score between -0.616 and 1. CONCLUSIONS: This study established a tariff for the WOOP, which will facilitate its use in economic evaluations of health and social care interventions targeted at older people, first of all in the Netherlands.

Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries.

Experiences with coverage with evidence development (CED) schemes are fairly limited in Central and Eastern European (CEE) countries, which are usually late adopters of new health technologies. Our aim was to put forward recommendations on how CEE health technology assessment bodies and payer organizations can apply CED to reduce decision uncertainty on reimbursement of medical devices, with a particular focus on transferring the structure and data from CED schemes in early technology adopter countries in Western Europe. Structured interviews on the practices and feasibility of transferring CED schemes were conducted and subsequently, a draft tool for the systematic classification of decision alternatives and recommendations was developed. The decision tool was reviewed in a focus group discussion and validated within a wider group of CEE experts in a virtual workshop. Transferability assessment is needed in case of (1) joint implementation of a CED scheme; (2) transferring the structure of an existing CED scheme to a CEE country; (3) reimbursement decisions that are linked to outcomes of an ongoing CED scheme in another country and (4) real-world evidence transferred from completed CED schemes. Efficient use of available resources may be improved by adequately transferring evidence and policy tools from early technology adopter countries.

Coverage with evidence development for medical devices in Europe: Can practice meet theory?

Health economists have written extensively on the design and implementation of coverage with evidence development (CED) schemes and have proposed theoretical frameworks based on cost-effectiveness modeling and value of information analysis. CED may aid decision-makers when there is uncertainty about the (cost-)effectiveness of a new health technology at the time of reimbursement. Medical devices are potential candidates for CED schemes, as regulatory regimes do not usually require the same level of efficacy and safety data normally needed for pharmaceuticals. The purpose of this research is to assess whether the actual practice of CED for medical devices in Europe meets the theoretical principles proposed by health economists and whether theory and practice can be more closely aligned. Based on decision-makers' perceptions of the challenges associated with CED schemes, plus examples from the schemes themselves, we discuss a series of proposals for assessing the desirability of schemes, their design, implementation, and evaluation. These proposals, while reflecting the practical challenges with developing CED programs, embody many of the principles suggested by economists and should support decision-makers in dealing with uncertainty about the real-world performance of devices.

Do Profit Margins of Pharmaceuticals Influence Reimbursement Decisions? A Discrete Choice Experiment Among Dutch Healthcare Decision Makers.

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.