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Objectives To respond to the ‘quality assurance’ of the EQ-5D-5L value set for England study. Methods We provide a point-by-point response to the issues raised by the authors of the quality assurance paper, drawing on theoretical arguments, empirical analyses and practical considerations. Results We provide evidence to show that many of the points made by the authors of the quality assurance are misleading, suggest misunderstandings, or are irrelevant. Conclusions The modeling approaches which were used appropriately address the characteristics of the data and provide a reasonable representation of the average stated preferences of general public in England. We provide reflections on the conduct of stated preference studies, and suggestions for the way forward.

Background EQ-5D-5L valuation studies previously reported many inconsistent responses in time trade-off (TTO) data. A number of possible elements, including ordering effects of the valuation tasks, mistakes at the sorting question, and interviewers' (learning) effects, may contribute to their inconsistency. Objectives This study aimed to evaluate the effect of two modifications on consistency of TTO data in The Netherlands (NL) and Hong Kong (HK): (1) separating the valuation of the Better than Dead (BTD) and Worse than Dead (WTD) states; and (2) Implementation of feedback (FB) module by offering an opportunity to review TTO responses. Methods A crossover design with two study arms was used to test the effect of the modifications. In each jurisdiction, six interviewers were involved where half the interviewers started using the standard version, and the other half started with the split version. Each version was switched after every 25 (NL) or 30 (HK) interviews until 400 interviews were completed. Results In the NL and HK, 404 and 403 respondents participated, respectively. With the use of the FB module, the proportion of respondents with inconsistent responses was lowered from 17.8% to 10.6% ( P P = 0.003) in HK. The result of separating the valuation of BTD and WTD states was not straightforward because it reduced the inconsistency rate in NL but not in HK. Conclusions The results support implementation of the FB module to promote the consistency of the data. The separation of the BTD and WTD task is not supported.

Background Health states defined by multiattribute instruments such as the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) can be valued using time trade-off (TTO) or discrete choice experiment (DCE) methods. A key feature of the tasks is the order in which the health state dimensions are presented. Respondents may use various heuristics to complete the tasks, and therefore the order of the dimensions may impact on the importance assigned to particular states. Objective To assess the impact of different EQ-5D-5L dimension orders on health state values. Methods Preferences for EQ-5D-5L health states were elicited from a broadly representative sample of members of the UK general public. Respondents valued EQ-5D-5L health states using TTO and DCE methods across one of three dimension orderings via face-to-face computer-assisted personal interviews. Differences in mean values and the size of the health dimension coefficients across the arms were compared using difference testing and regression analyses. Results Descriptive analysis suggested some differences between the mean TTO health state values across the different dimension orderings, but these were not systematic. Regression analysis suggested that the magnitude of the dimension coefficients differs across the different dimension orderings (for both TTO and DCE), but there was no clear pattern. Conclusions There is some evidence that the order in which the dimensions are presented impacts on the coefficients, which may impact on the health state values provided. The order of dimensions is a key consideration in the design of health state valuation studies.

This publication examines the importance and history of HTA evaluations for additional uses for cancer drugs after their initial approval. The cohort of cancer drugs included are the ten approved by the EMA during 2003–2005. This time period was chosen based on the assumption that cancer drugs on the market for eight years or more are likely to have been approved for additional indications. New indications, for example, may be for use in a different cancer, disease stage, treatment stage, treatment regimen, or patient population or subpopulation. The decisions of three entities were included in the study - the Haute Autorite de Sante (HAS) in France, NICE in England and Wales, and Aetna, a private health insurance company in the US. These three were selected to suggest how assessment approaches might differ in interpreting value. The value of a particular medicine, as this study illustrates well, may not be evident at the time of first approval and value can vary both over time and by indication. This may result in pricing and reimbursement decisions that fail to adequately reward important innovation and so discourage future innovation, to the detriment of society. Public policy options for addressing this challenge include, for example, pricing that varies by indication, and consideration of potential expanded use as part of the initial deliberations, and decisions about pricing and reimbursement.

Objectives: To investigate the feasibility of choice experiments for EQ-5D-5L states using computer-based data collection, and to examine the consistency of the estimated parameters values derived after modeling the stated preference data across countries in a multinational study. Methods: Similar choice experiments were executed in Canada, England, The Netherlands, and United States (US). Interactive software was developed to standardize the format of the choice tasks across countries, except for England where face-to-face interviewers were used. The choice task required respondents to choose between two sub-optimal health states. A Bayesian design was used to generate 200 pairs of states that were randomly grouped into 20 blocks. Each respondent completed one block consisting of 10 pairs. A main-effect alternative-specific multinomial probit regression model was used to estimate regression coefficients and to derive values for each health state that capture the relative differences in levels between states. Results: In total there were 1775 respondents, at least 400 respondents from each country, who completed 17750 paired comparisons, resulting into 35500 assessed health states. The mean time to perform one choice task was between 29.2 (US) and 45.2 (England) seconds. All regression coefficients were statistically significant, except level 2 for Usual Activities in The Netherlands (p= 0.51). Three regression coefficients with illogical ordering were observed (The Netherlands: level 3 Pain/ Discomfort, England: Level 3 Usual Activities & Pain/Discomfort). Predictions for the complete set of 3125 EQ-5D-5L states were similar for the four countries. Intra class correlation coefficients between the countries were high: from 0.89 (England vs. US) through 0.99 (Canada vs. US). Conclusions: This proof of concept study indicates that computer-based choice tasks for the EQ-5D-5L in the general population are feasible and parameter of the choice tasks estimates are generally consistent and logical, and the estimated values are largely consistent between the 4 countries.