Bayer (83%), Gilead (80%), and Boehringer-Ingelheim (80%). The average time to receive a CDR recommendation varied from 170 days to 248 days. The manufacturers with the fastest time to recommendation are GSK, Abbott, Roche, Boehringer-Ingelheim, and Watson. Time to reimbursement / formulary listings in all provinces ranged from 123 days to 593 days. ConClusions: This is the first analysis to describe the success rate of pharmaceutical manufacturers through the CDR. There appears to high variability in all the metrics that were measured and further research into the determinants of variability is warranted.

ObjectiveOur objective was to develop a value set based on Irish utility values for the EuroQol 5-Dimension, 5-Level instrument (EQ-5D-5L).MethodsThe research design and data collection followed a protocol developed by the EuroQol Group. The EuroQol Valuation Technology (EQ-VT) software was administered using computer-assisted personal interviews to a representative sample of adults resident in Ireland between 2015 and 2016. Utility values were elicited using two stated-preference techniques: time trade-off (TTO) and discrete-choice experiment (DCE). Each respondent completed a valuation exercise in which the EQ-VT system randomly selected one block of ten TTO questions from ten blocks relating to a possible 86 health states. One block of seven DCE pairs from 28 blocks of a possible 196 pairs of health states were randomly selected to accompany this. The relationship between utility values and health states was analysed using a hybrid regression model that combined data from the TTO and DCE techniques and expressed these as a function of the health state presented to the individual. This model estimated coefficients for 20 dummy variables that characterised each health state in the EQ-5D-5L framework, with the lowest level of severity providing the reference category in each domain. The relationship between weighted and unweighted TTO and DCE analyses of main effects was analysed separately.ResultsComparison of weighted and unweighted models revealed no substantive differences in results with respect to either DCE or TTO models. The unweighted hybrid model produced estimated effects, the ordering of which was intuitively consistent within each domain: lower levels of health were associated with lower utility values. Differences were evident between domains with respect to valuations; the disutility associated with conditions related to anxiety/depression and pain/discomfort was higher than for other domains. The decrement in utility associated with movement from the highest to the lowest level of health was 0.344 for mobility, 0.287 for self-care, 0.187 for usual activities, 0.510 for pain/discomfort and 0.646 for anxiety/depression.DiscussionThe results present the first value set based on the EQ-5D-5L framework for a representative sample of residents in Ireland. The set reveals a higher decrement in utility associated with anxiety/depression than with other domains of health. Caution is warranted in comparisons with other value sets. That said, those in England, the Netherlands, Uruguay and China reveal that, whereas Irish values are broadly consistent with respect to mobility, self-care and usual activities, residents of Ireland attach a higher decrement to pain/discomfort and anxiety/depression than do other populations.Electronic supplementary materialThe online version of this article (10.1007/s40273-018-0690-x) contains supplementary material, which is available to authorized users.

Objective The objective of this study was to develop a French value set for the EQ-5D-5L, for academic and clinical research, and for regulatory requirements for price-setting of drugs and medical devices. Method This study used the standardized valuation protocol developed by EuroQol, using computer-assisted personal interview software. A representative sample of 1048 French residents were interviewed by a market research company, under the supervision of the research team. Health states were valued using composite time trade-off and a discrete choice experiment. Modeling was used to create values for the 3125 possible health states. The composite time trade-off data were modeled using a Tobit model with censored observations at −1 and correcting for heteroscedasticity. A conditional logit model was used for the discrete choice results, and both models were combined using a hybrid model. An adjusted hybrid model was tested to correct for imbalance in the sample on age and sex compared with the general population. A comparison with the 3-level (3L) value set was performed. Results The adjusted model was preferred to comply with the representativeness of the general population. It provided a value set for which all coefficients were logically consistent. Values ranged from − 0.525 to 1. The distribution of values presented a shift towards higher values versus the 3L value set. Ranking of dimensions changed. Pain and discomfort and mobility were the dimensions with the highest potential for disutility compared with mobility and self-care for the 3L instrument. Conclusions This study provides a value set based on societal preferences of the French population, using an improved descriptive instrument of health-related quality-of-life health states. It will contribute to improve the quality of cost-effectiveness analysis in the French context and help stimulate disease-specific quality-of-life references for academic-, institutional-, and industry-promoted studies.

ObjectivesTo date, a value set for the EQ-5D-5L based on the health state preferences of the general Taiwanese population has not been available. This study aimed to develop a Taiwanese value set for EQ-5D-5L to facilitate health technology assessment for medical products and services.MethodsAn international standardized protocol for EQ-5D-5L valuation studies developed by the EuroQol group was adopted. Adult members of the general public were recruited from six geographic regions in Taiwan. In computer-based face-to-face interviews, each participant completed 10 composite time trade-off (C-TTO) tasks and 7 discrete choice experiment (DCE) tasks. The C-TTO and DCE data were modeled alone or in combination (using hybrid models) with additive models containing 20 dummy variables as main effects. The model performance was assessed both quantitatively and qualitatively (mainly logical consistency and prediction patterns).ResultsOf 1,073 recruited participants, 1,000 completed the study. Approximately 13% of observed utility values were -1 in the C-TTO tasks. The hybrid model, using all available data that assumed C-TTO response values left-censored at -1 and with main effects coefficients with logical consistency (monotonicity), was considered as the most appropriate model. The predicted utility ranged from -1.0259 to 1.ConclusionsAn EQ-5D-5L value set was developed for Taiwan using an established study protocol and a representative sample of the general population. This may facilitate health economic evaluations and decision making on resource allocation under Taiwan’s national health insurance program in the future.

BackgroundThe Bladder Cancer Index (BCI) is so far the only instrument applicable across all bladder cancer patients, independent of tumor infiltration or treatment applied. We developed a Spanish version of the BCI, and assessed its acceptability and metric properties.MethodsFor the adaptation into Spanish we used the forward and back-translation method, expert panels, and cognitive debriefing patient interviews. For the assessment of metric properties we used data from 197 bladder cancer patients from a multi-center prospective study. The Spanish BCI and the SF-36 Health Survey were self-administered before and 12 months after treatment. Reliability was estimated by Cronbach’s alpha. Construct validity was assessed through the multi-trait multi-method matrix. The magnitude of change was quantified by effect sizes to assess responsiveness.ResultsReliability coefficients ranged 0.75-0.97. The validity analysis confirmed moderate associations between the BCI function and bother subscales for urinary (r = 0.61) and bowel (r = 0.53) domains; conceptual independence among all BCI domains (r ≤ 0.3); and low correlation coefficients with the SF-36 scores, ranging 0.14-0.48. Among patients reporting global improvement at follow-up, pre-post treatment changes were statistically significant for the urinary domain and urinary bother subscale, with effect sizes of 0.38 and 0.53.ConclusionsThe Spanish BCI is well accepted, reliable, valid, responsive, and similar in performance compared to the original instrument. These findings support its use, both in Spanish and international studies, as a valuable and comprehensive tool for assessing quality of life across a wide range of bladder cancer patients.