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Six studies (21%) scored "excellent" in conduct and reporting. Stand-alone costing of EHSP had higher mean quality score (80). The projected increase in government budget to implement EHSP ranged from 17% to 117%. Limited availability of reliable data on resources, prices, and coverage of interventions were identified as major limitations for costing of EHSPs.

Substantial differences in the costing methods and reporting standards of EHSPs made comparisons across countries difficult. Proteasome inhibitor Existing costing guidelines and checklists should be adapted for EHSPs with more specific methodological guidance to allow harmonization of methods and reporting.

Substantial differences in the costing methods and reporting standards of EHSPs made comparisons across countries difficult. Existing costing guidelines and checklists should be adapted for EHSPs with more specific methodological guidance to allow harmonization of methods and reporting.

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.

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.

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 weere 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.

This study aimed to develop mapping algorithms from the Expanded Prostate Cancer Index Composite (EPIC) and the Short-Form (SF) Health Surveys to the Patient-Oriented Prostate Utility Scale (PORPUS), an econometric instrument specifically developed for patients with prostate cancer.

Data were drawn from 2 cohorts concurrently administering PORPUS, EPIC-50, and SF-36v2. The development cohort included patients who had received a diagnosis of localized or locally advanced prostate cancer from 2017 to 2019. The validation cohort included men who had received a diagnosis of localized prostate cancer from 2014 to 2016. Linear regression models were constructed with ln(1- PORPUS utility) as the dependent variable and scores from the original and brief versions of the EPIC and SF as independent variables. The predictive capacity of mapping models constructed with all possible combinations of these 2 instruments was assessed through the proportion of variance explained (R

) and the agreement between predicted an prostate cancer.

A respiratory bolt-on dimension for the EQ-5D-5L has recently been developed and valued by the general public. This study aimed to validate the EQ-5D-5L plus respiratory dimension (EQ-5D-5L+R) in a large group of patients with chronic obstructive pulmonary disease (COPD).

Validation was undertaken with data from the Birmingham COPD Cohort Study, a longitudinal UK study of COPD primary care patients. Data on the EQ-5D-5L+R were collected from 1008 responding participants during a follow-up questionnaire in 2017 and combined with (previously collected) data on patient and disease characteristics. Descriptive and correlation analyses were performed on the EQ-5D-5L+R dimensions and utilities, in relation to COPD characteristics and compared with the EQ-5D-5L without respiratory dimension. Multivariate regression models were estimated to test whether regression coefficients of clinical characteristics differed between the EQ-5D-5L+R utility and the EQ-5D-5L utility.

Correlation coefficients for the EQ-5D-5L+ty difference when adding the respiratory dimension.

To examine the association of self-reported health of patients in general practices, as measured by the EQ-5D-5L, with practice clinical quality and patient-reported satisfaction with accessibility and consultations.

We used data from the General Practitioner (GP) Patient Survey to construct a practice-level EQ-5D-5L index as the health outcome. Key explanatories were patient-reported measures of satisfaction with access and consultations (also derived from the GP Patient Survey) and clinical quality measured by the achievement of clinical quality indicators reported in the Quality and Outcomes Framework. We estimated practice-level linear panel data models with random and fixed practice effects and practice and patient covariates using 2012/13 to 2016/17 data on more than 7500 English general practices.

Bivariate correlations of the EQ-5D-5L index with quality measures were 0.048 for clinical quality, 0.071 for satisfaction with access, and 0.107 for satisfaction with GP consultations (all with P<.001). In both fixed effects regressions, which allow for unobserved time invariant practice characteristics, and random effects regressions which do not, the EQ-5D-5L index was positively associated with 1-year lags of patient satisfaction with access and GP consultations. Patient-reported health was positively associated with clinical quality in the fixed effects regressions. The implied effects were small in all cases.

Practice-level EQ-5D-5L is positively associated with clinical quality and with 1-year lags of patient-reported satisfaction with access and GP consultations.

Practice-level EQ-5D-5L is positively associated with clinical quality and with 1-year lags of patient-reported satisfaction with access and GP consultations.

There is growing interest in condition-specific preference measures, including the European Organisation for Research and Treatment of Cancer Quality of Life Utility Measure-Core 10 Dimensions (QLU-C10D). This research assessed the implications of using utility indices on the basis of the EQ-5D-3L, a mapping of EQ-5D-3L to the EQ-5D-5L, and the QLU-C10D, and compared their psychometric properties.

Data were taken from 8 phase 3 randomized controlled trials of nivolumab with or without ipilimumab for the treatment of solid tumors. Utilities for progression-related states were calculated using the UK and English value sets and incremental quality-adjusted life-years (QALYs) derived from established UK cost-effectiveness models. The psychometric properties of the utility indices were assessed using pooled trial data.

Compared with the EQ-5D-3L index, the mapped EQ-5D-5L index yielded an average of 6% more and the QLU-C10D index an average of 2% fewer incremental QALYs for nivolumab versus comparators. All large to affect health technology assessment decisions.

To compare finite mixture models with common survival models with respect to how well they fit heterogenous data used to estimate mean survival times required for cost-effectiveness analysis.

Publicly available overall survival (OS) and progression-free survival (PFS) curves were digitized to produce nonproprietary data. Regression models based on the following distributions were fit to the data Weibull, lognormal, log-logistic, generalized F, generalized gamma, Gompertz, mixture of 2 Weibulls, and mixture of 3 Weibulls. A second set of analyses was performed based on data in which patients who had not experienced an event by 30 months were censored. Model performance was compared based on the Akaike information criterion (AIC).

For PFS, the 3-Weibull mixture (AIC= 479.94) and 2-Weibull mixture (AIC= 488.24) models outperformed other models by more than 40 points and produced the most accurate estimates of mean survival times. For OS, the AIC values for all models were similar (all within 4 points). The means for the mixture 3-Weibulls mixture model (17.60 months) and the 2-Weibull mixture model (17.59 months) were the closest to the Kaplan-Meier mean estimate of (17.58 months). The results and conclusions from the censored analysis of PFS were similar to the uncensored PFS analysis. On the basis of extrapolated mean OS, all models produced estimates within 10% of the Kaplan-Meier mean survival time.

Finite mixture models offer a flexible modeling approach that has benefits over standard parametric models when analyzing heterogenous data for estimating survival times needed for cost-effectiveness analysis.

Finite mixture models offer a flexible modeling approach that has benefits over standard parametric models when analyzing heterogenous data for estimating survival times needed for cost-effectiveness analysis.

Curative treatments can result in complex hazard functions. The use of standard survival models may result in poor extrapolations. Several models for data which may have a cure fraction are available, but comparisons of their extrapolation performance are lacking. A simulation study was performed to assess the performance of models with and without a cure fraction when fit to data with a cure fraction.

Data were simulated from a Weibull cure model, with 9 scenarios corresponding to different lengths of follow-up and sample sizes. Cure and noncure versions of standard parametric, Royston-Parmar, and dynamic survival models were considered along with noncure fractional polynomial and generalized additive models. The mean-squared error and bias in estimates of the hazard function were estimated.

With the shortest follow-up, none of the cure models provided good extrapolations. Performance improved with increasing follow-up, except for the misspecified standard parametric cure model (lognormal). The performere robust to model misspecification, but standard parametric cure models were not.Gene therapy for hemophilia is designed to produce health gains for patients over many years. Rewarding that value creation on the basis of a one-time treatment implies a large upfront cost. This cost can only be justified by long-term health benefits and being cost-effective compared with conventional treatments. Yet, uncertainties about the long-term benefits make it challenging to assess clinical and economic value of gene therapies at launch. We identify and discuss key methodological challenges in assessing the value of gene therapy for hemophilia, including the immaturity of evidence on the durability of benefits, lack of definition and valuation of cure for chronic diseases, absence of randomized controlled trials, limitations of traditional quality of life measures in hemophilia, approach for qualifying cost-savings compared with current treatments, and choice of perspective. The Institute for Clinical and Economic Review has developed a framework for assessing single or short-term therapies (ICER-SST) and has applied it in hemophilia. After reviewing this framework and its application, we recommend the following when assessing the value of hemophilia gene therapies (1) leveraging expert clinical opinion to justify assumptions on the durability of benefits; (2) using external synthetic controls and lead-in, self-controlled trials to assess comparative effectiveness; (3) addressing limitations of traditional quality of life measures through the use of modified utility collection approaches; (4) adjusting cost offsets from gene therapies with caution; (5) considering outcome-based contracting to address uncertainties about prices and long-term outcomes; and (6) presenting societal and healthcare system perspectives in parallel.