Objective To investigate 1) the magnitude of indirect costs, 2) changes in cost components, and 3) correlations between changes in cost and social, clinical, and occupational variables within the first 3 years of rheumatoid arthritis (RA). Methods We evaluated the indirect costs per person‐year in 133 consecutive gainfully employed outpatients with early RA, in a prospective multicenter followup study. Costs due to RA‐related sick leave, work disability, and other work loss were assessed using the human capital approach. Variables associated with reduction in lost productivity were tested by multivariate logistic regression analysis. Results Mean ± SEM annual indirect costs were $11,750 ± 1,120 per person. During the 3‐year period of observation, a marked reduction in the costs associated with sick leave was seen, which exceeded the increase in costs due to work disability and other work loss. This phenomenon resulted in an overall reduction in indirect costs of 21%. The final logistic regression model of reduced loss of productivity included 3 variables: no problems with standing (odds ratio [OR] 7.1), no problems with working speed (OR 4.1), and no problems with outdoor work (OR 3.1). Conclusion High indirect costs in early RA were demonstrated. An overall decrease of costs can be seen in the first 3 years, due to the reduction in sick leave. Since the absence of problems due to strenuous working conditions was found to be associated with a reduction in indirect costs, it is assumed that early intensified vocational rehabilitation, apart from controlling disease activity by adequate treatment, might help to reduce indirect costs.

Adding orlistat as a pharmacological treatment to conventional diabetes and weight management approaches seems to be a cost-effective treatment option for overweight and obese patients with type 2 diabetes.

Objectives Since the introduction of the German health care reform in January 2011, an early benefit assessment (EBA) is required for all new medicines. Pharmaceutical manufacturers have to submit a benefit dossier for evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG). A final decision is made by the Federal Joint Committee (G-BA). The aim of this investigation was to analyse the outcomes 18 months after introduction of the new legislation and to identify critical areas requiring further discussion and development.MethodsAll EBAs commenced prior to June 2012 were included. The G-BA website was used to obtain manufacturers’ benefit dossiers, IQWiG assessments, and G-BA decisions. Four areas of interest were analysed: levels of additional benefit, appropriate comparative therapy (ACT), patient-relevant endpoints, and adverse events.ResultsTwenty-seven EBAs were analysed. IQWiG stated a benefit in 50 % of EBAs, whereas G-BA stated a benefit in 63 %, but only in 50 % of identified subgroups and 40 % of patients involved. In 12 EBAs, the ACT suggested by G-BA differed from the comparator used in phase III trials. The G-BA reported no benefits on health-related quality of life. Discrepancies arose in morbidity outcomes such as ‘progression-free survival’ and ‘sustained virological response’. Categorisation and balancing of adverse events was conducted within various assessments.Conclusions Considerable variance was observed in the levels of additional benefit reported by pharmaceutical manufacturers, IQWiG and G-BA. The areas of disagreement included ACT selection, definition of subgroups and patient-relevant endpoints, and classification and balancing of adverse events.