National differences in family burden may be related to different healthcare systems in Germany and Britain. Support for patients with schizophrenia may be shifted from the professional to the informal healthcare sector more in Britain than in Germany.
Background and objective: Background and objective: Drug repurposing has been considered a cost-effective and reduced-risk strategy for developing new drugs. Little is known and documented regarding the efficiency of repurposing strategies in drug development. The objective of this article is to assess the extent and meaning of this process in the CNS area. Methods: In order to identify repurposed drugs that target the CNS, an extensive search was performed. For each identified case, its initial and target indication, development status and the type of repurposing strategy (repositioning, reformulation or both) was recorded. Results: One hundred and eighteen source products were identified. They were repurposed (mainly repositioned) 203 times with 81 products repurposed once and 38 products repurposed twice or more. The highest number of source drugs originated from the CNS area. Alzheimer’s disease was targeted most often. Half of the new indications were approved. Regarding repurposing within the CNS area, epilepsy, schizophrenia and depression were the richest sources of repurposed drugs. Conclusions: Repurposing drugs into CNS is an efficient and very active drug development method, exemplified by the considerable number of new indications that have been found via this strategy, with approximately half of the target indications currently under development.
Quality of life (QOL) is an important outcome for people with schizophrenia, but most previous studies of its correlates have had small sample sizes or explored a limited number of variables. We conducted an analysis of the baseline data from the European Schizophrenia Cohort (EuroSC) study, a naturalistic investigation of people with schizophrenia living in France, Germany, and the United Kingdom (N = 1208). German participants had the highest subjective QOL. Country of residence, depression, accommodation status, and employment were the most important factors in explaining subjective QOL. Many correlates of subjective QOL in people with schizophrenia were similar to those in the general population. Many of the factors important in explaining subjective QOL in people with schizophrenia are not readily amenable to change. Differences in mental health service provision in the United Kingdom and Germany may in part explain variations in the QOL of people with schizophrenia resident there.
The samples were largely similar in clinical terms. Thus, the social differences between the samples seem likely to be due more to the societal context and may reflect relatively benign situations in the continental locations of our study.
Background: Many established products (EPs – marketed for eight years or more) are widely used off-label despite little evidence on benefit–risk ratio. This exposes patients to risks related to safety and lack of efficacy, and healthcare providers to liability. Introducing new indications for EPs may represent a high societal value; however, manufacturers rarely invest in R&D for EPs. The objective of this research was to describe incentives and disincentives for developing new indications for EPs in Europe and to investigate consequences of current policies.Methods: Targeted literature search and expert panel meetings.Results: Within the current European-level and national-level regulatory framework there are limited incentives for development of new indications with EPs. Extension of indication normally does not allow the price to be increased or maintained, the market protection period to be extended, or exclusion from a reference price system. New indication frequently triggers re-evaluation, resulting in price erosion, regardless of the level of added value with the new indication. In consequence, manufacturers are more prone to undertake R&D efforts at early to mid-stage of product life cycle rather than with EPs, or to invest in new chemical entities, even in therapeutic areas with broad off-label use. This represents a potentially missed opportunity as developing new indications for EPs offers an alternative to off-label use or lengthy and expensive R&D for new therapies, opens new opportunities for potentially cost-effective treatment alternatives, as well as greater equity in patients’ access to treatment options.Conclusion: There are potential benefits from the development of new indications for EPs that are currently not being realized due to a lack of regulatory and pricing incentives in Europe. Incentives for orphan or paediatric drugs have proven to be effective in promoting R&D. Similarly, incentives to promote R&D in EPs should be developed, for the benefit of patients and healthcare systems.
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