ABSTRACT
Despite a large number of approved therapies demonstrating efficacy in the treatment of rheumatic diseases, only 60-85 % of patients with the indications for rheumatoid arthritis are adequately treated in Germany. Additionally, approved therapies for other immune-mediated diseases are often entirely lacking, indicating the great medical need for the development of new innovative therapies in this specialized field. The development of new drugs is expensive due to the high costs of conducting clinical trials in all phases of development up to obtaining approval; therefore, pharmaceutical companies are looking for ways to save costs in the particular developmental stages. Although the classical regions for drug development (i.e. western Europe, the USA and Japan) offer both a high level of data quality and a good infrastructure to conduct clinical trials due to high standards of education and quality, clinical trials are expensive in these regions. Beside high costs, the comparatively low recruitment rates in these regions are one of the main reasons for the shifting of drug developmental stages from classical regions to eastern European, Latin American and Asian countries, which provide services for drug development and high recruitment rates for comparatively less money. However, there are many strong arguments for the participation of regions in western Europe, especially German sites in clinical trials. In this article these arguments are discussed and possible solutions and strategies for conducting and compensation of study centers in Germany for clinical trials in the field of rheumatology are provided.
Subject(s)
Antirheumatic Agents/therapeutic use , Clinical Studies as Topic/methods , Patient Selection , Rheumatic Diseases/drug therapy , Rheumatology/organization & administration , Europe , Germany , Humans , Treatment Outcome , United StatesABSTRACT
OBJECTIVES: The aim of this study was to evaluate annual direct medical costs of adult SLE patients with active autoantibody positive disease on medication in Germany. METHODS: A multicentre, observational, retrospective European study with German sub-analysis was performed. Costs were assessed according to national tariffs. RESULTS: 10 German centres included 77 patients. The mean (SD) annual direct medical costs of patients were 3 452.21 (3 777.07), and were 3.4 times higher in severe than non-severe patients ( 5 291.07 vs. 1 564.97; p<0.001). Cost of medication ( 2 349.40) represented 68.1% of the total cost. Flares, especially severe flares, were identified as cost predictors. Each flare increased the annual total cost by 2 164,01 (p<0,001). CONCLUSION: The annual direct medical cost of SLE patients in Germany is linked to disease severity. Medical treatments and severe flares were identified as the cost predictors and drivers, respectively.
