Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation

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. All 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. Twenty-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. 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.Roche Pharma A

Themenheft 13 "Arbeitslosigkeit und Gesundheit"

Arbeitslose Männer und Frauen haben einen ungünstigeren Gesundheitszustand und leben weniger gesundheitsbewusst als berufstätige Männer und Frauen..Während 49 % der im Bundes-Gesundheitssurvey 1998 befragten arbeitslosen Männer rauchen, sind es unter den berufstätigen männlichen Befragten 34 %. Die Unterschiede bei den Frauen sind mit 31 % Raucherinnen unter den arbeitslosen Frauen und 28 % Raucherinnen unter den berufstätigen Frauen geringer

Possibilities for intervention in adolescents\u27 and young adults\u27 depression from a public health perspective

When considering measures to decrease the burden of disease that is caused by depression, depressive disorders of adolescents and young adults are of increasing interest. The prevalence of depressive disorders in adolescents and young adults is high. The probable increases in prevalence affect predominantly young people and their prognosis is particularly bad. This review discusses the potentials to influence the burden of disease through interventions such as therapy, including measures to detect persons at risk early, selective and universal prevention, and health promotion for adolescents and young adults. It considers the available evidence for the effectiveness of these interventions on the public health level. In addition, the suitability of implementation and ethical considerations are discussed. As a conclusion, health policy in its aim to reduce the burden of depressive disease should focus on increasing treatment rates and improving the efficiency of treatment in adolescents and young adults as well for depression as for other mental disease that has high co-morbidity with depression. In addition, the focus should be set on indicated prevention for children of depressed parents and--for health promotion reasons--on policies that impact on living-conditions of families

Public health. Gesundheit und Gesundheitswesen

Schwartz F-W, Walter U, Siegrist J, Kolip P, eds. Public health. Gesundheit und Gesundheitswesen. München: Urban & Fischer; 2012

Themenheft 32 "Bürger- und Patientenorientierung"

Das Thema Bürger- und Patientenorientierung wird seitAnfang der 1990er Jahre nicht nur national, sonderninternational von unterschiedlichen Akteuren zunehmend angemahnt. Bürgerinnen und Bürger wollen in gesundheitspolitische Entscheidungen eingebunden werden, eine Forderung, die mit Inkrafttreten des GKV-Modernisierungsgesetzes (GMG) zum 1.1.2004 aufgegriffen wurde