Relevance of Health Technology Assessment for Benefit Decisions in Germany Now and in the Future

In Germany, health technology assessment (HTA) was discovered in 1995 when the Federal Ministry of Health commissioned a state-of-the- art review. In 2000, the German Agency for HTA was founded with the objective to develop a HTA information system. Since 2004, the new Institute for Quality and Efficiency in Health Care has even broader tasks. Between 1991 and 2003, the Federal Committee of Physicians and Sickness Funds made 50 decisions regarding the inclusion of technologies in the benefit catalogue for ambulatory care. Before 1997, HTA played a negligible role but then its role increased. Costs were considered explicitly only twice. Pharmaceuticals were not assessed. The committee's successor, the Federal Joint Committee, still uses three different evaluation procedures for ambulatory care, dental care and inpatient care respectively. Evidence is mainly based on studies, ranked according to criteria of evidence-based medicine. In future, HTA needs to become more rigid, more flexible and more innovative. The acceptance of the necessity of assessments has to growamong decision-makers as new technologies still get unevaluated into the benefit catalogue, and the evaluation procedures need to be standardised. The reliance on study designs needs to be lessened, e.g. to include the quality of study execution, the number of studies, their consistency and effect size into account. Besides Yes/No-decisions, intermediate categories are necessary, e.g. the limitation of technologies to particular centres or the inclusion of all patients into registers. Besides evaluating effectiveness, attention needs to be given to social, ethical, organisational and economic implications of a technology.