Objectives: Optional scientific advice (SA) for the early benefit assessment of pharmaceuticals is offered by the German decision maker, the Federal Joint Committee (FJC). The aim of this study was to elicit manufacturers’ experiences with the SA procedures offered by the FJC to date.

Methods: A preliminary survey on a small sample size was conducted. Subsequently, a questionnaire comprising eight items, which was developed on the basis of that survey, was used. Data were analyzed using qualitative and quantitative approaches.

Results: The elicitation, including a sample of 25 percent of the completed advice, highlighted the following, regarding the process as well as to the content shortcomings of the SA procedures from an industrial perspective: inconsistencies, FJC's lack of expertise in conducting clinical trials, partially incomplete answers. and a low willingness of the FJC to engage in dialogue with industry were criticized. On the other hand, the majority of respondents expressed a positive attitude concerning unambiguousness, completeness, traceability, discussion atmosphere, and the protocol of the advice. Early SA, before pivotal trials start, showed a significantly higher completeness compared with late SA with respect to endpoints and study duration. Within 4 years the quality of FJC's propositions on some topics improved significantly.

Conclusions: Only a few statistically significant differences were detectable between early versus late SA. A positive trend in industry's perception of the SA can be observed over time. A more active involvement of additional stakeholders and the incorporation of procedural elements from other healthcare systems could improve the quality of the SA offered by the FJC.

Objectives: To provide an overview of the development of health technology assessment (HTA) in Germany since the 1990s.

Methods: Analysis of key documents (e.g. literature, laws, and other official documentation) and personal experiences.

Results: Health technology assessment (HTA) entered the political agenda in Germany only in the mid-1990s, basically as the result of a top-down approach toward more efficiency in health care, but with a strong impetus of an evidence-based medicine movement. Accordingly, HTA became part of several healthcare reform laws since 1997, which led to the establishment of the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) in 2004. This tandem construction aims at using evidence in decision-making processes for coverage and other decisions.

Conclusions: These developments have led to a considerable impact of HTA in Germany. In addition, a broad spectrum of activities at universities and in other organizations, such as the German Institute for Medical Documentation and Information (DIMDI), can be observed that contribute to both teaching and research in HTA. German researchers in the field of HTA are actively involved in international projects, such as EUNetHTA, and contribute to scientific conferences and journals.