19 February 2018 - Optional scientific advice for the early benefit assessment of pharmaceuticals is offered by the German decision maker, the Federal Joint Committee. The aim of this study was to elicit manufacturers’ experiences with the SA procedures offered by the Federal Joint Committee to date.

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.

The elicitation, including a sample of 25% 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, Federal Joint Committee's (FJCs) lack of expertise in conducting clinical trials, partially incomplete answers. and a low willingness of the FJC to engage in dialogue with industry were criticised. 

Read International Journal of Technology Assessment in Health Care article