Flyer Check, Phase-III Portfolio

4 Underlying methodology and instruments used Not all dossiers are the same! Different types of dossiers are distinguished by their content structure, the way in which information is processed and presented, as well as in the actual goal and purpose for which they are created. The predominant form of presentation is still the report volume with many tables, figures and even more text. This type of dossier is usu- ally very extensive and often runs to several hundred pages. They are not suitable for direct communication, but must first be read and understood as completely as possible before the contents can be discussed. They are too text - heavy and cumbersome to use. For this reason, they are not suitable tools for effective, direct and fast communication with clients. Definitions and explanations of the assessment Definitions The following definitions and explanations are intended to familiarize the reader with the way of thinking and the framework conditions of the institutions IQWiG, G - BA and SpiBu. Significant added benefit if a sustained and, compared with the appropriate comparator therapy, previously unattained major improvement in the therapy - relevant benefit is achieved, in particular a cure of the disease, a signifi- cant prolongation of survival, long - term freedom from serious symptoms or the extensive avoidance of serious side effects. Considerable added benefit if a considerable improvement of the therapy - relevant benefit is achieved compared to the appropri- ate comparator therapy, in particular an attenuation of severe symptoms, a moderate prolongation of life, a noticeable alleviation of the disease for the patients, a relevant avoidance of severe side effects or a significant avoidance of other side effects. Minor additional benefit if a moderate and not only minor improvement of the therapy - relevant benefit is achieved compared to the appropriate comparator therapy, in particular a reduction of non - serious symptoms of the disease or a relevant avoidance of side effects. However, an additional benefit is not quantifiable because the scientific data basis does not allow this. Often true for orphan drugs. No additional benefit is proven. The benefit of the drug being evaluated is less than the benefit of the appropriate compara- tor therapy. Additional benefit (ZN)