Table 2 Levels of patient-relevant benefit, as per German Social Code

1

Major (“erheblich”)–Lasting major improvement

–Especially recovery from the disease, a significant extension in the duration of survival, long-term freedom from severe symptoms or extensive avoidance of serious side effects

2

Important (“beträchtlich”)–Significant improvement

–Especially a reduction of serious symptoms, a moderate extension of the duration of life, an alleviation of the disease that is noticeable for the patients, a relevant avoidance of serious side effects, or a significant avoidance of other side effects

3

Slight (“gering”)–Moderate and not just minor improvement

–Especially a reduction of non-serious symptoms of the disease or a relevantavoidance of side effects

4

Existing; but not quantifiable

–Because the scientific data basis does not allow such quantification

5

None

6

Smaller than the benefit of the appropriate comparator