Hence a greater or lesser harm from abiraterone is not proven, but cannot be excluded with certainty, either.
Hint instead of indication
Therefore only positive effects remained on the basis of the available data, namely indications of a minor added benefit regarding "mortality" (overall survival) and of a considerable added benefit regarding "morbidity" (time of occurrence of severe pain). Due to the uncertainty regarding harm, however, overall, IQWiG did not derive an indication, but a hint of a considerable added benefit of abiraterone in comparison with watchful waiting.
IQWiG already published a first dossier assessment of abiraterone in January 2012. This assessment dealt with a different indication, however, namely its use in men with metastatic prostate cancer that is no longer responsive to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel.
G-BA decides on the extent of added benefit
The approach for deriving an overall conclusion on the extent of added benefit is a proposal by IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on abiraterone.
The G-BA website contains both general English-language information on benefit assessment pursuant to 35a Social Code Book V and specific German-language information on the assessment of abiraterone.
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care