Advantages in "mortality" and "morbidity"
The results of the study showed that, on the one hand, abiraterone had advantages in the outcome "overall survival", as life expectancy was about five months higher on average (median) in this study arm. On the other hand, severe pain occurred later in the abiraterone group, where it took about three months longer until one quarter of the patients needed an opiate. IQWiG sees an indication of an added benefit for both outcomes: in the case of "mortality" (overall survival) with the extent "minor", and in the case of "morbidity" (occurrence of severe pain) with the extent "considerable".
Data on "health-related quality of life" not usable
Data on "health-related quality of life" were obtained in this study using a questionnaire. The way these data were analysed was unsuitable, however, and therefore the results could not be used for the assessment. Therefore it remained unclear whether the differences recorded between the two study arms were really noticeable for the patients.
Results on "side effects" are uncertain
Most data on "side effects" presented by the pharmaceutical company were also not analysed appropriately, and could therefore not be used. This was true for the overall rate of adverse events and for serious adverse events, as well as for the specific adverse events "fractures" and "fluid retention/oedema".
The main reason these data could not be used was that the difference in treatment duration in the two study arms (13.8 versus 8.3 months) was not considered appropriately by the manufacturer in the analyses.
An analysis of severe adverse events that occurred during the first three months of the treatment from the approval documents could be used, however. At this early time, when the
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care