Abiraterone acetate (abiraterone for short, trade name: Zytiga) has been approved in Germany since December 2012 for men with metastatic prostate cancer that is not responsive to hormone blockade, who only have mild symptoms or so far none at all, and in whom chemotherapy is not yet indicated. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy.
According to this, the new drug can prolong overall survival and delay the occurrence of severe pain in comparison with watchful waiting. Due to the poor data however, it cannot be excluded with certainty that abiraterone also causes greater harm in the form of side effects. Overall, IQWiG derives a hint of a considerable added benefit.
G-BA specified appropriate comparator therapy
The Federal Joint Committee (G-BA) specified watchful waiting, i.e. observation of the disease and its course without additional medical interventions, as the appropriate comparator therapy. However, current conventional androgen deprivation therapy, i.e. hormone blockade with drugs, was to be maintained or continued as combined, maximal androgen blockade with a non-steroidal anti-androgen (flutamide or bicalutamide).
Assessment on the basis of an approval study
The assessment was based on a direct comparative randomized controlled trial (RCT), namely the approval study for this indication (COU-AA-302). Patients in this study received either abiraterone and prednisone or placebo and prednisone. Almost all patients (94%) in both study arms also received a drug for hormone blockade.
In both study arms, treatment was continued until progression occurred, i.e. the disease got worse. In the abiraterone group, this was the case after 13.8 months on averag
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care