NICE has issued guidance not recommending cabazitaxel (Jevtana, Sanofi) in combination with prednisone or prednisolone as a second line treatment for prostate cancer. This is following further work by HEDS to comment on the response by Sanofi. Two of the key issues are common to cancer appraisals – utility values and survival analysis. HEDS has a massive amount of expertise in each of these topics and it is surprising that the same old mistakes are made in manufacturer submissions.
One further issue was the choice of population from the key (multi-national) trial; should the whole trial population be used or just the North America and Europe sub-population. This issue is becoming a key battleground in appraisals and has been the focus of discusison on at least two other recent appraisals – eribulin and belimumab. Future appraisals would certainly benefit from more clarity/guidance on the most appropriate approach to be used when such choices are possible.