The aim of this project, which was commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, was to review the evidence for the clinical and cost-effectiveness of Enzalutamide for treating metastatic, hormone-relapsed prostate cancer for people not previously treated with chemotherapy. The clinical evidence submitted by the company (Astellas) responsible for manufacturing Enzalutamide (Xtandi) consisted of a single large, international, multicentre trial of Enzalutamide versus placebo. The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company.

After taking into consideration the company submission and the findings of the ERG’s critique, NICE released clinical guidance (TA377, January 2016). Enzalutamide is currently recommended, within its marketing authorisation, as an option for treating metastatic hormone relapsed prostate cancer: (i) in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated and (ii) only when the company provides Enzalutamide in line with the commercial access agreement with NHS England. 


Clare Robertson: 




Robertson, C, Cummins, E, Fielding, S, Lam, T, Fraser, C, Ramsay, C. Enzalutamide for treating metastatic hormone-relapsed prostate cancer not previously treated with chemotherapy. Evidence Review Group report in support of the NICE STA Programme. 
Health Services Research Unit: University of Aberdeen; 2015. URL: