The aim of this technology assessment, commissioned by NICE through the NIHR SR Programme as part of the NICE Single Technology Appraisal process, was to review the submission received from the Bayer on the clinical and cost-effectiveness evidence of Darolutamide (Nubeqa®) for treating non‐metastatic hormone relapsed prostate cancer. The primary source of clinical effectiveness evidence submitted by Bayer consisted of a multinational phase III RCT (ARAMIS) comparing Darolutamide versus placebo. The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for this technology appraisal and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company (Bayer). Based on the findings of the submission received from the company and the ERG’s critique, NICE has now released appropriate clinical guidance. Darolutamide with ADT is recommended, within its marketing authorisation, as an option for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease. Darolutamide is recommended only if the company provides it according to the agreed commercial arrangement. For more information see:


Miriam Brazzelli;