The aim of this project, which has been commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, is to review the submission of the pharmaceutical company (Astellas) on the evidence for the clinical and cost-effectiveness of enzalutamide (Xtandi™) with androgen deprivation therapy (ADT) versus androgen deprivation therapy alone for the treatment of adults with non-metastatic hormone-relapsed prostate cancer (nmHRPC).
The clinical effectiveness evidence submitted by the company consists mainly of one RCT, the PROSPER trial, which compared enzalutamide plus ADT versus placebo plus ADT in adults with high risk nmHRPC. Further supporting evidence was presented by the STRIVE trial, which compared enzalutamide, ADT and bicalutamide with placebo, ADT and bicalutamide in adults with metastatic hormone-relapsed prostate cancer and nmHRPC.
The Aberdeen HTA Group acts as the Evidence Review Group (ERG) for the project and provides an independent critique of the clinical and cost-effectiveness evidence submitted by the company. Based on the findings of the company submission and of the ERG’s critique, NICE will release appropriate clinical guidance.
For more information see: https://www.nice.org.uk/guidance/TA580
Miriam Brazzelli; firstname.lastname@example.org