The aim of this project, 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 (Janssen-Cilag Ltd.) on the evidence for the clinical and cost-effectiveness of Abiraterone acetate (Zytiga®) with prednisone/prednisolone versus androgen deprivation therapy for the treatment of adults with newly diagnosed, high risk metastatic hormone-naïve prostate cancer in adults.
The clinical effectiveness evidence submitted by the pharmaceutical company consists mainly of one RCT, the LATITUDE trial (1199 participants), with supporting evidence of one further RCT, the STAMPEDE trial (1917 participants).
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. NICE guidance is expected in October 2018.
For more information see: https://www.nice.org.uk/guidance/indevelopment/gid-ta10122
Miriam Brazzelli; email@example.com