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 Radium-223 dichloride for the treatment of metastatic castration resistant prostate cancer. The clinical evidence submitted by the company (Bayer Health Care) responsible for manufacturing Radium-223 dichloride (Xofigo) consisted of one international, multicentre, double-blind phase three randomised controlled trial (RCT) sponsored by the company. Evidence from a smaller phase-two, international multicentre, double-blind RCT was presented in a supportive role. 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 (TA412, September 2016). Radium-223 dichloride is currently recommended as an option for treating hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases in adults only if i) they have already had docetaxel or docetaxel is contraindicated or is not suitable for them; ii) the company provides Radium-223 dichloride in line with the commercial access agreement with NHS England.
Craig Ramsay; firstname.lastname@example.org
Completed; for further information see: http://www.nets.nihr.ac.uk/projects/hta/125701
Robertson, C, Lam, T, Stewart, F, Scott, N, Cummins, E, Ramsay, C. Radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases. Evidence Review Group Report in support of the NICE STA Programme. University of Aberdeen: Health Services Research Unit; 2013
Scotland, G, Hernandez, R, Robertson, C, Scott, N, Fraser, C. Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (men who have not received docetaxel and for whom docetaxel is contraindicated or not suitable). ERG critique of the company submission for re-consideration of current CDF technologies under the new proposed CDF criteria. University of Aberdeen: Health Services Research Unit; 2016 URL: https://www.nice.org.uk/guidance/ta412/documents/committee-papers