3 The company's submission
The appraisal committee (see section 6) considered evidence submitted by Bayer and a review of this submission by the evidence review group (ERG). This appraisal was a Cancer Drugs Fund reconsideration of the published NICE technology appraisal guidance on radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases. It focused on updated cost-effectiveness analyses for the subgroup who have not had docetaxel and for whom docetaxel is not suitable.
3.1 In brief, the key clinical evidence in the company's submission came from ALSYMPCA, a randomised double-blind placebo-controlled trial comparing radium‑223 with placebo in people with hormone-refractory prostate cancer with painful bone metastases. It included people who had previously had docetaxel and people who had not, and the primary endpoint was overall survival. The trial collected quality-of-life data, which was assessed using the Functional Assessment of Cancer Therapy – Prostate (FACT‑P) and EuroQoL‑5 dimensions (EQ‑5D) questionnaires. See the committee papers for full details of the evidence, and the history for full details of the evidence used for NICE's original technology appraisal guidance on radium‑223 dichloride for treating hormone-relapsed prostate cancer with bone metastases.