Radium-223 dichloride for prostate cancer

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) (NICE re-consideration of current Cancer Drug Fund (CDF) technologies under the new proposed CDF criteria)

Advanced prostate cancer is often associated with bone metastases which cause significant morbidity and mortality. Radium‑223 dichloride (Xofigo, Bayer) is a radiopharmaceutical agent designed to deliver alpha radiation to bone metastases without affecting normal bone marrow.

This project was carried out to support NICE’s decision making process surrounding the re-consideration of current Cancer Drug Fund (CDF) technologies under the new proposed CDF criteria. Radium-223 was previously rejected by NICE for routine commissioning in men who had not previously received treatment with docetaxel. It was subsequently made available to these patients through the CDF in England. Following a decision to reform the old CDF, NICE began to reappraise all drugs already in the CDF in April 2016.

The company responsible for radium-223 (Bayer) submitted updated evidence for review and a revised economic model addressing the committee concerns from the previous appraisal. The Aberdeen HTA group were commissioned to act as the Evidence Review Group (ERG) for the appraisal, and to provide an independent report reviewing the company’s evidence submission. Following review of the revised modelling, the ERG established that the company’s revisions to the model were generally appropriate, and that these updates improved the cost-effectiveness estimates for radium-223.

Outcome and Translation

Following consideration of the company submission and the ERG reports, the NICE appraisal committee recommended radium-223 as an option for treating hormone-relapsed prostate cancer with symptomatic bone metastases (in men without prior docetaxel treatment), only if docetaxel is contraindicated or is not suitable for them: https://www.nice.org.uk/guidance/ta412.

National Institute for Health and Care Excellence (2016) Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases, Technology Appraisal Guidance (TA142), London: NICE.

HERU researchers involved in this research project: Graham Scotland and Rodolfo Hernández

External collaborators: C Robertson, C Fraser (Health Services Research Unit, University of Aberdeen); N Scott (Medical Statistics Team, University of Aberdeen)

Publications

Scotland, G., Hernández, R., Robertson, C., Scott, N. and Fraser, C. (2016) 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. Report from Aberdeen Health Technology Assessment Group to NICE Appraisal Committee.

Presentations

Scotland, G. (2016) 'Report of the Evidence Review Group on reconsideration of radium-223 for treating hormone-relapsed prostate cancer with bone metastases (men who have not received docetaxel and for whom docetaxel is contraindicated or not suitable)', National Institute for Health and Care Excellence (NICE) Appraisal Committee Meeting, Manchester, 26 July 2016.