Advice

following a full submission assessed under the end of life and orphan process:

radium-223 dichloride (Xofigo®) is accepted for use within NHS Scotland.

Indication under review: for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

In a randomised phase III study of adult men with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases, treatment with radium-223 dichloride was associated with a significant improvement in overall survival compared to placebo.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of radium-223 dichloride.  This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
 

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Medicine details

Medicine name:
radium 223 (Xofigo)
SMC ID:
1077/15
Indication:
for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Pharmaceutical company
Bayer plc/Bayer Schering Pharma
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published
12 October 2015
Additional notes

In September 2018 the marketing authorisation for radium-223 dichloride (Xofigo) was updated and it is now limited for use as monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment. Please refer to the current Summary of Product Characteristics for the most up to date information.