Xofigo®▼ (radium-223 dichloride) Guidelines in mCRPC

Approved by NICE

Xofigo is NICE recommended as an option for treating patients with hormone-relapsed prostate cancer with 2 or more symptomatic bone metastases and no known visceral metastases if they have experienced disease progression after at least 2 lines of prior systemic therapy (other than LHRH analogues) or are ineligible for available systemic therapy options. 

SMC accepted

For the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases.
 

Scottish Medicines Consortium advice

• 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.

Abbreviations: CRPC: castration-resistant prostate cancer; NICE: National Institute of Health and Care Excellence; SMC: Scottish Medicines Consortium.