Draft guidance issued by the National Institute for Health and Care Excellence (NICE) this morning (Monday) rejects the use of Bayer's Xofigo (radium-223 dichloride) in patients with prostate cancer on the National Health Service in England and Wales.
The cost regulator is currently assessing whether the drug should be funded by the NHS for treating patients with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases.
While clinical trials have shown that Xofigo can significantly improve overall survival compared to a placebo (14.0 months versus 11.2 months, respectively), the cost regulator said no data comparing it with alternative therapies (normally docetaxel first-line and abiraterone second-line) was provided, making it difficult to assess its value.
NICE's chief executive Sir Andrew Dillon expressed disappointment at not being able to recommend the drug at this time, but stressed "we have to be confident that its benefits justify its considerable cost".
Based on a comparison with best supportive care (not active treatment), NICE experts calculated the base case ICER to be at least £57,400 per QALY gained, and therefore could not be considered a cost-effective use of resources, particularly as it also failed to meet end-of-life criteria.
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments, and patients can still access the drug through the Cancer Drugs Fund if their physician feels it is appropriate.
The alpha-pharmaceutical, which works by binding with minerals in the bone to deliver radiation directly to bone tumours, was approved in Europe last November and in the US last May.