NICE Draft Guidance Rejects Bayer’s Xofigo
The National Institute for Health and Care Excellence (NICE) today published draft regulatory guidance rejecting Bayer’s Xofigo for patients with prostate cancer.
Xofigo has been submitted to the regulatory body to treat patients with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases.
Clinical trials have demonstrated that Xofigo can significantly improve overall survival compared to a placebo.
However, NICE confirmed that the recommendation for the drug not to be available for use on the National Health Service in England and Wales, was due to Bayer not providing any data comparing Xofigo to alternative therapies, making it difficult for the regulatory body to assess the drug’s value.
NICE’s chief executive, Sir Andrew Dillon, conveyed regret at not being able to recommend Xofigo at this time, but noted that the regulatory affairs body “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 a minimum of £57,400 per QALY gained, and meaning it could not be considered a cost-effective use of resources.
The alpha-pharmaceutical, which works by binding with minerals in the bone to deliver radiation directly to bone tumours, was approved by the European regulatory affairs body in November 2013 and by the US FDA in May 2013.