UK's NICE unable to give the go ahead to new prostate cancer drug Xofigo

The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued new draft guidance not recommending German drug major Bayer’s (BAYN: DE) Xofigo (radium-223 dichloride) for treating adults with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases.

Xofigo, which was developed by Norway’s Algeta, a company that Bayer has subsequently acquire, gained European regulatory approval last year (The Pharma Letter November 15, 2013). Algeta has said in the past it believes Xofigo could achieve $1.3-$1.6 billion or more in peak annual sales.

Metastatic prostate cancer describes when the primary cancer has spread from the prostate to other parts of the body, such as the bone. This appraisal looks at how well radium-223 dichloride works to treat bone metastases specifically.

Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: “At the beginning of the appraisal process, NICE works with stakeholders to identify the most appropriate treatments for the new drug to be compared to. Clinical specialists told the committee that radium-223 would be used as an alternative treatment option to docetaxel as an initial treatment, and abiraterone as a second-line treatment when the disease has progressed. However, Bayer did not to provide the Committee with any data on how well radium-223 works compared to docetaxel or abiraterone or, only comparing it to a placebo.”

Stakeholders, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. The manufacturer also has an opportunity to request permission to submit additional evidence if it is considered appropriate.

Sir Andrew continued: “Bone metastases are very distressing for patients and their families, particularly as a result of bone pain and fatigue, which have a profound effect on patients’ quality of life, by limiting their mobility and meaning full-time care would often be needed for daily activities. We know how important this could be to patients and we are disappointed not to able to recommend this drug, but we have to be confident that its benefits justify its considerable cost.”

Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

Drug’s cost assessment