Officials from the National Institute for Health and Care Excellence (Nice) have made a preliminary decision not to recommend covering the drug radium-223 dichloride (Xofigo) for use for men with prostate cancer that has spread to the bone.
This latest draft guidance from Nice states that Bayer has not provided information on how Xofigo performs in contrast to other currently available drugs for use in the health service in England and Wales.
Malecare is urging that Bayer provide the required information prior to NICE making their final determination so that men in need will not be denied this safe and effective drug. We know that Xofigo can extend survival by 3.6 months and improve the quality of life with only minor side effects.
Men qualifying for Xofigo are already have very progressed disease with multiple bone metastases. It is nothing short of criminal that they be denied this proven treatment, especially when they are in a position where there are so little alternatives and often suffering with significant pain.
According to Nice chief executive Sir Andrew Dillon: “Clinical specialists told the committee that radium-223 (Xofigo) 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.” I find this confusing, as Xofigo should not be used as an alternative to docetaxel or abiraterone, but as an additional treatment.
Joel T Nowak, M.A., M.S.W.
This news is very frustrating. Bayer provides plenty of data on the use of anti-androgens such as Aberaterone with Radium-223. Phase III trials for Radium-223 required continuation of Androgen Deprivation Therapies. The two work synergisticly with complimentary strategies without overlapping toxicities. Such positive survival results for Xofigo may not have been seen had ADT been considered an “alternative” to Radium 223. Docetaxel and Xofigo on the other hand, do have cumulative bone marrow toxicity and so should not be used together. Did NICE not read the publications?