In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether drug major Bayer’s (BAYN: DE) Xofigo (radium-223 dichloride) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).
Xofigo has been approved since November 2013 for men with advanced prostate cancer, in whom hormone blockade is no longer effective, and symptomatic bone metastases, but without visceral metastases.
Overall, said the IQWiG, there was an added benefit in the best supportive care (BSC) population, which depended on age and concomitant bisphosphonate treatment: IQWiG determined an indication of a major added benefit of radium-223 + BSC versus BSC as appropriate comparator therapy in patients younger than 65 years and in patients older than 65 years who were treated with bisphosphonate. An indication of a minor added benefit of radium-223 can be derived for patients older than 65 years without concomitant bisphosphonate treatment.
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