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lüll Radium-223 Dichloride -- Benefit Assessment According to section sign35a Social Code Book VäRadium-223 Dichloride -- Benefit Assessment According to section sign35a Social Code Book V-/-IQWiG Dossier Assessment Extracts 2014[Mar]; ä (ä): äThe aim of this report is to assess the added benefit of radium-223 dichloride (hereinafter referred to as "radium-223") in comparison with the appropriate comparator therapy (ACT) in patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The Federal Joint Committee (G-BA) specified an ACT for each different patient group: for patients with the primary treatment goal of prolongation of life: docetaxel in combination with prednisone or prednisolone; for patients with the primary treatment goal of symptom control and prevention of late complications and for patients for whom docetaxel treatment is not an option: best supportive care (BSC) (particularly adequate pain therapy, treatment with bisphosphonates and/or radionuclides). In this benefit assessment, the group of patients with the primary treatment goal of symptom control and prevention of late complications and the group of patients for whom docetaxel treatment is not an option were primarily considered jointly, also because of the identical ACT, and are hereinafter referred to as "BSC population". The group of patients with the primary treatment goal of prolongation of life is hereinafter referred to as "docetaxel population". Studies that investigated a comparison of radium-223 with or without BSC versus BSC could be considered for the benefit assessment of radium-223 compared with the ACT BSC. The assessment was based on patient-relevant outcomes. One direct comparative randomized controlled trial (RCT) was included in the assessment.ä |