摘要

Authors' objectives: Background Since 2010, denosumab (Prolia®) has been listed on the Spezialitätenliste for the treatment of osteoporosis in postmenopausal women, men with osteoporosis who have an increased fracture risk, women with breast cancer receiving adjuvant aromatase inhibitor therapy (AAIT), and men with prostate cancer on hormone ablation therapy (HAT). Pharmacovigilance reports in 2017 warned that discontinuation of denosumab therapy in patients with osteoporosis may lead to increased bone turnover, significant bone mineral loss and increased vertebral fracture risk. On the basis of these safety concerns, the Federal Office of Public Health (FOPH) is re-evaluating the available evidence for denosumab. Objective The objective of this Health Technology Assessment (HTA) is to evaluate the safety, effectiveness, cost-effectiveness and financial impact of denosumab (Prolia®) compared to placebo, bisphosphonates and selective oestrogen receptor modulators (SERMs) in four subgroups of patients. Legal, social, ethical and organisational impacts have also been considered.