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.