BACKGROUND: Androgen deprivation therapy (ADT) decreases bone mineral density (BMD), increasing risk of fragility fractures and decreasing quality of life over time. Until recently, there were no licensed treatments despite high unmet medical need. In a randomized, double-blind, placebo-controlled trial, denosumab increased BMD and reduced the incidence of vertebral fractures in nonmetastatic PrCa patients receiving ADT. OBJECTIVES: To assess the cost-effectiveness (CE) of denosumab versus no treatment in nonmetastatic PrCa CTIBL patients in Sweden. METHODS: A Markov model was adapted from previously developed models in osteoporosis. This includes six fracture states: hip, vertebral, wrist, other, post-hip, and post-vertebral fracture. Model inputs were based on a literature review conducted in PUBMED. The target population reflected patient characteristics of the trial. The model horizon was 5 years, reflecting progression to metastatic disease. General population fracture risks from Swedish males were adjusted by the relative risk of fracture due to ADT. Only the efficacy of denosumab on vertebral fractures was included in the base case. a societal perspective was used. Published trial data were used to validate the model in terms of fractures. RESULTS: The cost per QALY (ICER) for denosumab versus no treatment ranged from 46,683 to 58,282. Multiple deterministic sensitivity analyses (SA) were performed. The main driver of CE was the efficacy of denosumab; when it provides benefits at other fracture sites as shown in the postmenopausal pivotal trial FREEDOM, the ICER reduces to 19,726. a probabilistic SA showed that denosumab was a cost-effective option for a willingness to pay >60,000. CONCLUSIONS: Denosumab prevents vertebral fractures in patients with PrCa receiving ADT and is cost-effective versus no treatment. Vertebral fractures significantly reduce quality of life and since there is no other licensed treatment in Sweden, denosumab represents an important option in PrCa at commonly accepted CE thresholds in Sweden.
Shroff, S., Martin, M., Kearney, M., Lothgren, M., & Bracco, A. (2011). PCN83 A COST-EFFECTIVENESS ANALYSIS (CEA) FOR DENOSUMAB, A FULLY HUMAN MONOCLONAL ANTIBODY FOR CANCER TREATMENTINDUCED BONE LOSS (CTIBL) IN NON-METASTATIC PROSTATE CANCER (PRCA): A SWEDISH PERSPECTIVE. Value in Health, 13(7), A266–A267. https://doi.org/10.1016/s1098-3015(11)71978-7