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Abstract
Objective: A large, pivotal, phase 3 trial in patients with newly diagnosed multiple myeloma (MM) demonstrated that denosumab, compared with zoledronic acid, was non-inferior for the prevention of skeletal-related events (SREs), extended the observed median progression-free survival (PFS) by 10.7 months, and showed significantly less renal toxicity. The cost-effectiveness of denosumab vs zoledronic acid in MM in the US was assessed from societal and payer perspectives.
Methods: The XGEVA Global Economic Model was developed by integrating data from the phase 3 trial comparing the efficacy of denosumab with zoledronic acid for the prevention of SREs in MM. SRE rates were adjusted to reflect the real-world incidence. The model included utility decrements for SREs, administration, serious adverse events (SAEs), and disease progression. Drug, administration, SRE management, SAEs, and anti-MM treatment costs were based on data from published studies. For the societal perspective, the model additionally included SRE-related direct non-medical costs and indirect costs. The net monetary benefit (NMB) was calculated using a willingness-to-pay threshold of US$150,000. One-way deterministic and probabilistic sensitivity analyses were conducted.
Results: From a societal perspective, compared with zoledronic acid, the use of denosumab resulted in an incremental cost of US$26,329 and an incremental quality-adjusted life-year (QALY) of 0.2439, translating into a cost per QALY gained of US$107,939 and a NMB of US$10,259 in favor of denosumab. Results were sensitive to SRE rates and PFS parameters.
Limitations: Costs were estimated from multiple sources, which varied by tumor type, patient population, country, and other parameters. PFS and overall survival were extrapolated beyond the follow-up of the primary analysis using fitted parametric curves.
Conclusion: Denosumab’s efficacy in delaying or preventing SREs, potential to improve PFS, and lack of renal toxicity make it a cost-effective option for the prevention of SREs in MM compared with zoledronic acid.
Transparency
Declaration of funding
This study was funded by Amgen, Inc.
Declaration of financial/other relationships
NR has consulted for Amgen, Inc., BMS, Celgene, Merck, Novartis, Roche, and Takeda and received research funding from AstraZeneca. GDR has consulted for Amgen Inc. WW has participated in Steering Committees for Amgen; is an employee for Oncotyrol (20%); has participated in Advisory Boards and has consulted for Amgen, BMS, Celgene, cti, Gilead, Janssen, Novartis, Merck, Mundipharma, Pfizer, Roche, Sandoz, Takeda, and The Binding Site; has presented lectures for Amgen, Abbvie, BMS, Celgene, Gilead, Janssen, Mundipharma, Myelom- und Lymphomselbsthilfe Österreich, Novartis, Roche, Sandoz, Takeda, and The Binding Site; has participated in speaker bureau for Gilead; and has received research funding from Amgen, BMS, Celgene, Janssen, Novartis, Roche, Takeda, Oncotyrol, European Commission (FP7 - OPTATIO) and Bundesland Tirol Programm: ‘Translational research’. KS has consulted for Daiichi-Sankyo and Fujimoto Pharma; received research grants from Daiichi-Sankyo and honoraria from Daiichi-Sankyo and Fujimoto Pharma; and provided expert testimony for Amgen, Inc. RGS has received honoraria from Janssen, Takeda, and Pharmacyclics; received travel and accommodation expenses from Janssen, Takeda, and Celgene; and received research funding from Hospira. ET reports grants, personal fees, and non-financial support from Amgen, Celgene, and Janssen-Cilag; personal fees and non-financial support from Takeda; and personal fees from Novartis, GSK, Roche, and BMS, outside the submitted work. LK is a consultant for Amgen. LS, MI, and GH are employees of Amgen and hold Amgen stock. Peer reviewers on this manuscript have received an honorarium from JME for their review work. One reviewer discloses previous work on cost-effectiveness analyses sponsored by Novartis (maker of zoledronic acid) in which zoledronic acid was compared to denosumab; the results of these analyses have been reported in JME and elsewhere. This reviewer has not participated in work regarding denosumab or zoledronic acid or sponsored by Novartis since 2013. The remaining peer reviewers have no relevant financial relationships to disclose.
Acknowledgments
The authors would like to thank Jacqui Buchanan, Sumita Bhatta, Daniela Niepel, Nicolas Despiegel, and Aurelien Jamotte for their useful insights during the development of this manuscript. Medical writing support, funded by Amgen, Inc., was provided by Kelly Soady (PhD) from Oxford PharmaGenesis, Oxford, UK.