POS0476 Analysing the Economic Impact of Denosumab in the Treatment of Osteoporosis

Background: Denosumab is a fully human IgG2 monoclonal antibody approved to treat women who have postmenopausal osteoporosis (PMO) or are receiving adjuvant aromatase inhibitor therapy for breast cancer, men at high risk for fracture or receiving androgen deprivation therapy for non-metastatic prostate cancer, and glucocorticoid-induced osteoporosis in both men and women at high risk for fracture. Although denosumab has been shown to effectively improve bone mineral density and reduce the risk of fractures, some countries note the high price of the reference product which can be a barrier for cost-effectiveness and willingness to pay (WTP). A number of denosumab biosimilars are expected to launch globally which may help reduce existing spending on denosumab or enable budget-neutral expanded patient access. Objectives: To understand the economic impact of the denosumab reference product in the treatment of patients with osteoporosis. Methods: A literature search was conducted for models that evaluated the economic impact of denosumab. Search terms included molecular and brand names for denosumab, combined with "budget impact", "cost-consequence" "cost-effect*", "cost per responder", "cost-utility", or "economic model". The search was conducted for articles published between January 1, 2019, and December 15, 2024. Only studies published in English were eligible for inclusion. Results: A total of 45 records were screened for inclusion, resulting in 12 relevant studies that explored the economic impact of denosumab in patients with osteoporosis. Articles examined the economic impact from the perspective of healthcare payers in China (n = 4), the United States (US) (n = 2), South Korea (n = 2), Malaysia (n = 2), and Taiwan (n = 1); one study examined the impact from a societal perspective (Thailand). The economic models included cost-effectiveness analyses (n = 10), one cost-consequence analysis (CCA, Korea), and one budget impact analysis (BIA, Malaysia). Eleven of the studies assessed the economic impact in women with PMO and one study evaluated men and women with osteoporosis. Overall, 75% (n = 9) of studies found that reference denosumab was a cost-effective treatment option or had a positive economic impact for patients with osteoporosis, while 8% (n = 1) of studies found that denosumab was not cost-effective, and 17% (n = 2) deemed it cost-effective in some scenarios (Table 1). Six studies compared denosumab monotherapy to other monotherapies, and four of these studies reported higher intervention costs for denosumab. The single CCA identified concluded that among men and women with osteoporosis, continuous denosumab treatment (as opposed to treatment discontinuation) may lead to reduced fractures and fracture-related deaths, resulting in overall cost savings. The BIA found that among women with PMO, moderately increasing uptake of denosumab would have minimal additional budget impact, partially offset by savings in fracture-related treatment costs. Moreover, denosumab was a cost-effective option in Malaysia (n = 1), South Korea (n = 1), Taiwan (n = 1) and the US (n = 2), owing to fracture-related cost offsets or gains in quality-adjusted life years (QALY), at WTP thresholds of $5,175, $34,870, $30,038, $50,000, $100,000 US dollars per QALY gained, respectively. In some regions, these cost offsets may not be sufficient to meet country-specific WTP thresholds. In Thailand, denosumab was not cost-effective compared to other available treatments despite lower fracture-related costs for women with PMO. Moreover, cost-effectiveness may be dependent on the presence of a previous fracture, as two studies from China reported that denosumab was cost-effective among women with no history of fracture, while two studies reported that it was not cost-effective among women who had previously sustained fragility fractures (n = 2). No studies examined the economic impact of biosimilars. Table 1. Economic impact of reference denosumab by country. Abbreviations: N/A = not available; US=United States. *Among women without prior fragility fracture (as per findings from four cost-effectiveness studies). † Findings from a budget impact analysis. ‡ Findings from a cost-consequence analysis. § Findings from two cost-effectiveness studies. Conclusion: Published literature indicated reference product denosumab is generally cost-effective despite its high cost, owing to offsets from reductions in fracture-related treatment costs or QALY gains. However, affordability issues remain in regions with lower WTP thresholds. Further studies should be conducted to examine and quantify the impact of biosimilars which may help to mitigate the unmet needs in this therapeutic area. Specifically, the introduction of a denosumab biosimilar offered at a more affordable price could improve cost-effectiveness, thus contributing to further economic benefits and expanded patient access in many regions. REFERENCES: NIL . Acknowledgements: NIL . Disclosure of Interests: Kunal Shastri is an employee of Fresenius Kabi, Nathashi Jayawardena is an employee of CRG-EVERSANA which has received financial support from Fresenius Kabi for consulting work, Amanda Griffin is an employee of CRG-EVERSANA which has received financial support from Fresenius Kabi for consulting work, Margaret Ainslie-Garcia is an employee of CRG-EVERSANA which has received financial support from Fresenius Kabi for consulting work. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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