(287) Analyzing the economic impact of denosumab in the treatment of osteoporosis

Background: : Denosumab is a IgG2 monoclonal antibody approved for various indications including women who have postmenopausal osteoporosis (PMO) and men at high risk for fracture. Although denosumab can effectively improve bone mineral density and reduce the risk of fractures, some countries note the high price of the reference product which can impact its cost-effectiveness.

Objective: : 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”. Limits: January 2019 to December 2024; English language.

Results: : A total of 45 records were screened for inclusion, resulting in 12 relevant studies, 11 studies in women with PMO and one study in men and women with osteoporosis. Articles examined the economic impact from the perspective of healthcare payers in China (n=4), the United States (n=2), South Korea (n=2), Malaysia (n=2), and Taiwan (n=1); one study examined the impact from a societal perspective (Thailand). Ten cost-effectiveness analyses, one cost-consequence analysis (Korea), and one budget impact analysis (Malaysia) were included. Six studies compared denosumab monotherapy to other monotherapies, four of which reported higher treatment costs for denosumab. Nine studies reported that denosumab treatment was cost-effective or provided a positive economic impact due to fracture-related cost offsets, gains in quality-adjusted life years, and reduced fracture-related deaths. However, in some regions, cost offsets may not be sufficient to meet country-specific willingness to pay (WTP) thresholds, as seen in Thailand. The cost-effectiveness of denosumab may be dependent on the presence of a previous fracture, as reported by two Chinese studies. No studies examined the economic impact of biosimilars.

Conclusions: : Published literature showed reference product denosumab is generally cost-effective despite its high cost. However, affordability issues remain in regions with lower WTP thresholds. Future studies should evaluate the impact of biosimilars which may help to mitigate the unmet needs in this therapeutic area. The introduction of an affordably priced denosumab biosimilar may improve cost-effectiveness, thus contributing to further economic benefits and expanded patient access.

Sponsorship:: Fresenius Kabi USA, LLC