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Summary <p>Biosimilar denosumab is a dominant treatment strategy (i.e., more effective and less costly) across varying levels of baseline fracture risk with sufficient price reductions. Given its superior efficacy and safety, it may be considered a first-line therapy for the treatment of women with postmenopausal osteoporosis at high risk of fracture in the United States (US). Large-scale adoption of biosimilar denosumab as a first-line therapy in this population is anticipated to lead to health improvements at a lower overall cost.</p> Purpose <p>Postmenopausal osteoporosis (PMO) remains undertreated in the US. According to clinical practice guidelines, bisphosphonates and denosumab are recommended therapies for women at high risk of fracture, but bisphosphonates have been preferred due to lower cost. The introduction of biosimilar denosumab may reduce prices and improve access. This study evaluates the cost-effectiveness of biosimilar denosumab compared to bisphosphonates and no intervention in women with PMO in the US across different baseline fracture risks and biosimilar denosumab pricing scenarios.</p> Methods <p>A validated Markov cohort model estimated cost-effectiveness of biosimilar denosumab versus alendronate, risedronate, ibandronate, zoledronic acid, and no intervention. Patients were stratified into four risk categories based on T-score and prior vertebral fracture. The analyses explored the impact of changes in baseline fracture risk and biosimilar denosumab pricing.</p> Results <p>The cost-effectiveness of biosimilar denosumab improved with increasing fracture risk (categories 1–4 represent increasing risk). Biosimilar denosumab was dominant (i.e., more effective and less costly) when priced at $120–$180, $376–$451, $376–$481, and $857–$1188 for risk categories 1, 2, 3, and 4, respectively. At a 75% price reduction (i.e., $376), biosimilar denosumab was dominant versus all comparators for risk categories 2, 3, and 4.</p> Conclusion <p>With sufficient price reductions, biosimilar denosumab is a dominant strategy across varying levels of baseline fracture risk. Biosimilar denosumab’s superior efficacy and favorable safety profile compared to bisphosphonates, along with anticipated price declines, support its potential as a first-line therapy for women with PMO at high-risk of fracture in the US.</p>

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The cost-effectiveness of biosimilar denosumab in postmenopausal osteoporosis: implications of baseline fracture risk and drug price

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月31日

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  • Edward Li,
  • Fatemeh Mirzayeh Fashami,
  • Sarah Kane,
  • Rebecca McTavish,
  • Marion Schauf,
  • Stuart Silverman

摘要

Summary

Biosimilar denosumab is a dominant treatment strategy (i.e., more effective and less costly) across varying levels of baseline fracture risk with sufficient price reductions. Given its superior efficacy and safety, it may be considered a first-line therapy for the treatment of women with postmenopausal osteoporosis at high risk of fracture in the United States (US). Large-scale adoption of biosimilar denosumab as a first-line therapy in this population is anticipated to lead to health improvements at a lower overall cost.

Purpose

Postmenopausal osteoporosis (PMO) remains undertreated in the US. According to clinical practice guidelines, bisphosphonates and denosumab are recommended therapies for women at high risk of fracture, but bisphosphonates have been preferred due to lower cost. The introduction of biosimilar denosumab may reduce prices and improve access. This study evaluates the cost-effectiveness of biosimilar denosumab compared to bisphosphonates and no intervention in women with PMO in the US across different baseline fracture risks and biosimilar denosumab pricing scenarios.

Methods

A validated Markov cohort model estimated cost-effectiveness of biosimilar denosumab versus alendronate, risedronate, ibandronate, zoledronic acid, and no intervention. Patients were stratified into four risk categories based on T-score and prior vertebral fracture. The analyses explored the impact of changes in baseline fracture risk and biosimilar denosumab pricing.

Results

The cost-effectiveness of biosimilar denosumab improved with increasing fracture risk (categories 1–4 represent increasing risk). Biosimilar denosumab was dominant (i.e., more effective and less costly) when priced at $120–$180, $376–$451, $376–$481, and $857–$1188 for risk categories 1, 2, 3, and 4, respectively. At a 75% price reduction (i.e., $376), biosimilar denosumab was dominant versus all comparators for risk categories 2, 3, and 4.

Conclusion

With sufficient price reductions, biosimilar denosumab is a dominant strategy across varying levels of baseline fracture risk. Biosimilar denosumab’s superior efficacy and favorable safety profile compared to bisphosphonates, along with anticipated price declines, support its potential as a first-line therapy for women with PMO at high-risk of fracture in the US.