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Background/Objectives <p>Postmenopausal osteoporosis (PMO) is a major public health and economic burden in the USA. The objective of this study was to evaluate the cost-effectiveness of biosimilar denosumab compared with alendronate, risedronate, ibandronate, and zoledronic acid in treating women with PMO at high risk of fracture from a US payer perspective.</p> Methods <p>A cost-effectiveness analysis was conducted using a Markov cohort model and a lifetime horizon was applied to capture long-term costs and effects. Treatment effects were based on published network meta-analyses. The cost of biosimilar denosumab was estimated on the basis of assumptions; other costs were obtained from publicly available sources. Main outcomes included quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).</p> Results <p>Biosimilar denosumab was associated with greater efficacy and higher costs versus all comparators. Over a lifetime horizon, the ICER was $101,017, $93,544, $100,515, and $144,995 per QALY gained for biosimilar denosumab compared with alendronate, risedronate, ibandronate, and zoledronic acid, respectively. Cost-effectiveness was most sensitive to starting age, discount rate, treatment duration, and biosimilar price. At a willingness-to-pay (WTP) threshold of $150,000 per QALY gained, biosimilar denosumab was likely to be cost-effective compared with alendronate, risedronate, ibandronate, and zoledronic acid in the treatment of PMO. At a WTP threshold of $100,000 per QALY gained, biosimilar denosumab was likely to be cost-effective relative to risedronate, while ICERs relative to alendronate and ibandronate only marginally exceeded this WTP threshold.</p> Conclusions <p>Biosimilar denosumab was estimated to be cost-effective compared with alendronate, risedronate, ibandronate, and zoledronic acid at a WTP threshold of $150,000/QALY gained and compared with risedronate at a threshold of $100,000/QALY gained. As a lower-cost alternative to reference denosumab, biosimilar denosumab may enhance patient access to effective PMO treatment in the USA.</p>

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Cost-Effectiveness of Biosimilar Denosumab Versus Bisphosphonates in Postmenopausal Osteoporosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月14日

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  • Jeanine Flanigan,
  • Sarah Kane,
  • Fatemeh Mirzayeh Fashami,
  • Anna Zhou,
  • Lamees Almuallem,
  • Mike Tindal,
  • Marion Schauf,
  • Edward Li,
  • Gary H. Lyman

摘要

Background/Objectives

Postmenopausal osteoporosis (PMO) is a major public health and economic burden in the USA. The objective of this study was to evaluate the cost-effectiveness of biosimilar denosumab compared with alendronate, risedronate, ibandronate, and zoledronic acid in treating women with PMO at high risk of fracture from a US payer perspective.

Methods

A cost-effectiveness analysis was conducted using a Markov cohort model and a lifetime horizon was applied to capture long-term costs and effects. Treatment effects were based on published network meta-analyses. The cost of biosimilar denosumab was estimated on the basis of assumptions; other costs were obtained from publicly available sources. Main outcomes included quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).

Results

Biosimilar denosumab was associated with greater efficacy and higher costs versus all comparators. Over a lifetime horizon, the ICER was $101,017, $93,544, $100,515, and $144,995 per QALY gained for biosimilar denosumab compared with alendronate, risedronate, ibandronate, and zoledronic acid, respectively. Cost-effectiveness was most sensitive to starting age, discount rate, treatment duration, and biosimilar price. At a willingness-to-pay (WTP) threshold of $150,000 per QALY gained, biosimilar denosumab was likely to be cost-effective compared with alendronate, risedronate, ibandronate, and zoledronic acid in the treatment of PMO. At a WTP threshold of $100,000 per QALY gained, biosimilar denosumab was likely to be cost-effective relative to risedronate, while ICERs relative to alendronate and ibandronate only marginally exceeded this WTP threshold.

Conclusions

Biosimilar denosumab was estimated to be cost-effective compared with alendronate, risedronate, ibandronate, and zoledronic acid at a WTP threshold of $150,000/QALY gained and compared with risedronate at a threshold of $100,000/QALY gained. As a lower-cost alternative to reference denosumab, biosimilar denosumab may enhance patient access to effective PMO treatment in the USA.