A Model for Assessing the Clinical and Economic Benefits of Bone-forming Agents for Reducing Fractures in Postmenopausal Women at High, Near-term Risk of Osteoporotic Fracture

Clin Ther. 2017 Jul;39(7):1276-1290. doi: 10.1016/j.clinthera.2017.05.348. Epub 2017 Jun 17.

Abstract

Purpose: The goal of this study was to assess and compare the potential clinical and economic value of emerging bone-forming agents using the only currently available agent, teriparatide, as a reference case in patients at high, near-term (imminent, 1- to 2-year) risk of osteoporotic fractures, extending to a lifetime horizon with sequenced antiresorptive agents for maintenance treatment.

Methods: Analyses were performed by using a Markov cohort model accounting for time-specific fracture protection effects of bone-forming agents followed by antiresorptive treatment with denosumab. The alternative bone-forming agent profiles were defined by using assumptions regarding the onset and total magnitude of protection against fractures with teriparatide. The model cohort comprised 70-year-old female patients with T scores below -2.5 and a previous vertebral fracture. Outcomes included clinical fractures, direct costs, and quality-adjusted life years. The simulated treatment strategies were compared by calculating their incremental "value" (net monetary benefit).

Findings: Improvements in the onset and magnitude of fracture protection (vs the teriparatide reference case) produced a net monetary benefit of $17,000,000 per 10,000 treated patients during the (1.5-year) bone-forming agent treatment period and $80,000,000 over a lifetime horizon that included 3.5 years of maintenance treatment with denosumab.

Implications: Incorporating time-specific fracture effects in the Markov cohort model allowed for estimation of a range of cost savings, quality-adjusted life years gained, and clinical fractures avoided at different levels of fracture protection onset and magnitude. Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide.

Keywords: abaloparatide; bone fracture; bone-forming agents; cost-effectiveness; osteoporosis; romosozumab; teriparatide.

MeSH terms

  • Aged
  • Antibodies, Monoclonal / economics
  • Antibodies, Monoclonal / therapeutic use
  • Bone Density Conservation Agents / economics
  • Bone Density Conservation Agents / therapeutic use*
  • Cost-Benefit Analysis
  • Denosumab / economics
  • Denosumab / therapeutic use
  • Female
  • Humans
  • Models, Theoretical
  • Osteoporosis, Postmenopausal / drug therapy*
  • Osteoporosis, Postmenopausal / economics
  • Osteoporotic Fractures / economics
  • Osteoporotic Fractures / prevention & control*
  • Parathyroid Hormone-Related Protein / economics
  • Parathyroid Hormone-Related Protein / therapeutic use
  • Postmenopause
  • Quality-Adjusted Life Years
  • Risk
  • Teriparatide / economics
  • Teriparatide / therapeutic use

Substances

  • Antibodies, Monoclonal
  • Bone Density Conservation Agents
  • Parathyroid Hormone-Related Protein
  • Teriparatide
  • romosozumab
  • Denosumab
  • abaloparatide