title: Intervention thresholds for denosumab in the UK using a FRAX®-based cost-effectiveness analysis.
abstract: The objective was to undertake a health economic analysis of denosumab for the treatment of osteoporosis in women from the UK, using the FRAX® tool. Denosumab was cost-effective in women with a risk of major osteoporotic fracture meeting or exceeding approximately 20% who are unable to take, comply with or tolerate generic alendronate.
  
  
  BACKGROUND
  Denosumab is a novel biologic agent developed for the treatment of osteoporosis, which has been shown to reduce the risk of fractures in a phase-III trial. The objective of the present study was to undertake a health economic analysis of denosumab in women from the UK. Ten-year probabilities of a major osteoporotic fracture at which denosumab is a cost-effective alternative to no treatment, generic alendronate, risedronate and strontium ranelate were estimated.
  
  
  METHODS
  A previously published Markov model was adapted to incorporate fracture and mortality risk assessments based on absolute fracture probability, as estimated by FRAX®. The model included treatment persistence and residual effect after discontinuation.
  
  
  RESULTS
  At a willingness-to-pay (WTP) of £30,000 per quality-adjusted life year and a 10-year fracture probability equivalent to a woman with a prior fragility fracture, denosumab was cost-effective compared to no treatment from the age of 70 years. At the same WTP, denosumab was-irrespective of age-cost-effective compared to no treatment at a major osteoporotic fracture probability of approximately 20%. Denosumab was estimated to cost-effectively replace strontium, risedronate and generic alendronate at 10-year probabilities exceeding 11, 19 and 32%, respectively.
  
  
  CONCLUSIONS
  FRAX® facilitates the estimation of cost-effectiveness-based intervention thresholds applicable to patients with different combinations of clinical risk factors, which more closely matches the situation in clinical practice. Denosumab is cost-effective in patients with major osteoporotic fracture probabilities meeting or exceeding approximately 20% who are unable to take, comply with or tolerate generic alendronate.
authors.affiliation: Medical Management Centre, Karolinska Institutet, Stockholm, Sweden.
authors.forename: O
authors.initials: O
authors.lastname: Ström
authors.forename: B
authors.initials: B
authors.lastname: Jönsson
authors.forename: J A
authors.initials: JA
authors.lastname: Kanis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000191:economics / Q000627:therapeutic use; D000465:Algorithms; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use; D050071:Bone Density Conservation Agents / Q000191:economics* / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D000069448:Denosumab; D016527:Drug Costs / Q000706:statistics & numerical data; D012968:Etidronic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D008875:Middle Aged; D017059:Models, Econometric; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000191:economics; D058866:Osteoporotic Fractures / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D011788:Quality of Life; D053245:RANK Ligand / Q000037:antagonists & inhibitors; D000068296:Risedronic Acid; D018570:Risk Assessment / Q000379:methods; D013876:Thiophenes / Q000191:economics / Q000627:therapeutic use; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D053245:RANK Ligand; D013876:Thiophenes; C081587:strontium ranelate; D000069448:Denosumab; D000068296:Risedronic Acid; D012968:Etidronic Acid; D019386:Alendronate