title: Cost-effectiveness of denosumab in the treatment of postmenopausal osteoporosis in Canada.
abstract: OBJECTIVE
  Denosumab is a novel biologic agent approved in Canada for treatment of post-menopausal osteoporosis (PMO) in women at high risk for fracture or who have failed or are intolerant to other osteoporosis therapies. This study estimated cost-effectiveness of denosumab vs usual care from the perspective of the Ontario public payer.
  
  
  METHODS
  A previously published PMO Markov cohort model was adapted for Canada to estimate cost-effectiveness of denosumab. The primary analysis included women with demographic characteristics similar to those from the pivotal phase III denosumab PMO trial (FREEDOM; age 72 years, femoral neck BMD T-score -2.16 SD, vertebral fracture prevalence 23.6%). Three additional scenario sub-groups were examined including women: (1) at high fracture risk, defined in FREEDOM as having at least two of three risk factors (age 70+; T-score ≤ -3.0 SD at lumbar spine, total hip, or femoral neck; prevalent vertebral fracture); (2) age 75+; and (3) intolerant or contraindicated to oral bisphosphonates (BPs). Analyses were conducted over a lifetime horizon comparing denosumab to usual care ('no therapy', alendronate, risedronate, or raloxifene [sub-group 3 only]). The analysis considered treatment-specific persistence and post-discontinuation residual efficacy, as well as treatment-specific adverse events. Both deterministic and probabilistic sensitivity analyses were conducted.
  
  
  RESULTS
  The multi-therapy comparisons resulted in incremental cost-effectiveness ratios for denosumab vs alendronate of $60,266 (2010 CDN$) (primary analysis) and $27,287 per quality-adjusted life year gained for scenario sub-group 1. Denosumab dominated all therapies in the remaining scenarios.
  
  
  CONCLUSIONS
  Key limitations include a lack of long-term, real-world, Canadian data on persistence with denosumab as well as an absence of head-to-head clinical data, leaving one to rely on meta-analyses based on trials comparing treatment to placebo.
  
  
  CONCLUSIONS
  Denosumab may be cost-effective compared to oral PMO treatments for women at high risk of fractures and those who are intolerant and/or contraindicated to oral BPs.
authors.affiliation: Amgen Canada Inc, Mississauga, Ontario, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Chau
authors.forename: D L
authors.initials: DL
authors.lastname: Becker
authors.forename: M E
authors.initials: ME
authors.lastname: Coombes
authors.forename: G
authors.initials: G
authors.lastname: Ioannidis
authors.forename: J D
authors.initials: JD
authors.lastname: Adachi
authors.forename: R
authors.initials: R
authors.lastname: Goeree
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000191:economics / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use; D050071:Bone Density Conservation Agents / Q000191:economics / Q000627:therapeutic use; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D000069448:Denosumab; D012968:Etidronic Acid / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008390:Markov Chains; D008875:Middle Aged; D017059:Models, Econometric; D009864:Ontario; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D019057:Quality-Adjusted Life Years; D000068296:Risedronic Acid
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D000069448:Denosumab; D000068296:Risedronic Acid; D012968:Etidronic Acid; D019386:Alendronate