title: Cost-effectiveness and budget impact of the fixed-dose dual bronchodilator combination tiotropium-olodaterol for patients with COPD in the Netherlands.
abstract: OBJECTIVE
  The fixed-dose dual bronchodilator combination (FDC) of tiotropium and olodaterol showed increased effectiveness regarding lung function and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with the use of its mono-components. Yet, while effectiveness and safety have been shown, the health economic implication of this treatment is still unknown. The aim of this study was to assess the cost-utility and budget impact of tiotropium-olodaterol FDC in patients with moderate to very severe COPD in the Netherlands.
  
  
  METHODS
  A cost-utility study was performed, using an individual-level Markov model. To populate the model, individual patient-level data (age, height, sex, COPD duration, baseline forced expiratory volume in 1 second) were obtained from the tiotropium-olodaterol TOnado trial. In the model, forced expiratory volume in 1 second and patient-level data were extrapolated to utility and survival, and treatment with tiotropium-olodaterol FDC was compared with tiotropium. Cost-utility analysis was performed from the Dutch health care payer's perspective using a 15-year time horizon in the base-case analysis. The standard Dutch discount rates were applied (costs: 4.0%; effects: 1.5%). Both univariate and probabilistic sensitivity analyses were performed. Budget impact was annually assessed over a 5-year time horizon, taking into account different levels of medication adherence.
  
  
  RESULTS
  As a result of cost increases, combined with quality-adjusted life-year (QALY) gains, results showed that tiotropium-olodaterol FDC had an incremental cost-effectiveness ratio of €7,004/QALY. Without discounting, the incremental cost-effectiveness ratio was €5,981/QALY. Results were robust in univariate and probabilistic sensitivity analyses. Budget impact was estimated at €4.3 million over 5 years assuming 100% medication adherence. Scenarios with 40%, 60%, and 80% adherence resulted in lower 5-year incremental cost increases of €1.7, €2.6, and €3.4 million, respectively.
  
  
  CONCLUSIONS
  Tiotropium-olodaterol FDC can be considered a cost-effective treatment under current Dutch cost-effectiveness thresholds.
authors.affiliation: Department of Pharmacy, Unit of PharmacoEpidemiology & PharmacoEconomics; Department of General Practice, Groningen Research Institute for Asthma and COPD (GRIAC).
authors.forename: Job Fm
authors.initials: JF
authors.lastname: van Boven
authors.affiliation: Department of General Practice, Groningen Research Institute for Asthma and COPD (GRIAC).
authors.forename: Janwillem Wh
authors.initials: JW
authors.lastname: Kocks
authors.affiliation: Department of Pharmacy, Unit of PharmacoEpidemiology & PharmacoEconomics; Institute of Science in Healthy Aging & healthcaRE (SHARE); Department of Epidemiology, University Medical Center Groningen (UMCG), University of Groningen, Groningen, the Netherlands.
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Postma
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000191:economics* / Q000627:therapeutic use*; D000368:Aged; D048588:Benzoxazines / Q000191:economics* / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000191:economics* / Q000627:therapeutic use*; D002017:Budgets; D018680:Cholinergic Antagonists / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D004338:Drug Combinations; D016527:Drug Costs; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008390:Markov Chains; D055118:Medication Adherence; D008875:Middle Aged; D018803:Models, Economic; D009426:Netherlands; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality / Q000503:physiopathology; D019057:Quality-Adjusted Life Years; D012720:Severity of Illness Index; D013997:Time Factors; D000069447:Tiotropium Bromide / Q000191:economics* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D048588:Benzoxazines; D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D004338:Drug Combinations; C000611386:tiotropium-olodaterol; D000069447:Tiotropium Bromide
keywords: COPD; budget impact; cost-effectiveness; cost–utility; health economics