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- Title
The contribution of real-world evidence to cost-effectiveness analysis: case study of Dabigatran etexilate in France.
- Authors
de Pouvourville, Gérard; Blin, Patrick; Karam, Pierre
- Abstract
<bold>Objective: </bold>The goal of this study was to assess the differences between an ex ante and an ex post cost-effectiveness analysis of Dabigatran etexilate vs VKAs for the prevention of thromboembolic events in non-valvular atrial fibrillation patients and to draw lessons on the design and use of real-world data for decision making.<bold>Methods: </bold>The same model was used to calculate the cost-effectiveness ratio using two sets of parameters. One set included the efficacy and safety outcomes data from RE-LY, the pivotal trial comparing Dabigatran to warfarin; cost data came from an ex ante publication. Outcomes data for the second set came from real-world data studies. Cost data were a mix of real-world data and other sources. Two treatment strategies were compared: treatment initiation by either Dabigatran or VKAs, followed by either VKAs or Dabigatran. A crude comparison of results was performed; the impact of data differences was then assessed. Probabilistic sensitivity results of the two analyses were compared.<bold>Results: </bold>With real-world evidence, Dabigatran at both dosages was more effective for the prevention of ischemic strokes, intra-cranial haemorrhages, with less major extra-cranial haemorrhages and a similar risk of myocardial infarction. Using clinical trial data, Dabigatran150 mg (resp. Dabigatran110 mg) as a first-line treatment vs VKAs yielded an ICER of € 8077/QALY (resp. € 13,116/QALY). Real-world evidence scenarios were cost-saving and more effective for both dosages.<bold>Conclusion: </bold>The reassessment of outcomes and cost data had an impact on results, improving the efficiency of Dabigatran. We identify methodological issues which should be discussed if post-launch RWE based cost-effectiveness data become a standard in HTA decision making.
- Subjects
FRANCE; DABIGATRAN; THROMBOEMBOLISM prevention; ATRIAL fibrillation; COST effectiveness; MEDICAL decision making
- Publication
European Journal of Health Economics, 2020, Vol 21, Issue 2, p235
- ISSN
1618-7598
- Publication type
journal article
- DOI
10.1007/s10198-019-01123-5