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Eur J Health Econ. 2019 Oct 24. doi: 10.1007/s10198-019-01123-5. [Epub ahead of print]

The contribution of real-world evidence to cost-effectiveness analysis: case study of Dabigatran etexilate in France.

Author information

1
ESSEC Business School, 3, Avenue Bernard Hirsch, 95021, Cergy Pontoise Cedex, France. pouvourville@essec.edu.
2
Bordeaux Pharmacoepi, Bâtiment du Tondu, 146 rue Léon Saignat, 33076, Bordeaux Cedex, France.
3
PKCS, 7 rue de la Baie, 50300, Le Val Saint Père, France.

Abstract

OBJECTIVE:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:

Atrial fibrillation; Cost-effectiveness; Direct oral anticoagulants; Real-world evidence

PMID:
31650440
DOI:
10.1007/s10198-019-01123-5

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