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THE GAP BETWEEN ECONOMIC EVALUATIONS AND CLINICAL PRACTICE: A SYSTEMATIC REVIEW OF ECONOMIC EVALUATIONS ON DABIGATRAN FOR ATRIAL FIBRILLATION

Published online by Cambridge University Press:  18 June 2018

Herbert J.A. Rolden ,
Gert Jan van der Wilt ,
Angela H.E.M. Maas  and
Janneke P.C. Grutters
Herbert J.A. Rolden
Affiliation:
Council for Public Health and Society, Department for Health [email protected]
Gert Jan van der Wilt
Affiliation:
Department for Health Evidence
Angela H.E.M. Maas
Affiliation:
Department of Cardiology
Janneke P.C. Grutters
Affiliation:
Department for Health Evidence
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Abstract

Objectives:

As model-based economic evaluations (MBEEs) are widely used to make decisions in the context of policy, it is imperative that they represent clinical practice. Here, we assess the relevance of MBEEs on dabigatran for the prevention of stroke in patients with atrial fibrillation (AF).

Methods:

We performed a systematic review on the basis of a developed questionnaire, tailored to oral anticoagulation in patients with AF. Included studies had a full body text in English, compared dabigatran with a vitamin K antagonist, were not dedicated to one or more subgroup(s), and yielded an incremental cost-effectiveness ratio. The relevance of all MBEEs was assessed on the basis of ten context-independent factors, which encompassed clinical outcomes and treatment duration. The MBEEs performed for the United States were assessed on the basis of seventeen context-dependent factors, which were related to the country's target population and clinical environment.

Results:

The search yielded twenty-nine MBEEs, of which six were performed for the United States. On average, 54 percent of the context-independent factors were included per study, and 37 percent of the seventeen context-dependent factors in the U.S. studies. The share of relevant factors per study did not increase over time.

Conclusions:

MBEEs on dabigatran leave out several relevant factors, limiting their usefulness to decision makers. We strongly urge health economic researchers to improve the relevance of their MBEEs by including context-independent relevance factors, and modeling context-dependent factors befitting the decision context concerned.

Keywords

RelevanceSystematic reviewAnticoagulation drugsHealth technology assessmentModeling
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 34 , Issue 3 , 2018 , pp. 327 - 336
Copyright
Copyright © Cambridge University Press 2018 

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References

REFERENCES

1.Philips, Z, Bojke, L, Sculpher, M, et al. Good practice guidelines for decision-analytic modelling in health technology assessment. A review and consolidation of quality assessment. Pharmacoeconomics. 2006;24:355–371.Google Scholar
2.Vemer, P, Corro Ramos, I, van Voorn, GA, et al. AdViSHE: A validation-assessment tool of health-economic models for decision makers and model users. Pharmacoeconomics. 2016;34:349–361.Google Scholar
3.McCabe, C, Dixon, S. Testing the validity of cost-effectiveness models. Pharmacoeconomics. 2000;17:501–513.Google Scholar
4.Caro, JJ, Eddy, DM, Kan, H, et al. Questionnaire to assess relevance and credibility of modeling studies for informing health care decision making: An ISPOR-AMCP-NPC Good Practice Task Force Report. Value Health. 2014;17:174–182.Google Scholar
5.Grutters, JPC, Van Asselt, MBA, Chalkidou, K, et al. Healthy decisions: Towards uncertainty tolerance in health care policy. Pharmacoeconomics. 2014;33:1–4.Google Scholar
6.Briggs, AH, Weinstein, MC, Fenwick, EA, et al. Model parameter estimation and uncertainty analysis: A report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-6. Med Decis Making. 2012;32:722–732.Google Scholar
7.O'Brien, B. Economic evaluation of pharmaceuticals: Frankenstein's monster or vampire of trials? Med Care. 1996;34:DS99–DS108.Google Scholar
8.Neyt, M, Cleemput, I, Thiry, N, et al. Calculating an intervention's (cost-)effectiveness for the real-world target population: The potential of combining strengths of both RCTs and observational data. Health Policy. 2012;106:207–210.Google Scholar
9.Connolly, S, Ezekowitz, MD, Yusuf, S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–1151.Google Scholar
10.Patel, MR, Mahaffey, KW, Garg, J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–891.Google Scholar
11.Granger, CB, Alexander, JH, McMurray, JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–992.Google Scholar
12.Giugliano, RP, Ruff, CT, Braunwald, E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–2104.Google Scholar
13.Lozano, R, Naghavi, M, Foreman, K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: A systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2095–2128.Google Scholar
14.Ball, J, Carrington, MJ, McMurray, JJV, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Cardiol. 2013;167:1807–1824.Google Scholar
15.Lauffenburger, JC, Farley, JF, Gehi, AK, et al. Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation: A retrospective cohort study. J Am Heart Assoc. 2015;4:e001798.Google Scholar
16.Hernandez, I, Baik, SH, Piñera, A, et al. Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med. 2015;175:18–24.Google Scholar
17.Graham, DJ, Reichman, ME, Wernecke, M, et al. Cardiovascular, bleeding, and mortality risk in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131:157–164.Google Scholar
18.Freeman, JV, Zhu, RP, Owens, DK, et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011;154:1–11.Google Scholar
19.Shah, SV, Gage, BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011;123:2562–2570.Google Scholar
20.You, JHS, Tsui, KKN, Wong, RSM, et al. Cost-effectiveness of dabigatran versus genotype-guided management of warfarin therapy for stroke prevention in patients with atrial fibrillation. PLoS One. 2012;7:e39640.Google Scholar
21.Canestaro, WJ, Patrick, AR, Avorn, J, et al. Cost-effectiveness of oral anticoagulants for treatment of atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2013;6:724–731.Google Scholar
22.Harrington, AR, Armstrong, EP, Nolan, PE Jr, et al. Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation. Stroke. 2013;44:1676–1681.Google Scholar
23.Clemens, A, Peng, S, Brand, S, et al. Efficacy and cost-effectiveness of dabigatran etexilate versus warfarin in atrial fibrillation in different age subgroups. Am J Cardiol. 2014;114:849–855.Google Scholar
24.Sorensen, SV, Kansal, AR, Connolly, S, et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: A Canadian payer perspective. Thromb Haemost. 2011;105:908–919.Google Scholar
25.Coyle, D, Coyle, K, Cameron, C, et al. Cost-effectiveness of new oral anticoagulants compared with warfarin in preventing stroke and other cardiovascular events in patients with atrial fibrillation. Value Health. 2013;16:498–506.Google Scholar
26.Singh, SM, Micieli, A, Wijeysundera, HC. Economic evaluation of percutaneous left atrial appendage occlusion, dabigatran, and warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. Circulation. 2013;127:2414–2423.Google Scholar
27.Pink, J, Lane, S, Pirmohamed, M, et al. Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: Quantitative benefit-harm and economic analyses. BMJ. 2011;343:d6333.Google Scholar
28.Gonzalez-Juanatey, JR, Alvarez-Sabin, J, Lobos, JM, et al. Cost-effectiveness of dabigatran for stroke prevention in non-valvular atrial fibrillation in Spain. Revista Espanola de Cardiologia. 2012;65:901–910.Google Scholar
29.Kansal, AR, Sorensen, SV, Gani, R, et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation. Heart. 2012;98:573–578.Google Scholar
30.Langkilde, LK, Bergholdt Asmussen, M, Overgaard, M. Cost-effectiveness of dabigatran etexilate for stroke prevention in non-valvular atrial fibrillation. Applying RE-LY to clinical practice in Denmark. J Med Econ. 2012;15:695–703.Google Scholar
31.Andrikopoulos, GK, Fragoulakis, V, Maniadakis, N. Economic evaluation of dabigatran etexilate in the management of atrial fibrillation in Greece. Hellenic J Cardiol. 2013;54:289–300.Google Scholar
32.Davidson, T, Husberg, M, Janzon, M, et al. Cost-effectiveness of dabigatran compared with warfarin for patients with atrial fibrillation in Sweden. Eur Heart J. 2013;34:177–183.Google Scholar
33.Pletscher, M, Plessow, R, Eichler, K, et al. Cost-effectiveness of dabigatran for stroke prevention in atrial fibrillation in Switzerland. Swiss Med Wkly. 2013;143:w13732.Google Scholar
34.Wouters, H, Thijs, V, Annemans, L. Cost-effectiveness of dabigatran etexilate in the prevention of stroke and systemic embolism in patients with atrial fibrillation in Belgium. J Med Econ. 2013;16:407–414.Google Scholar
35.Chevalier, J, Delaitre, O, Hammes, F, et al. Cost-effectiveness of dabigatran versus vitamin K antagonists for the prevention of stroke in patients with atrial fibrillation: A French payer perspective. Arch Cardiovasc Dis. 2014;107:381–390.Google Scholar
36.Krejczy, M, Harenberg, J, Marx, S, et al. Comparison of cost-effectiveness of anticoagulation with dabigatran, rivaroxaban and apixaban in patients with non-valvular atrial fibrillation across countries. J Thromb Thrombolysis. 2014;37:507–523.Google Scholar
37.Lanitis, T, Cotte, FE, Gaudin, AF, et al. Stroke prevention in patients with atrial fibrillation in France: Comparative cost-effectiveness of new oral anticoagulants (apixaban, dabigatran, and rivaroxaban), warfarin, and aspirin. J Med Econ. 2014;17:587–598.Google Scholar
38.Rognoni, C, Marchetti, M, Quaglini, S, et al. Apixaban, dabigatran, and rivaroxaban versus warfarin for stroke prevention in non-valvular atrial fibrillation: A cost-effectiveness analysis. Clin Drug Investig. 2014;34:9–17.Google Scholar
39.Verhoef, TI, Redekop, WK, Hasrat, F, et al. Cost effectiveness of new oral anticoagulants for stroke prevention in patients with atrial fibrillation in two different European health care settings. Am J Cardiovasc Drugs. 2014;14:451–462.Google Scholar
40.Wisloff, T, Hagen, G, Klemp, M. Economic evaluation of warfarin, dabigatran, rivaroxaban, and apixaban for stroke prevention in atrial fibrillation. Pharmacoeconomics. 2014;32:601–612.Google Scholar
41.Zheng, Y, Sorensen, SV, Gonschior, AK, et al. Comparison of the cost-effectiveness of new oral anticoagulants for the prevention of stroke and systemic embolism in atrial fibrillation in a UK Setting. Clin Ther. 2014;36:2015–2028.Google Scholar
42.Janzic, A, Kos, M. Cost effectiveness of novel oral anticoagulants for stroke prevention in atrial fibrillation depending on the quality of warfarin anticoagulation control. Pharmacoeconomics. 2015;33:395–408.Google Scholar
43.Kongnakorn, T, Lanitis, T, Annemans, L, et al. Stroke and systemic embolism prevention in patients with atrial fibrillation in Belgium: Comparative cost effectiveness of new oral anticoagulants and warfarin. Clin Drug Investig. 2015;35:109–119.Google Scholar
44.Bergh, M, Marais, CA, Miller-Janson, H, et al. Economic appraisal of dabigatran as first-line therapy for stroke prevention in atrial fibrillation. S Afr Med J. 2013;103:241–245.Google Scholar
45.Chang, CH, Yang, YHK, Chen, JH, et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation in Taiwan. Thromb Res. 2014;133:782–789.Google Scholar
46.Wang, Y, Xie, F, Kong, MC, et al. Cost-effectiveness of dabigatran and rivaroxaban compared with warfarin for stroke prevention in patients with atrial fibrillation. Cardiovasc Drugs Ther. 2014;28:575–585.Google Scholar
47.Rothwell, PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet. 2005;365:82–93.Google Scholar
48.Boehringer Ingelheim. Dabigatran briefing document. 27 August 2010. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterialsDrugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM226009.pdf (accessed September 16, 2016).Google Scholar
49.Diener, HC, Connolly, SJ, Ezekowitz, MD, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: A subgroup analysis of the RE-LY trial. Lancet Neurol. 2010;9:1157–1163.Google Scholar
50.Wallentin, L, Yusuf, S, Ezekowitz, MD, et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: An analysis of the RE-LY trial. Lancet. 2010;376:975–983.Google Scholar
51.Eikelboom, JW, Wallentin, L, Connolly, SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation. An analysis of the Randomized Evaluation of Long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011;123:2363–2372.Google Scholar
52.Oldgren, J, Alings, M, Darius, H, et al. Risk for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: A subgroup analysis of the RE-LY trial. Ann Intern Med. 2011;155:660–667.Google Scholar
53.Hohnloser, SH, Oldgren, J, Yang, S, et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-term anticoagulant therapy) Trial. Circulation. 2012;125:669–676.Google Scholar
54.Ferreira, J, Ezekowitz, MD, Connolly, SJ, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and symptomatic heart failure: A subgroup analysis of the RE-LY trial. Eur J Heart Fail. 2013;15:1053–1061.Google Scholar
55.Hijazi, Z, Hohnloser, SH, Oldgren, J, et al. Efficacy and safety of dabigatran compared with warfarin in relation to baseline renal function in patients with atrial fibrillation. Circulation. 2014;129:961–970.Google Scholar
56.Hori, M, Connolly, SJ, Zhu, J, et al. Dabigatran versus warfarin. Effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation. Stroke. 2013;44:1891–1896.Google Scholar
57.Brambatti, M, Darius, H, Oldgren, J, et al. Comparison of dabigatran versus warfarin in diabetic patients with atrial fibrillation: Results from the RE-LY trial. Int J Cardiol. 2015;196:127–131.Google Scholar
58.Andrus, MR. Oral anticoagulant drug interactions with statins: Case report of fluvastatin and review of the literature. Pharmacotherapy. 2004;24:285–290.Google Scholar
59.Dans, AL, Connolly, SJ, Wallentin, L, et al. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Circulation. 2013;127:634–640.Google Scholar
60.Quinn, GR, Singer, DE, Chang, Y, et al. Effect of selective serotonin reuptake inhibitors on bleeding risk in patients with atrial fibrillation taking warfarin. Am J Cardiol. 2014;114:583–586.Google Scholar
61.Grutters, JP, Seferina, SC, Tjan-Heijnen, VC, et al. Bridging trial and decision: A checklist to frame health technology assessments for resource allocation decisions. Value Health. 2011;14:777–784.Google Scholar
62.Chalmers, I, Bracken, MB, Djulbegovic, B, et al. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383:156–165.Google Scholar
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