Skip to main content
Hauptrubriken
CME Facharzt-Training Webinare Zeitschriften Bücher e.Medpedia Podcast
Service
Jobbörse Info & Hilfe
Fachgebiete
Anästhesiologie Allgemeinmedizin Arbeitsmedizin Augenheilkunde Chirurgie Dermatologie Gynäkologie und Geburtshilfe HNO Innere Medizin Kardiologie Neurologie Onkologie und Hämatologie Orthopädie und Unfallchirurgie Pädiatrie Pathologie Psychiatrie Radiologie Rechtsmedizin Urologie Zahnmedizin
Themen
Klimawandel und Gesundheit Neues aus dem Markt COVID-19 Praxis und Beruf Seltene Erkrankungen GOÄ & EBM Panorama
Sammlungen
Kasuistiken Algorithmen & Infografiken Blickdiagnosen Arthropedia FlapFinder (für Dermatochirurgen) Videos Kongressberichterstattung Medizin für Apothekerinnen und Apotheker Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende
Erweiterte Suche
Anmelden
nach oben
PharmacoEconomics
Erschienen in: PharmacoEconomics 3/2015

01.03.2015 | Original Research Article

Cost Effectiveness of Rivaroxaban for Stroke Prevention in German Patients with Atrial Fibrillation

verfasst von: Alexander Mensch, Stephanie Stock, Björn Stollenwerk, Dirk Müller

Erschienen in: PharmacoEconomics | Ausgabe 3/2015

Einloggen, um Zugang zu erhalten

Abstract

Objective

The aim of this study was to assess the cost effectiveness of the novel fixed-dose anticoagulant rivaroxaban compared with the current standard of care, warfarin, for the prevention of stroke in patients with atrial fibrillation (AF).

Methods

A Markov model was constructed to model the costs and health outcomes of both treatments, potential adverse events, and resulting health states over 35 years. Analyses were based on a hypothetical cohort of 65-year-old patients with non-valvular AF at moderate to high risk of stroke. The main outcome measure was cost per quality-adjusted life-year (QALY) gained over the lifetime, and was assessed from the German Statutory Health Insurance (SHI) perspective. Costs and utility data were drawn from public data and the literature, while event probabilities were derived from both the literature and rivaroxaban’s pivotal ROCKET AF trial.

Results

Stroke prophylaxis with rivaroxaban offers health improvements over warfarin treatment at additional cost. From the SHI perspective, at baseline the incremental cost-effectiveness ratio of rivaroxaban was €15,207 per QALY gained in 2014. The results were robust to changes in the majority of variables; however, they were sensitive to the price of rivaroxaban, the hazard ratios for stroke and intracranial hemorrhage, the time horizon, and the discount rate.

Conclusions

Our results showed that the substantially higher medication costs of rivaroxaban were offset by mitigating the shortcomings of warfarin, most notably frequent dose regulation and bleeding risk. Future health economic studies on novel oral anticoagulants should evaluate the cost effectiveness for secondary stroke prevention and, as clinical data from direct head-to-head comparisons become available, new anticoagulation therapies should be compared against each other.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22:983–8.CrossRefPubMed
2.
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. 1987;147:1561–4.CrossRefPubMed
3.
Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the anticoagulation and risk factors in atrial fibrillation (ATRIA) study. JAMA. 2001;285:2370–5.CrossRefPubMed
4.
Feinberg WM, Blackshear JL, Laupacis A, et al. Prevalence, age distribution, and gender of patients with atrial fibrillation. Arch Intern Med. 1995;155:469–73.CrossRefPubMed
5.
Kannel WB, Wolf PA, Benjamin EJ, et al. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998;82:2N–9N.CrossRefPubMed
6.
7.
Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146:857–67.CrossRefPubMed
8.
Bungard TJ, Ghali WA, Teo KK, et al. Why do patients with atrial fibrillation not receive warfarin? Arch Intern Med. 2000;160:41–6.CrossRefPubMed
9.
Gage BF, Eby C, Milligan PE, et al. Use of pharmacogenetics and clinical factors to predict the maintenance dose of warfarin. Thromb Haemost. 2004;91:87–94.PubMed
10.
Hylek EM, Go AS, Chang Y, et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003;349:1019–26.CrossRefPubMed
11.
Levine MN, Raskob G, Landefeld S, et al. Hemorrhagic complications of anticoagulant treatment. Chest. 2001;119:108S–21S.CrossRefPubMed
12.
Kubitza D, Becka M, Roth A, et al. Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opin. 2008;24:2757–65.CrossRefPubMed
13.
Patel MR, Mahaffey KW, Garg J, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91.CrossRefPubMed
14.
Red List Service GmbH. Red List 2012. Frankfurt am Main: German List of Pharmaceuticals; 2012.
15.
Schwabe/Paffrath (Hrsg.). Arzneiverordnungs-report 2013. Berlin: Springer; 2013.
16.
Kourlaba G, Maniadakis N, Andrikopoulos G, et al. Economic evaluation of rivaroxaban in stroke prevention for patients with atrial fibrillation in Greece. Cost Eff Resour Alloc. 2014;12(1):5.CrossRefPubMedCentralPubMed
17.
Kleintjens J, Li X, Simoens S, et al. Cost-effectiveness of rivaroxaban versus warfarin for stroke prevention in atrial fibrillation in the Belgian healthcare setting. Pharmacoeconomics. 2013;31(10):909–18.CrossRefPubMedCentralPubMed
18.
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(1):9–17.CrossRefPubMed
19.
Morais J, Aguiar C, McLeod E, et al. Cost-effectiveness of rivaroxaban for stroke prevention in atrial fibrillation in the Portuguese setting. Rev Port Cardiol. 2014;33(9):535–44.
20.
Lanitis T, Cotté 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(8):587–98.CrossRefPubMed
21.
Lee S, Anglade MW, Pham D, et al. Cost-Effectiveness of rivaroxaban compared to warfarin for stroke prevention in atrial fibrillation. Am J Cardiol. 2012;110(6):845–51.CrossRefPubMed
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(6):1676–81.CrossRefPubMed
23.
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(4):498–506.CrossRefPubMed
24.
Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making. 1993;13:322–38.CrossRefPubMed
25.
Mueller S, Pfannkuche M, Breithardt G, et al. The quality of oral anticoagulation in general practice in patients with atrial fibrillation. Eur J Intern Med. 2014;25(3):247–54.CrossRefPubMed
26.
Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285:2864–70.CrossRefPubMed
27.
Camm AJ, Lip GY, De Caterina R, et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association [published errata appear in Eur Heart J. 2013;34(10):790, and Eur Heart J. 2013;34(36):2850-1]. Eur Heart J. 2012;33(21):2719–47.CrossRefPubMed
28.
Earnshaw SR, Wilson M, Mauskopf J, et al. Model-based cost-effectiveness analyses for the treatment of acute stroke events: a review and summary of challenges. Value Health. 2009;12(4):507–20.CrossRefPubMed
29.
Weinstein MC, Siegel JE, Gold MR, et al. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA. 1996;276:1253–8.CrossRefPubMed
30.
Weintraub WS. Pharmacoeconomic concepts in antiplatelet therapy: understanding cost-effectiveness analyses using clopidogrel as an example. J Cardiovasc Pharmacol Ther. 2008;13(2):107–19.CrossRefPubMed
31.
Federal Statistical Office of Germany. Life table for Germany. Wiesbaden; 2012.
32.
Wyse DG, Love JC, Yao Q, et al. Atrial fibrillation: a risk factor for increased mortality: an AVID registry analysis. J Interv Card Electrophysiol. 2001;5:267–73.CrossRefPubMed
33.
Dennis MS, Burn JP, Sandercock PA, et al. Long-term survival after first-ever stroke: the Oxfordshire Community Stroke Project. Stroke. 1993;24:796–800.CrossRefPubMed
34.
Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Arch Intern Med. 1994;154:1449–57.CrossRef
35.
Ariesen MJ, Claus SP, Rinkel GJ, et al. Risk factors for intracerebral hemorrhage in the general population: a systematic review. Stroke. 2003;34:2060–5.CrossRefPubMed
36.
Dodel RC, Haacke C, Zamzow K, et al. Resource utilization and costs of stroke unit care in Germany. Value Health. 2004;7(2):144–52.CrossRefPubMed
37.
Fang MC, Go AS, Chang Y, et al. Death and disability from warfarin-associated intracranial and extracranial hemorrhages. Am J Med. 2007;120(8):700–5.CrossRefPubMedCentralPubMed
38.
Prencipe M, Culasso F, Rasura M, et al. Long-term prognosis after a minor stroke: 10-year mortality and major stroke recurrence rates in a hospital-based cohort. Stroke. 1998;29:126–32.CrossRefPubMed
39.
Atanassova PA, Chalakova NT, Dimitrov BD. Major vascular events after transient ischaemic attack and minor ischaemic stroke: post hoc modelling of incidence dynamics. Cerebrovasc Dis. 2008;25(3):225–33.CrossRefPubMed
40.
Passero S, Burgalassi L, D’Andrea P, et al. Recurrence of bleeding in patients with primary intracerebral hemorrhage. Stroke. 1995;26(7):1189–92.CrossRefPubMed
41.
Barinagarrementeria F. Patterns of recurrence of intracerebral hemorrhage. Semin Cerebrovasc Dis Stroke. 2005;5:168–71.CrossRef
42.
Gage BF, Cardinalli AB, Owens DK. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch Intern Med. 1996;156:1829–36.CrossRefPubMed
43.
Tengs TO, Lin TH. A meta-analysis of quality-of-life estimates for stroke. Pharmacoeconomics. 2003;21:191–200.CrossRefPubMed
44.
Thomson R, Parkin D, Eccles M, et al. Decision analysis and guidelines for anticoagulant therapy to prevent stroke in patients with atrial fibrillation. Lancet. 2000;355:956–62.CrossRefPubMed
45.
O’Brien CL, Gage BF. Costs and effectiveness of ximelagatran for stroke prophylaxis in chronic atrial fibrillation. JAMA. 2005;293:699–706.CrossRefPubMed
46.
Gage BF, Cardinalli AB, Albers GW, et al. Cost-effectiveness of warfarin and aspirin for prophylaxis of stroke in patients with nonvalvular atrial fibrillation. JAMA. 1995;274(23):1839–45.CrossRefPubMed
47.
Gage BF, Fihn SD, White RH. Management and dosing of warfarin therapy. Am J Med. 2000;109:481–8.CrossRefPubMed
48.
The National Association of Statutory Health Insurance Physicians. Einheitlicher Bewertungsmaßstab (EBM), Stand: 4. Quartal 2012: Berlin; 2012.
49.
Weimar C, Weber C, Wagner M, et al. Management patterns and healthcare use after intracerebral hemorrhage. A cost-of-illness study from a societal perspective in Germany. Cerebrovasc Dis. 2003;15(1–2):29–36.CrossRefPubMed
50.
Brüggenjürgen B, Diener HC, Berger AK, et al. Cost of atherothrombotic diseases—myocardial infarction, ischaemic stroke and peripheral arterial occlusive disease—in Germany. J Public Health. 2005;13:216–24.CrossRef
51.
Brüggenjürgen B, Rossnagel K, Roll S, et al. The impact of atrial fibrillation on the cost of stroke: the Berlin Acute Stroke Study. Value Health. 2007;10(2):137–43.CrossRefPubMed
52.
Winter Y, Wolfram C, Schaeg M, et al. Evaluation of costs and outcome in cardioembolic stroke or TIA. J Neurol. 2009;256(6):954–63.CrossRefPubMed
53.
54.
55.
Weinstein MC. Recent developments in decision-analytic modelling for economic evaluation. Pharmacoeconomics. 2006;24:1043–53.CrossRefPubMed
56.
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;376:975–83.CrossRefPubMed
57.
White HD, Gruber M, Feyzi J, et al. Comparison of outcomes among patients randomized to warfarin therapy according to anticoagulant control: results from SPORTIF III and V. Arch Intern Med. 2007;167:239–45.CrossRefPubMed
58.
Desbiens NA. Deciding on anticoagulating the oldest old with atrial fibrillation: insights from cost-effectiveness analysis. J Am Geriatr Soc. 2002;50(5):863–9.CrossRefPubMed
59.
Institute for quality and efficiency in health care. General Methods for the Assessment of the Relation of Benefits to Costs. Version 1.0. 2009.
60.
61.
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):1–11.CrossRefPubMed
62.
Lee S, Mullin R, Blazawski J, Coleman CI. Cost-effectiveness of apixaban compared with warfarin for stroke prevention in atrial fibrillation. PLoS One. 2012;7(10):e47473.CrossRefPubMedCentralPubMed
63.
Lip GY, Kongnakorn T, Phatak H, et al. Cost-effectiveness of apixaban versus other new oral anticoagulants for stroke prevention in atrial fibrillation. Clin Ther. 2014;36(2):192–210.e20.CrossRefPubMed
64.
Levy E, Gabriel S, Dinet J. The comparative medical costs of atherothrombotic disease in European countries. Pharmacoeconomics. 2003;21:651–9.CrossRefPubMed
65.
Kansal AR, Zheng Y, Pokora T, et al. Cost-effectiveness of new oral anticoagulants in the prevention of stroke in patients with atrial fibrillation. Best Pract Res Clin Haematol. 2013;26(2):225–37.CrossRefPubMed
66.
Kansal AR, Sorensen SV, Guni R, et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation. Heart. 2012;98:573–8.CrossRefPubMedCentralPubMed
67.
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;105:908–19.CrossRefPubMed
68.
Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011;123:2562–70.CrossRefPubMed
69.
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.CrossRefPubMed
70.
Mantha S, Ansell J. An indirect comparison of dabigatran, rivaroxaban and apixaban for atrial fibrillation. Thromb Haemost. 2012;108(3):476–84.CrossRefPubMed
71.
Waterman AD, Milligan PE, Bayer L, et al. Effect of warfarin nonadherence on control of the International Normalized Ratio. Am J Health Syst Pharm. 2004;61:1258–64.PubMed
72.
Beyer-Westendorf J, Förster K, Pannach S, et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014;124(6):955–62.CrossRefPubMedCentralPubMed
73.
Davis NJ, Billett HH, Cohen HW, et al. Impact of adherence, knowledge, and quality of life on anticoagulation control. Ann Pharmacother. 2005;39(4):632–6.CrossRefPubMed
74.
Dimberg I, Grzymala-Lubanski B, Hägerfelth A, et al. Computerised assistance for warfarin dosage: effects on treatment quality. Eur J Intern Med. 2012;23(8):742–4.CrossRefPubMed
75.
Eckman MH, Rosand J, Knudsen KA, et al. Can patients be anticoagulated after intracerebral hemorrhage? A decision analysis. Stroke. 2003;34:1710–6.CrossRefPubMed
76.
Olesen JB, Torp-Pedersen C, Hansen ML, et al. The value of the CHA2DS2-VASc score for refining stroke risk stratification in patients with atrial fibrillation with a CHADS2 score 0–1: a nationwide cohort study. Thromb Haemost. 2012;107:1172–9.CrossRefPubMed
77.
Pisters R, Lane DA, Nieuwlaat R, et al. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138:1093–100.CrossRefPubMed
78.
Bamford J, Sandercock P, Dennis M, et al. A prospective study of acute cerebrovascular disease in the community: the Oxfordshire Community Stroke Project: 1981–1986. 2. Incidence, case fatality rates and overall outcome at one year of cerebral infarction, primary intracerebral and subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 1990;53:16–22.CrossRefPubMedCentralPubMed
Metadaten
Titel
Cost Effectiveness of Rivaroxaban for Stroke Prevention in German Patients with Atrial Fibrillation
verfasst von
Alexander Mensch
Stephanie Stock
Björn Stollenwerk
Dirk Müller
Publikationsdatum
01.03.2015
Verlag
Springer International Publishing
Erschienen in
PharmacoEconomics / Ausgabe 3/2015
Print ISSN: 1170-7690
Elektronische ISSN: 1179-2027
DOI
https://doi.org/10.1007/s40273-014-0236-9

Weitere Artikel der Ausgabe 3/2015

PharmacoEconomics 3/2015 Zur Ausgabe

Editorial

Is it Time to Update Societal Value Sets for Preference-Based Measures of Health?

Leading Article

Resource Modelling: The Missing Piece of the HTA Jigsaw?

Review Article

Alteplase for the Treatment of Acute Ischaemic Stroke: A NICE Single Technology Appraisal; an Evidence Review Group Perspective

Original Research Article

Costs of Health Resource Utilization Among HIV-Positive Individuals in British Columbia, Canada: Results From a Population-Level Study

Original Research Article

Value-Based Reimbursement Decisions for Orphan Drugs: A Scoping Review and Decision Framework

Systematic Review

A Systematic Review of Cost-Effectiveness Analyses of Drugs for Postmenopausal Osteoporosis