Cost-effectiveness of apixaban compared to other anticoagulants in patients with atrial fibrillation in the real-world and trial settings


Autoři: Lisa A. de Jong aff001;  Jessie Groeneveld aff001;  Jelena Stevanovic aff002;  Harrie Rila aff002;  Robert G. Tieleman aff003;  Menno V. Huisman aff005;  Maarten J. Postma aff001;  Marinus van Hulst aff007
Působiště autorů: Department of PharmacoTherapy, -Epidemiology & -Economics, University of Groningen, Groningen Research Institute of Pharmacy (GRIP), Groningen, the Netherlands aff001;  Bristol Myers Squibb, Utrecht, the Netherlands aff002;  Department of Cardiology, Martini Hospital, Groningen, the Netherlands aff003;  Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands aff004;  Department of Thrombosis and Hemostasis, Leiden University Medical Centre, Leiden, the Netherlands aff005;  Department of Economics, Econometrics & Finance, University of Groningen, Faculty of Economics & Business, Groningen, the Netherlands aff006;  Department of Health Sciences, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands aff007;  Department of Clinical Pharmacy and Toxicology, Martini Hospital, Groningen, The Netherlands aff008
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0222658

Souhrn

Introduction

Randomized clinical trials (RCTs) and real-world data (RWD) in patients with atrial fibrillation have shown that—compared to vitamin K antagonists (VKAs)—non-VKA oral anticoagulants (NOACs) are at least as effective in the prevention of ischaemic stroke, while decreasing the risk of bleeding.

Objective

We aim to evaluate the cost-effectiveness of the NOAC apixaban versus other NOACs (dabigatran, edoxaban and rivaroxaban) and VKA, for stroke prevention in patients with atrial fibrillation by including the available data both from RCT and real-world analyses of all NOACs into one integrative previously published model.

Methods

The model was updated to the current Dutch healthcare situation. The incremental cost-effectiveness ratio was calculated using either efficacy/effectiveness and safety data derived from a network meta-analysis (NMA) synthesizing NOAC RCTs or RWD. We conducted a systematic literature search to identify eligible publication to best inform the RWD-based analysis. Additional sensitivity and scenario analyses were conducted to test the robustness of the outcomes.

Results

In the NMA-based analysis, apixaban appeared to be cost-effective compared to VKA (€3,506 per quality adjusted life-year) and dominant (cost-saving and more effective) over dabigatran 110 mg, dabigatran 150 mg, edoxaban and rivaroxaban. In the RWD-based analysis, apixaban was dominant over all other anticoagulants. In the scenario analysis apixaban appeared to be not cost-effective compared to dabigatran 150 mg, when using equal event-unrelated treatment discontinuation rates for each drug. In all other scenarios apixaban is cost-effective or cost-saving compared to VKA and other NOACs.

Conclusion

Based on RCTs as well as RWD, we conclude that apixaban is generally cost-effective or even cost-saving (less costly and more effective) compared to VKA and other NOACs in the overall population of patients with atrial fibrillation.

Klíčová slova:

Medicine and health sciences – Neurology – Cerebrovascular diseases – Stroke – Ischemic stroke – Hemorrhagic stroke – Vascular medicine – Stroke – Ischemic stroke – Hemorrhagic stroke – Hemorrhage – Cardiology – Arrhythmia – Atrial fibrillation – Myocardial infarction – Diagnostic medicine – Signs and symptoms – Hemorrhage – Pathology and laboratory medicine – Signs and symptoms – Hemorrhage – Social sciences – Economics – Economic analysis – Cost-effectiveness analysis – Physical sciences – Chemistry – Chemical compounds – Organic compounds – Vitamins – B vitamins – Vitamin K – Organic chemistry – Organic compounds – Vitamins – B vitamins – Vitamin K – Mathematics – Statistics – Statistical methods – Metaanalysis – Research and analysis methods – Mathematical and statistical techniques – Statistical methods – Metaanalysis


Zdroje

1. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Ater D, Casadei B, et al. ESC GUIDELINES 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37:2893–962. doi: 10.1093/eurheartj/ehw210 27567408

2. Samenvatting Medische Jaarverslagen 2017. 2017 [cited 2018 May 27]; Available from: https://www.fnt.nl/algemeen/jaarverslagen

3. Heeringa J, van der Kuip DAM, Hofman A, Kors JA, van Herpen G, Stricker BHC, et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006;27(8):949–53. doi: 10.1093/eurheartj/ehi825 16527828

4. Heemstra HE, Nieuwlaat R, Meijboom M, Crijns HJ. The burden of atrial fibrillation in the Netherlands. Neth Heart J. 2011;19(9):373–8. doi: 10.1007/s12471-011-0175-4 21761194

5. Stevanović J, Pompen M, Le HH, Rozenbaum MH, Tieleman RG, Postma MJ. Economic evaluation of apixaban for the prevention of stroke in non-valvular atrial fibrillation in the Netherlands. Ahrens I, editor. PLoS One. 2014 Aug 5;9(8):e103974. doi: 10.1371/journal.pone.0103974 25093723

6. Camm JA, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33:2019–747.

7. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet (London, England). 2014 Mar 15;383(9921):955–62.

8. Lip GYH, Kongnakorn T, Phatak H, Kuznik A, Lanitis T, Liu LZ, 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. doi: 10.1016/j.clinthera.2013.12.011 24508420

9. Versteegh M. The iMTA Disease Burden Calculator [Internet]. 2016 [cited 2018 Aug 9]. Available from: www.imta.nl/idbc

10. Lip GYH, Mitchell SA, Liu X, Liu LZ, Phatak H, Kachroo S, et al. Relative efficacy and safety of non-Vitamin K oral anticoagulants for non-valvular atrial fibrillation: Network meta-analysis comparing apixaban, dabigatran, rivaroxaban and edoxaban in three patient subgroups. Int J Cardiol. 2016;204:88–94. doi: 10.1016/j.ijcard.2015.11.084 26655548

11. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med. 2009;6(7):e1000097. doi: 10.1371/journal.pmed.1000097 19621072

12. Lip GY, Keshishian A, Li X, Hamilton M, Masseria C, Gupta K, et al. Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients. Stroke. 2018;49(0):00.

13. Korenstra J, Petra E, Wijtvliet J, Veeger NJGM, Geluk CA, Bartels GL, et al. Effectiveness and safety of dabigatran versus acenocoumarol in “real-world” patients with atrial fibrillation. Europace. 2016;18:1319–27. doi: 10.1093/europace/euv397 26843571

14. Granger CB, Alexander JH, McMurray JJV, Lopes RD, Hylek EM, Hanna M, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2011;365(11):981–92. doi: 10.1056/NEJMoa1107039 21870978

15. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009;361(12):1139–51. doi: 10.1056/NEJMoa0905561 19717844

16. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med. 2011;365(10):883–91. doi: 10.1056/NEJMoa1009638 21830957

17. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013;369(22):2093–104. doi: 10.1056/NEJMoa1310907 24251359

18. Lip GYH, Lanitis T, Kongnakorn T, Phatak H, Chalkiadaki C, Liu X, et al. Cost-effectiveness of Apixaban Compared with Edoxaban for Stroke Prevention in Nonvalvular Atrial Fibrillation. Clin Ther. 2015;37(11):2476–88. doi: 10.1016/j.clinthera.2015.09.005 26477648

19. Easton JD, Lopes RD, Bahit MC, Wojdyla DM, Granger CB, Wallentin L, et al. Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of the ARISTOTLE trial. Lancet Neurol. 2012;11(6):503–11. doi: 10.1016/S1474-4422(12)70092-3 22572202

20. Statistics Netherlands (CBS). Life expectancy; sex, age (per year and period of five years) [Internet]. [cited 2018 Jun 14]. Available from: https://statline.cbs.nl/StatWeb/

21. Brønnum-Hansen H, Jørgensen T, Davidsen M, Madsen M, Osler M, Gerdes LU, et al. Survival and cause of death after myocardial infarction: the Danish MONICA study. J Clin Epidemiol. 2001;54(12):1244–50. doi: 10.1016/s0895-4356(01)00405-x 11750193

22. Claassen DO, Kazemi N, Zubkov AY, Wijdicks EFM, Rabinstein AA. Restarting anticoagulation therapy after warfarin-associated intracerebral hemorrhage. Arch Neurol. 2008;65(10):1313–8. doi: 10.1001/archneur.65.10.1313 18852344

23. Mandema J. Meta analysis of placebo, ASA and warfarin controlled studies in AF. Data file. 2011;

24. Sullivan PW, Slejko JF, Sculpher MJ, Ghushchyan V. Catalogue of EQ-5D Scores for the United Kingdom. Med Decis Mak. 2011;31(6):800–4.

25. Stevanović J, Pompen M, Le HH, Rozenbaum MH, Tieleman RG, Postma MJ. Economic Evaluation of Apixaban for the Prevention of Stroke in Non-Valvular Atrial Fibrillation in the Netherlands. PLoS One. 2014;9(8):e103974. doi: 10.1371/journal.pone.0103974 25093723

26. 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(16):1829–36. 8790077

27. Hakkaart-van Roijen L, van der Linden N, Bouwmans C, Kanters T, Swan Tan S. Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg. Zorginstituut Ned [Internet]. 2016;1–120. Available from: www.zorginstituutnederland.nl/publicaties/publicatie/2016/02/29/richtlijn-voor-het-uitvoeren-van-economische-evaluaties-in-de-gezondheidszorg

28. Briggs AH, Weinstein MC, Fenwick EAL, Karnon J, Sculpher MJ, David Paltiel A. Model Parameter Estimation and Uncertainty: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-6 Background to the Task Force. JVAL. 2012;15(6):835–42.

29. Z-index. The Pharmacy Purchase Price—apixaban. July [Internet]. 2018; Available from: https://www.z-index.nl/

30. Dutch Healthcare Authority (NZa). zorgproducten.nza.nl [Internet]. [cited 2018 Jun 6]. Available from: https://zorgproducten.nza.nl/

31. Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L, et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330–93. doi: 10.1093/eurheartj/ehy136 29562325

32. Dutch Healthcare Authority (NZa). DIS open data [Internet]. 2018 [cited 2018 Mar 14]. Available from: http://www.opendisdata.nl/msz/zorgproduct

33. Federation for Dutch Thrombosis Service (FNT). Medical Annual report 2017. 2017.

34. van den Berg B, Brouwer W, van Exel J, Koopmanschap M, van den Bos GAM, Rutten F. Economic valuation of informal care: lessons from the application of the opportunity costs and proxy good methods. Soc Sci Med. 2006;62(4):835–45. doi: 10.1016/j.socscimed.2005.06.046 16137814

35. CBS StatLine—Jaarmutatie consumentenprijsindex; vanaf 1963 [Internet]. [cited 2018 Jun 5]. Available from: http://statline.cbs.nl/Statweb/publication/?DM=SLNL&PA=70936NED&D1=0&D2=623,636,649,662,675,688,701,714&HDR=T&STB=G1&VW=T

36. Sterne JA, Bodalia PN, Bryden PA, Davies PA, López-López JA, Okoli GN, et al. Oral anticoagulants for primary prevention, treatment and secondary prevention of venous thromboembolic disease, and for prevention of stroke in atrial fibrillation: systematic review, network meta-analysis and cost-effectiveness analysis. Health Technol Assess (Rockv). 2017;21(9):1–386.

37. López-López JA, Sterne JAC, Thom HHZ, Higgins JPT, Hingorani AD, Okoli GN, et al. Oral anticoagulants for prevention of stroke in atrial fibrillation: systematic review, network meta-analysis, and cost effectiveness analysis. BMJ. 2017;359:j5058. doi: 10.1136/bmj.j5058 29183961

38. Verhoef TI, Redekop WK, Hasrat F, de Boer A, Maitland-van der Zee AH. Cost effectiveness of new oral anticoagulants for stroke prevention in patients with atrial fibrillation in two different European healthcare settings. Am J Cardiovasc Drugs. 2014 Dec 18;14(6):451–62. doi: 10.1007/s40256-014-0092-1 25326294

39. DUTCH-AF Registry–A nationwide registration of patients with atrial fibrillation - ZonMw (project number: 848050007) [Internet]. 2017 [cited 2018 Nov 26]. Available from: https://www.zonmw.nl/nl/onderzoek-resultaten/doelmatigheidsonderzoek/programmas/project-detail/goed-gebruik-geneesmiddelen/dutch-af-registry-a-nationwide-registration-of-patients-with-atrial-fibrillation/

40. Camm AJ, Fox KAA, Peterson E. Challenges in comparing the non-vitamin K antagonist oral anticoagulants for atrial fibrillation-related stroke prevention. EP Eur. 2018;20(1):1–11.

41. EPAR. ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS pradaxa [Internet]. 2018 [cited 2018 Nov 26]. Available from: https://www.ema.europa.eu/documents/product-information/pradaxa-epar-product-information_en.pdf


Článek vyšel v časopise

PLOS One


2019 Číslo 9

Nejčtenější v tomto čísle

Tomuto tématu se dále věnují…


Kurzy

Zvyšte si kvalifikaci online z pohodlí domova

Krvácení v důsledku portální hypertenze při jaterní cirhóze – od pohledu záchranné služby až po závěrečný hepato-gastroenterologický pohled
nový kurz
Autoři: PhDr. Petr Jaššo, MBA, MUDr. Hynek Fiala, Ph.D., prof. MUDr. Radan Brůha, CSc., MUDr. Tomáš Fejfar, Ph.D., MUDr. David Astapenko, Ph.D., prof. MUDr. Vladimír Černý, Ph.D.

Rozšíření možností lokální terapie atopické dermatitidy v ordinaci praktického lékaře či alergologa
Autoři: MUDr. Nina Benáková, Ph.D.

Léčba bolesti v ordinaci praktického lékaře
Autoři: MUDr. PhDr. Zdeňka Nováková, Ph.D.

Revmatoidní artritida: včas a k cíli
Autoři: MUDr. Heřman Mann

Jistoty a nástrahy antikoagulační léčby aneb kardiolog - neurolog - farmakolog - nefrolog - právník diskutují
Autoři: doc. MUDr. Štěpán Havránek, Ph.D., prof. MUDr. Roman Herzig, Ph.D., doc. MUDr. Karel Urbánek, Ph.D., prim. MUDr. Jan Vachek, MUDr. et Mgr. Jolana Těšínová, Ph.D.

Všechny kurzy
Kurzy Doporučená témata Časopisy