Direct costs in patients with nonvalvular atrial fibrillation newly indicated to apixaban: a retrospective‑ prospective single‑ arm cohort study
Authors:
Daniela Štrosová 1*; Jan Tužil 1,2*; Barbora Pilnáčková 1; Lada Lžičařová 1; Veronika Typovská 3; Helena Doležalová 1; Martin Herold 4,5; Tomáš Doležal 1,6; Tito Autoři Přispěli Stejnou Měrou *
Authors place of work:
VALUE OUTCOMES s. r. o., Praha
1; 1. lékařská fakulta, Univerzita Karlova, Praha
2; Pfizer, Praha
3; Kardiologická klinika, Fakultní nemocnice Královské Vinohrady, Praha
4; Kardiologická klinika, 3. lékařská fakulta, Univerzita Karlova, Praha
5; Farmakologický ústav, Masarykova univerzita, Brno
6
Published in the journal:
Vnitř Lék 2022; 68(1): 26-33
Category:
Original Contributions
Summary
Background: Atrial fibrillation (AF) affects 46.3 million people; its prevalence has tripled over the last 50 years. AF leads to formation of blood clots increasing four-fold the risk of a stroke. Preventive anticoagulant therapy with warfarin has been well established for over 50 years but has efficacy and safety limitations. New anticoagulants do not require laboratory monitoring of prothrombin time, have low risk of adverse events, yet are more costly.
Methods: This non-interventional (Act 378/2007 Coll.) retrospective-prospective single-arm cohort study consisted of 3 visits. The primary objective was to compare the total direct cost of treatment with warfarin and apixaban. Patients with non-valvular AF were enrolled at the time of discontinuation of warfarin and switching to apixaban. Costs were derived from the care provided and the list of medical procedures (Decrees 268/ 2019 Coll.). Satisfaction was assessed using SAFUCA® questionnaire.
Results: Between February 2017 and June 2019, 499 patients were enrolled in 29 Czech internal medicine clinics. The mean age of the patients was 73.6 ± 10.2 years, 36.5% were at high risk of bleeding (HAS-BLED score). Previous warfarin treatment lasted 5.9 ± 2.7 months, 63% were unable to achieve target prothrombin time, 18% switched due to adverse reactions. New apixaban treatment was followed for the first 6 months. Treatment with warfarin was associated with higher rates of major bleeding and adverse events (22 vs. 2), stroke (17 vs. 0), ischemic heart attack (11 vs. 0), and minor bleeding (173 vs. 2). The average daily cost following the switch to apixaban decreased from CZK 65.2 to CZK 4.8 (p <0.001). The price of anticoagulant treatment was considered, there was an insignificant increase from CZK 68.1 to CZK 71.7 (p = 0.509). Satisfaction increased significantly after 3 months, notably in the subjective evaluation of efficacy, comfort, impact on quality of life and the occurrence of side effects.
Conclusion: Switching patients with unsatisfactory outcomes on warfarin to apixaban resulted in lower risk of serious ischemic events, bleeding and side effects, and higher patient satisfaction. From the pharmacoeconomic perspective, apixaban is a better choice in this population as it brings higher efficacy and better safety within comparable overall direct costs.
Zdroje
1. Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020;127(1):4-20. doi:10.1161/ CIRCRESAHA.120.316340
2. Williams BA, Chamberlain AM, Blankenship JC, Hylek EM, Voyce S. Trends in Atrial Fibrillation Incidence Rates Within an Integrated Health Care Delivery System, 2006 to 2018. JAMA Netw Open. 2020;3(8):e2014874. doi:10.1001/jamanetworkopen.2020.14874
3. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. 1987;147(9):1561-1564.
4. Di Carlo A. Human and economic burden of stroke. Age Ageing. 2009;38(1):4-5. doi:10.1093/ageing/afn282
5. Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta‑analysis. Ann Intern Med. 1999;131(7):492-501. doi:10.7326/0003-4819-131-7-199910050-00003
6. Gallagher AM, Setakis E, Plumb JM, Clemens A, van Staa T‑P. Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost. 2011;106(5):968-977. doi:10.1160/TH11-05-0353
7. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365(21):2002-2012. doi:10.1056/ NEJMsa1103053
8. Witt DM, Delate T, Garcia DA et al. Risk of thromboembolism, recurrent hemorrhage, and death after warfarin therapy interruption for gastrointestinal tract bleeding. Arch Intern Med. 2012;172(19):1484-1491. doi:10.1001/archinternmed.2012.4261
9. Alberts MJ, Bhatt DL, Smith SC et al. Risk factors and outcomes for patients with vascular disease and serious bleeding events. Heart Br Card Soc. 2011;97(18):1507-1512. doi:10.1136/ hrt.2010.221788
10. Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883–891. doi:10.1056/NEJMoa1009638
11. Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151. doi:10.1056/NEJMoa0905561
12. Giugliano RP, Ruff CT, Braunwald E et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104. doi:10.1056/NEJMoa1310907
13. Laliberté F, Cloutier M, Crivera C et al. Effects of rivaroxaban versus warfarin on hospitalization days and other health care resource utilization in patients with nonvalvular atrial fibrillation: an observational study from a cohort of matched users. Clin Ther. 2015;37(3):554- 562. doi:10.1016/j.clinthera.2015. 02. 001
14. Raghavan N, Frost CE, Yu Z et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos Biol Fate Chem. 2009;37(1):74-81. doi:10.1124/dmd.108.023143
15. Amin A, Bruno A, Trocio J, Lin J, Lingohr‑Smith M. Comparison of differences in medical costs when new oral anticoagulants are used for the treatment of patients with non‑valvular atrial fibrillation and venous thromboembolism vs warfarin or placebo in the US. J Med Econ. 2015;18(6):399-409. doi:10.3111/13696998.2015.1007210
16. Lip GYH, 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. doi:10.1016/j.clinthera.2013. 12. 011
17. Lanitis T, Kongnakorn T, Jacobson L, De Geer A. Cost‑effectiveness of apixaban versus warfarin and aspirin in Sweden for stroke prevention in patients with atrial fibrillation. Thromb Res. 2014;134(2):278-287. doi:10.1016/j.thromres.2014. 05. 027
18. Costa J, Fiorentino F, Caldeira D et al. Custo-efetividade dos novos anticoagulantes orais na fibrilhação auricular em Portugal. Rev Port Cardiol. 2015;34(12):723-737. doi:10.1016/j. repc.2015. 07. 004
19. Amin A, Stokes M, Makenbaeva D, Wiederkehr D, Wu N, Lawrence JH. Estimated medical cost reductions associated with use of novel oral anticoagulants vs warfarin in a real‑world non‑valvular atrial fibrillation patient population. J Med Econ. 2014;17(11):771-781. doi:10.3111/13696998.2014.953682
20. Ruiz MA, González‑Porras JR, Aranguren JL et al. Development and validation of a new questionnaire measuring treatment satisfaction in patients with non‑valvular atrial fibrillation: SAFUCA®. Qual Life Res Int J Qual Life Asp Treat Care Rehabil. 2017;26(3):767-778. doi:10.1007/s11136-016-1474-4
21. Roldán V, Marín F, Fernández H et al. Predictive value of the HAS‑BLED and ATRIA bleeding scores for the risk of serious bleeding in a „real‑world“ population with atrial fibrillation receiving anticoagulant therapy. Chest. 2013;143(1):179-184. doi:10.1378/chest.12-0608
22. Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor‑based approach: the euro heart survey on atrial fibrillation. Chest. 2010;137(2):263- 272. doi:10.1378/chest.09-1584
23. Proietti M, Romanazzi I, Romiti GF, Farcomeni A, Lip GYH. Real‑World Use of Apixaban for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta‑Analysis. Stroke. 2018;49(1):98-106. doi:10.1161/STROKEAHA.117.018395 09.00
Štítky
Diabetology Endocrinology Internal medicineČlánok vyšiel v časopise
Internal Medicine
2022 Číslo 1
Najčítanejšie v tomto čísle
- A cirrhotic patient in an internal medicine ward
- Cholesterol measurement and current guidelines
- Levotyroxin
- Differential diagnosis of pituitary enlargement