Budget impact analysis of apixaban versus other NOACs for the prevention of stroke in Italian atrial fibrillation patients
DOI:
https://doi.org/10.7175/fe.v15i1s.973Keywords:
Apixaban, Novel oral anticoagulant agents, Atrial fibrillationAbstract
OBJECTIVE: This study aims to perform a budget impact analysis of the use of three available novel oral anticoagulant agents (NOACs) for preventing thromboembolic events in Italian patients with non‑valvular atrial fibrillation (NVAF).
METHODS: Estimated Italian population of patients was run through a previously published lifetime decision tree/Markov model simulating their treatment with the available therapeutic options: dabigatran at two dose levels (110 mg/bid for the over 80 years old, 150 mg/bid for younger NVAF patients), rivaroxaban (20 mg/uid), and apixaban (5 mg/bid). Effectiveness and safety estimates derive from an adjusted indirect treatment comparison using warfarin as link. The main clinical events considered in the model are ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Epidemiological data and unit costs, actualized to 2013, are collected from Italian published sources. The budget impact analysis evaluates the financial impact of apixaban introduction by comparing expected 1,2, and 3 years costs in hypothetical scenarios: with and without apixaban. Italian NVAF patient population estimation is based on official apixaban reimbursement criteria, applying the characteristics of the trial population to national epidemiologic data. Numbers of patients for each regimen are estimated by projecting share evolution. Sensitivity analysis is performed on an alternative non‑experimental population of NVAF patients.
RESULTS: Among available NOACs, apixaban was expected to be the least expensive in an estimated patient population of 364,000 Italian patients, allowing for savings of € 1,180,549, € 3,841,429 and € 5,368,918 at 1,2, and 3 years, respectively. Results of the simulation run on an alternative non‑experimental population of NVAF patients yields comparable estimates.
CONCLUSIONS: The different safety and effectiveness profiles of the three available NOACs emerging from the adjusted indirect comparison indicate that apixaban could improve health care expenditure control while maintaining or increasing therapeutic appropriateness in the Italian NVAF population.
References
European Heart Rhythm Association, European Association for Cardio-Thoracic Surgery, Camm AJ, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010; 31: 2369-429; http://dx.doi.org/10.1093/eurheartj/ehq278
Kannel WB, Benjamin EJ. Status of the epidemiology of atrial fibrillation. Med Clin North Am 2008; 92: 17-40; http://dx.doi.org/10.1016/j.mcna.2007.09.002
Wolf CD, Rudd AG. The Burden of Stroke White paper: Raising awareness of the global toll of stroke-related disability and death
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991; 22: 983-8; http://dx.doi.org/10.1161/01.STR.22.8.983
Lamassa M, Di Carlo A, Pracucci G, et al. Characteristics, outcome, and care of stroke associated with atrial fibrillation in Europe: data from a multicenter multinational hospital-based registry (The European Community Stroke Project). Stroke 2001; 32: 392-8; http://dx.doi.org/10.1161/01.STR.32.2.392
Sacchetti MA, Spandonaro F, Finzi G, et al. Prevenzione dell’ictus in Italia – diversità regionali ed assetti. Sole 24 Ore sanità Allegato al n.10 del 15-21 Marzo 2011
National Institute for Health and Care Excellence. Atrial fibrillation: the management of atrial fibrillation. NICE Clinical guideline 36. NHS, 2006
Summary of Product Characteristics [SPC] of apixaban
AIFA. Piano Terapeutico Eliquis® (apixaban)
Dorian P, Kongnakorn T, Phatak H, et al. Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in patients with atrial Fibrillation. Eur Heart J 2014; 35: 1897-906; http://dx.doi.org/10.1093/eurheartj/ehu006
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: 192-210; http://dx.doi.org/10.1016/j.clinthera.2013.12.011
Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-92; http://dx.doi.org/10.1056/NEJMoa1107039
Olesen JB, Lip GY, Hansen ML, et al. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ 2011; 342: d124; http://dx.doi.org/10.1136/bmj.d124
Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-51; http://dx.doi.org/10.1056/NEJMoa0905561
Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-91; http://dx.doi.org/10.1056/NEJMoa1009638
[No author listed]. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med 1994; 154: 1449-57; http://dx.doi.org/10.1001/archinte.1994.00420130036007
Ariesen M, Claus S, Rinkel G, et al. Risk factors for intracerebral hemorrhage in the general population: a systematic review. Stroke 2003; 34: 2060-5; http://dx.doi.org/10.1161/01.STR.0000080678.09344.8D
Mohan KM, Crichton SL, Grieve AP, et al. Frequency and predictors for the risk of stroke recurrence up to 10 years after stroke: the South London Stroke Register. J Neurol Neurosurg Psychiatry 2009; 80: 1012-8; http://dx.doi.org/10.1136/jnnp.2008.170456
Connolly S, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364: 806-17; http://dx.doi.org/10.1056/NEJMoa1007432
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; http://dx.doi.org/10.7326/0003-4819-154-1-201101040-00289
Scarborough P, Bhatnagar P. Coronary Heart Disease statistics 2010 edition; British Health Foundation Health Promotion research group, Department of Public Health, University of Oxford
ISTAT. Available at: www.ISTAT.it (last accessed February 2014)
Friberg L, Hammar N, Pettersson H, et al. Increased mortality in paroxysmal atrial fibrillation: report from the Stockholm Cohort-Study of Atrial Fibrillation (SCAF). Eur Heart J 2007; 28: 2346-53; http://dx.doi.org/10.1093/eurheartj/ehm308
Brønnum-Hansen H, Davidsen M, Thorvaldsen P. Long-Term Survival and Causes of Death After Stroke. Stroke 2001; 32: 2131-6; http://dx.doi.org/10.1161/hs0901.094253
Henriksson K, Farahmand B, Johansson S, et al. Survival after stroke - The impact of CHADS2 score and AF. Int J Cardiol 2010; 141: 18-23; http://dx.doi.org/10.1016/j.ijcard.2008.11.122
Huybrechts K, Caro J, Xenakis J. The prognostic value of the modified rankin scale score for long-term survival after first-ever stroke. Cerebrovasc Dis 2008; 26: 381-7; http://dx.doi.org/10.1159/000151678
Brønnum-Hansen H, Jorgensen T, Davidsen M, et al. Survival and cause of death after myocardial infarction: the Danish MONICA study. J Clin Epidemiol 2001; 54: 1244-50; http://dx.doi.org/10.1016/S0895-4356(01)00405-X
Informatore Farmaceutico on-line. Available at: http://www.codifa.it/ (last accessed February 2014)
Lucioni C, Garancini MP, Massi-Benedetti M, et al. The costs of type 2 diabetes mellitus in Italy: a CODE-2 sub-study. Treat Endocrinol 2003; 2: 121-33; http://dx.doi.org/10.2165/00024677-200302020-00005
Fattore G, Torbica A, Susi A, et al. The social and economic burden of stroke survivors in Italy: a prospective, incidence-based, multi-centre cost of illness study. BMC Neurology 2012; 12: 137; http://dx.doi.org/10.1186/1471-2377-12-137
Remunerazione prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza post acuzie e di assistenza specialistica ambulatoriale. DM 10/2012 on Gazzetta Ufficiale n. 23 of 1/28/2013
Mantovani LG, Fornari C, Madotto F, et al. Burden of acute myocardial infarction. Int J Cardiol 2011; 150: 111-2; http://dx.doi.org/10.1016/j.ijcard.2011.04.030
Colombo GL, Caruggi M, Vinci M, et al. Costo sociale annuo della dispepsia funzionale dopo l’eradicazione dell’Helicobacter pylori. PharmacoEconomics – Italian Research Articles 2005; 7: 27-42; http://dx.doi.org/10.1007/BF03320533
IMS Health of MAT September 2012, market shares of anticoagulants in atrial fibrillation (data on-file)
Epidemiologia della fibrillazione atriale. Bollettino informativo a cura del Sistema Epidemiologico Regionale del Veneto. Informazione Epidemiologia Salute 2009;VI(4). Available at: www.ser-veneto.it
Friberg L, Rosenqvist M, Lip GY. Net clinical benefit of warfarin in patients with atrial fibrillation: a report from the Swedish atrial fibrillation cohort study. Circulation 2012; 125: 2298-3; http://dx.doi.org/10.1161/CIRCULATIONAHA.111.055079
Gussoni G, Di Pasquale G, Vescovo G, et al. Decision making for oral anticoagulants in atrial fibrillation: the ATA-AF study. Eur J Intern Med 2013; 24: 324-32; http://dx.doi.org/10.1016/j.ejim.2013.04.008
Nichol MB, Knight TK, Dow T, et al, Quality of anticoagulation monitoring in nonvalvular atrial fibrillation patients: comparison of anticoagulation clinic versus usual care. Ann Pharmacother 2008; 42: 62-70; http://dx.doi.org/10.1345/aph.1K157
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