Venous tromboembolism treatment: budget impact analysis of rivaroxaban in Italy

Daniela Paola Roggeri, Alessandro Roggeri, Vittorio Pengo



BACKGROUND: Venous thromboembolism (VTE) is frequently leading to severe complications, particularly deep vein thrombosis (DVT) and pulmonary embolism (PE), and requires high cost healthcare intevention. Rivaroxaban, a novel oral factor Xa inhibitor approved for treatment of DVT, PE and reduction of the risk of recurrence, may represent a cost‑effective anticoagulant choice.
OBJECTIVE: This study aims to evaluate the economic impact of the use of rivaroxaban for preventing DVT and PE in Italy.
METHODS: We conducted a budget impact analysis to estimate clinical outcomes and economic consequences associated to rivaroxaban vs. standard therapy (low molecular weight heparin + vitamin K antagonists) in the prevention of DVT and PE, over a three‑year time horizon. In the analysis we performed two hypothesis: complete replacement of LMWH/VKA with rivaroxaban (hypothesis 1) and partial and progressive replacement of LMWH/VKA in the first three years of reimbursement (hypothesis 2). Only direct healthcare costs have been considered.

RESULTS: Total replacement of LMWH/VKA with rivaroxaban in DVT and PE is associated to a reduction of recurrent symptomatic thromboembolism, major bleeding, vascular events and mortality, with an expenditure saving of about € 11.3 mln (DVT) and € 6.6 mln (PE), corresponding to an average savings per patient treated with rivaroxaban amounted to € 112.9 and € 123,3, respectively. In hypothesis 2 it is estimated that 22%, 25%, and 27% of DVT patients and 12%, 16%, and 20% of PE patients, would be treated with rivaroxaban over the first three years. This would translate into a total saving on healthcare expenditure of € 8.4 mln for DVT and € 3.2 mln for PE and reduction of length of stay with a slight increase in pharmaceutical expenditure.

CONCLUSIONS: Rivaroxaban provides significant advantages in terms of events avoided and related costs that would result in a reduction in the total expenditure on the Italian NHS.


Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolism; Rivaroxaban

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  • Dobesh PP. Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy 2009; 29: 943-53;
  • Di Minno M, Tufano A, Pilotto A, et al. Prevenzione del tromboembolismo venoso nell’anziano nel 2007: nuove strategie antitrombotiche nel paziente medico e chirurgico. G Gerontol 2007; 55: 40-7
  • White RH. The epidemiology of venous thromboembolism. Circulation 2003; 107: I4-8;
  • Spencer FA, Emery C, Lessard D, et al. The Worchester Venous Thromboembolism Study. A population-based study of the clinical epidemiology of venous thromboembolism. J Gen Intern Med 2006; 21: 722-7;
  • Silverstein MD, Heit JA, Mohr DN, et al. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 1998; 158: 585-93;
  • Aylin P, Bottle A, Kirkwood G, et al. Trends in hospital admissions for pulmonary embolism in England: 1996/7 to 2005/6. Clin Med 2008; 8: 388-92;
  • Prandoni P, Lensing AW, Cogo A, et al. The long term clinical course of acute deep venous thrombosis. Ann Intern Med 1996; 125: 1-7;
  • Heit JA, Mohr DN, Silverstein MD, et al. Predictors of recurrence after deep vein thrombosis and pulmonary embolism: a population-based cohort study. Arch Intern Med 2000; 160: 761-8;
  • Ansell J, Hirsh J, Hylek E, et al. ; American College of Chest Physicians. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest 2008; 133: 160-98;
  • Kearon C, Akl EA, Comerota AJ, et al. American College of Chest Physicians. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 Suppl): 419-94;
  • Wittkowsky AK. Effective anticoagulation therapy: defining the gap between clinical studies and clinical practice. Am J Manag Care 2004; 10 (Suppl): 297-306
  • Kneeland PP, Fang MC. Current issues in patient adherence and persistence: focus on anticoagulants for the treatment and prevention of thromboembolism. Patient Prefer Adherence 2010; 4: 51-60
  • Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagu11. lant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med 2003; 139: 893;
  • Lip GY, Andreotti F, Fauchier L, et al. Bleeding risk assessment and 7. management in atrial fibrillation patients: a position document from European Heart Rhytm Association, endorsed by European Society of Cardiology Working Group on Thrombosis. Europace 2011; 13: 723-46;
  • Schulman S, Beyth RJ, Kearon C, et al; American College of Chest Physicians. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Ed). Chest 2008; 133(6 Suppl): 257-298; http://dx.doi.or/10.1378/chest.08-0674
  • Becattini C, Lignali A, Agnelli G. New anticoagulants for the prevention of venous thromboembolism. Drug Des Devel Ther 2010; 25: 49-60;
  • Garcia D, Libby E, Crowther MA. The new oral anticoagulants. Blood 2010; 115: 15-20;
  • Weitz JI, Hirsh J, Samama MM. New antithrombotic drugs: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133 (Suppl 6): 234-56;
  • Xarelto® – Riassunto delle caratteristiche di prodotto
  • The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510;
  • The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-97;
  • Pradelli L, Iannazzo S, Zaniolo O, et al. Organization and estimated patient-borne costs of oral anticoagulation therapy in Italy: results from a survey. Appl Health Econ Health Policy 2010; 8: 119-28;
  • van Bellen B, Bamber L, Correa de Carvalho F, et al. Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism. Curr Med Res Opin 2014; 30: 829-37;
  • Degli Esposti L, Didoni G, Simon T, et al. Analysis of disease patterns and cost of treatments for prevention of deep venous thrombosis after total knee or hip replacement: results from the Practice Analysis of THromboprophylaxis after Orthopaedic Surgery (PATHOS) study. Clinicoecon Outcomes Res 2013; 5: 1-7;
  • Le Prestazioni di Ricovero Ospedaliero. Rapporto sui costi. Indagine 2010. Regione Umbria
  • Capri S, Ageno W, Imberti D, et al. Extended prophylaxis of venous thromboembolism with fondaparinux in patients undergoing major orthopaedic surgery in Italy: a cost-effectiveness analysis. Intern Emerg Med 2010; 5: 33-40;
  • Roggeri A, Gnavi R, Dalmasso M, et al. Resource consumption and healthcare costs of acute coronary syndrome: a retrospective observational administrative database analysis. Crit Pathw Cardiol 2013; 12: 204-9;
  • 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;
  • Heidbuchel H, Verhamme P, Alings M, et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15: 625-51;
  • Remunerazione prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza post acuzie e di assistenza specialistica ambulatoriale. GU Serie Generale n.23 del 28-1-2013 - Suppl. Ordinario n. 8
  • Palareti G, Ageno W, Ferrari A., et al. Clinical management of rivaroxaban-treated patients. Expert Opin Pharmacother 2013; 14: 655-67;
  • Farmadati Italia. Banche Dati del Farmaco, Parafarmaco e Dispositivo Medico.
  • Modalità e condizioni di impiego del medicinale «PHT Eparine». GU Serie Generale n.175 del 27-7-2013
  • Rapporto annuale sull’attività di ricovero ospedaliero, Dati SDO 2012. Tavola 2.2.6 - Descrizione dell’attività per DRG (versione 24) – Attività per Acuti in Regime ordinario. Anno 2012


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