Venous tromboembolism treatment: budget impact analysis of rivaroxaban in Italy

Venous tromboembolism treatment: budget impact analysis of rivaroxaban in Italy

Authors

  • Daniela Paola Roggeri ProCure solutions
  • Alessandro Roggeri ProCure solutions
  • Vittorio Pengo Clinica Cardiologica, Centro Trombosi, Università degli Studi di Padova

DOI:

https://doi.org/10.7175/fe.v15i4.968

Keywords:

Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolism, Rivaroxaban

Abstract

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.

References

Dobesh PP. Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy 2009; 29: 943-53; http://dx.doi.org/10.1592/phco.29.8.943

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; http://dx.doi.org/10.1161/01.CIR.0000078468.11849.66

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; http://dx.doi.org/10.1111/j.1525-1497.2006.00458.x

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; http://dx.doi.org/10.1001/archinte.158.6.585

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; http://dx.doi.org/10.7861/clinmedicine.8-4-388

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; http://dx.doi.org/10.7326/0003-4819-125-1-199607010-00001

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; http://dx.doi.org/10.1001/archinte.160.6.761

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; http://dx.doi.org/10.1378/chest.08-0670

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; http://dx.doi.org/10.1378/chest.11-2301

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; http://dx.doi.org/10.7326/0003-4819-139-11-200312020-00007

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; http://dx.doi.org/10.1093/europace/eur126

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; http://dx.doi.org/10.2147/DDDT.S6074

Garcia D, Libby E, Crowther MA. The new oral anticoagulants. Blood 2010; 115: 15-20; http://dx.doi.org/10.1182/blood-2009-09-241851

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; http://dx.doi.org/10.1378/chest.08-0673

Xarelto® – Riassunto delle caratteristiche di prodotto

The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510; http://dx.doi.org/10.1056/NEJMoa1007903

The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-97; http://dx.doi.org/10.1056/NEJMoa1113572

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; http://dx.doi.org/10.2165/11313890-000000000-00000

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; http://dx.doi.org/10.1185/03007995.2013.879439

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; http://dx.doi.org/10.2147/CEOR.S39978

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; http://dx.doi.org/10.1007/s11739-009-0324-6

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; http://dx.doi.org/10.1097/HPC.0b013e3182a78c06

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

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; http://dx.doi.org/10.1093/europace/eut083

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; http://dx.doi.org/10.1517/14656566.2013.773310

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

Downloads

Published

2014-12-22

How to Cite

Roggeri, D. P., Roggeri, A., & Pengo, V. (2014). Venous tromboembolism treatment: budget impact analysis of rivaroxaban in Italy. Farmeconomia. Health Economics and Therapeutic Pathways, 15(4), 113–127. https://doi.org/10.7175/fe.v15i4.968

Issue

Section

Original research

Similar Articles

<< < 1 2 3 4 5 6 

You may also start an advanced similarity search for this article.

Loading...