Venous thrombo-embolism (VTE) prevention of patients undergoing total hip and knee replacement: budget impact analysis of apixaban in Italy

Venous thrombo-embolism (VTE) prevention of patients undergoing total hip and knee replacement: budget impact analysis of apixaban in Italy

Authors

  • Lorenzo Giovanni Mantovani Department of Clinical Medicine and Surgery Federico II University of Naples
  • Giovanni Di Minno Department of Clinical Medicine and Surgery Federico II University of Naples
  • Gianluca Furneri Fondazione Charta, Milan, Italy

DOI:

https://doi.org/10.7175/fe.v14i3.670

Keywords:

Apixaban, New oral anticoagulants, Venous thromboembolism

Abstract

BACKGROUND: Venous thromboembolism (VTE) is a common and burdensome cardiovascular condition, frequently leading to severe complications and requiring high-cost healthcare interventions. New oral anticoagulants (nOACs) have demonstrated to be efficacious and safe in VTE prevention of patients undergoing total hip replacement (THR) and total knee replacement (TKR), a condition that is typically associated to cardiovascular disease. The Italian Healthcare Service (SSN) has recently approved the latest nOAC, apixaban. The present article aims to evaluate its economic impact in the perspective of the Italian SSN.


METHODS: We conducted a budget impact analysis to estimate clinical outcomes and economic consequences associated to the reimbursement of apixaban, in the prevention of VTE as a consequence of major orthopedic surgery, over a three-year time horizon. In our analysis we compared two alternative scenarios, with apixaban either reimbursed (Scenario B) or not reimbursed (Scenario A) by the Italian SSN, and estimated the difference of healthcare costs between the two scenarios. Only direct healthcare costs have been considered.


RESULTS: According to market assumptions, it is estimated that 1.2%, 3.7%, and 6.5% of THR patients, and 1.2%, 3.8% and 6.7% of TKR patients, would be treated with apixaban over the first three years since launch. At the estimated daily cost of apixaban (€2.48/die), this would translate into a budget impact of €14.3 mln, €45.5 mln, and €81.4 mln at years 1, 2 and 3 since launch, respectively. This expenditure would be more than offset by savings, due to: i) reduction of prescriptions of alternative treatment options (other nOACs, low-molecular weight heparins, fondaparinux); ii) reduction of the economic burden attributable of CV complications of VTE. Finally, Scenario B resulted slightly favourable compared to Scenario A, leading to economic savings for about €50 thousands over three years. Sensitivity analyses confirmed findings of the base-case analysis.


CONCLUSIONS: Reimbursement of apixaban does not determine a budget impact increase for Italian SSN. Its usage may be considered fully sustainable from a pharmaco-economic viewpoint.

References

Goldhaber SZ. Pulmonary embolism thrombolysis: A clarion call for international collaboration. J Am Coll Cardiol 1992, 19: 246-7; http://dx.doi.org/10.1016/0735-1097(92)90473-Z

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

Baser O, Supina D, Sengupta N, et al. Clinical and cost outcomes of venous thromboembolism in Medicare patients undergoing total hip replacement or total knee replacement surgery. Curr Med Res Opin 2011; 27: 423-9; http://dx.doi.org/10.1185/03007995.2010.545940

Mantilla CB, Horlocker TT, Schroeder DR, et al. Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology 2002; 96: 1140-6; http://dx.doi.org/10.1097/00000542-200205000-00017

Geerts WH, Bergqvist D, Pineo GF, et al.; American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).Chest 2008; 133(6 Suppl): 381S-453S; http://dx.doi.org/10.1378/chest.08-0656

Vekeman F, LaMori JC, Laliberté F, et al. Risks and cost burden of venous thromboembolism and bleeding for patients undergoing total hip or knee replacement in a managed-care population. J Med Econ 2011; 14: 324-34; http://dx.doi.org/10.3111/13696998.2011.578698

Lefebvre P, Laliberté F, Nutescu EA, et al. All-cause and potentially disease-related health care costs associated with venous thromboembolism in commercial, Medicare, and Medicaid beneficiaries. J Manag Care Pharm 2012; 18: 363-74

Baser O, Supina D, Sengupta N, et al. Clinical and cost outcomes of venous thromboembolism in Medicare patients undergoing total hip replacement or total knee replacement surgery. Curr Med Res Opin 2011; 27: 423-9; http://dx.doi.org/10.1185/03007995.2010.545940

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

Ruppert A, Steinle T, Lees M. Economic burden of venous thromboembolism: a systematic review. J Med Econ 2011; 14: 65-74; http://dx.doi.org/10.3111/13696998.2010.546465

Chan CM, Shorr AF. Economic and outcomes aspects of venous thromboembolic disease. Crit Care Clin 2012; 28: 113-23; http://dx.doi.org/10.1016/j.ccc.2011.09.005

Kearon C. Natural history of venous thromboembolism. Circulation 2003; 107(23 Suppl 1): I22-30

Prandoni P. Healthcare burden associated with the post-thrombotic syndrome and potential impact of the new oral anticoagulants. Eur J Haematol 2012; 88: 185-94; http://dx.doi.org/10.1111/j.1600-0609.2011.01733.x

Piazza G, Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med 2011; 364: 351-60; http://dx.doi.org/10.1056/NEJMra0910203

Lassen MR, Raskob GE, Gallus A, et al.; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet 2010; 375: 807-15; http://dx.doi.org/10.1016/S0140-6736(09)62125-5

Lassen MR, Raskob GE, Gallus A, et al. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med 2009; 361: 594-604; http://dx.doi.org/10.1056/NEJMoa0810773

Lassen MR, Gallus A, Raskob GE, et al.; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010; 363: 2487-98; http://dx.doi.org/10.1056/NEJMoa1006885

Lassen MR, Ageno W, Borris LC, et al.; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776-86; http://dx.doi.org/10.1056/NEJMoa076016

Turpie AG, Lassen MR, Davidson BL, et al.; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373: 1673-80; http://dx.doi.org/10.1016/S0140-6736(09)60734-0

Eriksson BI, Borris LC, Friedman RJ, et al.; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008; 358: 2765-75; http://dx.doi.org/10.1056/NEJMoa0800374

Eriksson BI, Dahl OE, Rosencher N, et al.; RE-MODEL Study Group. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007; 5: 2178-85; http://dx.doi.org/10.1111/j.1538-7836.2007.02748.x

Eriksson BI, Dahl OE, Rosencher N, et al.; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007; 370: 949-56; http://dx.doi.org/10.1016/S0140-6736(07)61445-7

IMS. Thromboembolism prevention in patients undergoing total hip or total knee replacement surgery in Italy: market data 2010. February 2011.

National Institute of Statistics. National Demographic Report, Year 2010. Available at: http://www.istat.it/it/archivio/28491

Healthcare Superior Institute (ISS). ISTISAN report 09/22. Published in November 2009

Bristol-Myers Squibb Internal Market Research Data: VTEp Knowledge book Italy, 2010

Degli Esposti L, Didoni G, Simon T, et al. Analysis of the cost of illness for the prevention of deep venous thrombosis in patients with total knee or hip replacement: results from the PATHOS study (Practice Analysis of THromboprophylaxis after Orthopaedic Surgery). Clinicoecon Outcomes Res 2013; 5: 1-7; http://dx.doi.org/10.2147/CEOR.S39978

Abacus international. Meta-analysis of apixaban and comparators for preventing venous thromboembolism in people undergoing elective knee and hip replacement surgery: NICE MTC analysis. November, 2010

National Institute of Clinical Excellence (NICE). Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults: technology appraisal guidance 245. Issued: January 2012. Available at: http://www.nice.org.uk/nicemedia/live/13648/57895/57895.pdf

Italian Drug Agency (AIFA). Reimbursement and price of Eliquis (apixaban), authorized through European centralized procedure by European Commission. Official Gazette of the Italian Republic: August, 2012

National Institute of Statistics (ISTAT). Population in Italy, Year 2010. Available at: http://demo.istat.it

United Biosource. Resource consumption during total knee and hip replacement hospitalization. Last update: October 2012

Conference of Italian regions and and autonomous provinces. Unified conventional tariffs for hospital healthcare assistance (TUC), year 2009. Available at: http://www.regioni.it/it/show-doc_approvato_-_assistenza_ospedaliera_tariffa_unica_convenzionale_tuc_2009/news.php?id=104417

National Agency for Regional Healthcare Services (Agenzia Nazionale per i Servizi Sanitari Regionali; Age.Na.S). National and regional ambulatory/outpatient tariffs in 2009. Available at: http://www.agenas.it/monitoraggio_costi_tariffe/monitoraggio_costi_tariffe_prestazioni.htm

Nuijten MJ, Berto P, Kosa J, et al. Cost-effectiveness of enoxaparin as thromboprophylaxis in acutelly ill medical patients from the Italian NHS perspective. Recenti Prog Med 2002; 93: 80-91

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Published

2013-09-11

How to Cite

Mantovani, L. G., Di Minno, G., & Furneri, G. (2013). Venous thrombo-embolism (VTE) prevention of patients undergoing total hip and knee replacement: budget impact analysis of apixaban in Italy. Farmeconomia. Health Economics and Therapeutic Pathways, 14(3), 119–129. https://doi.org/10.7175/fe.v14i3.670

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Original research

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