期刊论文详细信息
Thrombosis Journal
Cost-effectiveness analysis of treatment of venous thromboembolism with rivaroxaban compared with combined low molecular weight heparin/vitamin K antagonist
Raj Patel2  Julia Lowin3  Anne Guillermin3  Euan McLeod3  Dominic Muston4  Luke Bamber1 
[1] Bayer Pharma AG, Wuppertal, Germany;Department of Haematological Medicine, King’s College Hospital, London, UK;IMS Health, London, UK;Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA
关键词: Venous thromboembolism treatment;    Rivaroxaban;    Cost-effectiveness;   
Others  :  1216840
DOI  :  10.1186/s12959-015-0051-3
 received in 2014-09-30, accepted in 2015-03-30,  发布年份 2015
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【 摘 要 】

Background

Venous thromboembolism (VTE) is a burden on healthcare systems. Standard treatment involves parenteral anticoagulation overlapping with a vitamin K antagonist, an approach that is effective but associated with limitations including the need for frequent coagulation monitoring. The direct oral anticoagulant rivaroxaban is similarly effective to standard therapy as a single-drug treatment for VTE and does not require routine coagulation monitoring. The objective of this economic evaluation was to estimate the cost-effectiveness of rivaroxaban compared with standard VTE treatment from a UK perspective.

Methods

A Markov model was constructed using data and probabilities derived from the EINSTEIN DVT and EINSTEIN PE studies of rivaroxaban and other published sources. Health outcomes included VTE rates, bleeding events avoided, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs).

Results

There was greater discounted quality-adjusted life expectancy with rivaroxaban than with standard therapy, irrespective of indication and treatment duration. Rivaroxaban was associated with per-patient cost savings for each treatment duration modelled (3, 6 and 12 months), and these were greatest with shorter durations. Rivaroxaban was found to be dominant (cheaper and more effective) and, therefore, cost-effective, in both patients with deep vein thrombosis and pulmonary embolism in all three treatment duration groups, and was also cost-effective in patients requiring lifelong anticoagulation (ICERs: £8677 per QALY and £7072 per QALY in patients with index deep vein thrombosis and pulmonary embolism, respectively). The cost-effectiveness of rivaroxaban was largely insensitive to variations in one-way sensitivity analysis. Probabilistic sensitivity analysis demonstrated that at a threshold of £20,000 per QALY, rivaroxaban had a consistent probability of being cost-effective, compared with LMWH/VKA treatment, of around 80% regardless of index VTE or duration of anticoagulation therapy (3, 6, 12 months or lifelong).

Conclusions

This analysis suggests that rivaroxaban represents a cost-effective choice for acute treatment of deep vein thrombosis and pulmonary embolism and secondary prevention of VTE in the UK, compared with LMWH/VKA treatment, regardless of the required treatment duration.

【 授权许可】

   
2015 Bamber et al.; licensee BioMed Central.

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【 参考文献 】
  • [1]Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG et al.. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007; 98:756-64.
  • [2]Dobesh PP. Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy. 2009; 29:943-53.
  • [3]Baser O. Prevalence and economic burden of venous thromboembolism after total hip arthroplasty or total knee arthroplasty. Am J Manag Care. 2011; 17:S6-S8.
  • [4]White RH. The epidemiology of venous thromboembolism. Circulation. 2003; 107:14-8.
  • [5]Oger E. Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d’Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost. 2000; 83:657-60.
  • [6]Tagalakis V, Patenaude V, Kahn SR, Suissa S. Incidence of and mortality from venous thromboembolism in a real-world population: the Q-VTE Study Cohort. Am J Med. 2013; 126:832-21.
  • [7]Martinez C, Cohen AT, Bamber L, Rietbrock S. Epidemiology of first and recurrent venous thromboembolism: a population-based cohort study in patients without active cancer. Thromb Haemost. 2014; 112:255-63.
  • [8]Schulman S, Lindmarker P, Holmström M, Lärfars G, Carlsson A, Nicol P et al.. Post-thrombotic syndrome, recurrence, and death 10 years after the first episode of venous thromboembolism treated with warfarin for 6 weeks or 6 months. J Thromb Haemost. 2006; 4:734-42.
  • [9]Pengo V, Lensing AWA, Prins MH, Marchiori A, Davidson BL, Tiozzo F et al.. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004; 350:2257-64.
  • [10]Ruppert A, Steinle T, Lees M. Economic burden of venous thromboembolism: a systematic review. J Med Econ. 2011; 14:65-74.
  • [11]Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ et al.. 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:e419S-e494S.
  • [12]National Institute for Health and Care Excellence. Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing. Clinical guidelines, CG144. http://guidance.nice.org.uk/CG144. Accessed 26 Jan 2015.
  • [13]Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galiè N, Pruszczyk P et al.. Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008; 29:2276-315.
  • [14]Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest. 2008; 133:160S-98S.
  • [15]Scottish Intercollegiate Guidelines Network. Prevention and management of venous thromboembolism. A national clinical guideline. http://www.sign.ac.uk/pdf/sign122.pdf. Accessed 26 Jan 2015.
  • [16]Baglin TP, Cousins D, Keeling DM, Perry DJ, Watson HG. Safety indicators for inpatient and outpatient oral anticoagulant care: [corrected] Recommendations from the British Committee for Standards in Haematology and National Patient Safety Agency. Br J Haematol. 2007; 136:26-9.
  • [17]National Institute for Health and Care Excellence. Clinical Knowledge Summaries: anticoagulation - oral. http://cks.nice.org.uk/anticoagulation-oral#!scenariorecommendation:34. Accessed 23 Apr 2014.
  • [18]British National Formulary. Pharmaceutical Press, London; 2014.
  • [19]Bjorholt I, Andersson S, Nilsson GH, Krakau I. The cost of monitoring warfarin in patients with chronic atrial fibrillation in primary care in Sweden. BMC Fam Pract. 2007; 8:6. BioMed Central Full Text
  • [20]Erkan D, Ortel TL, Lockshin MD. Warfarin in antiphospholipid syndrome–time to explore new horizons. J Rheumatol. 2005; 32:208-12.
  • [21]Schulman S, Anderson DR, Bungard TJ, Jaeger T, Kahn SR, Wells P et al.. Direct and indirect costs of management of long-term warfarin therapy in Canada. J Thromb Haemost. 2010; 8:2192-200.
  • [22]National Patient Safety Agency. Reducing treatment dose errors with low molecular weight heparins. Rapid response report. NPSA/2010/RRR014. http://www.nrls.npsa.nhs.uk/resources/?EntryId45=75208. Accessed 26 Jan 2015.
  • [23]Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C et al.. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol. 2011; 154:311-24.
  • [24]Cohen A, Martinez C, Wallenhorst C, Bamber L. Vitamin K antagonist treatment patterns and persistence after venous thromboembolism in non-cancer patients: VTE Epidemiology Group (VEG) Study [abstract]. J Thromb Haemost. 2013; 11:27-8.
  • [25]The EINSTEIN. Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010; 363:2499-510.
  • [26]Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012; 366:1287-97.
  • [27]Prins MH, Lensing AWA, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA et al.. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013; 11:21. BioMed Central Full Text
  • [28]Stevenson M, Scope A, Holmes M, Rees A, Kaltenthaler E. Rivaroxaban for the prevention of venous thromboembolism: a single technology appraisal. Health Technol Assess. 2009; 13 Suppl 3:43-8.
  • [29]National Institute for Health and Clinical Excellence. Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism. Technology appraisal 261. http://www.nice.org.uk/ta261. Accessed 26 Jan 2015.
  • [30]National Institute for Health and Care Excellence. Rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism; NICE technology appraisal guidance 287. http://www.nice.org.uk/guidance/TA287. Accessed 26 Jan 2015.
  • [31]Aujesky D, Smith KJ, Roberts MS. Oral anticoagulation strategies after a first idiopathic venous thromboembolic event. Am J Med. 2005; 118:625-35.
  • [32]Aujesky D, Smith KJ, Cornuz J, Roberts MS. Cost-effectiveness of low-molecular-weight heparin for treatment of pulmonary embolism. Chest. 2005; 128:1601-10.
  • [33]Gómez-Outes A, Berto P, Prandoni P. Cost-effectiveness of bemiparin in the prevention and treatment of venous thromboembolism. Expert Rev Pharmacoecon Outcomes Res. 2006; 6:249-59.
  • [34]Marchetti M, Pistorio A, Barone M, Serafini S, Barosi G. Low-molecular-weight heparin versus warfarin for secondary prophylaxis of venous thromboembolism: a cost-effectiveness analysis. Am J Med. 2001; 111:130-9.
  • [35]National Institute for Health and Care Excellence. Guide to the methods of technology appraisal 2013. http://www.nice.org.uk/article/PMG9/chapter/Foreword. Accessed 26 Jan 2015.
  • [36]Bayer Pharma AG. Xarelto® (rivaroxaban) Summary of Product Characteristics. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf. Accessed 6 Jan 2015.
  • [37]Sanofi-Aventis. Clexane (enoxaparin sodium) Summary of Product Characteristics. 2011. http://www.sanofi-aventis.co.uk/products/Clexane_SPC.pdf. Accessed 26 Jan 2015.
  • [38]Miniati M, Monti S, Bottai M, Scoscia E, Bauleo C, Tonelli L et al.. Survival and restoration of pulmonary perfusion in a long-term follow-up of patients after acute pulmonary embolism. Medicine (Baltimore). 2006; 85:253-62.
  • [39]Prandoni P, Lensing AWA, Cogo A, Cuppini S, Villalta S, Carta M et al.. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996; 125:1-7.
  • [40]Prandoni P, Villalta S, Bagatella P, Rossi L, Marchiori A, Piccioli A et al.. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica. 1997; 82:423-8.
  • [41]Prandoni P, Noventa F, Ghirarduzzi A, Pengo V, Bernardi E, Pesavento R et al.. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica. 2007; 92:199-205.
  • [42]Linkins L, O’Donnell M, Julian JA, Kearon C. Intracranial and fatal bleeding according to indication for long-term oral anticoagulant therapy. J Thromb Haemost. 2010; 8:2201-7.
  • [43]Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP et al.. Improved outcomes in medically and surgically treated chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med. 2008; 177:1122-7.
  • [44]Rivero-Arias O, Ouellet M, Gray A, Wolstenholme J, Rothwell PM, Luengo-Fernandez R. Mapping the modified Rankin scale (mRS) measurement into the generic EuroQol (EQ-5D) health outcome. Med Decis Making. 2010; 30:341-54.
  • [45]Meads DM, McKenna SP, Doughty N, Das C, Gin-Sing W, Langley J et al.. The responsiveness and validity of the CAMPHOR Utility Index. Eur Respir J. 2008; 32:1513-9.
  • [46]Locadia M, Bossuyt PM, Stalmeier PF, Sprangers MA, Van Dongen CJ, Middeldorp S et al.. Treatment of venous thromboembolism with vitamin K antagonists: patients’ health state valuations and treatment preferences. Thromb Haemost. 2004; 92:1336-41.
  • [47]Lenert LA, Soetikno RM. Automated computer interviews to elicit utilities: potential applications in the treatment of deep venous thrombosis. J Am Med Inform Assoc. 1997; 4:49-56.
  • [48]Kind P, Dolan P, Gudex C, Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. Br Med J. 1998; 316:736-41.
  • [49]Bamber L, Wang MY, Prins MH, Ciniglio C, Bauersachs R, Lensing AWA et al.. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost. 2013; 110:732-41.
  • [50]Prins MH, Bamber L, Cano SJ, Wang MY, Erkens PM, Bauersachs R et al.. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial. Thromb Res. 2015; 135:281-8.
  • [51]Rose P, James R, Chapman O, Marshall S. A real world evaluation to describe the characteristics, outcomes and resource use associated with patients being managed by a secondary care based anticoagulation service. [abstract]. Value Health. 2011; 14:A387-A388.
  • [52]van Bellen B, Bamber L, Correa de Carvalho F, Prins M, Wang M, Lensing AWA. 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.
  • [53]Department of Health. NHS Reference Costs 2010–11. 2011. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/215297/dh_131160.pdf. Accessed 26 Jan 2015.
  • [54]PSSRU. Unit costs of health & social care 2011. Canterbury: University of Kent; 2011. http://www.pssru.ac.uk/archive/pdf/uc/uc2011/uc2011.pdf. Accessed 26 Jan 2015.
  • [55]York Technology Assessment Group. Diagnostics technology assessment report: EOS 2D/3D X-ray imaging system. http://www.nice.org.uk/guidance/dg1/evidence/eos-2d3d-xray-imaging-system-assessment-report2. Accessed 7 Mar 2014.
  • [56]National Institute for Health and Care Excellence. Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. http://www.nice.org.uk/guidance/CG92. Accessed 26 Jan 2015.
  • [57]National Institute for Health and Care Excellence. Anticoagulation therapy commissioning and budgeting tool. http://www.nice.org.uk/proxy/?sourceUrl=http%3a%2f%2fwww.nice.org.uk%2fusingguidance%2fcommissioningguides%2fAnticoagulationTherapyCAB.jsp. Accessed 26 Jan 2015.
  • [58]Goodacre S, Sampson F, Stevenson M, Wailoo A, Sutton A, Thomas S et al.. Measurement of the clinical and cost-effectiveness of non-invasive diagnostic testing strategies for deep vein thrombosis. Health Technol Assess. 2006; 10:1-168.
  • [59]Eerenberg ES, Middeldorp S, Levi M, Lensing AWA, Buller HR. What is the clinical impact of major bleedings with rivaroxaban? Results from the pooled EINSTEIN studies [abstract]. J Thromb Haemost. 2013; 11:88.
  • [60]Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L et al.. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013; 128:2325-32.
  • [61]Streiff MB, Segal JB, Tamariz LJ, Jenckes MW, Bolger DT, Eng J et al.. Duration of vitamin K antagonist therapy for venous thromboembolism: a systematic review of the literature. Am J Hematol. 2006; 81:684-91.
  • [62]Boggon R, van Staa TP, Timmis A, Hemingway H, Ray KK, Begg A et al.. Clopidogrel discontinuation after acute coronary syndromes: frequency, predictors and associations with death and myocardial infarction–a hospital registry-primary care linked cohort (MINAP-GPRD). Eur Heart J. 2011; 32:2376-86.
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