Rivaroxaban for the treatment of deep vein thrombosis and ...

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38. U.S.Department of Health and Human Services Food and Drug Administration. Guidance for Industry Non-Inferiority Clinical Trials. 2010; available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/G uidances/UCM202140.pdf (accessed Dec. 11 A.D.). 39. Temerowski, M. Protocol and protocol amendments For the report entitled: Oncedaily oral direct factor Xa inhibitor rivaroxaban in the longterm prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deepvein thrombosis or pulmonary embolism. The Einstein-Extension study. 2011. Bayer PLC. 40. A report by IMS Health for Bayer Healthcare. Venous thromboembolism treatment: a systematic review of the literature. 2011. 41. Deitcher, S.R., Kessler, C.M., Merli, G., Rigas, J.R., Lyons, R.M., Fareed, J. Secondary prevention of venous thromboembolic events in patients with active cancer: enoxaparin alone versus initial enoxaparin followed by warfarin for a 180-day period. Clin Appl Thromb Hemost 2006; 12(4):389-396. 42. Hull, R.D., Pineo, G.F., Brant, R.F., Mah, A.F., Burke, N., Dear, R. et al. Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med 2006; 119(12):1062-1072. 43. Lee, A.Y., Levine, M.N., Baker, R.I., Bowden, C., Kakkar, A.K., Prins, M. et al. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med 2003; 349(2):146- 153. 44. Meyer, G., Marjanovic, Z., Valcke, J., Lorcerie, B., Gruel, Y., Solal-Celigny, P. et al. Comparison of low-molecular-weight heparin and warfarin for the secondary prevention of venous thromboembolism in patients with cancer: a randomized controlled study. Arch Intern Med 2002; 162(15):1729-1735. 45. Romera-Villegas, A., Cairols-Castellote, M.A., Vila-Coll, R., Marti-Mestre, X., Colome, E., Iguaz, I. Long-term use of different doses of low-molecular-weight heparin versus vitamin K antagonists in the treatment of venous thromboembolism. Ann Vasc Surg 2010; 24(5):628-639. 46. Anticoagulation with [blacktriangledown] dabigatran or [blacktriangledown] rivaroxaban. Drug Ther Bull 2009; 47(10):116-120. 47. Dias, S., Welton, N.J., ., Sutton, A.J., Ades, A.E. A Generalised Linear Modelling Framework for Pairwise and Network Meta-Analysis of Randomised Controlled Trials. 2011; available from http://www.nicedsu.org.uk 48. British National Formulary (BNF). 2011; available from http://bnf.org/bnf/bnf/current/index.htm (accessed Dec. 11 A.D.). 49. Microsoft Corporation. Excel 2007. 2012; available from http://office.microsoft.com/en-us/excel 50. EINSTEIN, I., Bauersachs, R., Berkowitz, S.D., Brenner, B., Buller, H.R., Decousus, H. et al. Oral rivaroxaban for symptomatic venous thromboembolism. The New England Journal of Medicine 2010; 363:2499-2510. 185 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
51. Department of Health. NHS Reference Costs 2009-10. Appendix NSRC4: NHS Trusts and PCTs combined. 2011; available from http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAn dGuidance/DH_123459 (accessed Jan. 12 A.D.). 52. Bayer PLC. DRAFT Summary of Product Characteristics:Xarelto 15 mg film-coated tablets. Manufacturer's submission to NICE 2011; (accessed Dec. 11 A.D.). 53. Bayer PLC. DRAFT Summary of Product Characteristics - Xarelto 20 mg film-coated tablets. Manufacturer's submission to NICE 2011; (accessed Dec. 11 A.D.). 54. 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 ). Medicine (Baltimore) 2006; 85(5):253-262. 55. 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(4):423-428. 56. Linkins, L.A., O'Donnell, M., Julian, J.A., Kearon, C. Intracranial and fatal bleeding according to indication for long term oral anticoagulant therapy. Journal of Thrombosis & Haemostasis 2010; 8(10):2201-2207. 57. Condliffe, R., Kiely, D.G., Gibbs, J.S.R., Corris, P.A., Peacock, A.J., Jenkins, D.P. et al. Improved outcomes in medically and surgically treated chronic thromboembolic pulmonary hypertension. Americal Journal of Respiratory and Critical Care Medicine 2008; 177(10):1122. 58. A report by pH Associates for Bayer Healthcare. A national survey to describe current and future planned changes in anticoagulation management and service structure in 2011. 2011. 59. PSSRU. Unit costs of health and social care. 2010; available from http://www.pssru.ac.uk/pdf/uc/uc2010/uc2010.pdf 60. NICE - Anticoagulation therapy servic. The commissioning and benchmarking tool. 2011; available from http://www.nice.org.uk/usingguidance/commissioningguides/anticoagulationtherapys ervice/commissioningtool.jsp 61. Seymour, H. Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism - Northumberland Care Trust submission to NICE. 2011. 62. Jowett, S., Bryan, S., Murray, E., McCahon, D., Raftery, J., Hobbs, F.D.R. et al. Patient self-management of anticoagulation 15 therapy: a trial-based costeffectiveness analysis. Br J Haematol 2006; 16(134):6-632. 63. Bayer PLC. VTE Treatment, Market Research. 2010. 64. 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(15):1-168. 186 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
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Rivaroxaban for the treatment of de
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TABLE OF CONTENTS List of Abbreviat
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Table 12 Time to therapeutic INR (I
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identified in the model). Table 40
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Figures Figure 1 Flow diagram for i
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Figure 23 Exploratory analysis in c
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MS Manufacturer’s submission NE S
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The dose of LMWH used reflects Amer
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xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
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The exploratory analysis in cancer
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intended treatment duration of 12 m
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VTE therefore has a substantial bur
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indefinite treatment. VTE LMWH, low
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3 Critique of manufacturer’s defi
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Subgroups to be considered Special
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contraindications for the drug (as
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3.1.3 MTC populations The populatio
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3.2.2 Length of treatment As discus
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“No preventative therapy” is th
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It could be argued that poor TTR ma
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3.4.2 Outcomes recommended by EMA r
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4 CLINICAL EFFECTIVENESS 4.1 Critiq
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competitor products were excluded f
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Figure 1 Flow diagram for identifyi
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Table 7: Table showing list of rele
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The approach taken to quality asses
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o EINSTEIN-DVT dose-ranging study 3
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Trial name References, study type E
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4.2.1 Critique of pivotal EINSTEIN-
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However, the study design did not i
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Table 10: Summary of outcomes for E
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Chi-square analyses were undertaken
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clarification on this matter, the m
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Both of these factors are likely to
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It remains unclear why these patien
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leeding may be less suited to longe
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may account for the apparent differ
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Table 13: Criteria used to define a
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DVT and/or PE xxxxxxxxx xxxxxxxxxxx
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There is some doubt about the appro
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Subgroup analyses - EINSTEIN-Ext Su
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o It is clear that bleed events wer
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is likely to be small as the outcom
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depends on the specific parameteris
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4.4.3 Between study standard deviat
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Table 19.2: VTE recurrence (dichoto
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Table 22 Uncertainties in clinical
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The ERG are of the understanding th
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For the primary analysis, the rates
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In the economic model, the manufact
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Finally, in cancer patients, the ma
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Our experts believed that patients
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Similarly, the manufacturer used da
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Table 25: baseline risk of events f
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y intended treatment duration given
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eflect the current long term risk o
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survival of 70% in the 148 non-surg
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Monitoring xxxxxxxxxxxxxxxxxxxxxxxx
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The ERG acknowledges that the monit
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For patients managed in the inpatie
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The searches identified 2,811 poten
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The health state utility value for
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xxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxx
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few occasions for both VTEs and ble
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2) the values used in the PSA for t
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5.2.1 Results included in the manuf
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Figure 8: Tornado plot - Net Moneta
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5.2.2.1.2. Results for patients for
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Figure 12: Cost-effectiveness plane
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Figure 14: Tornado plot - Net Monet
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5.2.2.2 Subgroup analysis - cancer
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Figure 17: Tornado plot - Net Monet
Page 145 and 146: 5.2.3 Comment on validity of result
Page 147 and 148: Table 36: Summary of uncertainties
Page 149 and 150: Summary of uncertainties Has the im
Page 155 and 156: Superseded - See Erratum 6. ADDITIO
Page 157 and 158: Superseded - See Erratum Table 37 S
Page 159 and 160: Superseded - See Erratum Table 38:
Page 163 and 164: Superseded - See Erratum Figure 21:
Page 167 and 168: Superseded - See Erratum 6.3. Proba
Page 173 and 174: 6.5. Exploratory analysis in cancer
Page 175 and 176: Figure 23: Exploratory analysis in
Page 177 and 178: Table 60: Deterministic base case a
Page 179 and 180: The ERG also examined the impact of
Page 181 and 182: days after stopping treatment.(Bull
Page 183 and 184: Both Phase II studies performed ana
Page 185 and 186: Appendix 2 Correction of Tables 29
Page 187 and 188: Appendix 3 Definition of `sufficien
Page 189 and 190: A bullet on page 42 states that `53
Page 191 and 192: Both numbers refer to the placebo a
Page 193 and 194: 9. REFERENCES 1. Bayer PLC. Rivarox
Page 195: http://www.dh.gov.uk/en/Publication
Page 199: 77. NICE Guidance. Atrial fibrillat
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