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

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Secondary analysis 2 is of data from `EINSTEIN-DVT – cancer subgroup’, Hull et al 2006, Lee et al 2003, Meyer et al 2002. Analyses presented in Tables 26-28 (pages 76-77) followed the same approach. 181 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
9. REFERENCES 1. Bayer PLC. Rivaroxaban in the treatment of deep vein thrombosis and prevention of recurrent venous thromboembolic events - Bayer plc submission to NICE STA. 2011. 2. Incidence of venous thromboembolism (VTE) in the general population - VTE Epidemiology Group study. XXIII Conference of The International Society on Thrombosis and Haematosis (ISTH); 11 Jul 11; 2011. 3. National Institute for Health and Clinical Excellence. Final scope. Single Technology Appraisal. Rivaroxaban for the treatment for deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism. 2011. 4. 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(5):657-660. 5. White, R.H. The epidemiology of venous thromboembolism. Circulation 2003; 107(23 Suppl 1):I4-I8. 6. Prandoni, P., Lensing, A.W., 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):1-7. 7. National Collaborating Centre for Acute Care. Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. 2009; available from http://www.nice.org.uk/nicemedia/pdf/CG92FullGuideline.pdf 8. 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(2):199-205. 9. Eichinger, S., Heinze, G., Jandeck, L.M., Kyrle, P.A. Risk assessment of recurrence in patients with unprovoked deep vein thrombosis or pulmonary embolism: the Vienna prediction model. Circulation 2010; 121(14):1630-1636. 10. Office for National Statistics. 2008-based National Population Projections. 2010; available from http://www.statistics.gov.uk/downloads/theme_population/NPP2008/NatPopProj2008 .pdf (accessed Dec. 11 A.D.). 11. 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(3):311- 324. 12. Winter, M., Keeling, D., Sharpen, F., Cohen, H., Vallance, P. Procedures for the outpatient management of patients with deep venous thrombosis. Clin Lab Haematol 2005; 27(1):61-66. 182 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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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
Page 141 and 142: 5.2.2.2 Subgroup analysis - cancer
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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
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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: Both numbers refer to the placebo a
Page 195 and 196: http://www.dh.gov.uk/en/Publication
Page 197 and 198: 51. Department of Health. NHS Refer
Page 199: 77. NICE Guidance. Atrial fibrillat
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