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

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65. McKenna, C., Wade, R., Farria, R., Yang, H., Stirk, L., Gummerson, N., Sculpher, M., Woolacott, N. EOS 2D/3D X-ray Imaging System - Technology Assessment Report for NICE - Diagnostics Assessment Report. 2011; available from http://www.nice.org.uk/nicemedia/live/13030/54603/54603.pdf (accessed Dec. 11 A.D.). 66. Kind, P., Dolan, P., Gudex, C., Williams, A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998; 316(7133):736-741. 67. Rivero-Arias, O., Ouellet, M., Gray, A., Wolstenholme, J., Rothwell, P.M., Luengo- Fernandez, R. Mapping the modified Rankin scale (mRS) measurement into the generic EuroQol (EQ-5D) health outcome. Med Decis Making 2010; 30(3):341-354. 68. Locadia, M., Bossuyt, P.M., Stalmeier, P.F., Sprangers, M.A., van Dongen, C.J., Middeldorp, S. et al. Treatment of venous thromboembolism with vitamin K antagonists: patients' health state valuations and treatment preferences. Thromb Haemost 2004; 92(6):1336-1341. 69. Lenert, L.A., Soetikno, R.M. Automated computer interviews to elicit utilities: potential applications in the treatment of deep venous thrombosis. J Am Med Inform Assoc 1997; 4(1):49-56. 70. Meads, D.M., McKenna, S.P., 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(6):1513-1519. 71. van Asch, C.J., Luitse, M.J., Rinkel, G.J., van der Tweel, I., Algra, A., Klijn, C.J. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol 2010; 9(2):167-176. 72. Marchetti, M., Pistorio, A., Barone, M., Serefini, S., Barosi, G. Low-molecularweight heparin versus warfarin for secondary prophylaxis of venous thromboembolism: a cost-effectiveness analysis. Am J Med 2001; 111(2):130-139. 73. O'Meara, J., McNutrt, R.A., Evans, A.T., Moore, S.W., Downs, S.M. A decision analysis of streptokinase plus heparin as compared with heparin alone for deep-vein thrombosis. N Engl J Med 1994; 330(26):1864-1869. 74. Meenan, R.T., Saha, S., Chou, R., Swarztrauber, K., Pyle Krages, K., O'Keeffe- Rosetti, M.C. et al. Cost-Effectiveness of Echocardiography to Identify Intracardiac Thrombus among Patients with First Stroke or Transient Ischemic Attack. Medical Decision Making 2007; 27(2):161-177. 75. Rachet, B., Ellis, L., Maringe, C., Chu, T., Nur, U., Quaresma, M. et al. Socioeconomic inequalities in cancer survival in England after the NHS cancer plan. Br J Cancer 2010; 103(4):446-453. 76. Levitan, B., Yuan, Z., Turpie, A.G.G., Friedman, R.J., Homering, M., Berlin, J.A. et al. Quantitative benefit-risk assessment of rivaroxaban for the prevention of venous thromboembolism. Blood Conference: 51st Annual Meeting of the American Society of Hematology, ASH New Orleans, LA United States Conference Start: 20091205 Conference End: 20091208 Conference Publication: (Var Pagings) 114 (22) , 2009 Date of Publication: 20 Nov 2009(var.pagings):20. 187 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
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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 and 196: http://www.dh.gov.uk/en/Publication
Page 197: 51. Department of Health. NHS Refer
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