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

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Superseded – See Erratum Table 40: Probabilistic base case analysis (in patients treated for 3 months) after amendment of errors identified in the model, assuming less intensive INR monitoring (same split DVTs/PEs between arms). LIFETIME (40 years) ICER estimate: £4,144 per QALY yielded Costs Rivaroxaban LMWH/VKA Increment Drug cost £216 £99 £117 Monitor cost £0 £128 -£128 Event costs £726 £711 £16 Bleed cost £78 £159 -£81 PTS/CTEPH £304 £295 £10 Total Cost £1,324 £1,391 -£66 Outcomes No of deaths 0.94 0.94 0.00 No of VTEs 1.23 1.22 0.01 No of maj Bleeds 0.01 0.02 -0.01 QALYs (discounted) 12.97 12.99 -0.02 WTP = £20,000 WTP = £30,000 NMB -£253.44 -£413.28 Table 41: Probabilistic base case analysis (in patients treated for 3 months) using the manufacturer’s assumptions on INR monitoring (after amendment of errors identified in the model) and assuming a different split DVTs/PEs between treatment arms. LIFETIME (40 years) ICER estimate: £5,031 per QALY yielded Costs Rivaroxaban LMWH/VKA Increment Drug cost £216 £99 £117 Monitor cost £0 £240 -£240 Event costs £891 £870 £21 Bleed cost £79 £161 -£81 PTS/CTEPH £296 £282 £13 Total Cost £1,482 £1,651 -£170 Outcomes No of deaths 0.94 0.94 0.00 No of VTEs 1.22 1.21 0.01 No of maj Bleeds 0.01 0.02 -0.01 QALYs (discounted) 12.96 12.99 -0.03 WTP = £20,000 WTP = £30,000 NMB -£505.59 -£843.35 149 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
Superseded – See Erratum Table 42: Probabilistic base case analysis (in patients treated for 3 months) after amendment of errors identified in the model assuming less intensive INR monitoring and assuming a different split DVTs/PEs between treatment arms. LIFETIME (40 years) ICER estimate: £1,203 per QALY yielded Costs Rivaroxaban LMWH/VKA Increment Drug cost £215 £99 £117 Monitor cost £0 £128 -£128 Event costs £726 £703 £23 Bleed cost £74 £155 -£80 PTS/CTEPH £299 £282 £17 Total Cost £1,315 £1,366 -£51 Outcomes No of deaths 0.94 0.94 0.00 No of VTEs 1.22 1.21 0.01 No of maj Bleeds 0.01 0.02 -0.01 QALYs (discounted) 12.97 13.01 -0.04 WTP = £20,000 WTP = £30,000 NMB -£798.56 -£1,223.39 150 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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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
Page 109 and 110: y intended treatment duration given
Page 111 and 112: eflect the current long term risk o
Page 113 and 114: survival of 70% in the 148 non-surg
Page 115 and 116: Monitoring xxxxxxxxxxxxxxxxxxxxxxxx
Page 117 and 118: The ERG acknowledges that the monit
Page 119 and 120: For patients managed in the inpatie
Page 121 and 122: The searches identified 2,811 poten
Page 123 and 124: The health state utility value for
Page 125 and 126: xxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxx
Page 127 and 128: few occasions for both VTEs and ble
Page 129 and 130: 2) the values used in the PSA for t
Page 131 and 132: 5.2.1 Results included in the manuf
Page 133 and 134: Figure 8: Tornado plot - Net Moneta
Page 135 and 136: 5.2.2.1.2. Results for patients for
Page 137 and 138: Figure 12: Cost-effectiveness plane
Page 139 and 140: Figure 14: Tornado plot - Net Monet
Page 141 and 142: 5.2.2.2 Subgroup analysis - cancer
Page 143 and 144: 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: Superseded - See Erratum Table 38:
Page 163 and 164: Superseded - See Erratum Figure 21:
Page 165 and 166: Superseded - See Erratum Table 46:
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 and 198: 51. Department of Health. NHS Refer
Page 199: 77. NICE Guidance. Atrial fibrillat
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