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

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Superseded – See Erratum difference did not reach statistical significance (p=0.14) this could be due to a small number of events. Given the marked differences in the health and financial consequences following PE or DVT conducting an exploratory analysis was deemed prudent. The analysis assumes that; a. xxxxxx VTEs are DVTs in patients treated with dual therapy LMWH/VKA b. xxxxxx VTEs are DVTs in patients treated with rivaroxaban Finally, a cost-minimisation was undertaken assuming the treatment effect to be the same between rivaroxaban and LMWH/VKA. This scenario assumes that the two drugs provide the same clinical benefits, but are associated with different costs in terms of drug acquisition, administration and monitoring. Results are presented using a lifetime horizon for the PSA results only (1,000 iterations) as the model showed non-linearity when comparing the results from the deterministic and probabilistic analysis. In addition to the ICER, the net monetary benefit (NMB) at a WTP of £20,000 or £30,000 per QALY gained was also reported. A positive NMB indicates that rivaroxaban is cost-effective at the examined WTP. Finally, the analyses use data by intended treatment duration. 6.1. Probabilistic cost-effectiveness results in patients for whom 3 months of anticoagulation treatment is appropriate – exploratory analyses conducted by the ERG. A summary of the analyses undertaken by the ERG are provided in Table 37; care must be taken in interpreting the cost-effectiveness of interventions which are cost saving but provide a reduction in overall QALYs. 145 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
Superseded – See Erratum Table 37 Summation of ERG exploratory analyses in patients for whom 3 months of anticoagulation treatment is appropriate. Incremental Cost Incremental Cost Per QALY lost (£) QALY (£) * 1 Manufacturer Basecase -180 -0.02 11,787 2 As 1, but errors corrected -182 -0.02 11,792 3 As 2 with INR monitoring costs altered -66 -0.02 4,144 4 As 2 with differential PE:DVT ratio assumed -170 -0.03 5,031 5 As 2 with INR monitoring costs altered and with differential PE:DVT ratio assumed -51 -0.04 1,203 * When evaluating cost per QALY lost, values greater than the assumed threshold are deemed costeffective, with values under the threshold indicating that a treatment would not be cost-effective More detailed results for the different analyses are presented in Table 38 to Table 42 with the mean incremental cost and QALY values plotted in Figure 20. 146 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
Page 105 and 106: Similarly, the manufacturer used da
Page 107 and 108: 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
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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: Superseded - See Erratum 6. ADDITIO
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 and 198: 51. Department of Health. NHS Refer
Page 199: 77. NICE Guidance. Atrial fibrillat
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