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

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- the treatment effect (HR) of rivaroxaban for major bleedings at the upper 95% CI Figure 11: Tornado plot - Net Monetary Benefit of rivaroxaban vs. LMWH/VKA, 6 months of treatment, lifetime horizon, duration specific inputs (reproduction of Figure 6, p. 34, Clarification letter 17 December 2011) Results for the PSA were run over 1,000 iterations, using effectiveness data specific to patients treated for 6 months under a lifetime horizon are presented in Figure 12 for the cost-effectiveness plane and Figure 13 for the CEAC. OWSA Tornado diagram for strategy (Net monetary benefit, QALY based): 1 vs 2 (lifetime) HR of VTE in 6 months patient group (EINSTEIN acute) HR of major bleed in 6 months patient group (EINSTEIN acute) Cost of ambulatory visits (OPs by different treatment setting plus district nurse) Cost of GP visit VKA Number of warfarin monitoring visits during initiation period (months 1- 3) Number of warfarin monitoring visits per period of 3 months, after initiation period Disutility associated with WARF Discount rate applied to outcomes Mean age cohort State-related mortality (all parameters) Proportion of patients who self inject LMWH Probability major bleed is intra-cranial Death given treated PE (overall) Probability of major bleed in 6 months patient group over 0-3 months (EINSTEIN acute) Cost of subsequent appointments for follow-up VKA -300 -200 -100 0 100 200 300 400 500 600 700 The manufacturer reported that rivaroxaban had a 85.0% chance of being cost-effective at a WTP of £20,000 per QALY gained. Rivaroxaban was dominant (provided more QALYs at a lower cost) in 68.7% of cases and was dominated (provided less QALYs at a higher cost) in 6.4% of iterations. 125 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved. Low variation High variation
Figure 12: Cost-effectiveness plane, rivaroxaban vs. LMWH/VKA, 6 months of anticoagulation treatment, lifetime horizon, duration specific inputs (reproduction of Figure 7, p. 35, Clarification letter 17 December 2011) Figure 13: CEAC, rivaroxaban vs. LMWH/VKA, 6 months of anticoagulation treatment, lifetime horizon, duration specific inputs (reproduction of Figure 8, p. 35, Clarification letter 17 December 2011) Likelihood of being cost effective Incremental cost 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 6.4% Cost-effectiveness plane (lifetime horizon) 400 300 200 100 -0.06 -0.04 -0.02 0 -100 0 0.02 0.04 0.06 0.08 13.7% -200 -300 -400 -500 -600 -700 Incremental QALY Cost-effectiveness acceptability curve (lifetime horizon) 126 11.2% 68.7% 0 20000 40000 60000 80000 100000 120000 WTP threshold 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
Page 85 and 86: is likely to be small as the outcom
Page 87 and 88: depends on the specific parameteris
Page 89 and 90: 4.4.3 Between study standard deviat
Page 91 and 92: Table 19.2: VTE recurrence (dichoto
Page 93 and 94: Table 22 Uncertainties in clinical
Page 95 and 96: The ERG are of the understanding th
Page 97 and 98: For the primary analysis, the rates
Page 99 and 100: In the economic model, the manufact
Page 101 and 102: Finally, in cancer patients, the ma
Page 103 and 104: 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: 5.2.2.1.2. Results for patients for
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 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
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Appendix 3 Definition of `sufficien
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A bullet on page 42 states that `53
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Both numbers refer to the placebo a
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9. REFERENCES 1. Bayer PLC. Rivarox
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http://www.dh.gov.uk/en/Publication
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51. Department of Health. NHS Refer
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77. NICE Guidance. Atrial fibrillat
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