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

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Table 28: Management costs for the different health states (reproduction of Table 52, p. 155, MS, 1 November 2011) Health states Value Source 1 DVT £899.81 Derived from results of a survey 63 , NHS reference cost 51 , NICE CG92. 18 and BNF 48 2 PE £1,873.31 Derived from results of a survey 63 , NHS reference cost 51 , NICE CG92. 18 and BNF 48 3 Minor bleed £126.34 Derived from NHS reference cost 51 4 Extra-cranial bleed £942.05 Derived from NHS reference cost 51 5 Intra-cranial bleed £6,906.13 Derived from NHS reference cost 51 and expert opinion 6 Off-treatment £0 7 Off-treatment (post IC bleed) £1,206.50 Derived from NICE CG92 18 8 CTEPH (surgery and on-going)* £7,901 Derived from 57 , NICE CG92, 18 PSSRU 59 9 CTEPH (on-going)* £3,719 Derived from NICE CG92 18 PSSRU 59 12 PTS severe £96.01 Derived from Goodacre, 64 NICE CG92 18 NHS Reference Costs 2009-10 51 * ongoing costs o Management cost for recurrent DVTs and PEs. The manufacturer assumed that patients with a recurrent DVT or PE can be managed either in an inpatient or outpatient setting. The proportion of patients managed in the outpatient setting was taken from a survey 63 and showed that 69% of DVTs and 17% of PEs are managed in the outpatient setting. These proportions were varied in SA by the manufacturer. For patients managed in the outpatient setting, the manufacturer assumed that patients with DVTs would require one emergency admission, one Doppler ultrasound, and one D-dimer. Patients with PEs were assumed to require one emergency admission, one CT angiography, one chest x-ray, one electrocardiogram and one D-dimer. The management cost in the outpatient setting was calculated to be £194.84 for DVTs and £271.29 for PEs. Most of the unit costs for the resource use in the outpatient setting were taken from NHS reference costs, 51 with the exception of the cost of a chest x-ray and the cost of a D-Dimer. These costs were taken from a recent diagnostics technology report for NICE 65 and from NICE CG92 18 respectively. 107 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
For patients managed in the inpatient setting, the unit cost for the management of a recurrent DVT was taken from the NHS Reference Costs (Healthcare Research Group (HRG) code QZ20Z: Deep Vein Thrombosis –£814.39) 51 The unit cost for the management of PEs was also taken from the NHS Reference Costs but calculated as an average cost across three HRG codes relating to PEs, weighted by activity (DZ09A, DZ09B and DZ09C – £1,584.68). Based on the proportion of patients treated in the outpatient and inpatient setting, the weighted average cost for the management of a DVT and a PE was calculated to be £386.90 and £1,361.40 respectively. In addition to the management costs associated with a DVT and a PE, the manufacturer included the cost of 6 months treatment with dual therapy LMWH/VKA (£512) in order to account for the treatment of recurrent VTE assumed within the model. This equated to a cost of £899.81 and £1,873.31 for the DVT and PE health state. Clinical advisors to the ERG believe the assumptions made by the manufacturer to be reasonable. o Management costs associated with bleeding events The cost associated with the management of a major EC bleeding event was taken from the NHS reference costs and was assumed to be £942.05 as an average of the costs across 10 HRGs relating to gastrointestinal bleeds with intermediate or major complications (FZ16Z, FZ25A, FZ29Z, FZ30Z, FZ38D, FZ38E, FZ38F, FZ43A, FZ43B, FZ43C). 51 Similarly, the cost associated with the management of a minor EC bleeding event was taken from the NHS reference cost (HRG code: VB07Z: Accident and Emergency Services: Minor Injury Service: Not Leading to Admitted - £126.34). The cost associated with the management of an IC bleeding event was assumed to be £6,906.13 by the manufacturer and was taken from the NHS reference cost 51 supplemented by expert opinions. The cost was based on the HRG AA23Z (Haemorrhagic Cerebrovascular Disorders – £2.580.99) and the assumption that patients stay 14 days in rehabilitation (HRG VC04Z: Rehabilitation for stroke - £308.94 per day). 108 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
Page 67 and 68: Both of these factors are likely to
Page 69 and 70: It remains unclear why these patien
Page 71 and 72: leeding may be less suited to longe
Page 73 and 74: may account for the apparent differ
Page 75 and 76: Table 13: Criteria used to define a
Page 77 and 78: DVT and/or PE xxxxxxxxx xxxxxxxxxxx
Page 79 and 80: There is some doubt about the appro
Page 81 and 82: Subgroup analyses - EINSTEIN-Ext Su
Page 83 and 84: 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: The ERG acknowledges that the monit
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 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
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Superseded - See Erratum Table 50:
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Superseded - See Erratum Table 54:
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6.5. Exploratory analysis in cancer
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Figure 23: Exploratory analysis in
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Table 60: Deterministic base case a
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The ERG also examined the impact of
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days after stopping treatment.(Bull
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Both Phase II studies performed ana
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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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