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

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RCTs selected. However, there are some minor points to note where accuracy, transparency and reproducibility are lacking: 35 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
Figure 1 Flow diagram for identifying RCTs (reproduced from Figure 2 ‘Study flow diagram for the identification of references relating to RCTs’ in the MS, page 31) 1 MEDLINE n=116 EMBASE n=535 The MS stated that 687 records were identified from the conducted searches; of these, one record was obtained from ‘non-literature database sources’. It is unclear what this source was, as this does not appear to have been defined in the MS, and is also not reflected in the flow diagram. Potentially relevant records (titles/abstracts) screened n=687 Relevant RCTs identified n=4 Although, the MS explained that 687 of the records retrieved were excluded, the ERG assumed that this was minor typo error as the flow diagram indicated that the number of records excluded was 683. This was confirmed by the manufacturer. 17 The study selection process lacked transparency. Details on number of duplicates, number of studies excluded at title and abstract stage and number of full text papers screened for possible inclusion were missing. Though the manufacturer stated that, ‘Where studies were published as abstracts then subsequently as full papers, the abstracts were excluded’, it is unclear at what stage this decision was made. Lack of clarity in this case introduces the potential for bias in the review; linking the two publications and documenting that decision would have been a more acceptable approach. However, the ERG does not feel this is likely to have introduced bias to the review in this case. 36 CENTRAL n=36 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved. Records excluded n=683 Most were duplicates, review/editorials articles, non- English language publications related to included RCTs or concerning orthopaedic or non- VTE indications.
Page 1 and 2: Rivaroxaban for the treatment of de
Page 3 and 4: TABLE OF CONTENTS List of Abbreviat
Page 5 and 6: Table 12 Time to therapeutic INR (I
Page 7 and 8: identified in the model). Table 40
Page 9 and 10: Figures Figure 1 Flow diagram for i
Page 11 and 12: Figure 23 Exploratory analysis in c
Page 13 and 14: MS Manufacturer’s submission NE S
Page 15 and 16: The dose of LMWH used reflects Amer
Page 17 and 18: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Page 19 and 20: The exploratory analysis in cancer
Page 21 and 22: intended treatment duration of 12 m
Page 23 and 24: VTE therefore has a substantial bur
Page 25 and 26: indefinite treatment. VTE LMWH, low
Page 27 and 28: 3 Critique of manufacturer’s defi
Page 29 and 30: Subgroups to be considered Special
Page 31 and 32: contraindications for the drug (as
Page 33 and 34: 3.1.3 MTC populations The populatio
Page 35 and 36: 3.2.2 Length of treatment As discus
Page 37 and 38: “No preventative therapy” is th
Page 39 and 40: It could be argued that poor TTR ma
Page 41 and 42: 3.4.2 Outcomes recommended by EMA r
Page 43 and 44: 4 CLINICAL EFFECTIVENESS 4.1 Critiq
Page 45: competitor products were excluded f
Page 49 and 50: Table 7: Table showing list of rele
Page 51 and 52: The approach taken to quality asses
Page 53 and 54: o EINSTEIN-DVT dose-ranging study 3
Page 55 and 56: Trial name References, study type E
Page 57 and 58: 4.2.1 Critique of pivotal EINSTEIN-
Page 59 and 60: However, the study design did not i
Page 61 and 62: Table 10: Summary of outcomes for E
Page 63 and 64: Chi-square analyses were undertaken
Page 65 and 66: 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
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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
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Table 36: Summary of uncertainties
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Summary of uncertainties Has the im
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Page 153 and 154:
Page 155 and 156:
Superseded - See Erratum 6. ADDITIO
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Superseded - See Erratum Table 37 S
Page 159 and 160:
Superseded - See Erratum Table 38:
Page 161 and 162:
Page 163 and 164:
Superseded - See Erratum Figure 21:
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Page 167 and 168:
Superseded - See Erratum 6.3. Proba
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Page 171 and 172:
Page 173 and 174:
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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