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

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List of Abbreviations AAFP American Academy of Family Physicians ACCP American College of Chest Physicians ACP American College of Physicians ACS Acute Coronary Syndrome ACTS Anti Clot Treatment Scale AE Adverse Event AF Atrial fibrilation BCSH British Committee for Standards in Haematology BNF British National Forumlary CAMPH Cambridge PH Outcome Review OR CEAC Cost effectiveness acceptability curve CG Clinical Guideline CHMP Committee for Medicinal Products for Human Use CI Confidence Interval CPMP European Committee for Medical Products for Human Use CrI Credible Interval CRNM Clinically Relevant Non Major CSR Clinical Study Report CT Computed Tomography CTEPH Chronic ThromboEmbolic Pulmonary Hypertension CUS Compression Ultrasound DSU Decision Support Unit DVT Deep Vein Thrombosis EPAR European public assessment report. EC ExtraCranial EED Economic Evaluation Database EMA European Medicines Agency (formerly the European Agency for the Evaluation of Medicinal Products) EOSM End Of Study Medication ERG Evidence review group FDA US Food and Drug Administration GP General Practitioner HR Hazard Ratio HRG Healthcare Resource Group HRQoL Health Related Quality of Life HTA Health Technology Assessment IC IntraCranial ICER Incremental Cost Effectiveness Ratio INR International Normalised Range IQR InterQuartile Range ISTH International Society of Thrombosis and Haematosis ITT Intention To Treat LMWH Low Molecular Weight Heparin LYG Life Years Gained MTC Muliple/Mixed treatment analysis 1 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
MS Manufacturer’s submission NE SHA North East Strategic Health Authority NETAG North East Treatment Advisory Group NHS National Health Service NICE National Institute for health and Clinical Excellence NMB Net monetary benefit ODIXa- Oral Direct Factor Xa Inhibitor BAY-59-7939 in Patients with Acute DVT Symptomatic Deep-Vein Thrombosis (ODIXa-DVT) study OR Odds Ratio PCT Primary Care Trust PE Pulmonary Embolism PEA Pulmonary Endodardectomy PH Pulmonary hypertension PCO Primary care organistions PP Per Protocol PSA Probabilistic Sensitivity Analysis PSSRU Personal Social Services Research Unit PTS Post Thrombotic Syndrome QALY Quality Adjusted Life Years RCT Randomised Controlled Trial RR Risk ratio SA Sensitivity analyses SIGN Scottish Intercollegiate Guidelines Network SMC Scottish Medicines Consortium SmPC Summary of Product Characteristics TIA Transient Ischaemic Attack TSQM Treatment Satisfaction Questionnaire TTR Time in Target Range UH Unfractionated Heparin UK United Kingdom ULN Upper limit of normal USA Univariate Sensitivity Analysis VKA Vitamin K Antagonist VPLS Ventilation/Perfusion Lung Scan VTE Venous Thromboembolism WTP Willingness to pay 2 Copyright 2012 Queen's Printer and Controller of HMSO. All rights reserved.
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: Figure 23 Exploratory analysis in c
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 and 46: competitor products were excluded f
Page 47 and 48: Figure 1 Flow diagram for identifyi
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
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clarification on this matter, the m
Page 67 and 68:
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
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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
Page 117 and 118:
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:
Page 165 and 166:
Page 167 and 168:
Superseded - See Erratum 6.3. Proba
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
6.5. Exploratory analysis in cancer
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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
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days after stopping treatment.(Bull
Page 183 and 184:
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
Page 195 and 196:
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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