Apixaban for the prevention of venous thromboembolism in people ...

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xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxxxxx xxxx. These results were the same for THR and TKR. The results of the indirect comparisons showed that apixaban: when compared to rivaroxaban showed no significant differences in terms of xxxxxxx xxxxx xxxxxxxxxxx any DVT, xxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxx. when compared to dabigatran was significantly superior in terms of xxxxxxx xxxxxxx xxxxxxxx xxxxxxx xxxxxxxxxxx any DVT; xxxxx xxxxxxx xxxxxx xxxxxxx xxxxxx xxxxxx xxxxxxxx xxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxxxx. These results were the same for THR and TKR. when compared to fondaparinux in THR showed no significant differences in terms of any DVT, xxxxxxxx xxxxxxxxx xxxxxxx. Other main outcomes (Total VTE and all-cause mortality, Major VTE, and Any bleeding) were not reported using indirect comparisons; although, for the total VTE and all-cause mortality the MTC showed no significant differences. For TKR an indirect comparison with enoxaparin, 40mg od was not possible. There are no differences of opinion between the manufacturer and the ERG that might influence the size of the ICER in a way that it would alter general conclusions. The full incremental analyses indicate that in THR the ICER of rivaroxaban versus apixaban amounts to £21,661/QALY. In TKR apixaban is dominated by rivaroxaban. These results are robust. The strengths of the submission are: - In general, the submission appeared to present a thorough and well performed analysis. - The submission includes an overview of all available evidence. - Errors identified in the economic model and report by the ERG were all relatively minor, and did not substantially impact the results and conclusions. Weaknesses are: - The submission was not concise and lacked transparency. Therefore, the ERG cannot guarantee that no errors are still undiscovered. - The effectiveness and safety of apixaban, and therefore its cost-effectiveness, are based on a single trial that included a population that is not entirely representative for the NHS. 8.1 Implications for research Further trials of apixaban compared to other LMWHs in both THR and TKR would serve to lessen the uncertainty surrounding the effectiveness and cost-effectiveness of these treatments. Head to head trials of apixaban versus rivaroxaban, dabigatran and fondaparinux would strengthen the evidence base for these comparisons. The key parameters that drive cost-effectiveness are the relative risks for ‘total VTE and all-cause death’ and ‘bleeding events’. These were derived from single trials. Additional trials that support these results could be valuable. 70 Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
References [1] White RH. The epidemiology of venous thromboembolism. Circulation 2003;107(23 Suppl 1):I4- 8. [2] House of Commons Health Committee. The prevention of venous thromboembolism in hospitalised patients. Second report of session 2004–05. London, 2005 [cited 27.7.11]. 112p. Available from: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/- 99.pdf [3] National Institute for Health and Clinical Excellence. Venous thromboembolism: reducing the risk. Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital [CG92] [Internet], 2010 [cited 31.8.11] Available from: http://www.nice.org.uk/nicemedia/live/12695/47195/47195.pdf [4] Autar R. A review of the evidence for the efficacy of anti-embolism stockings (AES) in venous thromboembolism (VTE) prevention J Orthop Nurs 2009;13(1):41-9 [5] National Institute for Health and Clinical Excellence. Venous thromboembolism: costing report: implementing NICE guidance [CG46] [Internet], 2007 [cited 31.8.11] Available from: http://www.nice.org.uk/nicemedia/live/12695/47234/47234.pdf [6] National Joint Registry for England and Wales. 7th annual report [Internet], 2010 [cited 27.7.11] Available from: http://www.njrcentre.org.uk/njrcentre/AbouttheNJR/Publicationsandreports/- Annualreports/tabid/86/Default.aspx [7] McGowan J, Sampson M, Lefebvre C. An evidence based checklist for the peer review of electronic search strategies (PRESS EBC). Evid Based Libr Inf Pract 2010;5(1):1-6. [8] National Institute for Health and Clinical Excellence. Single Technology Appraisal: specification for manufacturer/sponsor submission of evidence. London: NICE, October 2009, 2009. 76p. [9] National Institute for Health and Clinical Excellence. Single Technology Appraisal: apixaban for the prevention of venous thromboembolism in people undergoing elective knee and hip replacement surgery: final scope London: NICE, 2011 [10] Bristol-Myers Squibb Pharmaceuticals Ltd., Pfizer Ltd. Apixaban for prevention VTE after elective THR and TKR – Response to request for clarification from the ERG: Bristol-Myers Squibb Pharmaceuticals Ltd. and Pfizer Ltd., 2011. 79p. [11] Bristol-Myers Squibb Pharmaceuticals Ltd., Pfizer Ltd. Apixaban (Eliquis®) for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery: Submission to National Institute of Health and Clinical Excellence. Single technology appraisal (STA). Bristol-Myers Squibb Pharmaceuticals Ltd. and Pfizer Ltd., 2011: 217. 71 Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
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in collaboration with: Apixaban for
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Abbreviations AAOS American Academy
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1. SUMMARY ........................
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1. SUMMARY 1.1 Scope of the manufac
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The three identified trials, which
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Table 2.1. Summary of Annual TKR an
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The NICE clinical guideline on redu
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Indirect and mixed treatment compar
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4.1.2 State the inclusion/exclusion
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