Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation: A NICE single technology appraisal

PharmacoEconomics

Volumn 31, Issue 7, 2013, Pages 551-562

  Faria, Rita ^a   Spackman, Eldon ^a   Burch, Jane ^a   Corbacho, Belen ^a   Todd, Derick ^b   Pepper, Chris ^c   Woolacott, Nerys ^a   Palmer, Stephen ^a  

^a UNIVERSITY OF YORK   (United Kingdom)

^b LIVERPOOL HEART AND CHEST HOSPITAL   (United Kingdom)

^c LEEDS GENERAL INFIRMARY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; DABIGATRAN; DABIGATRAN ETEXILATE; WARFARIN;

ANTICOAGULANT THERAPY; BLEEDING; CEREBROVASCULAR ACCIDENT; COST EFFECTIVENESS ANALYSIS; COST OF ILLNESS; DRUG COST; DRUG EFFICACY; DRUG INDICATION; DRUG MARKETING; DRUG MONITORING; DRUG SUBSTITUTION; DRUG WITHDRAWAL; EMBOLISM; EMBOLISM PREVENTION; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HUMAN; INTERNATIONAL NORMALIZED RATIO; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; THROMBOEMBOLISM;

ANTITHROMBINS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; BETA-ALANINE; COST-BENEFIT ANALYSIS; DRUG COSTS; EMBOLISM; HUMANS; QUALITY-ADJUSTED LIFE YEARS; STROKE; TECHNOLOGY ASSESSMENT, BIOMEDICAL;

EID: 84879983351     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.1007/s40273-013-0051-8     Document Type: Review

References (54)

1. National Institute for Health and Clinical Excellence. Developing NICE single technology appraisals. 2011. http://www.nice.org.uk/aboutnice/howwework/ devnicetech/developing-nice-single-technology-appraisals.jsp. Accessed 20 Nov 2011.
2. Sculpher M. Single technology appraisal at the UK National Institute for Health and Clinical Excellence: a source of evidence and analysis for decision making internationally. Pharmacoeconomics. 2010;28(5):347-9.
3. Rodgers M, Griffin S, Paulden M, et al. Alitretinoin for severe chronic hand eczema: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(5):351-62.
4. Bagust A, Greenhalgh J, Boland A, et al. Cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(6):439-48.
5. Stevenson M, Pandor A. Febuxostat for the management of hyperuricaemia in patients with gout: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(2):133-40.
6. Scotland G, Waugh N, Royle P, et al. Denosumab for the prevention of osteoporotic fractures in post-menopausal women: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(11):951-61.
7. Dickson R, Bagust A, Boland A, et al. Erlotinib monotherapy for the maintenance treatment of non-small cell lung cancer after previous platinum-containing chemotherapy: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(12):1051-62.
8. McKenna C, Maund E, Sarowar M, et al. Dronedarone for the treatment of atrial fibrillation: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(1):35-46.
9. Holmes M, Carroll C, Papaioannou D. Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(2):137-46.
10. Yang H, Craig D, Epstein D, et al. Golimumab for the treatment of psoriatic arthritis: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(4):257-70.
11. Boyers D, Jia X, Jenkinson D, et al. Eltrombopag for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(6):483-95.
12. Burch J, Griffin S, McKenna C, et al. Omalizumab for severe persistent asthma in children aged 6-11 years: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(11):991-1004.
13. Whyte S, Pandor A, Stevenson M. Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(12):1119-32.
14. Kilonzo M, Hislop J, Elders A, et al. Pazopanib for the first-line treatment of patients with advanced and/or metastatic renal cell carcinoma: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(1):15-24.
15. Craig D, Rice S, Paton F, et al. Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(2):101-10.
16. Spackman E, Rice S, Norman G, et al. Trastuzumab for the treatment of HER2 positive metastatic gastric cancer: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(3):185-94.
17. Rafia R, Simpson E, Stevenson M, et al. Trabectedin for the treatment of advanced metastatic soft tissue sarcoma: a NICE single technology appraisal. Pharmacoeconomics. In press.
18. Simpson EL, Fitzgerald P, Evans P, et al. Bivalirudin for the treatment of ST-segment elevation myocardial infarction: a NICE single technology appraisal. Pharmacoeconomics. 2013. doi: 10.1007/s40273-013-0036-7.
19. Greenhalgh J, Bagust A, Boland A, et al. Rituximab for the first-line maintenance treatment of follicular non-Hodgkin's lymphoma: a NICE single technology appraisal. Pharmacoeconomics. In press.
20. Armstrong N, Manuela J, van Asselt T, et al. Golimumab for the treatment of ankylosing spondylitis: a NICE single technology appraisal. Pharmacoeconomics. In press.
21. Tosh J, Archer R, Davis S, et al. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs: a NICE single technology appraisal. Pharmacoeconomics. In press.
22. Kearns B, Lloyd Jones M, Stevenson M, et al. Cabazitaxel for the second-line treatment of metastatic hormone refractory prostate cancer: a NICE single technology appraisal. Pharmacoeconomics. In press.
23. NHS. Stroke. 2010. http://www.nhs.uk/conditions/Stroke/Pages/ Introduction.aspx?WT.mc-id=110901. Accessed 20 Nov 2011.
24. Saka Ö, McGuire A, Wolfe C. Cost of stroke in the United Kingdom. Age Ageing. 2009;38(1):27-32.
25. Intercollegiate Stroke Working Party. National clinical guideline for stroke. London: Royal College of Physicians; 2008.
26. Atrial Fibrillation Association. Atrial fibrillation - the report, chap 1. What is AF? 2011. http://www.preventaf-strokecrisis.org/report/chapter1. Accessed 20 Nov 2011.
27. National Collaborating Centre for Chronic Conditions. Atrial fibrillation: the management of atrial fibrillation. London: National Institute for Health and Clinical Excellence; 2006.
28. Baxter K, editor. Stockley's drug interactions pocket companion. London: Pharmaceutical Press; 2011.
29. Joint Formulary Committee. British National Formulary 62. London: BNF; 2011.
30. Jones M, McEwan P, Morgan CL, Peters JR, Goodfellow J, Currie CJ. Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart. 2005;91:472-7.
31. Currie CJ, Jones M, Goodfellow J, McEwan P, Morgan CL, Emmas C, et al. Evaluation of survival and ischaemic and thromboembolic event rates in patients with non-valvar atrial fibrillation in the general population when treated and untreated with warfarin. Heart. 2006;92:196-200.
32. European Medicines Agency. Committee for Medicinal Products for Human Use assessment report - Pradaxa. London: European Medicines Agency; 2011.
33. Drugs@FDA - Drug details for Pradaxa. 2011 daily update. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction= Search.DrugDetails. Accessed 20 Nov 2011.
34. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. London: National Institute for Health and Clinical Excellence; 2008.
35. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
36. Boehringer Ingelheim Pharmaceuticals. Randomized evaluation of long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY Study). ClinicalTrials.gov Identifier: NCT00262600. http://clinicaltrials.gov/show/ NCT00262600. Accessed 2 Aug 2012.
37. Beasley N, Thompson A. Medical review(s) - application number 22-512. Pradaxa (dabigatran). Silver Spring: Centre for Drug Evaluation and Research; 2010.
38. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002;21:2917-30.
39. Sorensen SV, Dewilde S, Singer DE, Goldhaber SZ, Monz BU, Plumb JM. Cost-effectiveness of warfarin: trial versus "real-world" stroke prevention in atrial fibrillation. Am Heart J. 2009;157(6):1064-73.
40. Gallagher AM, Rietbrock S, Plumb J, van Staa TP. Initiation and persistence of warfarin or aspirin in patients with chronic atrial fibrillation in general practice: do the appropriate patients receive stroke prophylaxis? J Thromb Haemost. 2008;6(9):1500-6.
41. Connock M, Stevens C, Fry-Smith A, Jowett S, Fitzmaurice D, Moore D, et al. Clinical effectiveness and cost-effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling. Health Technol Assess. 2007;11(38):iii-iv, ix-66.
42. Spackman E, Burch J, Faria R, Corbacho B, Fox D, Woolacott N. Dabigatran-comments to the new information provided by manufacturer by the evidence review group. York: Centre for Reviews and Dissemination and Centre for Health Economics; 2011. http://www.nice.org.uk/nicemedia/live/12225/56917/ 56917.pdf.
43. NHS Salford. Letter of appeal to the Chair of the Appeal Committee of the National Institute for Health and Clinical Excellence; 2011.
44. National Institute for Health and Clinical Excellence. Appeal panel hearing for health technology appraisal; 2012.
45. Lenzini P, Wadelius M, Kimmel S, Anderson J, et al. Integration of genetic, clinical, and INR data to refine warfarin dosing. Nature. 2010;87(5):572-8.
46. Kangelaris KN, Bent S, Nussbaum RL, Garcia DA, Tice JA. Genetic testing before anticoagulation? A systematic review of pharmacogenetic dosing of warfarin. J Gen Intern Med. 2009;24(5):656-64.
47. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Brussels: European Union; 2004.
48. Pink J, Lane S, Primohamed M, Hughes DA. Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses. BMJ. 2011;343:d6333.
49. Boehringer Ingelheim. Single technology appraisal: specification for manufacturer/sponsor submission of evidence: dabigatran. Boehringer Ingelheim; 2009. http://www.nice.org.uk/nicemedia/live/12225/55922/55922.pdf. Accessed 22 March 2013.
50. Spackman E, Burch J, Faria R, Corbacho B, Fox D, Woolacott N. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: evidence review group report. York: Centre for Reviews and Dissemination and Centre for Health Economics; 2011.
51. Boehringer Ingelheim. Atrial fibrillation - dabigatran etexilate: manufacturer response to the NICE clarification letter. Boehringer Ingelheim; 2011. http://www.nice.org.uk/nicemedia/live/12225/55926/55926.pdf. Accessed 22 March 2013.
52. Boehringer Ingelheim. Response to new information requested by the committee. Boehringer Ingelheim; 2011. http://www.nice.org.uk/nicemedia/live/ 12225/56906/56906.pdf. Accessed 22 March 2013.
53. Curtis L. Unit costs of health and social care 2009. Canterbury: Personal Social Services Research Unit, University of Kent; 2009.
54. National Institute for Health and Clinical Excellence. Atrial fibrillation: the management of atrial fibrillation. Costing report: implementing NICE guidance in England. London: National Institute for Health and Clinical Excellence; 2006.